溶组织梭状芽孢杆菌胶原酶联合注射治疗多发杜普伊特伦挛缩症的疗效与安全性
Efficacy and safety of concurrent collagenase clostridium histolyticum injections for multiple Dupuytren contractures.
作者信息
Coleman Stephen, Gilpin David, Kaplan F Thomas D, Houston Anthony, Kaufman Gregory J, Cohen Brian M, Jones Nigel, Tursi James P
机构信息
Brisbane Hand and Upper Limb Clinic, Brisbane, Queensland, Australia; the Indiana Hand to Shoulder Center, Indianapolis, IN; the Caboolture Clinical Research Centre, Caboolture, Queensland, Australia; Auxilium Pharmaceuticals, Inc., Chesterbrook, PA; and Auxilium Pharmaceuticals, Inc., Windsor, United Kingdom..
Brisbane Hand and Upper Limb Clinic, Brisbane, Queensland, Australia; the Indiana Hand to Shoulder Center, Indianapolis, IN; the Caboolture Clinical Research Centre, Caboolture, Queensland, Australia; Auxilium Pharmaceuticals, Inc., Chesterbrook, PA; and Auxilium Pharmaceuticals, Inc., Windsor, United Kingdom.
出版信息
J Hand Surg Am. 2014 Jan;39(1):57-64. doi: 10.1016/j.jhsa.2013.10.002. Epub 2013 Dec 4.
PURPOSE
To assess the safety and efficacy of 2 concurrent injections of collagenase clostridium histolyticum (CCH) in the same hand to treat multiple Dupuytren flexion contractures.
METHODS
In a multicenter, open-label phase IIIb study, 60 patients received two 0.58-mg CCH doses injected into cords affecting 2 joints in the same hand during 1 visit, followed by finger extension approximately 24 hours later. Efficacy at postinjection day 30 (change in flexion contracture and active range of motion, patient satisfaction, physician-rated improvement, and rates of clinical success [flexion contracture 5° or less]) and adverse events were summarized.
RESULTS
The concurrent injections were most commonly administered in cords affecting metacarpophalangeal (MCP) and proximal interphalangeal (PIP) joints on the same finger (47%) or 2 MCP joints on different fingers of the same hand (37%). Mean total (sum of the 2 treated joints) flexion contracture decreased 76%, from 87° to 24° (MCP joints: 86%; PIP joints: 66%). Mean total range of motion increased from 100° to 161°. Clinical success was 76% for MCP joints and 33% for PIP joints. Most patients were very satisfied (60%) or quite satisfied (28%) with treatment. Most investigators rated treated joints as very much improved (55%) or much improved (37%). The most common treatment-related adverse events (> 75% of patients) were contusion, pain in extremity, and edema peripheral (local edema). Most adverse events were mild to moderate in severity. Serious complications included 1 pulley rupture related to study medication and 1 flexor tendon rupture (following conclusion of the study). There were no systemic complications.
CONCLUSIONS
Results suggest that 2 affected joints can be effectively and safely treated with concurrent CCH injections. There was an increased incidence of some adverse events with concurrent treatment (pruritus, lymphadenopathy, blood blister, and skin laceration) compared with treatment of a single joint. High degrees of patient satisfaction and physician-rated improvement were reported.
TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic IV.
目的
评估在同一只手同时注射两次溶组织梭菌胶原酶（CCH）治疗多个杜普伊特伦挛缩症的安全性和有效性。
方法
在一项多中心、开放标签的IIIb期研究中，60例患者在一次就诊时接受两次0.58毫克CCH剂量注射，注入影响同一只手2个关节的条索，约24小时后进行手指伸展。总结注射后第30天的疗效（屈曲挛缩和主动活动范围的变化、患者满意度、医生评定的改善情况以及临床成功率[屈曲挛缩5°或更小]）和不良事件。
结果
同时注射最常用于影响同一手指的掌指（MCP）关节和近端指间（PIP）关节的条索（47%）或同一只手不同手指的2个MCP关节（37%）。平均总（2个治疗关节之和）屈曲挛缩减少76%，从87°降至24°（MCP关节：86%；PIP关节：66%）。平均总活动范围从100°增加到161°。MCP关节的临床成功率为76%，PIP关节为33%。大多数患者对治疗非常满意（60%）或相当满意（28%）。大多数研究者将治疗的关节评定为改善非常大（55%）或改善很大（37%）。最常见的与治疗相关的不良事件（>75%的患者）是挫伤、肢体疼痛和外周水肿（局部水肿）。大多数不良事件的严重程度为轻度至中度。严重并发症包括1例与研究用药相关的滑车破裂和1例屈肌腱破裂（研究结束后）。无全身并发症。
结论
结果表明，同时注射CCH可有效且安全地治疗2个受影响的关节。与单关节治疗相比，同时治疗时一些不良事件的发生率增加（瘙痒、淋巴结病、血泡和皮肤撕裂）。报告了高度的患者满意度和医生评定的改善情况。
研究类型/证据水平：治疗性IV级。
Zotero 插件