Witthaut Jörg, Jones Graeme, Skrepnik Nebojsa, Kushner Harvey, Houston Anthony, Lindau Tommy R
Department of Hand Surgery, Uppsala University Hospital, Uppsala, Sweden.
J Hand Surg Am. 2013 Jan;38(1):2-11. doi: 10.1016/j.jhsa.2012.10.008. Epub 2012 Dec 4.
The JOINT I (United States) and JOINT II (Australia and Europe) studies evaluated the efficacy and safety of collagenase clostridium histolyticum (CCH) injection for the treatment of Dupuytren contracture.
Both studies used identical open-label protocols. Patients with fixed-flexion contractures of metacarpophalangeal (MCP) (20° to 100°) or proximal interphalangeal (PIP) joints (20° to 80°) could receive up to three 0.58-mg CCH injections per cord (up to 5 total injections per patient). We performed standardized finger extension procedures to disrupt injected cords the next day, with follow-up 1, 2, 6, and 9 months thereafter. The primary end point (clinical success) was reduction in contracture to within 0° to 5° of full extension 30 days after the last injection. Clinical improvement was defined as 50% or more reduction from baseline contracture.
Dupuytren cords affecting 879 joints (531 MCP and 348 PIP) in 587 patients were administered CCH injections at 14 U.S. and 20 Australian/European sites, with similar outcomes in both studies. Clinical success was achieved in 497 (57%) of treated joints using 1.2 ± 0.5 (mean ± SD) CCH injections per cord. More MCP than PIP joints achieved clinical success (70% and 37%, respectively) or clinical improvement (89% and 58%, respectively). Less severely contracted joints responded better than those more severely contracted. Mean change in contracture was 55° for MCP joints and 25° for PIP joints. With average contracture reductions of 73% and improvements in range of motion by 30°, most patients (92%) were "very satisfied" (71%) or "quite satisfied" (21%) with treatment. Physicians rated change from baseline as "very much improved" (47%) or "much improved" (35%). The CCH injections were well tolerated, causing no tendon ruptures or systemic reactions.
Collagenase clostridium histolyticum was an effective, minimally invasive option for the treatment of Dupuytren contracture of a broad range of severities. Most treated joints (625 of 879) required a single injection. Treatment earlier in the course of disease provided improved outcomes.
TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic IV.
联合I（美国）和联合II（澳大利亚及欧洲）研究评估了溶组织梭状芽孢杆菌胶原酶（CCH）注射治疗掌腱膜挛缩症的疗效和安全性。
两项研究均采用相同的开放标签方案。掌指关节（MCP）固定性屈曲挛缩20°至100°或近端指间关节（PIP）固定性屈曲挛缩20°至80°的患者，每条索带最多可接受3次0.58毫克CCH注射（每位患者最多共5次注射）。次日我们进行标准化的手指伸展操作以破坏注射的索带，此后在1、2、6和9个月进行随访。主要终点（临床成功）是最后一次注射后30天挛缩减少至完全伸展0°至5°以内。临床改善定义为挛缩较基线减少50%或更多。
在14个美国和20个澳大利亚/欧洲地点，对587例患者中影响879个关节（531个MCP和348个PIP）的掌腱膜索带进行了CCH注射，两项研究结果相似。使用每条索带1.2±0.5（均值±标准差）次CCH注射，497个（57%）治疗关节取得了临床成功。取得临床成功（分别为70%和37%）或临床改善（分别为89%和58%）的MCP关节比PIP关节更多。挛缩程度较轻的关节比挛缩程度较重的关节反应更好。MCP关节挛缩平均变化为55°，PIP关节为25°。随着挛缩平均减少73%且活动范围改善30°，大多数患者（92%）对治疗“非常满意”（71%）或“相当满意”（21%）。医生将与基线相比的变化评为“改善非常大”（47%）或“改善很大”（35%）。CCH注射耐受性良好，未导致肌腱断裂或全身反应。
溶组织梭状芽孢杆菌胶原酶是治疗各种严重程度掌腱膜挛缩症的一种有效、微创的选择。大多数治疗关节（879个中的625个）只需单次注射。在疾病进程中尽早治疗可取得更好的结果。
研究类型/证据水平：治疗性IV级。
