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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：胶原酶溶组织梭状芽胞杆菌注射液治疗Dupuytren挛缩症。

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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：胶原酶组织溶解梭状芽胞杆菌是一种用于Dupuytren挛缩的新型治疗方法，于2010年2月获得美国食品和药物管理局的批准。在此之前，手术是与这种疾病相关的挛缩的唯一治疗方法。 Dupuytren病是一种良性，进行性纤维增生性疾病，会影响手掌。它的特征是富含胶原的结节和脐带的形成，由于成肌纤维细胞的作用逐渐缩短，导致手指挛缩。在临床开发过程中，共计1,082例患者接受了2,630剂注射，评估了梭菌胶原酶的局部使用，包括2项大型前瞻性，随机，双盲，安慰剂对照试验：胶原酶用于减少Dupuytren I（CORD I）和CORD II。两项研究均显示，与安慰剂相比，挛缩症在统计学上有显着减少，并且治疗耐受性良好，且大多数不良反应是自限性的。与胶原酶活性有关的严重不良事件很少见。挛缩程度较轻且掌指关节挛缩的患者最大改善。这种一流的生物可注射梭菌胶原酶组织溶解术为患有Dupuytren挛缩症的患者提供了一种安全，有效的手术替代方法。

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