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DOI 10.1016/j.jhsa.2017.02.010

Медицинская библиотека · The Journal of hand surgery · 2017

Treatment of Recurrent Dupuytren Contracture in Joints Previously Effectively Treated With Collagenase Clostridium histolyticum.

Bear Brian J, Peimer Clayton A, Kaplan F Thomas D, Kaufman Gregory J, Tursi James P, Smith Ted

Клиническое исследование IV фазыСтатьяМногоцентровое исследованиеПеревод в очереди

Аннотация

PURPOSE: Collagenase Clostridium histolyticum (CCH) is approved for the treatment of adults with Dupuytren contracture with a palpable cord. This open-label, phase 4 study evaluated the safety and efficacy of CCH for the retreatment of recurrent contractures in joints that were previously effectively treated with CCH.

METHODS

Patients participating in a long-term follow-up study who had contracture recurrence (increased ≥ 20° with a palpable cord) after successful treatment in the previous study were eligible. Recurrent joint contractures were treated with up to 3 CCH injections (∼ 1 month apart). Patients were followed for 1 year to evaluate safety. Assessments included change in joint contracture, range of motion, and the percentage of joints that achieved contracture of 5° or less at day 30 after the last injection.

RESULTS

The efficacy analysis included 51 patients with 1 treated joint per patient (31 metacarpophalangeal, 20 proximal interphalangeal). A total of 35 joints (69%) received 1 injection, 12 (24%) received 2 injections, and 4 (8%) received 3 injections. Fifty-seven percent of joints achieved contracture of 5° or less (29 of 51). Overall, 86% (43 of 50) patients had a 20° or greater increase in range of motion. The adverse event profile was consistent with previous studies. One ligament injury was reported.

CONCLUSIONS

At a short-term follow-up of 1 year, recurrent contracture in joints previously successfully treated with CCH may be effectively retreated with up to 3 injections of CCH.

TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic IV.

Для цитирования: Bear Brian J, Peimer Clayton A, Kaplan F Thomas D, Kaufman Gregory J, Tursi James P, Smith Ted. Treatment of Recurrent Dupuytren Contracture in Joints Previously Effectively Treated With Collagenase Clostridium histolyticum.. The Journal of hand surgery. 2017. DOI: 10.1016/j.jhsa.2017.02.010.

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