本文由小咖机器人翻译整理

期刊来源：Lancet

原文链接：https://doi.org/10.1016/S0140-6736(24)00968-1

摘要内容如下：

背景

长期秋水仙碱抗炎治疗可预防冠心病患者血管复发。与通常由动脉粥样硬化引起的冠状动脉疾病不同，缺血性中风由多种机制引起，包括动脉粥样硬化和小血管疾病，或者通常由未知原因引起。我们的目的是研究长期秋水仙碱可以减少缺血性卒中后复发事件的假设。

方法

我们进行了一项随机、平行组、开放标签、盲法终点评估试验，比较了长期秋水仙碱（每天口服0.5 mg）加基于指南的常规治疗与仅常规治疗。以医院为基础的非严重、非心源性栓塞性缺血性卒中或高危短暂性脑缺血发作患者符合入选条件。主要终点是首次致死性或非致死性复发性缺血性卒中、心肌梗死、心脏骤停或因不稳定型心绞痛住院（定义为入院或急诊就诊，导致至少住院24小时[或更改日历日期，如果入院或出院时间不可用]）的复合终点。对数据监测委员会进行的两项预先指定的中期分析进行调整后，显著性P值为0.048，指导委员会和试验研究者对此保持盲态。该试验已在ClinicalTrials.gov（NCT02898610）上注册并完成。

调查结果

3154名患者在2016年12月19日至2022年11月21日期间被随机分配，最后一次随访时间为2024年1月31日。由于COVID-19大流行导致的预算限制，试验在预期结果数量（计划367个结果）累积之前完成。10名患者撤回了对其数据进行分析的同意书，剩下3144名患者进行意向治疗分析:1569名（秋水仙碱和常规护理）和1575名（仅常规护理）。主要终点发生在338例患者中，1569例患者中153例（9.8%）分配到秋水仙碱和常规治疗，1575例患者中185例（11.7%）分配到单独常规治疗（发生率3.32 vs 3.92/100人-年，风险比0.84；95%CI 0.68~1.05，P=0.12）。尽管在基线时未观察到C-反应蛋白（CRP）的组间差异，但在第28天和第1、2和3年，接受秋水仙碱治疗的患者的CRP较低（所有时间点均P<0.05）。两组的严重不良事件发生率相似。

解释

尽管在主要意向治疗分析中没有观察到统计学上显著的益处，但在进一步的随机试验中，研究结果提供了支持抗炎治疗基本原理的新证据。

英文原文如下：

Abstracts

BACKGROUND  Anti-inflammatory therapy with long-term colchicine prevented vascular recurrence in coronary disease. Unlike coronary disease, which is typically caused by atherosclerosis, ischaemic stroke is caused by diverse mechanisms including atherosclerosis and small vessel disease or is frequently due to an unknown cause. We aimed to investigate the hypothesis that long-term colchicine would reduce recurrent events after ischaemic stroke.

METHODS  We did a randomised, parallel-group, open-label, blinded endpoint assessed trial comparing long-term colchicine (0·5 mg orally per day) plus guideline-based usual care with usual care only. Hospital-based patients with non-severe, non-cardioembolic ischaemic stroke or high-risk transient ischaemic attack were eligible. The primary endpoint was a composite of first fatal or non-fatal recurrent ischaemic stroke, myocardial infarction, cardiac arrest, or hospitalisation (defined as an admission to an inpatient unit or a visit to an emergency department that resulted in at least a 24 h stay [or a change in calendar date if the hospital admission or discharge times were not available]) for unstable angina. The p value for significance was 0·048 to adjust for two prespecified interim analyses conducted by the data monitoring committee, for which the steering committee and trial investigators remained blinded. The trial was registered at ClinicalTrials.gov (NCT02898610) and is completed.

FINDINGS  3154 patients were randomly assigned between Dec 19, 2016, and Nov 21, 2022, with the last follow-up on Jan 31, 2024. The trial finished before the anticipated number of outcomes was accrued (367 outcomes planned) due to budget constraints attributable to the COVID-19 pandemic. Ten patients withdrew consent for analysis of their data, leaving 3144 patients in the intention-to-treat analysis: 1569 (colchicine and usual care) and 1575 (usual care alone). A primary endpoint occurred in 338 patients, 153 (9·8%) of 1569 patients allocated to colchicine and usual care and 185 (11·7%) of 1575 patients allocated to usual care alone (incidence rates 3·32 vs 3·92 per 100 person-years, hazard ratio 0·84; 95% CI 0·68-1·05, p=0·12). Although no between-group difference in C-reactive protein (CRP) was observed at baseline, patients treated with colchicine had lower CRP at 28 days and at 1, 2, and 3 years (p<0·05 for all timepoints). The rates of serious adverse events were similar in both groups.

INTERPRETATION  Although no statistically significant benefit was observed on the primary intention-to-treat analysis, the findings provide new evidence supporting the rationale for anti-inflammatory therapy in further randomised trials.

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