英国莱斯特大学医院Joseph Dias团队比较了胶原酶注射与有限筋膜切除术治疗掌腱膜挛缩症的疗效。该项研究成果发表在2024年10月9日出版的《新英格兰医学杂志》上。

治疗掌腱膜挛缩症的策略包括有限筋膜切除术和胶原酶注射。这些治疗方法的有效性比较有限。

研究组进行了一项非盲、多中心、实用、两组、随机、对照的非劣效性试验，比较了胶原酶注射和有限筋膜切除术在中度掌腱膜挛缩患者中的效果。主要结局是治疗后1年患者评估量表-手部健康状况（PEM）的得分，这是一份用于评估患者报告的手部健康的问卷。PEM的得分范围为0到100，得分越高，结果越差。预先设定的非劣效性界限为6分。

共有672人（每组336人）被分配接受胶原酶注射或有限筋膜切除术。初步分析包括599人：胶原酶组314人，有限筋膜切除组285人。胶原酶组284名有可用数据的患者在1年时的PEM平均得分为17.8，有限筋膜切除组250名有可用信息的患者在一年时的平均得分为11.9（估计差异为5.9分；95%置信区间[CI]为3.1至8.8；非劣效性单侧P=0.49）。在有可用数据的患者中（胶原酶组229名患者和有限筋膜切除组197名患者），2年时PEM平均得分的估计差异为7.2分（95%CI，4.2至10.9）。胶原酶组1.8%的患者和有限筋膜切除术组5.1%的患者出现中度或重度治疗并发症；复发性挛缩导致再次介入的比例分别为14.6%和3.4%。

研究结果表明，就治疗后1年的PEM评分而言，胶原酶注射并不劣于有限筋膜切除术。

附：英文原文

Title: Collagenase Injection versus Limited Fasciectomy for Dupuytren’s Contracture

Author: Joseph Dias, Puvanendran Tharmanathan, Catherine Arundel, Charlie Welch, Qi Wu, Paul Leighton, Maria Armaou, Nick Johnson, Sophie James, John Cooke, Lionel Bainbridge, Michael Craigen, David Warwick, Samantha Brady, Lydia G. Flett, Judy Jones, Catherine N. Knowlson, Michelle Watson, Ada Keding, Catherine E. Hewitt, David Torgerson

Issue&Volume: 2024-10-09

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.

DOI: NJ202410090000002

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2312631