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注射溶组织梭状芽孢杆菌胶原酶治疗掌腱膜挛缩症。

Collagenase clostridium histolyticum injection for the treatment of Dupuytren's contracture.

作者信息

Kaplan F T D

机构信息

Indiana Hand to Shoulder Center, Indianapolis, USA.

出版信息

Drugs Today (Barc). 2011 Sep;47(9):653-67. doi: 10.1358/dot.2011.47.9.1656502.

DOI:10.1358/dot.2011.47.9.1656502
PMID:21971540
Abstract

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.

摘要

溶组织梭状芽孢杆菌胶原酶是一种治疗掌腱膜挛缩症的新型疗法,于2010年2月获得美国食品药品监督管理局批准。在其问世之前,手术是治疗与此病症相关挛缩的唯一方法。掌腱膜疾病是一种影响手掌的良性、进行性纤维增生性疾病。其特征是形成富含胶原蛋白的结节和索带,这些结节和索带在肌成纤维细胞的作用下逐渐缩短,导致手指挛缩。在其临床研发过程中,共有1082名患者接受了2630次注射,对病灶内使用梭状芽孢杆菌胶原酶进行了评估,其中包括2项大型前瞻性、随机、双盲、安慰剂对照试验:掌腱膜挛缩症减少的胶原酶选择I(CORD I)和CORD II。两项研究均显示,与安慰剂相比,挛缩有统计学意义的减轻,且治疗耐受性良好,大多数不良事件为自限性。与胶原酶活性相关的严重不良事件很少见。病情较轻的挛缩患者以及掌指关节挛缩患者改善最为明显。这种一流的生物注射用溶组织梭状芽孢杆菌胶原酶,为掌腱膜挛缩症患者提供了一种安全、有效的手术替代方案。

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Collagenase clostridium histolyticum injection for the treatment of Dupuytren's contracture.注射溶组织梭状芽孢杆菌胶原酶治疗掌腱膜挛缩症。
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