秋水仙碱预防冠心病患者主要心脑血管事件的疗效和安全性：对 12869 例患者的系统评价和荟萃分析。
Efficacy and safety of colchicine for the prevention of major cardiovascular and cerebrovascular events in patients with coronary artery disease: a systematic review and meta-analysis on 12 869 patients.
机构信息
Department of Cardiovascular and Thoracic, University Cardiology, A.O.U. Città della Salute e della Scienza di Torino, Corso Bramante 88, 10126 Turin, Italy.
出版信息
Eur J Prev Cardiol. 2022 Feb 3;28(17):1916-1925. doi: 10.1093/eurjpc/zwab045.
AIMS
The key role of inflammation in the pathogenesis of coronary artery disease (CAD) is an urgent call for innovative treatments. Several trials have proposed colchicine as a therapeutic option for secondary prevention in CAD patients but its utilization is hampered by fears about drug-related adverse events (DAEs) and conflicting evidences. The aim of this meta-analysis was to consolidate evidence on the efficacy and safety of colchicine for secondary prevention in patients with CAD.
METHODS AND RESULTS
A systematic search in electronic bibliographic databases of Medline, Scopus, Embase, and the Cochrane Library was performed to identify randomized controlled trials (RCTs) assessing the cardiovascular effects of colchicine in CAD patients, compared with placebo. Outcomes of interest were the occurrence of major adverse cardiovascular and cerebrovascular events (MACCE) and DAEs. Estimates were pooled using inverse-variance random-effects model. A total of 11 RCTs, including 12 869 patients, were identified as eligible. A total of 6501 patients received colchicine, while 6368 received placebo. After a median follow-up of 6 months (interquartile range, 1-16), patients receiving colchicine had a lower risk of MACCE [6% vs. 8.8%, relative risk (RR) = 0.67, 95% confidence interval (CI) 0.56-0.80, I2 = 19%], myocardial infarction (3.3% vs. 4.3%, RR = 0.76, 95% CI 0.61-0.96, I2 = 17%), coronary revascularization (2.9% vs. 4.2%, RR = 0.61, 95% CI 0.42-0.89, I2 = 40%), stroke (0.4% vs. 0.9%, RR = 0.48, 95% CI 0.30-0.77, I2 = 0%), hospitalization for cardiovascular cause (0.9% vs. 2.9%, RR = 0.32, 95% CI 0.12-0.87, I2 = 0%). Colchicine was associated with an increased risk of gastrointestinal DAEs (11% vs. 9.2%, RR = 1.67, 95% CI 1.20-2.34, I2 = 76%), myalgia (18% vs. 16%, RR = 1.16, 95% CI 1.02-1.32, I2 = 0%) and DAEs-related discontinuation (4.1% vs. 3%, RR = 1.54, 95% CI 1.02-2.32, I2 = 65%). However, gastrointestinal DAEs and discontinuation may be prevented with a lower daily dose. Colchicine did not increase the risk of cardiovascular death (0.7% vs. 1%, RR = 0.73, 95% CI 0.45-1.21, I2 = 14%), all-cause death (2% vs. 1.9%, RR = 1.01, 95% CI 0.71-1.43, I2 = 16%), or other DAEs.
CONCLUSIONS
The use of colchicine in patients with CAD is safe and efficacious for MACCE prevention.
目的
炎症在冠状动脉疾病（CAD）发病机制中的关键作用迫切需要创新的治疗方法。几项试验提出秋水仙碱作为 CAD 患者二级预防的治疗选择，但由于对药物相关不良事件（DAE）的担忧和相互矛盾的证据，其应用受到阻碍。本荟萃分析的目的是整合秋水仙碱在 CAD 患者二级预防中的疗效和安全性证据。
方法和结果
系统检索 Medline、Scopus、Embase 和 Cochrane 图书馆的电子文献数据库，以确定评估秋水仙碱在 CAD 患者中心血管作用的随机对照试验（RCT），并与安慰剂进行比较。感兴趣的结局是主要不良心血管和脑血管事件（MACCE）和 DAE 的发生。使用逆方差随机效应模型汇总估计值。共确定了 11 项 RCT，包括 12869 名患者符合条件。共有 6501 名患者接受秋水仙碱治疗，6368 名患者接受安慰剂治疗。中位随访 6 个月（四分位距，1-16）后，接受秋水仙碱治疗的患者 MACCE 风险较低[6% vs. 8.8%，相对风险（RR）=0.67，95%置信区间（CI）0.56-0.80，I2=19%]，心肌梗死（3.3% vs. 4.3%，RR=0.76，95%CI 0.61-0.96，I2=17%），冠状动脉血运重建（2.9% vs. 4.2%，RR=0.61，95%CI 0.42-0.89，I2=40%），中风（0.4% vs. 0.9%，RR=0.48，95%CI 0.30-0.77，I2=0%），因心血管原因住院（0.9% vs. 2.9%，RR=0.32，95%CI 0.12-0.87，I2=0%）。秋水仙碱与胃肠道 DAE 风险增加相关（11% vs. 9.2%，RR=1.67，95%CI 1.20-2.34，I2=76%），肌痛（18% vs. 16%，RR=1.16，95%CI 1.02-1.32，I2=0%）和 DAE 相关停药（4.1% vs. 3%，RR=1.54，95%CI 1.02-2.32，I2=65%）。然而，较低的每日剂量可预防胃肠道 DAE 和停药。秋水仙碱不会增加心血管死亡（0.7% vs. 1%，RR=0.73，95%CI 0.45-1.21，I2=14%）、全因死亡（2% vs. 1.9%，RR=1.01，95%CI 0.71-1.43，I2=16%）或其他 DAE 的风险。
结论
秋水仙碱在 CAD 患者中的应用是安全且有效的，可以预防 MACCE。
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