Injectable Collagenase Clostridium Histolyticum: A New Nonsurgical Treatment for Dupuytren's Disease

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作者：

D Gilpin，S Coleman，S Hall，A Houston，J Karrasch，N Jones

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摘要：

The Collagenase Option for the Reduction of Dupuytren's (CORD) II study investigated the efficacy and safety of injectable Xiaflex (collagenase clostridium histolyticum), in patients with Dupuytren's contracture.MethodsThis was a prospective, randomized, placebo-controlled trial with 90-day double-blind and 9-month open-label phases. We randomized patients with contractures affecting metacarpophalangeal (MCP) or proximal interphalangeal (PIP) joints 2 to 1 to collagenase (0.58 mg) or placebo. Cords received a maximum of 3 injections. Cord disruption was attempted the day after injection using a standardized finger extension procedure. Primary end point was reduction in contracture to 0° to 5° of normal 30 days after the last injection.ResultsWe enrolled 66 patients; 45 cords (20 MCP to 25 PIP joints) received collagenase and 21 cords (11 MCP to 10 PIP joints) received placebo in the double-blind phase. Statistically significantly more cords injected with collagenase than placebo met the primary end point (44.4% vs 4.8%; p ConclusionsCollagenase clostridium histolyticum is the first Food and Drug Administration–approved, nonsurgical treatment option for adult Dupuytren's contracture patients with a palpable cord that is highly effective and well tolerated.Type of study/level of evidenceTherapeutic I.

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关键词：

cord contracture Dupuytren's contracture enzymatic fasciotomy recurrence

DOI：

10.1016/j.jhsa.2010.08.007

被引量：

310

年份：

2010