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秋水仙碱与冠心病风险:随机对照临床试验的荟萃分析

Colchicine and coronary heart disease risks: A meta-analysis of randomized controlled clinical trials.

作者信息

Ma Zijun, Chen Jun, Jin Kaiqin, Chen Xin

机构信息

Sinopharm Dongfeng General Hospital, Hubei University of Medicine, Shiyan, China.

Department of Cardiology, The Second Affiliated Hospital of Anhui Medical University, Hefei, China.

出版信息

Front Cardiovasc Med. 2022 Sep 12;9:947959. doi: 10.3389/fcvm.2022.947959. eCollection 2022.

Abstract

BACKGROUND

Several trials have considered the safety and clinical benefits of colchicine as a treatment option for secondary prevention in patients with coronary atherosclerotic heart disease (CAD), but its safety and clinical benefits remain controversial. The purpose of this study was to explore the clinical benefits of colchicine, focusing on certain subgroups of patients.

METHODS

Randomized controlled trials (RCTs) of colchicine in subjects with acute or chronic CAD compared with controls were included to assess all-cause mortality, non-cardiovascular mortality, gastrointestinal adverse effects, diarrhea, MACE, cardiovascular mortality, MI, stroke, and revascularization. We analyzed the association of cardiovascular, mortality, and gastrointestinal risk with colchicine in all subjects. We also focused on the cardiovascular risk of colchicine in subgroups with different drug doses, different treatment durations, age, gender, and associated comorbidities.

RESULTS

This meta-analysis included 15 clinical RCTs, including 13,539 subjects. Colchicine reduced the risk of MACE (RR: 0.65; 95% CI: 0.38-0.77, p for heterogeneity < 0.01; I2 = 70%; < 0.01), stroke (RR: 0.48; 95% CI: 0.30-0.76; p heterogeneity = 0.52; I2 = 0%; < 0.01), MI by 40% (RR: 0.60; 95% CI: 0.43-0.83; p for heterogeneity = 0.01; I2 = 59%; < 0.01) and risk of revascularization (RR: 0.68; 95% CI: 0.56-0.83; p for heterogeneity = 0.17; I2 = 40%; < 0.01), but had no significant effect on risk of cardiovascular death and risk of all-cause mortality. In addition, colchicine increased the risk of gastrointestinal side effects and diarrhea. In a subgroup analysis, low-dose colchicine and treatment duration > 1 month reduced the risk of MACE, MI, stroke, and revascularization. Also, the cardiovascular benefits of colchicine were observed in subjects up to 65 years of age. The results showed that hypertension and diabetes did not have a specific effect on colchicine and MACE risk.

CONCLUSION

Colchicine has a positive effect in reducing the incidence of MACE, MI, stroke, and revascularization, but can increase the risk of gastrointestinal and diarrhea events. Low-dose colchicine significantly reduces the risk of MACE more than high-dose colchicine, and the benefits of long-term treatment are higher than those of short-term treatment. Long-term low-dose colchicine treatment may significantly reduce the risk of cardiovascular events. Furthermore, colchicine significantly reduced the risk of cardiovascular events in patients up to 65 years of age, but it did not appear to reduce cardiovascular risk in patients over 65 years of age or in preoperative PCI patients.

SYSTEMATIC REVIEW REGISTRATION

[https://www.crd.york.ac.uk/prospero/], identifier [CDR42022332170].

摘要

背景

多项试验探讨了秋水仙碱作为冠状动脉粥样硬化性心脏病(CAD)患者二级预防治疗选择的安全性和临床益处,但其安全性和临床益处仍存在争议。本研究旨在探讨秋水仙碱的临床益处,重点关注特定亚组患者。

方法

纳入秋水仙碱用于急性或慢性CAD患者与对照组比较的随机对照试验(RCT),以评估全因死亡率、非心血管死亡率、胃肠道不良反应、腹泻、主要不良心血管事件(MACE)、心血管死亡率、心肌梗死(MI)、中风和血运重建。我们分析了所有受试者中秋水仙碱与心血管、死亡率和胃肠道风险的关联。我们还关注了不同药物剂量、不同治疗持续时间、年龄、性别和相关合并症亚组中秋水仙碱的心血管风险。

结果

该荟萃分析纳入了15项临床RCT,共13539名受试者。秋水仙碱降低了MACE风险(风险比:0.65;95%置信区间:0.38 - 0.77,异质性p < 0.01;I² = 70%;p < 0.01)、中风风险(风险比:0.48;95%置信区间:0.30 - 0.76;异质性p = 0.52;I² = 0%;p < 0.01)、MI风险降低40%(风险比:0.60;95%置信区间:0.43 - 0.83;异质性p = 0.01;I² = 59%;p < 0.01)和血运重建风险(风险比:0.68;95%置信区间:0.56 - 0.83;异质性p = 0.17;I² = 40%;p < 0.01),但对心血管死亡风险和全因死亡风险无显著影响。此外,秋水仙碱增加了胃肠道副作用和腹泻的风险。在亚组分析中,低剂量秋水仙碱和治疗持续时间>1个月降低了MACE、MI、中风和血运重建的风险。此外,在65岁及以下的受试者中观察到了秋水仙碱的心血管益处。结果表明,高血压和糖尿病对秋水仙碱和MACE风险没有特定影响。

结论

秋水仙碱在降低MACE、MI、中风和血运重建发生率方面有积极作用,但会增加胃肠道和腹泻事件的风险。低剂量秋水仙碱比高剂量秋水仙碱更显著地降低MACE风险,长期治疗的益处高于短期治疗。长期低剂量秋水仙碱治疗可能显著降低心血管事件风险。此外,秋水仙碱显著降低了65岁及以下患者的心血管事件风险,但在65岁以上患者或术前PCI患者中似乎并未降低心血管风险。

系统评价注册

[https://www.crd.york.ac.uk/prospero/],标识符[CDR42022332170]

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1853/9512890/4b9688426a99/fcvm-09-947959-g001.jpg

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