荷兰阿姆斯特丹大学Camiel Verhamme团队比较了腕管综合征接受手术与皮质类固醇注射（DISTRICTS）的疗效。相关论文于2025年6月14日发表在《柳叶刀》杂志上。

手术和皮质类固醇注射是治疗腕管综合征的常用方法，但最佳治疗策略尚不清楚。该研究旨在比较以手术开始治疗与以皮质类固醇注射开始治疗的效果。

研究组在荷兰的31家医院进行了一项开放标签、随机对照试验。诊断为腕管综合征至少6周并经电生理或超声检查证实的符合条件的患者，通过基于网络的系统随机分配（1:1），通过手术或注射开始治疗。随机分组根据单侧或双侧症状、腕管综合征伴或不伴疾病作为危险因素以及既往同侧注射进行分层。如果需要，可以进行额外的治疗，例如额外的注射或手术。在意向治疗人群中评估的主要结局是患者在18个月时康复的比例（定义为在6项腕管综合征量表中得分低于8分）。该试验已在ISRCTN注册中心（ISRCTN13164336）预注册，现已完成。

从2017年11月7日到2021年11月4日，共纳入934名参与者（545名女性和389名男性）。随机分为手术组468例，注射组466例。在18个月时，934名参与者中有805名（86%）获得了主要结局数据。手术组401例患者中有243例（61%）康复，明显高于注射组404例患者中180例（45%）康复(相对危险度为1.36；95% ci为1.19 - 1.56；术;0·0001)。手术组436名参与者中有376名（86%）发生了一次或多次不良事件，注射组453名参与者中有384名（85%）发生了不良事件。手术组中一名参与者因并发症住院。没有与治疗相关的死亡报告。

研究结果表明，对于腕管综合征患者，在18个月后开始手术治疗比开始注射皮质类固醇有更高的康复机会，即使可能有额外的干预措施。

附：英文原文

Title: Surgery versus corticosteroid injection for carpal tunnel syndrome (DISTRICTS): an open-label, multicentre, randomised controlled trial

Author: Wijnand A C Palmbergen, Roy Beekman, A Marijne Heeren, Bart F L van Nuenen, Tim W H Alleman, Esther Verstraete, Korné Jellema, Wim I M Verhagen, Leo H Visser, Godard C W de Ruiter, Diederik van de Beek, Corianne A J M de Borgie, Johannes A Bogaards, Rob M A de Bie, Camiel Verhamme

Issue&Volume: 2025/06/14

Abstract:

Background

Surgery and corticosteroid injections are established treatments for carpal tunnel syndrome, but the optimal treatment strategy remains unclear. This study aimed to compare starting treatment with surgery versus starting with a corticosteroid injection.

Methods

We conducted an open-label, randomised controlled trial across 31 hospitals in the Netherlands. Eligible patients, diagnosed with carpal tunnel syndrome for at least 6 weeks and confirmed by electrophysiological or sonographic testing, were randomly assigned (1:1) to start treatment with either surgery or an injection via a web-based system. Randomisation was stratified by unilateral or bilateral symptoms, carpal tunnel syndrome with or without concomitant disease as risk factor, and previous ipsilateral injections. If needed, additional treatments were allowed, such as additional injections or surgery. The primary outcome, assessed in the intention-to-treat population, was the proportion of patients who were recovered (defined as a score of less than eight points on the six-item carpal tunnel syndrome scale) at 18 months. The trial was preregistered with the ISRCTN Registry (ISRCTN13164336) and is now completed.

Findings

From Nov 7, 2017, to Nov 4, 2021, 934 participants (545 female and 389 male participants) were included. 468 were randomised to the surgery group and 466 to the injection group. At 18 months, 805 (86%) of 934 participants had primary outcome data. In the surgery group, 243 (61%) of 401 participants had recovered, significantly higher than the 180 (45%) of 404 participants recovered in the injection group (relative risk 1·36; 95% CI 1·19–1·56; p<0·0001). One or more adverse event occurred in 376 (86%) of 436 participants in the surgery group and in 384 (85%) of 453 participants in the injection group. One participant in the surgery group was hospitalised due to complications. No treatment-related deaths were reported.

Interpretation

In patients with carpal tunnel syndrome, initiating treatment with surgery offers a higher chance of recovery after 18 months compared with starting with a corticosteroid injection, even with the possibility of additional interventions.

DOI: 10.1016/S0140-6736(25)00368-X

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)00368-X/abstract