首都医科大学附属北京天坛医院王拥军教授团队研究了秋水仙碱治疗急性缺血性中风患者是否能改善后续卒中风险。这一研究成果于2024年6月26日发表在《英国医学杂志》上。

为了评估秋水仙碱与安慰剂相比，在症状出现后三个月内降低高危非心源性栓塞性缺血性卒中或短暂性缺血性发作后发生卒中风险的有效性和安全性（CHANCE-3），2022年8月11日至2023年4月13日，研究组在中国的244家医院进行了一项多中心、双盲、随机、安慰剂对照试验。

招募8343名年龄在40岁及以上的轻度至中度缺血性中风或短暂性缺血性发作且高敏C反应蛋白≥2 mg/L的患者。在症状出现后24小时内，患者被1:1随机分配接受秋水仙碱（0.5 mg，第1-3天每天两次，之后每天0.5 mg）或安慰剂治疗90天。主要疗效结局是随机分组后90天内出现任何新的卒中。主要安全性结局是治疗期间的任何严重不良事件。所有疗效和安全性分析均为意向性治疗。

4176名患者被分配到秋水仙碱组，4167名被分配到安慰剂组。秋水仙碱组264名患者（6.3%）和安慰剂组270名患者（6.5%）在90天内发生卒中（危险比0.98（95%置信区间0.83-1.16）；P＝0.79）。秋水仙碱组91名（2.2%）患者和安慰剂组88名（2.1%）患者出现任何严重不良事件（P=0.83）。

该研究没有提供证据表明，与安慰剂相比，低剂量秋水仙碱可以在90天内降低急性非心源性栓塞性轻度至中度缺血性卒中或短暂性缺血性发作以及高敏C反应蛋白≥2 mg/L的患者的后续卒中风险。

附：英文原文

Title: Colchicine in patients with acute ischaemic stroke or transient ischaemic attack (CHANCE-3): multicentre, double blind, randomised, placebo controlled trial

Author: Jiejie Li, Xia Meng, Fu-Dong Shi, Jing Jing, Hong-Qiu Gu, Aoming Jin, Yong Jiang, Hao Li, S Claiborne Johnston, Graeme J Hankey, J Donald Easton, Liguo Chang, Penglai Shi, Lihua Wang, Xianbo Zhuang, Haitao Li, Yingzhuo Zang, Jianling Zhang, Zengqiang Sun, Dongqi Liu, Ying Li, Hongqin Yang, Jinguo Zhao, Weiran Yu, Anxin Wang, Yuesong Pan, Jinxi Lin, Xuewei Xie, Wei-Na Jin, Shuya Li, Siying Niu, Yilong Wang, Xingquan Zhao, Zixiao Li, Liping Liu, Huaguang Zheng, Yongjun Wang

Issue&Volume: 2024/06/26

Abstract:

Objectives To assess the efficacy and safety of colchicine versus placebo on reducing the risk of subsequent stroke after high risk non-cardioembolic ischaemic stroke or transient ischaemic attack within the first three months of symptom onset (CHANCE-3).

Design Multicentre, double blind, randomised, placebo controlled trial.

Setting 244 hospitals in China between 11 August 2022 and 13 April 2023.

Participants 8343 patients aged 40 years of age or older with a minor-to-moderate ischaemic stroke or transient ischaemic attack and a high sensitivity C-reactive protein ≥2 mg/L were enrolled.

Interventions Patients were randomly assigned 1:1 within 24 h of symptom onset to receive colchicine (0.5 mg twice daily on days 1-3, followed by 0.5 mg daily thereafter) or placebo for 90 days.

Main outcome measures The primary efficacy outcome was any new stroke within 90 days after randomisation. The primary safety outcome was any serious adverse event during the treatment period. All efficacy and safety analyses were by intention to treat.

Results 4176 patients were assigned to the colchicine group and 4167 were assigned to the placebo group. Stroke occurred within 90 days in 264 patients (6.3%) in the colchicine group and 270 patients (6.5%) in the placebo group (hazard ratio 0.98 (95% confidence interval 0.83 to 1.16); P=0.79). Any serious adverse event was observed in 91 (2.2%) patients in the colchicine group and 88 (2.1%) in the placebo group (P=0.83).

Conclusions The study did not provide evidence that low-dose colchicine could reduce the risk of subsequent stroke within 90 days as compared with placebo among patients with acute non-cardioembolic minor-to-moderate ischaemic stroke or transient ischaemic attack and a high sensitivity C-reactive protein ≥2 mg/L.

DOI: 10.1136/bmj-2023-079061

Source: https://www.bmj.com/content/385/bmj-2023-079061