【原】小剂量秋水仙碱治疗心肌梗死的疗效与安全性

罂粟花anesthGH 2021-07-21

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Efficacy and Safety of Low-Dose Colchicine after Myocardial Infarction

背景与目的

实验和临床证据支持炎症在动脉粥样硬化及其并发症中具有一定作用。秋水仙碱是一种口服的强效抗炎药物，用于治疗痛风和心包炎。有研究发现，口服小剂量秋水仙碱治疗稳定型冠心病的患者发生心血管意外事件比不服用秋水仙碱的患者少。由于急性冠状动脉综合征与炎症加剧密切相关，因此，本研究旨在评估秋水仙碱对心血管结局的影响，以及对近期发生心肌梗死患者的长期安全性。

方法

我们收集了心肌梗死后30天内的患者并进行了随机、双盲试验。这些患者被随机分配为口服小剂量秋水仙碱(0.5mg，每天一次)或口服安慰剂。主要治疗结局是由心血管疾病引起的死亡、心肺复苏、心肌梗死、卒中或心绞痛紧急住院施行冠状动脉血管重建术。并对主要结局和安全性进行了综合评估。

结果

本研究共纳入4745名患者；其中，2366名患者被分配到秋水仙碱组，2379名患者被分配到安慰剂组。患者随访时间中位数为22.6个月。与安慰剂组患者7.1%的主要结局发生率相比，秋水仙碱组患者主要结局发生率为5.5%（风险比0.77；95% CI 0.61~0.96；P=0.02）。心血管原因所致死亡的风险比为0.84（95%CI 0.46~1.52），心肺复苏的风险比为0.83（95%CI0.25~2.73），心肌梗死的风险比为0.91 （95%CI0.68~1.21），卒中的风险比为0.26（95%CI 0.10~0.70），因心绞痛紧急住院施行冠状动脉重建术治疗的风险比为0.50（95%CI 0.31~0.81）。秋水仙碱组有9.7%的患者出现腹泻，安慰剂组有8.9%的患者出现腹泻(P=0.35)。秋水仙碱组有0.9%的患者出现肺炎等严重不良反应，安慰剂组有0.4%（P=0.03）。

结论

在近期发生心肌梗死的患者中，与安慰剂相比，每日口服秋水仙碱0.5 mg明显降低了缺血性心血管事件的发生风险。

原始文献摘要

Tardif JC, Kouz S, Waters DD, et al. Efficacy and Safety of Low-Dose Colchicine after Myocardial Infarction.[J]. N. Engl. J. Med. 2019. DOI：10.1056/NEJMoa1912388.

BACKGROUND

Experimental and clinical evidence support the role of inflammation in atherosclerosis and its complications. Colchicine is an orally administered, potent antiinflammatory medication that is indicated for the treatment of gout and pericarditis.

METHODS

We performed a randomized, double-blind trial involving patients recruited within 30 days after a myocardial infarction. The patients were randomly assigned to receive either low-dose colchicine (0.5 mg once daily) or placebo. The primary efficacy end point was a composite of death from cardiovascular causes, resuscitated cardiac arrest, myocardial infarction, stroke, or urgent hospitalization for angina leading to coronary revascularization. The components of the primary end point and safety were also assessed.

RESULTS

A total of 4745 patients were enrolled; 2366 patients were assigned to the colchicine group, and 2379 to the placebo group. Patients were followed for a median of 22.6 months. The primary end point occurred in 5.5% of the patients in the colchicine group, as compared with 7.1% of those in the placebo group (hazard ratio, 0.77; 95% confidence interval [CI], 0.61 to 0.96; P=0.02). The hazard ratios were 0.84 (95% CI, 0.46 to 1.52) for death from cardiovascular causes, 0.83 (95% CI, 0.25 to 2.73) for resuscitated cardiac arrest, 0.91 (95% CI, 0.68 to 1.21) for myocardial infarction, 0.26 (95% CI, 0.10 to 0.70) for stroke, and 0.50 (95% CI, 0.31 to 0.81) for urgent hospitalization for angina leading to coronary revascularization. Diarrhea was reported in 9.7% of the patients in the colchicine group and in 8.9% of those in the placebo group (P=0.35). Pneumonia was reported as a serious adverse event in 0.9% of the patients in the colchicine group and in 0.4% of those in the placebo group (P=0.03).

CONCLUSIONS

Among patients with a recent myocardial infarction, colchicine at a dose of 0.5 mg daily led to a significantly lower risk of ischemic cardiovascular events than placebo.

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