秋水仙碱预防急性脑出血后血管事件：安慰剂对照试验
本研究为在加拿大11家中心开展的双盲、安慰剂对照、随机先导试验，纳入发病48小时内的急性脑出血成人患者，随机接受秋水仙碱0.5 mg每日一次或安慰剂。主要评估招募可行性，结果显示平均招募率为8.9人/中心/年，6个月保留率92%。结论认为在急性脑出血后测试低剂量秋水仙碱具有可行性。
要点
- 急性脑出血后48小时内启动低剂量秋水仙碱测试具备可行性。
- 两组永久停药率均为27%，未来试验需重视早期停药问题。
- 中位随访364天，探索性疗效与安全性终点两组无差异。
核心结论
- 在急性脑出血后测试低剂量秋水仙碱是可行的。
- 未来随机临床试验应考虑该患者群体早期永久停药率较高的问题。
研究设计与样本
- 双盲、安慰剂对照、先导随机临床试验，在加拿大11家中心开展。
- 纳入发病48小时内、有血管神经影像证据或动脉粥样硬化危险因素的成人脑出血患者。
- 参与者随机接受口服秋水仙碱0.5 mg每日一次或安慰剂，并随访至共同研究终止日期。
- 试验注册号：NCT05159219。
主要发现
- 2022年8月至2024年3月，52例分配至秋水仙碱组，48例分配至安慰剂组。
- 参与者平均年龄68岁，60%为男性，从脑出血发病到随机化的平均时间为35小时。
- 平均招募率为8.9人/中心/年，6个月保留率为92%（秋水仙碱91%对安慰剂93%）。
- 秋水仙碱组14例（27%）和安慰剂组13例（27%）永久停用研究药物。
- 排除死亡或永久停用研究干预的参与者后，12个月药物依从性为97%，秋水仙碱组100%对安慰剂组93%。
关键数值与推荐
- 主要可行性结局为招募率（参与者/中心/年），平均为8.9人/中心/年。
- 次要可行性结局包括6个月参与者保留率和12个月药物依从性。
- 6个月保留率为92%，秋水仙碱组91%，安慰剂组93%。
- 12个月药物依从性为97%，秋水仙碱组100%，安慰剂组93%。
- 永久停药率：秋水仙碱组27%，安慰剂组27%。
临床怎么用
- 急性脑出血后48小时内启动秋水仙碱0.5 mg每日一次的临床试验路径具备操作性。
- 临床实践中需预期约四分之一的急性脑出血患者可能早期永久停药。
局限性
- 本试验为先导研究，主要评价可行性，未设计足够效力验证疗效或安全性差异。
- 探索性疗效和安全性终点在两组间虽未检测到差异，但样本量有限。
以上解读依据论文摘要（全文未开放获取或许可不允许翻译转载）。
原文
Stroke, Volume 57, Issue 10, Page 2971-2980, October 1, 2026. BACKGROUND:There is a need for novel treatments that lower the risk of major adverse cardiovascular events and secondary inflammatory brain injury after an intracerebral hemorrhage (ICH).METHODS:We performed a double-blind, placebo-controlled, pilot randomized clinical trial at 11 centers across Canada to determine the feasibility of testing colchicine after an acute ICH. We recruited adults presenting within 48 hours of ICH onset with vascular neuroimaging evidence or risk factors for atherosclerosis. Participants were randomized to oral colchicine 0.5 mg daily or placebo and followed to a common study termination date. The primary feasibility outcome was the recruitment rate (participants/center per year). Secondary feasibility outcomes included retention of participants at 6 months and medication adherence at 12 months. This trial is registered (URL:https://www.clinicaltrials.gov; Unique identifier: NCT05159219).RESULTS:Between August 2022 and March 2024, 52 participants were allocated to colchicine 0.5 mg daily and 48 participants to placebo daily. Participants were, on average, 68 years old, and 60% were male. The mean time from ICH onset to randomization was 35 hours. The average recruitment rate was 8.9 participants/site per year. Retention at 6 months was 92% (colchicine 91% versus placebo 93%). Following randomization, 14 participants (27%) in the colchicine group and 13 participants (27%) in the placebo group permanently discontinued the study drug. Excluding participants who died or permanently discontinued the study intervention, 12-month medication adherence was 97%, with similar rates between the colchicine and placebo groups (100% versus 93%). We detected no difference in predefined exploratory efficacy or safety end points between the 2 groups over the median follow-up time of 364 days.CONCLUSIONS:It is feasible to test low-dose colchicine after an acute ICH. Future randomized clinical trials should account for the high rates of early permanent study drug discontinuation in this patient population.REGISTRATION:URL:https://www.clinicaltrials.gov; Unique identifier: NCT05159219.
引用
- Stroke：Colchicine for the Prevention of Vascular Events After an Acute Intracerebral Hemorrhage: A Placebo-Controlled Trial
供执业医师工作参考，不替代临床判断；数值与分级以指南原文为准。