Injectable Collagenase Clostridium Histolyticum for Dupuytren's Contracture.
Injectable Collagenase Clostridium Histolyticum for Dupuytren's Contracture.
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DOI：
10.1056/nejmoa0810866
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发表时间：
2009-09-03
影响因子：
158.5
通讯作者：
Rodzvilla, John
中科院分区：
文献类型：
--
作者：
Hurst, Lawrence C.;Badalamente, Marie A.;Rodzvilla, John
背景：迪皮特伦病限制了手的功能，降低了生活质量，并可能最终使手残疾。手术后进行手部治疗是标准的治疗方法，但它与严重的潜在并发症有关。注射胶原酶溶组织梭菌，一个办公室为基础的，非手术的选择，可能会减少关节挛缩所造成的Dupuytren's diseases.Methods：我们招募了308例关节挛缩的20度或以上的前瞻性，随机，双盲，安慰剂对照，多中心试验。这些患者的原发性掌指关节或近端指间关节被随机分配接受最多3次胶原酶溶组织梭菌注射（每次注射剂量为0.58 mg）或安慰剂注射，间隔30天。注射后一天，操作关节。主要终点是最后一次注射后30天挛缩减少到0至5度的完全伸展。26个次要终点进行了评估，并收集了不良事件的数据。结果：胶原酶治疗显着改善的结果。注射胶原酶的脐带比注射安慰剂的脐带更多达到主要终点（64.0% vs. 6.8%，P
Background: Dupuytren's disease limits hand function, diminishes the quality of life, and may ultimately disable the hand. Surgery followed by hand therapy is standard treatment, but it is associated with serious potential complications. Injection of collagenase clostridium histolyticum, an office-based, nonsurgical option, may reduce joint contractures caused by Dupuytren's disease.Methods: We enrolled 308 patients with joint contractures of 20 degrees or more in this prospective, randomized, double-blind, placebo-controlled, multicenter trial. The primary metacarpophalangeal or proximal interphalangeal joints of these patients were randomly assigned to receive up to three injections of collagenase clostridium histolyticum (at a dose of 0.58 mg per injection) or placebo in the contracted collagen cord at 30-day intervals. One day after injection, the joints were manipulated. The primary end point was a reduction in contracture to 0 to 5 degrees of full extension 30 days after the last injection. Twenty-six secondary end points were evaluated, and data on adverse events were collected.Results: Collagenase treatment significantly improved outcomes. More cords that were injected with collagenase than cords injected with placebo met the primary end point (64.0% vs. 6.8%, P