From the Department of Plastic Surgery, Cleveland Clinic Florida; the Department of General Surgery, Mount Sinai Medical Center; and the Department of Internal Medicine, University of Pittsburgh Medical Center Pinnacle.
Plast Reconstr Surg. 2019 Apr;143(4):782e-787e. doi: 10.1097/PRS.0000000000005443.
The U.S. Food and Drug Administration approved collagenase clostridium histolyticum for treatment of Dupuytren's contracture in 2010, and for the concurrent treatment of up to two cords in 2014. Although outcomes and adverse events have been well described for single injections, comparative data on concurrent injections are lacking.
The authors reviewed 121 concurrent collagenase clostridium histolyticum injections and compared these with 177 single injections over 8 years. All injections were performed by a single surgeon, our senior author (D.F.). A retrospective cohort model was used to compare clinical outcomes and adverse events (i.e., skin tears, spontaneous cord rupture, tendon rupture, lymphadenopathy, blood blisters, and ecchymosis) between groups.
There were no statistical differences between groups in clinical success rate or change in contracture per joint. The rate of skin tears per joint in concurrent injections (22.3 percent) was not statistically different from that of single injections (18.6 percent; p = 0.46), and was consistent with previously reported rates. The rate of skin tears did not change significantly over time in either group. Concurrent injection did not influence the incidence of skin tears in a dose-dependent manner (relative risk, 1.20). Patients receiving concurrent injections experienced a higher rate of lymphadenopathy compared with those receiving single injections (p = 0.001).
Concurrent collagenase clostridium histolyticum injections for Dupuytren's contracture have a similar safety profile and treatment efficacy when compared to single injections. The authors did not find a dose-dependent relationship between skin tears and collagenase clostridium histolyticum injected.
CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.
美国食品和药物管理局于 2010 年批准胶原酶梭菌组织溶菌素用于治疗杜普伊特伦挛缩症，于 2014 年批准其用于同时治疗最多两条挛缩带。虽然单次注射的效果和不良反应已有详细描述，但同时注射的对比数据尚缺乏。
作者回顾了 121 例同时注射胶原酶梭菌组织溶菌素的病例，并与 8 年内 177 例单次注射的病例进行比较。所有注射均由一位医生（D.F.）进行，采用回顾性队列模型比较两组的临床疗效和不良反应（即皮肤撕裂、自发性索断裂、肌腱断裂、淋巴结病、血疱和瘀斑）。
两组在临床成功率或每关节挛缩改善方面无统计学差异。同时注射的皮肤撕裂发生率（22.3%）与单次注射（18.6%）无统计学差异（p=0.46），且与既往报道的发生率一致。两组的皮肤撕裂发生率均无随时间推移而显著变化。同时注射并未以剂量依赖的方式影响皮肤撕裂的发生率（相对风险，1.20）。与接受单次注射的患者相比，接受同时注射的患者更易发生淋巴结病（p=0.001）。
与单次注射相比，同时注射胶原酶梭菌组织溶菌素治疗杜普伊特伦挛缩的安全性和疗效相当。作者未发现皮肤撕裂与注射胶原酶梭菌组织溶菌素之间存在剂量依赖性关系。
临床问题/证据水平：治疗性，III 级。
