胶原酶组织溶解梭菌与针式筋膜切开术治疗原发性掌指关节杜普伊特伦挛缩症:一项随机对照试验的五年结果。

IF 2.3 Q2 ORTHOPEDICS
JBJS Open Access Pub Date : 2024-11-20 eCollection Date: 2024-10-01 DOI:10.2106/JBJS.OA.24.00038
Ingi Thor Hauksson, Morten Beier Havdal, Jūratė Šaltytė Benth, Sigurd E Hoelsbrekken, Per-Henrik Randsborg
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引用次数: 0

摘要

背景:胶原酶溶解梭菌(CCH)和经皮穿刺筋膜切开术(PNF)是治疗杜普伊特伦病的两种方法。本研究的目的是比较这两种方法的临床和患者报告结果:80名患有单指原发性掌指关节(MCP)挛缩≥30°的患者(中位年龄72岁,83%为男性)被随机分配到CCH或PNF治疗方案中,并随访5年。主要结果是 MCP 关节屈曲-挛缩减少量从基线到 2 年间的差异,另外还对主要终点变量的影响进行了长达 5 年的分析。次要结果包括并发症、握力、疼痛视觉模拟量表(VAS)评分、缩短版手臂、肩部和手部残疾、简短密歇根手部问卷调查、Unité Rhumatologique des Affections de la Main、治疗满意度VAS以及复发和复治率:CCH组的平均MCP关节挛缩基线为48°,5年后为2°;PNF组的平均MCP关节挛缩基线为50°,5年后为7°。CCH组MCP关节挛缩在2年时减少的幅度大于PNF组,组间平均差异为12°(95%置信区间[CI],1.5°至22.3°;P = 0.026)。5 年后,这一平均差异缩小至 6°(-1.5° 至 12.8°;p = 0.1)。除 5 年后的密歇根手部问卷调查外,4 周后患者报告的任何结果评分或握力在两组间均无差异。在 2 年时,PNF 组有 10 名(25%)患者的 MCP 关节复发(挛缩≥30°),而 CCH 组没有患者复发。5 年时,PNF 组 40 名患者中有 17 人(42.5%)复发,而 CCH 组 40 名患者中有 4 人(10%)复发(P < 0.001)。CCH组在第一周经历了更多的一过性并发症(僵硬和血肿),而从1年到5年的随访中,CCH组的满意度(VAS满意度)更高:本研究的主要发现是,CCH和PNF对减少MCP屈曲挛缩同样有效,但CCH组的挛缩矫正持续时间更长:有关证据等级的完整描述,请参阅 "作者须知"。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Collagenase Clostridium histolyticum Versus Needle Fasciotomy for Primary Metacarpophalangeal Dupuytren Contracture: Five-Year Results from a Randomized Controlled Trial.

Background: Collagenase Clostridium histolyticum (CCH) and percutaneous needle fasciotomy (PNF) are 2 treatment options for Dupuytren disease. The purpose of this study was to compare these 2 methods in terms of clinical and patient-reported outcomes.

Methods: Eighty patients (median age, 72 years; 83% male) with a single-digit primary metacarpophalangeal (MCP) joint contracture of ≥30° were randomized to either CCH or PNF and followed for 5 years. The primary outcome was the difference in flexion-contracture reduction at the MCP joint from baseline to 2 years, with additional analysis examining the effect of the primary endpoint variable up to 5 years. Secondary outcomes included complications, grip strength, scores on the visual analogue scale (VAS) for pain, the shortened version of the Disabilities of the Arm, Shoulder and Hand, the brief Michigan Hand Questionnaire, Unité Rhumatologique des Affections de la Main, and a VAS for treatment satisfaction as well as recurrence and retreatments.

Results: The mean MCP joint contracture was 48° at baseline and 2° at 5 years in the CCH group, and 50° at baseline and 7° at 5 years in the PNF group. The reduction in MCP contracture at 2 years was larger in the CCH group than in the PNF group, with a mean difference between the groups of 12° (95% confidence interval [CI], 1.5° to 22.3°; p = 0.026). At 5 years, this mean difference was reduced to 6° (-1.5° to 12.8°; p = 0.1). There was no difference between the groups in any patient-reported outcome scores or grip strength beyond 4 weeks, with the exception of the brief Michigan Hand Questionnaire at 5 years. Ten (25%) of the patients in the PNF group compared with no patient in the CCH group had recurrence (contracture of ≥30°) at the MCP joint at 2 years. At 5 years, 17 (42.5%) of 40 patients in the PNF group had been retreated compared with 4 (10%) of 40 in the CCH group (p < 0.001). The CCH group experienced more transient complications (stiffness and hematoma) during the first week and were more satisfied (VAS satisfaction) from 1 year to the 5-year follow-up.

Conclusions: The main finding of this study is that CCH and PNF were equally effective in reducing MCP flexion contracture, but the correction of contracture lasted longer in the CCH group.

Level of evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

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来源期刊
JBJS Open Access
JBJS Open Access Medicine-Surgery
CiteScore
5.00
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0.00%
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77
审稿时长
6 weeks
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