Tesis sobre el tema "Langfristige Behandlung"

Background: Pimecrolimus cream 1% is a non-steroid, selective inflammatory cytokine inhibitor indicated for atopic dermatitis (AD). Objective: To compare the safety and efficacy of pimecrolimus cream 1%-based treatment versus conventional therapy in adults with moderate AD. Methods: Patients were randomized to receive pimecrolimus cream 1% (n = 62) or vehicle (n = 68) at the first signs/symptoms of AD, for 24 weeks as required. A moderately potent topical corticosteroid (prednicarbate 0.25% cream) was allowed in both groups to treat flares. Results: Corticosteroids were required on fewer days in the pimecrolimus group, compared with the vehicle group (9.7 vs. 37.8%, p < 0.001). Furthermore, 59.7% of pimecrolimus-treated patients experienced no flares during the study period, compared with 22.1% of vehicle-treated patients (p < 0.001). Pimecrolimus cream 1% was well tolerated throughout the study. Conclusion: For adults with moderate AD, pimecrolimus cream 1% is well tolerated, reduces the incidence of flares, reduces/eliminates corticosteroid use, improves long-term disease control and enhances the patients’ quality of life
Dieser Beitrag ist mit Zustimmung des Rechteinhabers aufgrund einer (DFG-geförderten) Allianz- bzw. Nationallizenz frei zugänglich

Background: Pimecrolimus cream (Elidel®, SDZ ASM 981), a non-steroid inhibitor of inflammatory cytokines, is effective in the treatment of atopic dermatitis (AD). We assessed whether early treatment of AD signs/symptoms reduces the need for topical corticosteroids. Objective: To investigate the efficacy and safety of pimecrolimus cream 1% in the long-term management of adult AD. Methods: 192 adults with moderate to severe AD were randomised (1:1) for twice daily (b.i.d.) treatment of early signs or symptoms of AD with either pimecrolimus cream 1% or vehicle cream (control group) to prevent progression to flares. Treatment was given as needed for 24 weeks. In the event of flares, a moderately potent corticosteroid (prednicarbate 0.25% cream) was permitted as rescue medication in both groups. The percentage of days on which a topical corticosteroid was used to treat disease flares was the main outcome measure. Results: Corticosteroid medication was used on 14.2% (95% confidence interval, CI: 8.3–21.1) of the days of the 24-week treatment period in the pimecrolimus group and on 37.2% (95% CI: 30.4–44.0) of the days in the control group (p < 0.001). In total, 44.8% (43/96) of patients in the pimecrolimus group did not experience a flare compared with 18.8% (18/96) of patients in the control group. The median time to first flare was 144 days in the pimecrolimus group and 26 days in the control group (p < 0.001). Pimecrolimus treatment was also associated with improvement in signs and symptoms of AD, pruritus, patients’ self-assessment and quality of life. Conclusions: Pimecrolimus cream 1% b.i.d. is an effective, well-tolerated, long-term treatment for AD in adults, substantially reducing the number of flares compared to a conventional therapy and consequently reducing or eliminating the need for corticosteroid treatment
Dieser Beitrag ist mit Zustimmung des Rechteinhabers aufgrund einer (DFG-geförderten) Allianz- bzw. Nationallizenz frei zugänglich

Background: Pimecrolimus cream 1% is a non-steroid, selective inflammatory cytokine inhibitor indicated for atopic dermatitis (AD). Objective: To compare the safety and efficacy of pimecrolimus cream 1%-based treatment versus conventional therapy in adults with moderate AD. Methods: Patients were randomized to receive pimecrolimus cream 1% (n = 62) or vehicle (n = 68) at the first signs/symptoms of AD, for 24 weeks as required. A moderately potent topical corticosteroid (prednicarbate 0.25% cream) was allowed in both groups to treat flares. Results: Corticosteroids were required on fewer days in the pimecrolimus group, compared with the vehicle group (9.7 vs. 37.8%, p < 0.001). Furthermore, 59.7% of pimecrolimus-treated patients experienced no flares during the study period, compared with 22.1% of vehicle-treated patients (p < 0.001). Pimecrolimus cream 1% was well tolerated throughout the study. Conclusion: For adults with moderate AD, pimecrolimus cream 1% is well tolerated, reduces the incidence of flares, reduces/eliminates corticosteroid use, improves long-term disease control and enhances the patients’ quality of life.
Dieser Beitrag ist mit Zustimmung des Rechteinhabers aufgrund einer (DFG-geförderten) Allianz- bzw. Nationallizenz frei zugänglich.

Background: Pimecrolimus cream (Elidel®, SDZ ASM 981), a non-steroid inhibitor of inflammatory cytokines, is effective in the treatment of atopic dermatitis (AD). We assessed whether early treatment of AD signs/symptoms reduces the need for topical corticosteroids. Objective: To investigate the efficacy and safety of pimecrolimus cream 1% in the long-term management of adult AD. Methods: 192 adults with moderate to severe AD were randomised (1:1) for twice daily (b.i.d.) treatment of early signs or symptoms of AD with either pimecrolimus cream 1% or vehicle cream (control group) to prevent progression to flares. Treatment was given as needed for 24 weeks. In the event of flares, a moderately potent corticosteroid (prednicarbate 0.25% cream) was permitted as rescue medication in both groups. The percentage of days on which a topical corticosteroid was used to treat disease flares was the main outcome measure. Results: Corticosteroid medication was used on 14.2% (95% confidence interval, CI: 8.3–21.1) of the days of the 24-week treatment period in the pimecrolimus group and on 37.2% (95% CI: 30.4–44.0) of the days in the control group (p < 0.001). In total, 44.8% (43/96) of patients in the pimecrolimus group did not experience a flare compared with 18.8% (18/96) of patients in the control group. The median time to first flare was 144 days in the pimecrolimus group and 26 days in the control group (p < 0.001). Pimecrolimus treatment was also associated with improvement in signs and symptoms of AD, pruritus, patients’ self-assessment and quality of life. Conclusions: Pimecrolimus cream 1% b.i.d. is an effective, well-tolerated, long-term treatment for AD in adults, substantially reducing the number of flares compared to a conventional therapy and consequently reducing or eliminating the need for corticosteroid treatment.
Dieser Beitrag ist mit Zustimmung des Rechteinhabers aufgrund einer (DFG-geförderten) Allianz- bzw. Nationallizenz frei zugänglich.

Thrombosis and restenosis are two major complications associated with current commercial vascular stents. In situ regeneration of a healthy endothelium has been recognized as a promising strategy to address these issues. Numerous strategies have been explored for this goal. However, in most of the cases, they only focused on enhancing endothelial cell growth, ignoring antithrombotic requirements and the competition between smooth muscle cells (SMCs) and endothelial cells (ECs) for their growth. This resulted in non-satisfying clinical results. In this study, we created a multifunctional surface that meets the need of antithrombosis and re-endothelialization. A nanotubular titanium oxide (TiO₂) system has been developed, which elutes the direct thrombin inhibitor, bivalirudin (BVLD); moreover, polydopamine (PDAM) is used to tailor the surface functionality of TiO₂ nanotubes (NTs) for controlling the elution of BVLD. PDAM-functionalized TiO₂ NTs controls the BVLD for more than two months. BVLD eluted from NTs was bioactive and showed a substantial inhibitory effect on thrombin bioactivity, platelet adhesion and activation. In addition, the BVLD-eluting nanotubular TiO₂ system has high selectivity to enhance human umbilical vein endothelial cell (HUVEC) growth, while it inhibits human umbilical artery smooth muscle cell (HUASMC) proliferation. Our design strategy for the BVLD-eluting nanotubular TiO₂ system creates a favorable microenvironment for durable thromboresistance and the promotion of reendothelialization, and thus it is suitable for the long-term treatment of cardiovascular diseases.

Die equine Regenerationsmedizin versucht nach einer Sehnenverletzung (oberflächliche, tiefe Beugesehne: OBS, TBS) oder Bandverletzung (Fesselträger FT) die konsekutive Narbenbildung mit intraläsional applizierten potenziell regenerativen Therapeutika (prT) zu vermeiden. PrT sind mesenchymale stromale multipotente Progenitorzellen (MSC) aus unterschiedlichen Gewebequellen, sowie blutzellbasierende - meist Platelet Rich Plasma (PRP) - oder azelluläre Blutprodukte. Ein Langzeiterfolg ist noch nicht evident nachgewiesen; die Arbeit möchte dazu beitragen, die bestehende Lücke zu schließen. Die Arbeitsfrage lautet: Wie kann mit einer einzigen quantitativen Effektvariable bei Sportpferden, die nach einer natürlich entstandenen Erkrankung der OBS,TBS oder FT konservativ, mit kontrollierter Bewegung allein (KtrB) oder regenerativ (PrTB) behandelt werden, die ‚langfristige Gebrauchsfähigkeit’ (GF) valide gemessen und bisherige Studienergebnisse verglichen werden? Material: Inkludiert sind 51 in vivo Studien (1983-2016) entsprechend der Arbeitsfrage. Exkludiert sind in vivo Studien mit künstlich induzierten Erkrankungen, mit konventioneller oder chirurgischer Behandlung sowie in vitro Studien Methoden: Da die Studienergebnisse nicht direkt vergleichbar sind, wird ein evidenzbasiertes einfaches Evaluationsmodell mit der neuen quantitativen Effektgröße 'Gebrauchsfähigkeitsrate' GFR entworfen. Die metaanalytische gepoolte Reanalyse kann damit unabhängig von den Ergebnissen der Primärstudien die GF der Sportpferde neu bewerten. Als maßgebliche Einflussfaktoren auf GF werden u.a. definiert: Gewebestruktur, prT, sportliche Disziplin, Läsionsgrad, Altersklasse der Pferde, Prüfzeitdauer nach Rehabilitation zur Kontrolle des ‚Erfolgsmerkmals’ (EM) auf ein Rezidiv. Die Daten werden aus den Studien extrahiert und zu sog. Behandlungsgruppen (BehG) zusammengefasst. Nach Gewebestruktur (OBS-TBS, FT-Ursprung/-Körper/-Schenkel) und Behandlungsform (KtrB, PrTB) geordnete BehG werden soweit vergleichbar zu größeren BehG mit präziserem GFR gepoolt. Der Effektunterschied zwischen prT wird gegebenenfalls statistisch gesichert. Als EM ist definiert: 'Nach Rehabilitation kehren die Sportpferde zur Arbeit auf (mindestens) dem ursprünglichen Leistungsniveau zurück'. Die Erfolgsrate bzgl. EM ist E. In der Prüfzeitdauer nach Rehabilitation wird die Rezidivrate (R) ermittelt. E und R ergeben die Effektgröße GFR = E(1-R). Diese wird mittels 3 ganzzahliger Variablen A, B, C normiert: GFR = (N-A-B-C)/(N-A). A, B, C sind disjunkte Fallgruppen der N Patienten einer BehG. Die standardisierte Studiendauer ergibt sich aus der projektierten Rehabilitationsdauer (proj. Reha) und der ‚standardisierten Prüfzeit’ (P). Im Konsens mit den untersuchten Studien ist sie bei OBS-TBS 3 Jahre (1 Jahr proj. Reha + 2 Jahre P), beim FT 2,25 Jahre (0,75 Jahre proj. Reha + 1,5 Jahre P). Ergebnisse und Schlussfolgerung: Bei der OBS erscheint die Chance (OR, odds ratio) auf die zweijährige GF mit Amnion-MSC (2GFR = 94,1 %, n* = 34) 7-fach größer (OR = 7,2 [1,7-31,4]) sowohl vs. Knochenmark-MSC (2GFR = 68,8 %, n* = 145) als auch 9-fach größer (OR = 9,7 [2,1-45]) vs. PRP (2GFR = 60,4 %, n* = 51) sowie 11-fach größer (OR = 11,4 [2,5-52,1]) vs. KtrB (2GFR = 57,5 %, n* = 60). Erstmals kann bei diesen prT die Effektdifferenz dGFR > 25 % mittels Poweranalyse per Signifikanznachweis (Power >90 %; p < 0,025) durch die erforderliche Fallzahl statistisch gesichert werden. Allerdings stützt sich das Ergebnis für Amnion-MSC noch auf nur eine Studie. Bei TBS und FT fehlen Vergleichsgruppen noch. Da replizierbare wissenschaftliche Ergebnisse mit hoher interner und externer Evidenz nur mit standardisierten Parametern erzielt werden können, erscheint das GFR-Modell für zukünftige Studien von wesentlichem Interesse.
The equine regenerative medicine is seeking to avoid the subsequent scarring after a tendon (superficial and deep digital flexor tendon: SDFT, DDFT) or ligament (suspensory ligament: SL) injury by intralesionally applicated potential regenerative therapeutics (prT). PrT are mesenchymal stromal multipotential progenitor cells (MSC) from different sources of tissue, as well as products of blood, based on blood cells (PRP in most cases, platelet rich plasma) or acellular. Evidence of long-term treatment-success has not yet provided. This study wants to go towards closing the gap on this front. The leading question is: How can the 'long-term fit for use' (FfU) of sport horses, which are treated either conservatively with controlled exercise allone (CtrT) or regeneratively (PrTT) after suffering from naturally occuring tendinopathies of SDFT, DDFT or FT, be quantified in a valid way with a single effect variable? And how can the results of previous research studies be compared? Material: Includet are 51 in vivo studies (1983-2016) relating to the leading question. Excluded are in vivo studies with artificially induced lesions, with conventional or surgical treatment as well as in vitro studies. Methods: Findings of the studies are not directly comparable. As a consequence an evidence-based simple evaluation-model with the new quantitative effect size called ‘rate of fit for use’ (FFU) is developed. Based on this model the meta-analytical pooled re-analysis can re-assess FfU of the sport horses independently from findings of primary studies. The following influencing factors affecting FfU are defined: Structure of tissue, prT, sportive kind-of-use, degree of lesion, age class of horses, duration of monitoring after rehabilitation to controll the outcome (OC) for recurrence. The data are extracted from the studies and configured to so-called treatment groups (TGs). According to structure of tissue (SDFT, DDFT, SL-body, SL-origin, SL-branches) and kind of treatment (CtrT, PrTT) comparable TGs are pooled to bigger TGs with more precise FFU. If possible difference of effect between prTs is statistically assured. OC is defined as: 'After rehabilitation the sport horses return to work at (not less than) the initial level of performance'. Rate of OC is E. During duration of monitoring after rehabilitation the rate of recurrence (R) is checked. E and R are combined to FFU = E(1-R). In addition FFU is standardized in accord with the formula FFU = (N-A-B-C)/(N-A). A, B, C are integer variables representing disjunctive case groups of N, which is the total number of treated patients of a TG. The standardized duration of study results from the 'planned duration of rehabilitation' (planReha) and ‘standardized duration of monitoring’ (DoM). In consence with research studies it adds up to 3 years at SDFT-DDFT (1 year planReha +2 years DoM) and 2.25 years at SL (0.75 year planReha +1.5 years DoM). Results and conclusion: The chance (OR, odds ratio) with AM-MSC for biennial FfU (2FFU = 94.1 %, N-A = 34) appears to be more than at least 7-fold (OR = 7.2 [1.7-31.4]) as high as with BM-MSC (2FFU = 68.8 %, N-A = 145) as well as 9-fold (OR = 9.7 [2.1-45]) high as with PRP (2FFU = 60.4 %, N-A = 51) as well as 11-fold (OR = 11.4 [2.5-52.1]) high as with CtrT (2FFU = 57.5 %, N-A = 60). For the first time, power-analysis can statistically assure the difference of effect 25 % < dFFU (power > 90 %; p < 0.025) between these TGs through significant evidence based on the needed number of cases. However 2FFU with AM-MSC still relies on only 1 study. At DDFT and at LS comparison groups still are lacking. Because replicable scientific results with high internal and external evidence only can be approached based on standardized parameters, FFU-model seems to be essential for future studies.