Almalki Ziyad S, Guo Jeff Jianfei
Graduate Student, The James L. Winkle College of Pharmacy, University of Cincinnati Academic Health Center, OH.
Professor of Pharmacoeconomics and Pharmacoepidemiology, The James L. Winkle College of Pharmacy, University of Cincinnati Academic Health Center, OH.
Am Health Drug Benefits. 2014 Sep;7(6):318-28.
Azithromycin has been used for many years for the treatment of patients with various types of bacterial infections, as well as for the secondary prevention of coronary events. There is a growing concern, however, that azithromycin may be associated with an increased cardiovascular (CV) risk and may lead to CV-related death in high-risk patients.
This systematic review of randomized controlled trials was conducted to analyze and describe the CV risk and safety outcomes associated with azithromycin therapy.
A meta-analysis was conducted based on the MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials databases from 1990 through September 2013. Specific medical search terms in the English language included "azithromycin," "macrolide," "antibiotic," "cardiovascular diseases," and "cardiovascular events" and were used to identify relevant randomized clinical trials that assessed the risk for CV events in patients receiving azithromycin therapy or placebo. The randomized clinical trials that were selected included patients who received azithromycin or placebo for the treatment of infection or for the secondary prevention of coronary events. Major health outcome measures included mortality, hospitalization, and coronary intervention. Meta-analyses were performed using a random effects model.
A total of 12 randomized clinical trials included 15,588 patients. Patients were divided into 2 groups, either to azithromycin therapy or to placebo. Compared with patients who had not received azithromycin, patients who had received azithromycin had an overall risk ratio (RR) of death of 0.877 (95% confidence interval [CI], 0.752-1.024; P = .097). No heterogeneity was observed (I(2) = 0%). Similarly, no differences were found in the pooled RRs for hospitalization or for clinical intervention for CV events (RR, 1.005; 95% CI, 0.922-1.094; P = .915; I(2) = 0% and RR, 0.999; 95% CI, 0.896-1.125; P = .984; I(2) = 0%, respectively).
No increased risks for mortality or for CV events associated with azithromycin therapy compared with placebo were found among patients included in the 12 randomized clinical trials reviewed in this analysis.
阿奇霉素多年来一直用于治疗各类细菌感染患者以及冠心病事件的二级预防。然而，人们越来越担心阿奇霉素可能与心血管（CV）风险增加有关，并可能导致高危患者发生CV相关死亡。
本随机对照试验的系统评价旨在分析和描述与阿奇霉素治疗相关的CV风险和安全性结果。
基于1990年至2013年9月的MEDLINE、EMBASE和Cochrane对照试验中央注册库数据库进行荟萃分析。英文的特定医学检索词包括“阿奇霉素”、“大环内酯类”、“抗生素”、“心血管疾病”和“心血管事件”，用于识别评估接受阿奇霉素治疗或安慰剂的患者发生CV事件风险的相关随机临床试验。入选的随机临床试验包括接受阿奇霉素或安慰剂治疗感染或冠心病事件二级预防的患者。主要健康结局指标包括死亡率、住院率和冠状动脉干预。使用随机效应模型进行荟萃分析。
共有12项随机临床试验，纳入15588例患者。患者分为两组，分别接受阿奇霉素治疗或安慰剂治疗。与未接受阿奇霉素的患者相比，接受阿奇霉素的患者的总体死亡风险比（RR）为0.877（95%置信区间[CI]，0.752 - 1.024；P = 0.097）。未观察到异质性（I² = 0%）。同样，在住院或CV事件临床干预的合并RR中未发现差异（RR，1.005；95% CI，0.922 - 1.094；P = 0.915；I² = 0%和RR，0.999；95% CI，0.896 - 1.125；P = 0.984；I² = 0%，分别）。
在本分析中纳入的12项随机临床试验的患者中，未发现与安慰剂相比，阿奇霉素治疗会增加死亡风险或CV事件风险。
