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Author: Grafiati

Published: 9 March 2023

Last updated: 10 March 2023

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1

Camelier, Aquiles A., Daniel Hugo Winter, José Roberto Jardim, Carlos Eduardo Galvão Barboza, Alberto Cukier, and Marc Miravitlles. "Deficiência de alfa-1 antitripsina: diagnóstico e tratamento." Jornal Brasileiro de Pneumologia 34, no. 7 (July 2008): 514–27. http://dx.doi.org/10.1590/s1806-37132008000700012.

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A deficiência de alfa-1 antitripsina é um distúrbio genético de descoberta recente e que ocorre com freqüência comparável à da fibrose cística. Resulta de diferentes mutações no gene SERPINA1 e tem diversas implicações clínicas. A alfa-1 antitripsina é produzida principalmente no fígado e atua como uma antiprotease. Tem como principal função inativar a elastase neutrofílica, impedindo a ocorrência de dano tecidual. A mutação mais freqüentemente relacionada à doença clínica é o alelo Z, que determina polimerização e acúmulo dentro dos hepatócitos. O acúmulo e a conseqüente redução dos níveis séricos de alfa-1 antitripsina determinam, respectivamente, doença hepática e pulmonar, sendo que esta se manifesta principalmente sob a forma de enfisema de aparecimento precoce, habitualmente com predomínio basal. O diagnóstico envolve a detecção de níveis séricos reduzidos de alfa-1 antitripsina e a confirmação fenotípica. Além do tratamento usual para doença pulmonar obstrutiva crônica, existe atualmente uma terapia específica com infusão de concentrados de alfa-1 antitripsina. Essa terapia de reposição, aparentemente segura, ainda não teve a eficácia clínica definitivamente comprovada, e o custo-efetividade também é um tema controverso e ainda pouco abordado. Apesar da sua importância, não existem dados epidemiológicos brasileiros a respeito da prevalência da doença ou da freqüência de ocorrência dos alelos deficientes. O subdiagnóstico também tem sido uma importante limitação tanto para o estudo da doença quanto para o tratamento adequado dos pacientes. Espera-se que a criação do Registro Internacional de Alfa-1 venha a resolver essas e outras importantes questões.

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Souza, Fabiano Inácio de, Arnaldo Valdir Zumiotti, and Ciro Ferreira da Silva. "Neuregulinas 1-alfa e 1-beta na regeneração de nervos periféricos." Acta Ortopédica Brasileira 18, no. 5 (2010): 250–54. http://dx.doi.org/10.1590/s1413-78522010000500003.

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OBJETIVO: Avaliar o efeito das neuregulinas 1-alfa e 1-beta na regeneração de nervos ciáticos de camundongos C57BL/6J, adultos, machos, através da técnica de tubulização. MÉTODOS: Utilizaram-se 18 animais, divididos em 3 grupos, implantando-se prótese de polietileno em falhas de 4,0 mm no nervo ciático esquerdo: grupo 1 contendo apenas colágeno purificado (Vitrogen®); grupo 2, colágeno associado a neuregulina 1-alfa; grupo 3 com colágeno e neuregulina 1-beta. O grupo controle foi formado por 6 segmentos de nervos ciáticos direitos. Após 4 semanas, os animais foram sacrificados; extraiu-se segmento do ponto médio do nervo regenerado no interior das próteses, padronizaram-se cortes histológicos e confecção das lâminas para análise histomorfométrica. Confrontaram-se os resultados estatisticamente. RESULTADOS: Os animais tratados com neuregulinas tiveram maior número de axônios mielinizados, com diferença estatisticamente significante quando comparados ao grupo colágeno. Não houve diferença estatística entre os grupos de neuregulinas 1-alfa e 1-beta. CONCLUSÃO: a adição de neuregulinas proporcionou aumento significativo do número de fibras mielinizadas.

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MINAFRA, I., A. MARIAFACCINI, and S. MINAFRA. "Alfa 1 chains of the onco-fetal trimer collagen are structurally distinct from alfa 1(I) chains." Cell Biology International Reports 14 (September 1990): 121. http://dx.doi.org/10.1016/0309-1651(90)90585-m.

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4

Lara, Beatriz. "EPOC y déficit de alfa-1-antitripsina." Archivos de Bronconeumología 46 (January 2010): 2–8. http://dx.doi.org/10.1016/s0300-2896(10)70026-0.

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5

Roig Figueroa, V., A. Herrero Pérez, and R. Castrodeza Sanz. "Bronquiectasias y déñcit de alfa-1-antitripsina." Archivos de Bronconeumología 31, no. 8 (October 1995): 429. http://dx.doi.org/10.1016/s0300-2896(15)30889-9.

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6

Lissitchkov, Toshko, Annemieke Willemze, Suresh Katragadda, Kara Rice, Stacey Poloskey, and Craig Benson. "Efanesoctocog alfa for hemophilia A: results from a phase 1 repeat-dose study." Blood Advances 6, no. 4 (February 11, 2022): 1089–94. http://dx.doi.org/10.1182/bloodadvances.2021006119.

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Abstract Efanesoctocog alfa (rFVIIIFc-VWF-XTEN; BIVV001) is a new class of factor VIII (FVIII) replacement that breaks the von Willebrand factor–imposed FVIII half-life ceiling. In a phase 1/2a study, single-dose efanesoctocog alfa was well tolerated, and no safety concerns were identified. We evaluated the safety, tolerability, and pharmacokinetics of repeat-dose efanesoctocog alfa in a phase 1 study in previously treated adults (≥150 exposure days) with severe hemophilia A. Participants received 4 once weekly doses of efanesoctocog alfa (cohort 1, 50 IU/kg; cohort 2, 65 IU/kg). All enrolled participants (cohort 1, n = 10; cohort 2, n = 14) completed the study. Inhibitor development to FVIII was not detected. After the last dose of efanesoctocog alfa, geometric mean (range) FVIII activity half-life, area under the activity-time curve, and steady-state maximum concentration for cohort 1 and cohort 2 were 41.3 (34.2-50.1) and 37.3 (28.9-43.8) hours, 8290 (5810-10 300) and 11 200 (7040-15 800) hours × IU/dL, and 131 (96-191) and 171 (118-211) IU/dL, respectively. There was minimal accumulation after 4 doses. Mean FVIII activity for cohort 1 and cohort 2, respectively, was 46% and 69% on day 3 postdose and 10% and 12% on day 7 postdose. Overall, 4 once-weekly doses of efanesoctocog alfa were well tolerated, no safety concerns were identified, and no bleeds were reported during the treatment period. Once-weekly efanesoctocog alfa provided high sustained FVIII activity within the normal to near-normal range for 3 to 4 days postdose and may improve protection against bleeds in patients with hemophilia A. The trial is study 2018-001535-51 in the EU Clinical Trials Register.

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Zimran, Ari, Gheona Altarescu, Mici Philips, Drorit Attias, Marina Jmoudiak, Maher Deeb, Nan Wang, Kiran Bhirangi, Gabriel M. Cohn, and Deborah Elstein. "Phase 1/2 and extension study of velaglucerase alfa replacement therapy in adults with type 1 Gaucher disease: 48-month experience." Blood 115, no. 23 (June 10, 2010): 4651–56. http://dx.doi.org/10.1182/blood-2010-02-268649.

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Abstract Enzyme replacement therapy is the standard of care for symptomatic Gaucher disease. Velaglucerase alfa is a human β-glucocerebrosidase produced in a well-characterized human cell line. A 9-month phase 1/2 open-label, single-center trial and ongoing extension study were conducted to evaluate safety and efficacy of velaglucerase alfa. Twelve symptomatic adult type 1 Gaucher patients (intact spleens) received velaglucerase alfa (60 U/kg per infusion) during phase 1/2. An extension study was offered to patients completing the trial; step-wise dose reduction (to 30 U/kg per infusion) was instituted. Eleven patients completed phase 1/2; 10 entered the extension; 9 patients reached 39 months of extension. No drug-related serious adverse events or withdrawals, and no antibodies were observed. Home therapy was successfully implemented during the extension. Statistically significant improvements (P < .004) were noted in mean percentage change from baseline to 9 months and baseline to 48 months for hemoglobin (+19.2%, +21.7%, respectively), platelet counts (+67.6%, +157.8%, respectively), normalized liver volume (−18.2%, −42.8%, respectively), and normalized spleen volume (−49.5%, −79.3%, respectively). These significant clinical changes and safety profile led to phase 3 trials and highlight the potential of velaglucerase alfa as alternative therapy for type 1 Gaucher disease. The extension trial is registered at http://www.clinicaltrials.gov as NCT00391625.

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Souza, Luciane Cristina Del Ben de. "Projeto Alfa Tuning América Latina." Educação e Ensino Superior Online 1, no. 2 (July 27, 2021): 1–11. http://dx.doi.org/10.24115/2763-762x20211242p.1-11.

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Este artigo analisa o reflexo do Projeto Alfa Tuning América Latina (PATAL) no Projeto Pedagógico de Curso de Pedagogia da Universidade Federal do Ceará (UFC), considerando o sistema de créditos, com a finalidade de verificar se, e, em que medida, a metodologia do PATAL está em sintonia com as propostas apresentadas no documento institucional. Para tanto, busca-se como orientação metodológica a pesquisa qualitativa conduzida por uma análise bibliográfica e documental. A investigação revelou que embora o Projeto Tuning América Latina não seja mencionado explicitamente no projeto pedagógico supracitado, sua influência pode ser observada por meio de algumas mudanças e adequações realizadas nos últimos anos pela UFC com vistas a construir e implementar as medidas do tempo de trabalho/estudo do aluno, o que pode contribuir sobremaneira na promoção da mobilidade acadêmica.

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9

Fishbane, Steven, Bhupinder Singh, Seema Kumbhat, Wayne A. Wisemandle, and Nancy E. Martin. "Intravenous Epoetin Alfa-epbx versus Epoetin Alfa for Treatment of Anemia in End-Stage Kidney Disease." Clinical Journal of the American Society of Nephrology 13, no. 8 (June 19, 2018): 1204–14. http://dx.doi.org/10.2215/cjn.11631017.

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Background and objectivesThis study was conducted to compare the safety and efficacy of intravenous epoetin alfa-epbx, an epoetin alfa biosimilar, to epoetin alfa in patients on hemodialysis with ESKD and anemia.Design, setting, participants, & measurementsIn this 24-week, multicenter, double-blind comparative efficacy and safety study, 612 patients on hemodialysis with ESKD and anemia who had stable hemoglobin and were receiving stable doses of intravenous epoetin alfa were randomized (1:1) to intravenous epoetin alfa or epoetin alfa-epbx. Dosing was adjusted according to the epoetin alfa prescribing information. The coprimary efficacy end points were the least squares mean difference between the two treatments in mean weekly hemoglobin level and mean weekly epoetin dose per kilogram of body weight during the last 4 weeks of treatment.ResultsThe least squares mean difference between epoetin alfa-epbx and epoetin alfa in weekly hemoglobin was −0.12 g/dl and the 95% confidence interval (−0.25 to 0.01) was contained within the prespecified equivalence margin (−0.5 to 0.5 g/dl). The least squares mean difference between epoetin alfa-epbx and epoetin alfa in weekly epoetin dose per kilogram of body weight was 0.37 U/kg per week, and the 95% confidence interval (−10.40 to 11.13) was contained within the prespecified equivalence margin (−45 to 45 U/kg per week). Incidences of adverse events (77.1% versus 75.3%), serious adverse events (24.9% versus 27.0%), and deaths (n=5 versus 6) were similar between the epoetin alfa-epbx and epoetin alfa groups, respectively. Five patients tested positive for anti-recombinant human erythropoietin antibodies at baseline, and two additional patients (n=1 per group) developed anti-recombinant human erythropoietin antibodies while on study treatment. All patients tested negative for neutralizing antibodies, and no patient in either group experienced an event of pure red cell aplasia.ConclusionsThis 24-week, comparative, clinical trial in patients on hemodialysis with ESKD and anemia demonstrated there is no clinically meaningful difference in efficacy or safety between epoetin alfa-epbx and epoetin alfa.

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10

Tolcher, Anthony W., Michael Gordon, Kathleen M. Mahoney, Anna Seto, Marianna Zavodovskaya, Chia-Hsiang Hsueh, Shuyan Zhai, et al. "Phase 1 first-in-human study of dalutrafusp alfa, an anti–CD73-TGF-β-trap bifunctional antibody, in patients with advanced solid tumors." Journal for ImmunoTherapy of Cancer 11, no. 2 (February 2023): e005267. http://dx.doi.org/10.1136/jitc-2022-005267.

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BackgroundCluster of differentiation (CD)73-adenosine and transforming growth factor (TGF)-β pathways are involved in abrogated antitumor immune responses and can lead to protumor conditions. This Phase 1 study (NCT03954704) evaluated the safety, pharmacokinetics, pharmacodynamics, and efficacy of dalutrafusp alfa (also known as GS-1423 and AGEN1423), a bifunctional, humanized, aglycosylated immunoglobulin G1 kappa antibody that selectively inhibits CD73-adenosine production and neutralizes active TGF-β signaling in patients with advanced solid tumors.MethodsDose escalation started with an accelerated titration followed by a 3+3 design. Patients received dalutrafusp alfa (0.3, 1, 3, 10, 20, 30, or 45 mg/kg) intravenously every 2 weeks (Q2W) up to 1 year or until progressive disease (PD) or unacceptable toxicity.ResultsIn total, 21/22 patients received at least one dose of dalutrafusp alfa. The median number of dalutrafusp alfa doses administered was 3 (range 1–14). All patients had at least one adverse event (AE), most commonly fatigue (47.6%), nausea (33.3%), diarrhea (28.6%), and vomiting (28.6%). Nine (42.9%) patients had a Grade 3 or 4 AE; two had Grade 5 AEs of pulmonary embolism and PD, both unrelated to dalutrafusp alfa. Target-mediated drug disposition appears to be saturated at dalutrafusp alfa doses above 20 mg/kg. Complete CD73 target occupancy on B cells and CD8+ T cells was observed, and TGF-β 1/2/3 levels were undetectable at dalutrafusp alfa doses of 20 mg/kg and higher. Free soluble (s)CD73 levels and sCD73 activity increased with dalutrafusp alfa treatment. Seventeen patients reached the first response assessment, with complete response, partial response, stable disease, and PD in 0, 1 (4.8%), 7 (33.3%), and 9 (42.9%) patients, respectively.ConclusionsDalutrafusp alfa doses up to 45 mg/kg Q2W were well tolerated in patients with advanced solid tumors. Additional evaluation of dalutrafusp alfa could further elucidate the clinical utility of targeting CD73-adenosine and TGF-β pathways in oncology.

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Neto, Luiza Érika Schmid Melo, Cyro Teixeira da Silva, Gilberto Perez Cardoso, Ângela Santos Ferreira, Guilherme da Costa Marino, and Nicolau Pedro Monteiro. "Aspectos pulmonares na deficiência de alfa-1-antitripsina." Revista Portuguesa de Pneumologia 10, no. 2 (March 2004): 145–54. http://dx.doi.org/10.1016/s0873-2159(15)30566-3.

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12

Paradela, Sabela, and Eduardo Fonseca. "Manifestaciones cutáneas del déficit de alfa-1-antitripsina." Piel 23, no. 7 (August 2008): 331–32. http://dx.doi.org/10.1016/s0213-9251(08)72298-6.

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13

Yasuda, Satoshi, Masafumi Yamada, Shinsaku Maruta, and Toshiaki Arata. "Conformational Change of alfa-1 helix of Kinesin." Biophysical Journal 100, no. 3 (February 2011): 146a. http://dx.doi.org/10.1016/j.bpj.2010.12.1004.

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14

Duijvestijn, Y. C. M., W. M. C. van Aalderen, and H. S. A. Heymans. "Alfa-1-antitrypsinedeficiëntie: klinische implicatie van een vouwdefect." Tijdschrift voor kindergeneeskunde 72, no. 5 (October 2004): 198–202. http://dx.doi.org/10.1007/bf03061518.

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15

Tamayo, Mauricio Robayo, and Bartholomeu Tôrres Tróccoli. "Construção e validação fatorial da Escala de Caracterização do Burnout (ECB)." Estudos de Psicologia (Natal) 14, no. 3 (December 2009): 213–21. http://dx.doi.org/10.1590/s1413-294x2009000300005.

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Este artigo descreve o desenvolvimento da Escala de Caracterização do Burnout (ECB). No primeiro estudo, 375 trabalhadores de enfermagem e do ensino responderam a primeira versão da ECB com 77 itens. Análises fatoriais revelaram os fatores Exaustão Emocional (Alfa = 0,94); Desumanização (Alfa = 0,88), Realização Pessoal (Alfa = 0,76) e Decepção no Trabalho (Alfa = 0,80). No segundo estudo, 787 membros da Policia Civil responderam a segunda versão da ECB com 46 itens. Os resultados de novas análises fatoriais evidenciaram os mesmos três fatores do estudo 1: Exaustão Emocional (Alfa = 0,93); Desumanização (Alfa = 0,84) e Decepção no Trabalho (Alfa = 0,90). Os itens do fator Realização Pessoal, observado no estudo 1, foram incorporados ao fator Decepção no Trabalho. A versão final da ECB apresentou 35 itens. O fator Exaustão Emocional evidenciou a maior consistência interna. Os níveis de consistência interna dos outros dois fatores superaram índices apresentados por outras medidas de burnout.

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Kis, János Tibor, Bernadett Balogh, Zsófia Kiss, and László Schandl. "Az inzulin: alfa és ómega." Lege Artis Medicinae 31, no. 12 (2021): 581–85. http://dx.doi.org/10.33616/lam.31.044.

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Az 1-es típusú cukorbetegséget az inzulint termelő β-sejtek autoimmun pusztulása okozza. A folyamat hátterében az elsődleges antigén (ha az elsődleges antigén teóriája helytálló) nagy valószínűséggel maga az inzulin vagy a proinzulin. Ugyanakkor az 1-es típusú cukorbetegség kezelése gyakorlatilag egyet jelent az inzulinkezeléssel. Minél korábban ismerjük fel és kezdjük kezelni az 1-es típusú cukorbetegséget, és minél jobb glykaemiás eredményeket érünk el, annál nagyobb a valószínűsége annak, hogy a β-sejt-állomány tovább marad működőképes. Az inzulin az 1-es típusú cukorbetegség kialakulásának immunpatogenezisében és kezelésében is alapvető szerepet játszik, tehát az alfa és ómega ebben a betegségben.

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Gabriel, Sthefano Atique, Leila Antonangelo, Vera Luiza Capelozzi, Camila Baumann Beteli, Otacílio de Camargo Júnior, José Luis Braga de Aquino, and Roberto Augusto Caffaro. "Hidrocortisona reduz as concentrações séricas dos biomarcadores inflamatórios séricos em pacientes submetidos a endarterectomia de carótida." Jornal Vascular Brasileiro 14, no. 3 (September 2015): 231–40. http://dx.doi.org/10.1590/1677-5449.0022.

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ResumoContextoA hidrocortisona pode reduzir a concentração dos biomarcadores inflamatórios séricos e teciduais.ObjetivoAnalisar a atividade inflamatória da proteína C-reativa ultrassensível (PCR-US), do fator de necrose tumoral (FNT)-alfa e do fator de crescimento do endotélio vascular (FCEV) séricos e teciduais, mediante administração intraoperatória de hidrocortisona, após endarterectomia de artéria carótida (EAC).MétodoVinte e dois pacientes foram divididos em Grupo Controle (5 assintomáticos e 6 sintomáticos) – não foi administrada hidrocortisona – e Grupo 1 (4 assintomáticos e 7 sintomáticos) – foram administrados 500 mg intravenoso de hidrocortisona. O PCR-US, o FNT-alfa e o FCEV séricos foram dosados no pré-operatório e em 1 hora, 6 horas e 24 horas após a EAC. Na placa carotídea, mensuramos os níveis de FNT-alfa e FCEV.ResultadosO grupo 1 exibiu menor concentração sérica de FNT-alfa em 1 hora (p=0,031), 6 horas (p=0,015) e 24 horas (p=0,017) após a EAC, e menor concentração de FCEV em 1 hora (p=0,006) e 6 horas (p=0,005) após a EAC, em relação ao grupo controle. Os pacientes sintomáticos do grupo 1 exibiram menor concentração de FNT-alfa em 1 hora e 6 horas após a EAC, e menor concentração de FCEV em 1 hora após a EAC, em relação ao grupo controle. Não houve diferença estatística entre as concentrações teciduais de FNT-alfa e FCEV entre o grupo controle e o grupo 1.ConclusãoA hidrocortisona reduz as concentrações séricas pós-operatórias de FNT-alfa e FCEV, em especial nos sintomáticos; porém, não reduz os níveis teciduais destes biomarcadores.

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Kuca, Paweł. "Rozedma jako płucna manifestacja wrodzonego niedoboru alfa-1 antytrypsyny (?-1 AT)." Pneumonologia i Alergologia Polska 72, no. 9-10 (February 18, 2008): 342–48. http://dx.doi.org/10.5603/arm.28217.

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19

Jones, D. L., R. J. Allen, J. P. Basart, T. Bastian, W. H. Blume, J. L. Bougeret, B. K. Dennison, et al. "The ALFA medium explorer mission." Advances in Space Research 26, no. 4 (January 2000): 743–46. http://dx.doi.org/10.1016/s0273-1177(99)01204-1.

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20

Lindsey, Heather. "Darbepoetin alfa offers dose flexibility." Lancet Oncology 6, no. 7 (July 2005): 449. http://dx.doi.org/10.1016/s1470-2045(05)70232-1.

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Walker, R., and BA Pussell. "PUK4 HAEMOGLOBIN FLUCTUATIONS IN HAEMODIALYSIS PATIENTS RECEIVING INTRAVENOUS EPOETIN ALFA OR INTRAVENOUS DARBEPOETIN ALFA." Value in Health 10, no. 3 (May 2007): A103. http://dx.doi.org/10.1016/s1098-3015(10)68851-1.

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22

Lewis, Grace, Amanda M. Morrill, Stephanie L. Conway-Allen, and Bernard Kim. "Review of Cerliponase Alfa: Recombinant Human Enzyme Replacement Therapy for Late-Infantile Neuronal Ceroid Lipofuscinosis Type 2." Journal of Child Neurology 35, no. 5 (December 29, 2019): 348–53. http://dx.doi.org/10.1177/0883073819895694.

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The objective of this review is to summarize the pharmacology, efficacy, and safety of cerliponase alfa for the treatment of late infantile neuronal ceroid lipofuscinosis type 2 (CLN2). Cerliponase alfa is recombinant human tripeptidyl peptidase 1 enzyme replacement therapy. A phase 1/2 trial established the efficacy and safety of cerliponase alfa for treatment of neuronal ceroid lipofuscinosis type 2. Treatment with intracerebroventricular cerliponase alfa resulted in slower decline of motor and language functions compared with natural history controls. Common adverse events include convulsions, electrocardiography abnormalities, pyrexia, vomiting, and upper respiratory tract infections. Intracerebroventricular device–related adverse events also occur. Cerliponase alfa is the first therapy for neuronal ceroid lipofuscinosis type 2 that targets the disease etiology. Cerliponase alfa is effective in delaying the progression of motor language decline for patients with neuronal ceroid lipofuscinosis type 2.

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Zorenko, Vladimir Yu, Georgy Mishin, Tatiana Severova, Alexandr Shuster, Dmitry Kudlay, Sergey Lukyanov, Anton Borozinets, Eugene Nikitin, and Ekaterina Klykova. "The Pharmacokinetic Properties, Safety and Tolerability of a New Nonacog Alfa (Innonafactor) in Patients with Hemophilia B." Blood 126, no. 23 (December 3, 2015): 4691. http://dx.doi.org/10.1182/blood.v126.23.4691.4691.

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Abstract Nonacog alfa is a recombinant factor IX (rFIX) product for hemophilia B, developed by CJSC «GENERIUM» (Russia). Nonacog alfa is safe with regard to transmitted infections because proteins of animal and human origin (including albumin) are not used in the process of rFIX production. Ðharmacokinetic parameters, safety and efficacy of Innonafactor has been studied in the phase I study in patients with severe and moderate hemophilia B. The primary aims of the study were to: 1. Determine the pharmacokinetic parameters of nonacog alfa in patients with severe and moderate hemophilia B. 2. Assess the safety and tolerability of different doses of nonacog alfa in patients with severe and moderate hemophilia B. The secondary aims of this study were to: 1. Set the maximum tolerated dose of nonacog alfa in practically possible range of doses. 2. Evaluate rFIX activity and the activated partial thromboplastin time (APTT) after nonacog alfa infusions in doses 50 IU kg-1 and 75 IU kg-1. During phase I clinical study the pharmacokinetic properties, safety and tolerability of the new nonacog alpha were evaluated. After screening and washout period lasting at least 4 days 12 men, aged from 23 to 50 years old with severe (n = 6) and moderate (n = 6) hemophilia B were included in the study. Patients consecutively were enrolled in 3 groups: in the 1st group (n = 3) nonacog alfa was injected slowly intravenously in a single dose of 25 IU kg-1, in the 2nd group (n = 6) - a single dose of 50 IU kg-1, then after 4 days of observation and laboratory monitoring - a second single dose of 75 IU kg-1 was administered, in the 3rd group (n = 3) - a single dose of 100 IU kg-1 (fig.1). The introduction of the nonacog alfa in doses of 50 and 75 IU kg-1 resulted in the normalization of FIX activity and activated partial thromboplastin time (APTT) within 15 min after injection. Normal FIX activity was maintained for at least 1 h after injection of the nonacog alfa at dose of 50 IU kg-1 and for 6 h after drug administration at a dose of 75 IU kg-1. Reduction of the FIX activity less than 5% was observed not earlier than 72 h after injection of the both drug doses. Significant increase of the APTT was observed only after 12 h after injection of the nonacog alfa at a dose of 50 IU kg-1 and after 24 h after administration of the nonacog alfa at a dose of 75 IU kg-1. The pharmacokinetics of nonacog alfa was studied at doses of 50 and 75 IU kg-1 (fig.1). A single dose injection of nonacog alfa led to a rapid accumulation of drug in the blood [median value of time to reach the maximum concentration (Cmax) - Tmax amounted to 0.33 ± 0,13 h] with the achievement of the average Cmax depending on the input dose (53,18 ± 9,79 IU DL-1 for doses of 50 IU kg-1 and 94,35 ± 18,47 IU DL-1 for doses of 75 IU kg-1) and the gradual elimination of the drug from the body [median value of area under the curve based on the concentration of FIX in plasma from the time of the study (AUC0-96 h) - 1069,9 ± 321,1 IU DL-1 × h for doses of 50 IU kg-1 and 1604,2 ± 389,41 IU DL-1 × h for the dose of 75 IU kg-1, the AUC0-∞ - 1125,49 ± to 300.36 and 1700,82 ± 369,95 IU DL-1 × h, the elimination half-life (T1/2) - is 24.05 ± 7,67 and 25,18 ± 6,16 h, respectively]. Nonacog alfa was well tolerated regardless of the administered dose. The maximum tolerated dose was not established because it exceeds the studied doses of the drug. A single application of the nonacog alfa in doses from 25 to 100 IU kg-1 was not accompanied by toxic, thrombogenic, immunogenic and allergic reactions. Figure 2. Average pharmacokinetic curve of the coagulation factor IX activity in the blood plasma during administration of two doses of the drug Figure 2. Average pharmacokinetic curve of the coagulation factor IX activity in the blood plasma during administration of two doses of the drug Disclosures No relevant conflicts of interest to declare.

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Suckristiana, Elvi Setianingsih, Ni Luh Dewi Aryani, and Ririn Sumiyani. "Pengaruh Komposisi Molar terhadap Karakteristik dan Stabilitas Fisikokimia Komplek Inklusi Alfa Arbutin dengan Hidroksipropil Beta Siklodekstrin Menggunakan Metode Kneading." MPI (Media Pharmaceutica Indonesiana) 2, no. 3 (June 28, 2019): 153–64. http://dx.doi.org/10.24123/mpi.v2i3.1700.

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Penelitian ini bertujuan untuk mengetahui pengaruh variasi komposisi alfa arbutin dengan hidroksipropilbeta siklodekstrin (HPBCD) yang dibentuk kompleks inklusi dengan menggunakan metode kneading,dibandingkan campuran fisiknya terhadap karakteristik dan stabilitasnya, yang disimpan pada suhu40o±2oC dan kelembaban 75%±5% selama 30 hari. Variasi komposisi molar alfa arbutin : HPBCD pada campuran fisik yaitu 1:1 (F1), 2:1 (F2), dan 1:2 (F3), sedangkan pada komplek inklusinya adalah 1:1 (F4), 2:1 (F5),dan 1:2 (F6). Interaksi padatan yang terbentuk pada komplek inklusi dan campuran fisik dikarakterisasi denganmorfologi, gugus fungsi, titik lebur, kadar alfa arbutin dan hidrokinon sebagai hasil urainya, serta uji disolusi.Berdasarkan hasil penelitian dapat disimpulkan bahwa telah terjadi pembentukan komplek inklusi antara alfaarbutin dengan HPBCD yang dibuat dengan metode kneading. Hasil pembentukan komplek inklusi yang palingbaik secara berurutan adalah pada F6, F4, dan F5, karena memberikan perbedaan karakteristik fisikokimiasecara bermakna. Komplek inklusi menunjukkan kristal amorf yang lebih homogen, kadar alfa arbutin yanglebih tinggi dan stabil (48,32 ± 0,10%), serta laju disolusi yang lebih cepat dengan persen terdisolusi palingtinggi dibanding formula lainnya. Tidak terjadi perubahan fisikokimia baik pada campuran fisik maupun komplek inklusinya, dan hidrokinon yang merupakan hasil urai alfa arbutin tidak terbentuk selama dilakukan ujistabilitas dipercepat.

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Miravitlles, M., M. Torrella, R. Vidal, R. Jardí, F. Rodríguez-Frías, and D. Pelegrí. "Utilidad de la cuantífícación de la banda alfa-1 del proteinograma sérico en el cribado del déficit de alfa-1-antitripsina." Archivos de Bronconeumología 34, no. 11 (December 1998): 536–40. http://dx.doi.org/10.1016/s0300-2896(15)30335-5.

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Mehta, A., H. Ben Turkia, DE Gonzalez, M. Kabra, EA Lukina, P. Giraldo, I. Kisinovsky, et al. "Two-Year Safety and Tolerability of Velaglucerase Alfa in Patients with Type 1 Gaucher Disease, Including Patients Switched From Imiglucerase: Phase III Trial HGT-GCB-039 and Extension,." Blood 118, no. 21 (November 18, 2011): 3214. http://dx.doi.org/10.1182/blood.v118.21.3214.3214.

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Abstract Abstract 3214 BACKGROUND Type 1 Gaucher disease (GD1) is a chronic, multisystem disease that varies considerably among individuals with regard to organ involvement, presentation, severity, and progression rate. Because hematologic signs and symptoms are common (e.g., anemia, thrombocytopenia, splenomegaly, and hepatomegaly), treatment is often guided by a hematologist. OBJECTIVE To describe the safety and tolerability of velaglucerase alfa after 15 months of treatment in an ongoing, open-label extension study (HGT-GCB-044 [ClinicalTrials.gov identifier, NCT00635427]) in GD1 patients who received either velaglucerase alfa or imiglucerase in a preceding 9-month, double-blind, randomized, Phase III trial (HGT-GCB-039 [NCT00553631]). METHODS In HGT-GCB-039, treatment-naïve GD1 patients aged ≥2 years were randomized to velaglucerase alfa or imiglucerase as a continuous 60-minute intravenous infusion (60 U/kg body weight every other week [EOW]; 9 months). HGT-GCB-039 completers could enroll in extension study HGT-GCB-044, receiving velaglucerase alfa (60 U/kg EOW; ongoing). Safety and tolerability were assessed after 15 months of participation in HGT-GCB-044 (i.e., after a total of 2 years of enzyme replacement therapy). RESULTS Of 35 patients enrolled in HGT-GCB-039, 34 received study drug and 32 completed the trial (1 velaglucerase alfa patient was lost to follow-up after a serious adverse event [AE] of life-threatening convulsion, which was considered unrelated to treatment; 1 imiglucerase patient withdrew consent because of AEs). This analysis included only the 32 patients completing HGT-GCB-039 who enrolled in the HGT-GCB-044 extension phase: 16 had received velaglucerase alfa (median age, 38 years [range, 8–60 years]; 50% [n=8] male; 56% [n=9] splenectomized) and 16 had received imiglucerase (median age, 27 years [range, 4–59 years]; 44% [n=7] male; 63% [n=10] splenectomized). These patients had received velaglucerase alfa for 24 months (continuous velaglucerase alfa group) or imiglucerase for 9 months + velaglucerase alfa for 15 months (imiglucerase-switch group) at the time of the current analysis. No differences were observed between the safety profiles of the continuous velaglucerase alfa and imiglucerase-switch treatment arms (Table). AEs most commonly reported (≥20% of patients) during the extension phase were nasopharyngitis and arthralgia in the continuous velaglucerase alfa group and headache and upper respiratory tract infection in the imiglucerase-switch group. Most AEs were mild or moderate in severity and, apart from the patient who was lost to follow-up in HGT-GCB-039 after a convulsion, there were no other life-threatening AEs. None of the serious AEs were considered drug related. The proportion of patients with infusion-related AEs remained low in HGT-GCB-044. Anti-imiglucerase antibodies developed in 4 patients receiving imiglucerase in trial HGT-GCB-039, 1 of whom discontinued following multiple infusion-related AEs and did not enter HGT-GCB-044. This patient also had anti-velaglucerase alfa antibodies, which was attributed to assay cross-reactivity, as he had never been exposed to velaglucerase alfa. No patients developed anti-velaglucerase alfa antibodies during the first 9 or subsequent 15 months of drug exposure. CONCLUSIONS Velaglucerase alfa was generally well tolerated in both the continuous velaglucerase alfa and imiglucerase-switch arms of these controlled clinical trials. Although 4 patients had anti-imiglucerase antibodies in trial HGT-GCB-039, no patient has developed anti-velaglucerase alfa antibodies over the course of the trials to date. Disclosures: Mehta: Shire HGT: Consultancy. Giraldo:Shire HGT: Consultancy. Kisinovsky:Shire Argentina: Consultancy. Kishnani:Shire HGT: Honoraria; Genzyme: Honoraria; Pfizer: Honoraria. Barton:Shire HGT: Employment. Wang:Shire HGT: Employment. Crombez:Shire HGT: Employment. Bhirangi:Shire HGT: Employment. Zimran:Shire HGT: Consultancy; Protalix: Consultancy, Equity Ownership, Membership on an entity's Board of Directors or advisory committees; Genzyme: Research Funding; Actelion: Honoraria; Pfizer: Honoraria.

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Solms, Alexander, Anita Shah, Erik Berntorp, Andreas Tiede, Alfonso Iorio, Camila Linardi, Maurice Ahsman, Maria Elisa Mancuso, Tihomir Zhivkov, and Toshko Lissitchkov. "Direct comparison of two extended half-life PEGylated recombinant FVIII products: a randomized, crossover pharmacokinetic study in patients with severe hemophilia A." Annals of Hematology 99, no. 11 (September 24, 2020): 2689–98. http://dx.doi.org/10.1007/s00277-020-04280-3.

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Abstract An open-label, crossover randomized study was performed to compare the pharmacokinetics (PK) of damoctocog alfa pegol and rurioctocog alfa pegol, two recombinant factor VIII (FVIII) products indicated in patients with hemophilia A, both conjugated to polyethylene glycol to reduce clearance and extend time in circulation. Adult patients (N = 18) with severe hemophilia A (FVIII < 1 IU/dL), previously treated with any FVIII product for ≥ 150 exposure days, were randomized to receive a single 50 IU/kg infusion of damoctocog alfa pegol followed by rurioctocog alfa pegol, or vice versa, with ≥ 7-day washout between doses. FVIII activity was measured using the one-stage clotting assay. PK parameters, including area under the curve from time 0 to the last data point (AUC0–tlast, primary parameter), dose-normalized AUC (AUCnorm), and time to threshold, were calculated based on 11 time points between 0.25 and 120 h post-dose and evaluated using a noncompartmental model. Due to differences in batch-specific vial content used for the study, actual administered median doses were 54.3 IU/kg for damoctocog alfa pegol and 61.4 IU/kg for rurioctocog alfa pegol. Based on actual dosing, a significantly higher geometric mean (coefficient of variation [%CV]) AUCnorm was observed for damoctocog alfa pegol (43.8 h kg/dL [44.0]) versus rurioctocog alfa pegol (36.0 h kg/dL [40.1, P < 0.001]). Based on population PK modeling, median time to reach 1 IU/dL was 16 h longer for damoctocog alfa pegol compared with rurioctocog alfa pegol. No adverse events or any immunogenicity signals were observed. Overall, damoctocog alfa pegol had a superior PK profile versus rurioctocog alfa pegol. Trial registration number: NCT04015492 (ClinicalTrials.gov identifier). Date of registration: July 9, 2019

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Mody, S., V. Padmanabhan, S. McKenzie, and CT Piech. "PUK10 EPOETIN ALFA AND DARBEPOETIN ALFA DOSING TRENDS IN PRE-DIALYSIS CHRONIC KIDNEY DISEASE PATIENTS." Value in Health 8, no. 3 (May 2005): 416. http://dx.doi.org/10.1016/s1098-3015(10)63136-1.

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Chang, Jose, Felix Couture, Scott Young, Kara-Lee McWatters, and Catherine Y. Lau. "Weekly Epoetin Alfa Maintains Hemoglobin, Improves Quality of Life, and Reduces Transfusion in Breast Cancer Patients Receiving Chemotherapy." Journal of Clinical Oncology 23, no. 12 (April 20, 2005): 2597–605. http://dx.doi.org/10.1200/jco.2004.12.027.

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Purpose Epoetin alfa administered at 40,000 U once weekly (qw) to anemic cancer patients receiving chemotherapy increases hemoglobin levels, improves quality of life (QOL), and reduces transfusions. The benefit of epoetin alfa in maintaining hemoglobin levels in cancer patients with hemoglobin less than 12 g/dL has not been evaluated. Methods Breast cancer patients (N = 354) receiving chemotherapy were randomly assigned in 1:1 ratio to epoetin alfa (40,000 U qw) or standard of care (SOC). QOL was assessed at baseline and week 12. Hemoglobin responses, transfusion requirements, and prognostic factors for responses were measured. Results At week 12, Functional Assessment of Cancer Therapy–Anemia (FACT–An; mean, 2.16 ± 12.84 for epoetin alfa v −4.43 ± 13.42 for SOC) and FACT–An fatigue (mean, 1.85 ± 10.52 for epoetin alfa v −3.55 ± 11.14 for SOC) change scores were significantly higher in the epoetin alfa group (P < .0001). Hemoglobin responses defined as mean hemoglobin ≥ 12 g/dL or a ≥ 2 g/dL increase compared with baseline were significantly higher in the epoetin alfa group versus SOC: 52.0% v 5.1% and 65.7% v 6.3%, respectively (P < .0001 for both comparisons). Percentage transfused was significantly lower in the epoetin alfa group compared with SOC (8.6% v 22.9%). More than 90% of patients did not require a dose increase and 28.7% had a dose reduction. Conclusion Epoetin alfa administered at 40,000 U qw is effective in improving QOL, maintaining hemoglobin level, and reducing transfusion requirements in breast cancer patients. The high effectiveness observed could be attributed in part to early treatment with epoetin alfa.

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Ovcharenko, S. I., and E. A. Son. "Effects of alfa-1-antitripsin deficiency on lung disease." Russian Pulmonology, no. 5 (January 1, 2011): 79–86. http://dx.doi.org/10.18093/0869-0189-2011-0-5-79-86.

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Averyanov, A. V., and A. E. Polivanova. "Alfa-1-antitripsin deficiency and chronic obstrictive pulmonary disease." PULMONOLOGIYA, no. 3 (June 28, 2007): 103–9. http://dx.doi.org/10.18093/0869-0189-2007-0-3-103-109.

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Picheth, Geraldo, Paula L. Bresolin, Osmar Pereira Jr., Maria Cristina G. Jaworski, Celso M. Santos, Adriana P. Pinto, Marileia Scartezini, Vânia M. Alcântara, and Cyntia M. T. Fadel-Picheth. "Mucoproteína versus alfa-1-glicoproteína ácida: o que quantificar?" Jornal Brasileiro de Patologia e Medicina Laboratorial 38, no. 2 (2002): 87–91. http://dx.doi.org/10.1590/s1676-24442002000200004.

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Figueira Gonçalves, Juan Marco, Francisco Martínez Bugallo, Ignacio García-Talavera, and Jesús Rodríguez González. "Déficit de alfa-1-antitripsina asociado a alelos nulos." Archivos de Bronconeumología 53, no. 12 (December 2017): 700–702. http://dx.doi.org/10.1016/j.arbres.2017.05.012.

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Koivisto, VeikkoA. "Interferon alfa and development of type 1 diabetes mellitus." Lancet 340, no. 8829 (November 1992): 1236. http://dx.doi.org/10.1016/0140-6736(92)92944-b.

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Wainer, Gabriel A., Sergio Daicz, Luis F. De Simoni, and Demian Wassermann. "Using the Alfa-1 simulated processor for educational purposes." Journal on Educational Resources in Computing 1, no. 4 (December 2001): 111–51. http://dx.doi.org/10.1145/514144.514743.

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Vidal, Rafael, Ignacio Blanco, Francisco Casas, Rosend Jardí, and Marc Miratvilles. "Diagnóstico y tratamiento del déficit de alfa-1-antitripsina." Archivos de Bronconeumología 42, no. 12 (December 2006): 645–59. http://dx.doi.org/10.1157/13095974.

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Füeßl, Hermann S. "Öfter auch mal Alfa-1-Antitrypsinmangel in Überlegungen einbeziehen." Pneumo News 9, no. 4 (June 2017): 30–31. http://dx.doi.org/10.1007/s15033-017-0697-6.

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Lu, Genmin, Pamela B. Conley, Janet M. Leeds, Mark J. Karbarz, Gallia G. Levy, Vandana S. Mathur, Janice Castillo, Mark Crowther, and John T. Curnutte. "A phase 2 PK/PD study of andexanet alfa for reversal of rivaroxaban and edoxaban anticoagulation in healthy volunteers." Blood Advances 4, no. 4 (February 24, 2020): 728–39. http://dx.doi.org/10.1182/bloodadvances.2019000885.

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Abstract As with any anticoagulant, factor Xa (FXa) inhibitors are associated with a risk of major bleeding. Andexanet alfa is a recombinant modified human FXa lacking enzymatic activity, developed for reversal of FXa inhibitor–induced anticoagulation. In two phase 2, randomized, double-blind, placebo-controlled, single-center studies, different regimens of andexanet alfa were administered to healthy volunteers after therapeutic anticoagulation with rivaroxaban or edoxaban, and multiple anticoagulation reversal and safety end points were evaluated. Andexanet alfa rapidly and effectively reversed anticoagulation with both rivaroxaban and edoxaban. Within 2 minutes after bolus, anti-FXa activity decreased significantly, with maximum decreases of ≈93% (P < .05) and ≈82% (P < .05), respectively, compared with placebo. The stoichiometric ratios of andexanet alfa:total anticoagulant at maximum reversal of anti-FXa activity ranged from 1:1 to 1.3:1 for rivaroxaban and 1.41:1 to 2.58:1 for edoxaban. Sustained normalization of thrombin generation for ≈2 hours and sustained decrease in unbound anticoagulant (maximum ≈80%) for up to ≈4 hours following completion of andexanet alfa administration, compared with placebo, were observed when andexanet was administered as a bolus or as a bolus followed by continuous infusion. Andexanet alfa was well tolerated, and there were no serious adverse events or thrombotic events. Andexanet alfa has been approved in the United States and Europe for reversal of anticoagulation in patients treated with rivaroxaban or apixaban who experience life-threatening or uncontrolled bleeding. These studies were registered with clinicaltrials.gov (#NCT03578146 and #NCT03551743).

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Tanvetyanon, Tawee, Edward A. Stadtmauer, and Lawrence A. Kerson. "Concurrent Administration of Interferon Alfa-2b and Beta-1a." Annals of Pharmacotherapy 37, no. 1 (January 2003): 77–79. http://dx.doi.org/10.1345/aph.1c120.

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OBJECTIVE To describe the concurrent use of interferon (IFN) alfa and beta in a patient with multiple sclerosis (MS) and chronic myeloid leukemia (CML). CASE SUMMARY A 60-year-old white man developed CML while receiving IFN beta-1a treatment for MS. The patient was started on IFN alfa-2b 1 million units 3 times weekly with IFN beta-1a 30 μg weekly. The dosage of IFN alfa was increased to 3 million units/d 1 month later. He achieved complete hematologic remission in 3 months. The observed adverse effects were mild and included fatigue, somnolence, weight loss, and difficulty with memory. At 19 months after treatment, the patient remained in hematologic remission and his expanded disability status scale score remained unchanged. DISCUSSION Concomitant treatment with interferon alfa and beta by a gradual increase in the dosage of IFN alfa was well tolerated. Although imatinib mesylate may be a preferred treatment for patients with CML and MS at this time, our experience with safe concurrent use of IFN alfa and beta may benefit other patients who require this combined treatment. CONCLUSIONS Concurrent administration of interferon alfa-2b and beta-1a was well tolerated by our patient with CML and MS.

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Putra, Alfatah Reski Basevi, and Desri Nora. "Faktor Penghambat dalam Mengatasi Ketidakhadiran Siswa Kelas XI IPS di SMAN 1 Lubuk Basung." Jurnal Sikola: Jurnal Kajian Pendidikan dan Pembelajaran 1, no. 4 (May 13, 2020): 253–64. http://dx.doi.org/10.24036/sikola.v1i4.45.

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Artikel ini dilatarbelakangi oleh fenomena tingginya ketidakhadiran siswa pada jam pelajaran di SMAN 1 Lubuk Basung. Adapun penyebab ketidakhadiran siswa tersebut karena ada keperluan (izin), sakit dan tanpa keterangan (alfa). Pihak sekolah sudah menerapkan aturan wajib kehadiran 80% dan sanksi bagi siswa yang kehadirannya kurang dari 80%, untuk mengantisipasi hal ini, namun sekolah mengalami kendala dalam meminimalkan ketidakhadiran siswa (alfa) agar dapat terus mengikuti proses pembelajaran. Tujuan dari penelitian ini ialah mengetahui faktor penghambat dalam mengatasi ketidakhadiran siswa kelas XI IPS di SMAN 1 Lubuk Basung. Penelitian ini menggunakan pendekatan Kualitatif dengan tipe Studi Kasus. Penelitian menggunakan teori dari Talcott Parson yaitu teori Struktural Fungsional dengan skema AGIL. Teknik pemilihan informan adalah purposive sampling, dengan jumlah informan 32 orang. Adapun yang menghambat dalam usaha mengatasi ketidakhadiran siswa alfa disebabkan oleh faktor : (a) Penerapan Sanksi Yang Kurang Tegas, (b) Kurangnya Kerjasama Antara Personil Sekolah, (c) Jadwal Sekolah Yang Kurang Efektif, (d) Kurangnya Minat Siswa Dalam Mengikuti Proses Pembelajaran, (e) Fasilitas Sekolah Pasca Kebakaran.

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Perova, K. A., D. G. Shchurov, D. V. Blinov, N. V. Bashmakova, and N. Z. Musina. "Pharmacoeconomic analysis of the application of follitropin alfa in combination with assisted reproductive technologies." FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology 15, no. 1 (April 14, 2022): 40–50. http://dx.doi.org/10.17749/2070-4909/farmakoekonomika.2022.129.

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Objective: to evaluate clinical-economic feasibility and impact of follitropin alfa on the state healthcare budget of the Russian Federation in the population of women with diagnosed infertility and poor ovarian response, who undergo treatment with assisted reproductive technologies (ART).Material and methods. A cost minimization analysis to evaluate clinical-economic feasibility of follitropin alfa in women with infertility and poor ovarian response who underwent ART was performed. The model of the budget impact analysis included the costs required for the ovarian stimulation of patients distributed by various variants of their management. The current practice involved the application only of fixed dose combinations (FDC) of follitropin alfa + lutropin alfa. The expected practice suggested a change in the approach by shifting 25% of patients with poor ovarian response from FDC of follitropin alfa + lutropin alfa to follitropin alfa. A time horizon of modeling was 1 year.Results. The cost minimization analysis demonstrated that the application of drug with international nonproprietary name follitropin alfa is characterized by the cost cut of 12,020 rubles (–21.56%) per patient compared with FDС of follitropin alpha + lutropin alpha. The results of budget impact analysis showed that a shift of 25% of population from FDC of follitropin alfa + lutropin alfa to follitropin alfa could cut direct medical costs by 7.96 million rubles per year (–5.39%).Conclusion. Evaluation of clinical-economic feasibility and budget impact analysis showed that the application of follitropin alfa during ovarian stimulation in women with infertility and poor ovarian response leads to a decrease in budget expenses.

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Izzati, Arfa, and Ani Riyani. "Variasi Konsentrasi Alfa Siklodekstrin dan Waktu Sentrifugasi Dalam Preparasi Serum Lipemik Pada Pemeriksaan Glukosa Metode GOD-PAP." Jurnal Teknologi Laboratorium 7, no. 1 (May 3, 2018): 31. http://dx.doi.org/10.29238/teknolabjournal.v7i1.121.

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Pemeriksaan kadar glukosa metode GOD-PAP di dalam serum dapat terganggu dengan adanya kekeruhan disebabkan oleh serum lipemik yang menyebabkan hasil kadar glukosa dalam serum tinggi palsu. Penambahan alfa-siklodekstrin (α-CD) dapat mengikat lipemik di dalam serum. Penelitian ini bertujuan untuk mengetahui konsentrasi dari alfa-siklodekstrin dan waktu sentrifugasi yang optimal dengan penambahan alfa-siklodekstrin. Menambahkan variasi konsentrasi alfa-siklodekstrin 0.5%, 1%, dan 1.5% pada pooled serum dengan variasi kadar trigliserida ±1000 mg/dL, ±1500 mg/dL dan ±2000 mg/dL lalu inkubasi selama 30 menit pada suhu 4oC. Sentrifugasi dengan kecepatan 3000 rpm pada variasi waktu sentrifugasi selama 5 menit, 10 menit dan 15 menit pada suhu 4oC sampai terbentuk endapan dan supernatan. Supernatan yang terbentuk diukur kadar glukosa metode GOD-PAP dan trigliserida metode GPO-PAP menggunakan alat fotometer. Hasil yang didapatkan, tidak terdapat perbedaan pada suatu nilai secara signifikan dari variasi waktu sentrifugasi dan variasi konsentrasi alfa-siklodekstrin setelah dibandingkan dengan kadar glukosa pooled serum awal (base line) pada uji ANOVA, uji Kruskall Wallis dan uji Mann Whitney. Kesimpulan yang didapatkan, tidak terdapat perbedaan signifikan terhadap pooled serum awal (base line) pada waktu sentrifugasi dengan kadar trigliserida ± 1000 mg/dL dengan kadar alfa-siklodekstrin 0.5% pada waktu sentrifugasi selama 10 menit, kadar trigliserida ± 1500 mg/dL dan ± 2000 mg/dL dengan kadar alfa-siklodekstrin 1%, dengan waktu sentrifugasi selama 5 menit.

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Шаров, М. К. "Тепловое расширение кристаллов Pb-=SUB=-1-x-=/SUB=-Cd-=SUB=-x-=/SUB=-Te." Физика и техника полупроводников 55, no. 12 (2021): 1216. http://dx.doi.org/10.21883/ftp.2021.12.51708.9715.

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The values of the lattice period and the linear coefficient of thermal expansion (alfa) of Pb1-xCdxTe solid solutions are determined depending on the cadmium content and temperature using high-temperature X-ray diffractometry. Аn increase in the concentration of cadmium in Pb1-xCdxTe in the range x = 0.02–0.08 leads to a significant increase in the linear coefficient of thermal expansion. A change in temperature range T = 293–673 K leads to decrease in the linear coefficient of thermal expansion. Besides, an increase in temperature does not affect the value alfa of the undoped PbTe in the indicated temperature range.

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Lohner, Szimonetta, Tamás Marosvölgyi, István Burus, János Schmidt, Dénes Molnár, and Tamás Decsi. "Dietary supplementation of obese children with 1000 mg alpha-linolenic acid per day: a placebo-controlled double blind study." Orvosi Hetilap 148, no. 32 (August 1, 2007): 1499–503. http://dx.doi.org/10.1556/oh.2007.28015.

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Az omega-3 zsírsav fogyasztásának növelése kedvező hatású lehet a fokozott cardiovascularis kockázatú személyek, köztük az elhízottak számára. A kedvező hatások létrejöttének feltétele az omega-3 zsírsavaknak a szervezet plazmalipideibe történő beépülése, azonban a gyermekkorban ehhez szükséges szupplementációs dózisra vonatkozóan igen kevés adat áll rendelkezésre. A jelen vizsgálatunk célja napi 1000 mg alfa-linolénsavval kiegészített étrend a plazmalipidek zsírsavösszetételére kifejtett hatásának vizsgálata volt elhízott gyermekekben. Személyek és módszerek: Ebben a placebóval kontrollált, keresztező önkontrollos, 2 × 6 hétig tartó vizsgálatban a részt vevő 9 elhízott gyermek (életkor: 13,1 [±2,5] év, testtömegindex: 31,2 [±6,2] kg/m 2 , medián [IQR]) étrendjébe speciális takarmánnyal etetett tyúkoktól származó napi 1 tojást és 50 g csirkehúst építettünk be, amivel napi 1000 mg alfa-linolénsav bevitelét tudtuk biztosítani. A plazmalipidek zsírsavösszetételét nagy felbontóképességű kapilláris gáz-folyadék kromatográfiával határoztuk meg. Eredmények: Az alfa-linolénsav-értékek emelkedő tendenciája volt megfigyelhető az alfa-linolénsavval történő szupplementációt követően a foszfolipid-, a triacil-glicerin- és a szterol-észter-frakcióban egyaránt, azonban egyik frakcióban sem volt a változás szignifikáns. A nem észterifikált zsírsavfrakcióban az alfa-linolénsav értékei szignifikánsan emelkedtek (0,11 [0,08] szemben 0,14 [0,20], tömeg%, p < 0,05), jelezve az alfa-linolénsav plazmalipidekben történő feldúsulásának a kezdetét. Következtetés: Az elhízott gyermekekben az étrend 6 héten keresztül napi 1000 mg alfa-linolénsavval történő kiegészítése csak a plazma nem észterifikált zsírsavaiban növelte szignifikánsan az omega-3 zsírsavak arányát, az észterifikált frakciókban nem volt szignifikáns hatás. Elhízott gyermekekben az omega-3-zsírsavellátottság befolyásolásához az alfa-linolénsav-szupplementáció dózisának 1 g/nap fölé történő növelése tűnik szükségesnek.

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Hoy, Sheridan M. "Eftrenonacog Alfa: A Review in Haemophilia B." Drugs 77, no. 11 (June 23, 2017): 1235–46. http://dx.doi.org/10.1007/s40265-017-0778-1.

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Patton, Jeffrey, Yong Mun, and Joel Wallace. "Darbepoetin alfa Maintains Hemoglobin Levels in Patients with Myelodysplastic Syndromes (MDS) after Therapeutic Interchange from Epoetin alfa: Results of a Retrospective Chart Review." Blood 104, no. 11 (November 16, 2004): 4708. http://dx.doi.org/10.1182/blood.v104.11.4708.4708.

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Abstract Patients with MDS often receive erythropoietic therapy for the treatment of anemia resulting from the disease. This retrospective chart review examined the impact of switching patients from their current dosing regimens of epoetin alfa (Procrit®) to darbepoetin alfa (Aranesp®) 200 mcg every two weeks (Q2W) following the implementation of therapeutic substitution guidelines in September 2003. Key eligibility criteria included: ≥ 18 years old with a diagnosis of MDS, and treatment with epoetin alfa therapy between May 2003 and January 2004. Patients receiving epoetin alfa therapy were either switched to darbepoetin alfa, or allowed to remain on epoetin alfa, depending on whether their treating physician had adopted therapeutic substitution guidelines. To ensure full characterization of the patient population, in the 16 weeks prior to the time of the therapeutic substitution, detailed demographic and disease characteristics were collected, in addition to dose requirements, transfusion status and hemoglobin profiles. To assess the impact on clinical outcomes, data were collected for 16 weeks after the therapeutic substitution guidelines were implemented (defined as the treatment period). Patients identified in the chart review who received at least one dose of study drug during both time periods were included in the analysis. Response was defined according to the international working group on MDS definitions (Cheson et al., Blood, 2000; 96(12):3671–4). Kaplan-Meier estimates (95% CL) for the percentage of patients with a major response (hemoglobin [Hb] change ≥ 2 g/dL over baseline or transfusion independence) or a minor response (Hb increase ≥ 1 g/dL to < 2 g/dL or a 50% reduction in transfusion requirements) during the treatment period were calculated. Data were abstracted from 142 patient charts, 112 (62 darbepoetin alfa; 50 epoetin alfa) of whom had confirmatory evidence of MDS available in their records (a documented bone marrow biopsy, French-American-British [FAB] classification, or karyotype [confirmed MDS population]). Baseline demographics for the confirmed MDS population were similar between the two cohorts. For those patients with data available, the majority had a FAB classification of refractory anemia with ≤ 5% bone marrow blasts. Mean baseline Hb was 11.0 g/dL for the darbepoetin alfa cohort (n=61) and 11.3 g/dL for the epoetin alfa cohort (n=48). The Kaplan-Meier percentage (95% CL) of patients with a major response was 27% (15, 39) for the darbepoetin alfa cohort and 19% (7, 30) for the epoetin alfa cohort; a minor response was noted for 46% (33, 59) and 47% (31, 63) of patients in the darbepoetin alfa and epoetin alfa cohorts, respectively. The Kaplan-Meier (95% CL) proportion of patients receiving red blood cell transfusions was similar between the groups: 8% (1, 15) for the darbepoetin alfa cohort and 12% (3, 22) for the epoetin alfa cohort. This study indicates that darbepoetin alfa achieved comparable clinical outcomes with epoetin alfa for the treatment of anemia in patients with confirmed MDS.

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Saczewski, F., E. Kobierska, T. Debowski, S. Charakchiewa-Minol, M. Mokrosz, M. Gdaniec, and E. Nowak. "Synthesis, Structure, and Binding of Some 2-Imidazolines to Rat Brain Alfa-1 and Alfa-2-Adrenergic Receptors." Archiv der Pharmazie 333, no. 12 (December 2000): 425–30. http://dx.doi.org/10.1002/1521-4184(200012)333:12<425::aid-ardp425>3.0.co;2-a.

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Solms, Alexander, Anita Shah, Sara Wiegmann, Maurice Ahsman, Erik Berntorp, Andreas Tiede, Alfonso Iorio, Maria Elisa Mancuso, Tihomir Zhivkov, and Toshko Lissitchkov. "Potency-Adjusted Analyses of a Head-to-Head Pharmacokinetic Study of Damoctocog Alfa Pegol (BAY 94-9027) and Efmoroctocog Alfa (rFVIIIFc) in Patients with Severe Hemophilia A." Blood 136, Supplement 1 (November 5, 2020): 24–25. http://dx.doi.org/10.1182/blood-2020-136586.

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Background Damoctocog alfa pegol (BAY 94-9027; Jivi®) is a B-domain-deleted recombinant factor VIII (FVIII), site-specifically PEGylated with a single, dual-branched 60 kDa polyethylene glycol molecule to extend its half-life. A previous head-to-head crossover study demonstrated that damoctocog alfa pegol has an improved pharmacokinetic (PK) profile compared with efmoroctocog alfa (rFVIIIFc; Elocta®/Eloctate®), an extended-half-life (EHL), recombinant FVIII fusion protein. A single infusion of damoctocog alfa pegol resulted in 25% higher area under the curve (AUClast) and 20% lower clearance (CL) compared with efmoroctocog alfa. Owing to differences in batch-specific FVIII activity, the actual dose of efmoroctocog alfa administered was subsequently found to be higher than for damoctocog alfa pegol. Thus, to provide a more accurate assessment of the differences in PK parameters between these two products, actual dosing should be considered. In the present study, dose-normalized analyses considering the dosing based on actual potency were performed for an accurate and valid comparison of PK parameters between damoctocog alfa pegol and efmoroctocog alfa. Methods The head-to-head comparison of the PK of EHL FVIII products was a single-center, randomized, open-label, crossover study of damoctocog alfa pegol and efmoroctocog alfa (ClinicalTrials.gov identifier: NCT03364998). Eligible patients were male, aged 18-65 years with severe hemophilia A (FVIII <1%). After a wash-out period of ≥3 or ≥5 days for prior treatment with standard-half-life or EHL FVIII products respectively, patients were randomized 1:1 to receive a single 60 IU/kg dose of either damoctocog alfa pegol or efmoroctocog alfa. Patients received a single dose of the other product following a ≥7-day wash-out after the dose of the first product. In the study, doses were determined based on the nominal potency value as labeled on the vial. In the present study, PK parameters including normalized AUC (AUCnorm), CL, normalized maximum concentration (Cmax norm), volume of distribution at steady state (Vss) and incremental recovery, were assessed using doses adjusted for actual potencies, according to the certificates of analysis provided by the manufacturers for the actual batches used. Results As previously described elsewhere, one patient with pre-existing anti-PEG antibodies was considered an outlier for the PK analysis and was excluded from this analysis. In total, 17 patients were included in this analysis, and had a median age of 34 years (Table 1). For both drugs, vials with nominal potency of 1000 IU/vial were used, while actual potencies of efmoroctocog alfa and damoctocog alfa pegol used in this study were 1093 IU/vial and 990 IU/vial, respectively. Hence, the actual dose of efmoroctocog alfa administered was approximately 10.4% higher than the administered dose of damoctocog alfa pegol. After potency-adjustment, AUCnorm and CL were in favor of damoctocog alfa pegol (Table 2). AUCnorm was significantly increased by 39% (P < 0.001) for damoctocog alfa pegol compared with efmoroctocog alfa; an increase with damoctocog alfa pegol compared with efmoroctocog alfa was observed in 16 (94.1%) out of 17 patients. Geometric mean CL was significantly reduced with damoctocog alfa pegol versus efmoroctocog alfa (0.0198 dL/h/kg vs 0.0273 dL/h/kg; P < 0.001), with 16 (94.1%) patients exhibiting a difference in favor of damoctocog alfa pegol. No significant differences in Cmax norm between the two products were observed. Conclusion In the precedent analysis, published elsewhere, damoctocog alfa pegol demonstrated improvements in AUC, CL and t½ compared with efmoroctocog alfa. The improvements are confirmed in this potency-adjusted analysis, while, compared with the unadjusted analysis, a greater improvement for AUCnorm is observed for damoctocog alfa pegol versus efmoroctocog alfa. These data further support the superior PK profile of damoctocog alfa pegol compared with efmoroctocog alfa. Disclosures Solms: Bayer: Current Employment, Current equity holder in private company. Shah:Bayer: Current Employment, Current equity holder in private company. Wiegmann:Bayer: Current Employment. Ahsman:Bayer: Consultancy. Berntorp:Bayer: Consultancy, Honoraria, Research Funding, Speakers Bureau; CSL Behring: Research Funding; Shire: Research Funding; Sobi/Bioverativ: Research Funding; Octapharma: Consultancy, Honoraria; Shire/Takeda: Consultancy, Honoraria. Tiede:Biotest: Consultancy, Honoraria, Research Funding; Novo Nordisk: Consultancy, Honoraria, Research Funding; Octapharma: Consultancy, Honoraria, Research Funding; Roche: Consultancy, Honoraria, Research Funding; Takeda: Consultancy, Honoraria, Research Funding; Bayer: Consultancy, Honoraria; Chugai: Consultancy, Honoraria; CSL Behring: Consultancy, Honoraria. Iorio:Bayer: Research Funding; BioMarin: Research Funding; CSL: Research Funding; Freeline: Research Funding; Grifols: Research Funding; Sanofi: Research Funding; Spark: Research Funding; Takeda: Research Funding; Uniqure: Research Funding; NovoNordisk: Research Funding; Octapharma: Research Funding; Pfizer: Research Funding; Roche: Research Funding. Mancuso:Center for Thrombosis and Hemorrhagic Diseases, Humanitas Clinical and Research Center - IRCCS, Rozzano, Milan, Italy: Current Employment; Bayer, CSL Behring, Novo Nordisk, Pfizer, F. Hoffmann-La Roche Ltd, Octapharma, Kedrion, Grifols, Catalyst, Kedrion, Sobi: Membership on an entity's Board of Directors or advisory committees; Bayer, CSL Behring, Novo Nordisk, F. Hoffmann-La Roche Ltd, Octapharma, Grifols, Sobi: Speakers Bureau; Bayer, CSL Behring, Novo Nordisk, Pfizer, F. Hoffmann-La Roche Ltd, Octapharma, Kedrion, Grifols, Sobi, PedNet Foundation: Consultancy. Zhivkov:Bayer: Other: Sub-Investigator of clinical trials, Research Funding; Apellis: Other: Sub-Investigator of clinical trials; Catalyst: Other: Sub-Investigator of clinical trials; Octapharma: Other: Sub-Investigator of clinical trials; Sanofi: Other: Sub-Investigator of clinical trials. Lissitchkov:Bayer: Other: Principal investigator of clinical trials ; CSL Behring: Other: Principal investigator of clinical trials ; Novo Nordisk: Other: Principal investigator of clinical trials ; Octapharma: Other: Principal investigator of clinical trials ; Sanofi: Other: Principal investigator of clinical trials ; Roche: Membership on an entity's Board of Directors or advisory committees, Other: lecturer; Shire: Other: lecturer; Sobi: Membership on an entity's Board of Directors or advisory committees, Other: lecturer; Catalyst Biosciences: Other: Principal investigator of clinical trials .

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Fokina, D. S., O. V. Zhukova, A. L. Khokhlov, D. A. Kudlay, A. Yu Borozinets, and F. G. Pilyus. "The clinical use and cost-effectiveness of domestic blood coagulation factors VIII and IX." Pediatric Hematology/Oncology and Immunopathology 21, no. 1 (March 29, 2022): 72–82. http://dx.doi.org/10.24287/1726-1708-2022-21-1-72-82.

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According to the data from the Federal Center for Planning and Organization of Medicine Provision for Citizens of Ministry of Healthcare of Russia, as of 2021, a total of 11 151 people have been diagnosed with hemophilia, 35.9% of them being children. Here we aimed to analyze data on the use of domestic recombinant coagulation factors VIII and IX in real clinical practice and to evaluate their cost-effectiveness. For our analysis, we used data from an observational study and a comparative clinical study of moroctocog alfa (Octofactor) in patients with moderate and severe hemophilia A as well as data from a comparative clinical study of nonacog alfa (Innonafactor) in patients with moderate and severe hemophilia B. The observational study of moroctocog alfa (Octofactor) lasted 85 weeks (from 09 January 2016 to 01 September 2017) and included 30 Russian clinical centers with a total of 237 patients diagnosed with moderate or severe hemophilia A. All patients were male, aged between 19 and 78 years (the mean age was 35.2 ± 11.1 years). The comparative study of moroctocog alfa included 18 hemophilia patients receiving prophylactic treatment at 3 Russian clinical centers. The mean age in the study cohort was 38.2 ± 12.9 years. Similarly, the comparative study of nonacog alfa (Innonafactor) included 18 hemophilia patients receiving prophylactic treatment at 3 Russian clinical centers. The mean age in this study cohort was 34.1 ± 9.5 years. The clinical studies were approved by the Ethics Board of the Ministry of Healthcare of Russia. The observational study was approved by the Interuniversity Ethics Committee (Moscow) and local ethics committees. A health economic evaluation was conducted using the following methodologies: a cost-effectiveness analysis, a budget impact analysis, an opportunity cost analysis, and a sensitivity analysis. The main measure of moroctocog alfa (Octofactor) effectiveness was the frequency of spontaneous bleeding within 48–72 hours after the administration of a prophylactic drug. The frequency of bleeding episodes was reported to be 1.4 ± 2.9. The main measure of nonacog alfa (Innonafactor) effectiveness was the mean number of bleeding episodes in patients receiving prophylactic treatment. It was reported to be 0.22 ± 0.44 episodes. Our health economic evaluation showed that the cost-effectiveness ratio for moroctocog alfa (Octofactor) was 1.8 fold lower than that for the comparator (Octanate, a plasma-derived factor VIII product); the cost-effectiveness ratio for nonacog alfa (Innonafactor) was 2.1 fold lower than that for the comparator (Octanine F, a coagulation factor IX) meaning that domestic coagulation factor products allow patients to achieve better treatment results (i.e. fewer bleeding episodes) at lower cost. The budget impact and opportunity cost analyses in two model groups of patients (n = 100 each) revealed that the use of moroctocog alfa (Octofactor) would enable us to treat 36 more patients, while the use of nonacog alfa (Innonafactor) would allow 3 more patients to receive care. The sensitivity analysis showed that switching 50% of patients from the foreign comparator to moroctocog alfa (Octofactor) would save 5.32% of the budget, while switching 50% of patients from the foreign comparator (Octanine F) to nonacog alfa (Innonafactor) would save 0.98% of the budget meaning that more patients could receive treatment. It was also demonstrated that changes in the proportion of patients receiving Octofactor and Octanate within the range of ± 50% would result in cumulative costs ranging from ₽12 994 million to ₽15 233 million that correspond to a budget surplus of 5.32% and a budget deficit of 10.99%, respectively. Similarly, treatment costs for Innonafactor and Octanine F would vary from ₽2 473 million to ₽2 516 million that correspond to a budget surplus of 0.98% and a budget deficit of 0.74%, respectively.

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Loaiza-Bonilla, Arturo, Andrew Artz, Francis Salerno, Sean X. Leng, Shing-Shing Yeh, Rex Biedenbender, Stefan Gravenstein, Jose Loera, Zeba Shaheen Geloo, and William B. Ershler. "Correction of Anemia in the Frail Elderly (CAFÉ): Results of a Randomized, Double-Blind, Placebo-Controlled Study with Darbepoetin Alfa in Elderly Patients with Chronic Unexplained Anemia." Blood 120, no. 21 (November 16, 2012): 5153. http://dx.doi.org/10.1182/blood.v120.21.5153.5153.

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Abstract Abstract 5153 Objectives: To evaluate the effect of darbepoetin alfa treatment on hemoglobin (Hb) levels in frail, community dwelling elderly patients with chronic unexplained anemia and its correlation with the presence of comorbidities, serum baseline erythropoietin concentrations and renal function. Design: A 24 weeks, prospective, randomized (1:1), double-blind, placebo-controlled clinical trial. Participants: Eighty community-dwelling, consenting pre-frail or frail (Hopkins Frailty Index score 1 to 3) patients 70 years or older with chronic anemia (Hb <11. 5 g/dL). Intervention: Subcutaneous darbepoetin alfa or placebo weekly for 24 weeks with a 22 week open-label extension. Initial dose 60 μg every other week (bi-weekly). Measurements: Hemoglobin, Erythropoietin serum levels, estimated glomerular filtration rate, Charlson Comorbidity Index and Age Adjusted Comorbidity Index scores. Results: 80 subjects were enrolled, and complete data was analyzed. Of those enrolled, most were White (86. 25%) and male (58. 75%) and had a low comorbidity score, and a mean age ± standard deviation 81. 34 ± 6. 34. Mean baseline Hb was 10. 93 ± 0. 57 g/dL (9. 1–11. 9). Erythropoietin baseline levels (mU/mL) for placebo arm were 21. 4 ± 15 and 17. 6 ± 12. 4 for treatment arm. Estimated Glomerular filtration rates at baseline, mL/min per 1. 73m2 were 58. 7 ± 22. 4 and 50. 5 ± 17. 7 for placebo and treatment arms, respectively. During the observation period, there was a significantly greater hematopoietic response (mean 1. 13 ± 0. 59 g/dL) in the participants treated with darbepoetin alfa than in those receiving placebo (0. 3 ± 0. 18 g/dL). All participants (100%) responded to darbepoetin alfa treatment by week 8, attaining the target Hb level of 12 g/dL and maintaining those levels throughout the observation period. The average bi-weekly dose of darbepoetin alfa required to achieve the hemoglobin goal of 12 g/dL by week 8 was 63. 1 ± 3. 5 μg. After the eight week, 77% required less than 40. 46 ± 5. 4/week, and 23 patients (58. 9%) were maintained on weekly average dosages of less than 35 μg/week. The mean bi-weekly dose of darbepoetin alfa during the 24-week observation period was 74. 7 ± 12. 4 μg subcutaneously. The calculated average weekly dose of darbepoetin alfa needed to increase the hemoglobin levels by 1 g/dL was 40. 63μg/Hb/wk. Among the participants receiving placebo, only 3 out of 41 (7. 31%) patients had levels of Hb 12 g/dL or greater at end of the study (week 24) (P 0. 00006). This response was maintained and more significant among patients with lower age-adjusted comorbidity scores (<9) irrespective of gender, renal function and baseline erythropoietin levels. No significant differences were found between treatment and placebo on high comorbidity scores (≥9). Darbepoetin alfa was well tolerated and no major adverse events were reported in this group of patients with Hb target level of 12 g/dL. Conclusion: In this trial involving predominantly older white community dwelling patients with anemia, a direct relationship existed between increases in Hb during darbepoetin alfa therapy, this finding being more evident in the groups with lower age-adjusted comorbidity scores. Relatively lower dosages of darbepoetin alfa were required to attain a durable Hb response, with a good safety profile. Disclosures: Off Label Use: To evaluate the effect of darbepoetin alfa treatment on hemoglobin (Hb) levels in frail, community dwelling elderly patients with chronic unexplained anemia and its correlation with the presence of comorbidities, serum baseline erythropoietin concentrations and renal function.

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