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胶原酶注射与有限掌腱膜切除术治疗Dupuytren 挛缩。

Collagenase Injection versus Limited Fasciectomy for Dupuytren's Contracture.

机构信息

From the Academic Team of Musculoskeletal Surgery, Undercroft, Leicester General Hospital, University Hospitals of Leicester NHS Trust (J.D., M.A., J.J.), Leicester (J.C.), the York Trials Unit (P.T., C.A., C.W., S.J., S.B., L.G.F., C.N.K., M.W., A.K., C.E.H., D.T.) and the Department of Health Sciences (Q.W.), University of York, York, the University of Nottingham, Nottingham (P.L.), University Hospitals of Derby and the Burton NHS Trust, Derby (N.J., L.B.), the Royal Orthopaedic Hospital NHS Foundation Trust, Birmingham (M.C.), and the University Hospital Southampton NHS Foundation Trust, Southampton (D.W.) - all in the United Kingdom.

出版信息

N Engl J Med. 2024 Oct 24;391(16):1499-1510. doi: 10.1056/NEJMoa2312631. Epub 2024 Oct 9.

DOI:10.1056/NEJMoa2312631

PMID:39383454

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7616701/

Abstract

BACKGROUND

Treatments for Dupuytren's contracture include limited fasciectomy and collagenase injection. Comparisons of the effectiveness of these treatments have been limited.

METHODS

We performed an unblinded, multicenter, pragmatic, two-group, randomized, controlled noninferiority trial comparing collagenase injection with limited fasciectomy in persons with moderate Dupuytren's contracture. The primary outcome was the score on the Patient Evaluation Measure-Hand Health Profile (PEM), a questionnaire for assessing hand health as reported by the patient, at 1 year after treatment. Scores on the PEM range from 0 to 100, with higher scores indicating worse outcomes. The prespecified noninferiority margin was 6 points.

RESULTS

A total of 672 persons (336 per group) were assigned to receive collagenase injection or to undergo limited fasciectomy. The primary analysis included 599 persons: 314 in the collagenase group and 285 in the limited-fasciectomy group. The mean score on the PEM at 1 year was 17.8 among the 284 patients with available data in the collagenase group and 11.9 among the 250 patients with available data in the limited-fasciectomy group (estimated difference, 5.9 points; 95% confidence interval [CI], 3.1 to 8.8; one-sided P = 0.49 for noninferiority). Among the patients with available data (229 patients in the collagenase group and 197 patients in the limited-fasciectomy group), the estimated difference in the mean score on the PEM at 2 years was 7.2 points (95% CI, 4.2 to 10.9). Moderate or severe complications of treatment occurred in 1.8% of the patients in the collagenase group and in 5.1% of those in the limited-fasciectomy group; recurrent contracture resulted in reintervention in 14.6% and 3.4%, respectively.

CONCLUSIONS

Collagenase injection was not noninferior to limited fasciectomy with respect to the score on the PEM at 1 year after treatment. (Funded by the National Institute for Health and Care Research Health Technology Assessment Programme; DISC ISRCTN Registry number ISRCTN18254597.).

摘要

背景

治疗杜普伊特伦挛缩症的方法包括有限的筋膜切开术和胶原酶注射。这些治疗方法的效果比较有限。

方法

我们进行了一项非盲、多中心、实用、两组、随机、对照非劣效性试验，比较了胶原酶注射与局限性筋膜切开术治疗中度杜普伊特伦挛缩症患者的效果。主要结局是治疗后 1 年时患者评估测量手部健康状况（PEM）问卷的评分，这是一种评估手部健康状况的患者报告问卷。PEM 的评分范围为 0 到 100，评分越高表明结果越差。预先设定的非劣效性边界为 6 分。

结果

共有 672 人（每组 336 人）被分配接受胶原酶注射或接受局限性筋膜切开术。主要分析包括 599 人：胶原酶组 314 人，局限性筋膜切开术组 285 人。胶原酶组 284 名有可用数据的患者的 PEM 平均得分为 17.8，局限性筋膜切开术组 250 名有可用数据的患者的 PEM 平均得分为 11.9（估计差值，5.9 分；95%置信区间 [CI]，3.1 至 8.8；单侧 P=0.49，非劣效性）。在有可用数据的患者中（胶原酶组 229 名患者，局限性筋膜切开术组 197 名患者），2 年后 PEM 平均评分的估计差值为 7.2 分（95%CI，4.2 至 10.9）。胶原酶组 1.8%的患者和局限性筋膜切开术组 5.1%的患者发生治疗相关的中度或重度并发症；分别有 14.6%和 3.4%的患者因复发性挛缩而再次干预。