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首页> 外文期刊>Drugs of today: Medicamentos de actualidad >Collagenase clostridium histolyticum injection for the treatment of Dupuytren's contracture.
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Collagenase clostridium histolyticum injection for the treatment of Dupuytren's contracture.

机译：胶原酶蛋白酶组织溶液注射器治疗Dupuytren挛缩。

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摘要

Collagenase clostridium histolyticum is a novel treatment for Dupuytren's contracture, approved by the U.S. Food and Drug Administration in February 2010. Prior to its availability, surgery was the only treatment for contracture related to this disorder. Dupuytren's disease is a benign, progressive fibroproliferative disorder affecting the palms of the hands. It is characterized by the formation of collagen- rich nodules and cords, which gradually shorten by the action of myofibroblasts, resulting in finger contractures. Intralesional use of clostridial collagenase has been evaluated in a total of 1,082 patients receiving 2,630 injections during its clinical development, including 2 large prospective, randomized, double-blind, placebo-controlled trials: Collagenase Option for Reduction of Dupuytren's I (CORD I) and CORD II. Both studies showed a statistically significant reduction in contracture compared to placebo and treatment was well-tolerated with the majority of adverse events self-limited. Serious adverse events related to collagenase activity were rare. Maximal improvement was seen in patients with less severe contractures and with contractures of the metacarpophalangeal joint. This first-in-class biologic, injectable clostridial collagenase histolyticum, provides a safe, effective alternative to surgery for patients with Dupuytren's contracture.
机译：胶原酶Clostridium Histolyticum是对Dupuytren的挛缩的新颖治疗，由美国食品和药物管理局于2010年2月批准。在其可用性之前，手术是与这种疾病有关的挛缩的唯一治疗方法。 Dupuytren的疾病是一种良性，渐进性纤维增生症，影响手掌手掌。它的特征在于形成胶原富胶的结节和帘线，其逐渐通过肌纤维细胞的作用逐渐缩短，导致手指挛缩。在其临床开发期间，在患有1,082名患者中，共评估了梭菌胶原酶的体内用途，其中包括2种大型前瞻性，随机，双盲，安慰剂对照试验：胶原酶选项，用于减少Dupuytren的I（绳索）和绳索。与安慰剂相比，这两项研究表明，与安慰剂和治疗相比，随着自我限制的大多数不良事件耐受耐受良好的耐受性。与胶原酶活性有关的严重不良事件是罕见的。患有较严重的挛缩患者和Metacarpalangalangeal关节挛缩的患者中看到最大改善。这种先进一体的生物学可注射梭菌胶原酶组织溶液为杜普ytren挛缩患者提供安全，有效的手术替代。

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