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期刊来源：Ann Intern Med

原文链接：https://doi.org/10.7326/M23-1485

摘要内容如下：

背景

手术、针刺筋膜切开术和胶原酶注射可用于治疗掌腱膜挛缩。治疗决策需要平衡手术的初始发病率和成本与针刺筋膜切开术和胶原酶的潜在长期效益。

客观

在3个月和2年（试验的次要时间点）比较手术、针刺筋膜切开术和胶原酶注射的有效性。

设计

一项多中心、随机、结果评估者盲法、优效性试验。（ClinicalTrials.gov：NCT03192020）

设置

芬兰6家公立医院。

参与者

302名未经治疗的掌腱膜挛缩患者（挛缩角度<135°）。

干预

手术（n=101）、针刺筋膜切开术（n=101）或胶原酶（n=100）。

测量

主要结果是成功率，定义为大于50%的挛缩缓解和患者达到患者可接受的症状状态。次要转归包括手功能、疼痛、生活质量、患者满意度、残余挛缩角度、手指屈曲、再治疗风险和严重不良事件。

结果

共有292名（97%）和284名（94%）参与者完成了3个月和2年的随访。3个月时的成功率相似：手术为71%（95%CI，62%-80%），针刺筋膜切开术为73%（CI，64%-82%），胶原酶为73%（CI，64%-82%）。在2年时，与针式筋膜切开术相比，手术的成功率更高（78%对50%；调整后的风险差异[ARD]，0.30[CI，0.17至0.43]）和胶原酶（78%对65%；ARD，0.13[CI，0.01至0.26]）。与主要分析平行的次要分析。

局限性

参与者没有失明。

结论

两种治疗的最初结果相似，但在2年时，手术组的成功率保持不变，但尽管再次治疗，针刺筋膜切开术和胶原酶的成功率较低。

主要资金来源

芬兰研究理事会。

英文原文如下：

Abstracts

BACKGROUND  Surgery, needle fasciotomy, and collagenase injection are used to treat Dupuytren contracture. The treatment decision requires balancing initial morbidity and costs of surgery against its potential long-term benefits over needle fasciotomy and collagenase.

OBJECTIVE  To compare the effectiveness of surgery, needle fasciotomy, and collagenase injection at 3 months and 2 years (secondary time points of the trial).

DESIGN  A multicenter, randomized, outcome assessor-blinded, superiority trial. (ClinicalTrials.gov: NCT03192020).

SETTING  6 public hospitals in Finland.

PARTICIPANTS  302 persons with treatment-naive Dupuytren contracture (contracture angle <135°).

INTERVENTION  Surgery (n = 101), needle fasciotomy (n = 101), or collagenase (n = 100).

MEASUREMENTS  The primary outcome was the success rate, defined as greater than 50% contracture release and patients reaching the patient acceptable symptom state. Secondary outcomes included hand function, pain, quality of life, patient satisfaction, residual contracture angle, finger flexion, risk for retreatment, and serious adverse events.

RESULTS  A total of 292 (97%) and 284 (94%) participants completed the 3-month and 2-year follow-ups. Success rates were similar at 3 months: 71% (95% CI, 62% to 80%) for surgery, 73% (CI, 64% to 82%) for needle fasciotomy, and 73% (CI, 64% to 82%) for collagenase. At 2 years, surgery had superior success rates compared with both needle fasciotomy (78% vs. 50%; adjusted risk difference [aRD], 0.30 [CI, 0.17 to 0.43]) and collagenase (78% vs. 65%; aRD, 0.13 [CI, 0.01 to 0.26]). Secondary analyses paralleled with the primary analysis.

LIMITATION  Participants were not blinded.

CONCLUSION  Initial outcomes are similar between the treatments, but at 2 years success rates were maintained in the surgery group but were lower with both needle fasciotomy and collagenase despite retreatments.

PRIMARY FUNDING SOURCE  Research Council of Finland.

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