Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, Switzerland.
Int J Cardiol. 2012 Jun 28;158(1):93-100. doi: 10.1016/j.ijcard.2011.01.033. Epub 2011 Feb 4.
The short-term effects of early statin therapy in acute coronary syndromes (ACS) on clinical outcomes remain unclear. Our objective was to update the evidence on patient relevant outcomes from all randomized trials comparing early statin therapy with placebo or usual care at 1 and 4 months following ACS.
We performed a systematic review and meta-analysis of randomized trials that compared statins to control, initiated within 14 days after onset of ACS and with minimal follow-up of 30 days. Data were extracted in duplicate and analyzed by a random effects model. Investigators from individual trials contributed additional data where needed.
A total of 18 trials involving 14,303 patients with ACS were included in the meta-analysis. We found no evidence for further trials on the topic. Risk ratios for the combined endpoint of death, myocardial infarction, and stroke of early statin therapy compared to control were 0.93 (95% confidence interval [CI], 0.80-1.08; P=0.34) at 1 month and 0.93 (95% CI, 0.81-1.06; P=0.27) at 4 months following ACS. There were favorable trends related to statin use for all individual secondary endpoints but there was no statistically significant risk reduction except for unstable angina with a risk ratio of 0.76 (95% CI, 0.59-0.96; P=0.02) at 4 months following ACS.
Initiation of statin therapy within 14 days following ACS results in directionally favorable but non-significant reduction in death, myocardial infarction, or stroke up to 4 months, and significant reduction in the occurrence of unstable angina at 4 months following ACS.
急性冠脉综合征（ACS）早期他汀类药物治疗对临床结局的短期影响仍不清楚。我们的目的是更新所有比较 ACS 发病后 1 和 4 个月内早期他汀类药物治疗与安慰剂或常规治疗的随机试验中与患者相关结局的证据。
我们对比较他汀类药物与对照的随机试验进行了系统评价和荟萃分析，这些试验在 ACS 发病后 14 天内开始，并进行了至少 30 天的随访。数据由两名研究人员独立提取，并通过随机效应模型进行分析。如有需要，来自各个试验的调查人员提供了额外的数据。
共有 18 项涉及 14303 例 ACS 患者的试验被纳入荟萃分析。我们没有发现关于该主题的进一步试验的证据。与对照组相比，早期他汀类药物治疗的死亡、心肌梗死和卒中联合终点的风险比在 ACS 发病后 1 个月时为 0.93（95%置信区间，0.80-1.08；P=0.34），4 个月时为 0.93（95%置信区间，0.81-1.06；P=0.27）。尽管没有统计学意义的风险降低，但与他汀类药物使用相关的所有次要终点都呈现出有利的趋势，除了 ACS 发病后 4 个月时不稳定型心绞痛的风险比为 0.76（95%置信区间，0.59-0.96；P=0.02）。
ACS 发病后 14 天内开始他汀类药物治疗可使死亡、心肌梗死或卒中的发生率在 4 个月内呈方向有利但无统计学意义的降低，并且在 ACS 发病后 4 个月时可显著降低不稳定型心绞痛的发生率。
