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DOI 10.1177/1753193413519926

Медицинская библиотека · The Journal of hand surgery, European volume · 2014

Collagenase clostridium histolyticum in patients with Dupuytren's contracture: results from POINT X, an open-label study of clinical and patient-reported outcomes.

Warwick D, Arner M, Pajardi G, Reichert B, Szabo Z, Masmejean E H, Fores J, Chapman D S, Gerber R A, Huard F, Seghouani A, Szczypa P P, POINT X Investigators

Клиническое исследование III фазыСтатьяПоддержка исследования: вне правительства СШАПеревод в очереди

Аннотация

In POINT X, a study designed to reflect clinical practice and patient treatment choices, 254 European patients received open-label collagenase for Dupuytren's contracture. The most severely affected joint was treated first in 74% of patients. In total, 52%, 41%, 7%, and 1% of patients selected the little, ring, middle, and index finger, respectively; 79% had one or two joints treated. Only 9% of patients (n = 24) received 4 or 5 injections. The mean improvement in total passive extension deficit (TPED) was 34° on day 1, improving further by day 7 to 42°. This secondary improvement was maintained by day 90 and month 6. The mean number of injections/joint was 1.2 for the metacarpophalangeal joint and 1.25 for the proximal interphalangeal joint. Median time to recovery was 4 days; the mean improvement in hand function was clinically relevant as measured by the Unité Rhumatologique des Affections de la Main (URAM) score. In total, 87% and 86% of patients and physicians, respectively, were very satisfied or satisfied with treatment at month 6, although correlation between TPED and patient satisfaction was weak (Spearman -0.18, 95% CI -0.32 to -0.06). Collagenase was well tolerated, with 10 (3.9%) patients experiencing severe adverse events. As a real-world study, the POINT X findings can be generalized to the at-large population.

Для цитирования: Warwick D, Arner M, Pajardi G, Reichert B, Szabo Z, Masmejean E H, Fores J, Chapman D S, Gerber R A, Huard F, Seghouani A, Szczypa P P, POINT X Investigators. Collagenase clostridium histolyticum in patients with Dupuytren's contracture: results from POINT X, an open-label study of clinical and patient-reported outcomes.. The Journal of hand surgery, European volume. 2014. DOI: 10.1177/1753193413519926.

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