Briel Matthias, Schwartz Gregory G, Thompson Peter L, de Lemos James A, Blazing Michael A, van Es Gerrit-Anne, Kayikçioglu Meral, Arntz Hans-Richard, den Hartog Frank R, Veeger Nic J G M, Colivicchi Furio, Dupuis Jocelyn, Okazaki Shinya, Wright R Scott, Bucher Heiner C, Nordmann Alain J
Basel Institute for Clinical Epidemiology, University Hospital Basel, Basel, Switzerland.
JAMA. 2006 May 3;295(17):2046-56. doi: 10.1001/jama.295.17.2046.
The short-term effects of early treatment with statins in patients after the onset of acute coronary syndromes (ACS) for the outcomes of death, myocardial infarction (MI), and stroke are unclear.
To evaluate relevant outcomes of patients from randomized controlled trials comparing early statin therapy with placebo or usual care at 1 and 4 months following ACS.
Systematic search of electronic databases (MEDLINE, EMBASE, PASCAL, Cochrane Central Register) from their inception to August 2005, which was supplemented by contact with experts in the field. Two reviewers independently determined the eligibility of randomized controlled trials that compared treatment with statins with a control, were initiated within 14 days after onset of ACS, and had a minimal follow-up of 30 days. Trials with cerivastatin were only included in a sensitivity analysis.
Information on baseline characteristics of included trials and patients, reported methodological quality, lipid levels, and clinical outcome was independently extracted by 2 investigators. Investigators from each included trial contributed additional data if necessary.
Twelve trials involving 13 024 patients with ACS were included in the meta-analysis. The risk ratios for the combined end point of death, MI, and stroke for patients treated with early statin therapy compared with control therapy were 0.93 (95% confidence interval [CI], 0.80-1.09; P = .39) at 1 month and 0.93 (95% CI, 0.81-1.07; P = .30) at 4 months following ACS. There were no statistically significant risk reductions from statins for total death, total MI, total stroke, cardiovascular death, fatal or nonfatal MI, or revascularization procedures (percutaneous coronary intervention or coronary artery bypass graft surgery). Sensitivity analyses with restriction to trials of high quality or with additional data from a large trial using cerivastatin indicated summary risk ratios even closer to 1.
Based on available evidence, initiation of statin therapy within 14 days following onset of ACS does not reduce death, MI, or stroke up to 4 months.
急性冠状动脉综合征（ACS）发作后早期使用他汀类药物治疗对死亡、心肌梗死（MI）和中风结局的短期影响尚不清楚。
评估在ACS后1个月和4个月时，比较早期他汀类药物治疗与安慰剂或常规治疗的随机对照试验中患者的相关结局。
对电子数据库（MEDLINE、EMBASE、PASCAL、Cochrane中央对照试验注册库）从创建到2005年8月进行系统检索，并与该领域专家联系作为补充。两名评审员独立确定随机对照试验的纳入资格，这些试验比较了他汀类药物治疗与对照治疗，在ACS发作后14天内启动，且最短随访30天。使用西立伐他汀的试验仅纳入敏感性分析。
由2名研究人员独立提取纳入试验和患者的基线特征、报告的方法学质量、血脂水平和临床结局的信息。如有必要，每个纳入试验的研究人员会提供额外数据。
荟萃分析纳入了12项涉及13024例ACS患者 的试验。与对照治疗相比，早期他汀类药物治疗患者的死亡、MI和中风联合终点的风险比在ACS后1个月时为0.93（95%置信区间[CI]，0.80 - 1.09；P = 0.39），在4个月时为0.93（95%CI，0.81 - 1.07；P = 0.30）。他汀类药物对总死亡、总MI、总中风、心血管死亡、致命或非致命MI或血运重建术（经皮冠状动脉介入治疗或冠状动脉旁路移植术）没有统计学上显著的风险降低。对高质量试验进行限制或使用西立伐他汀的大型试验的额外数据进行敏感性分析表明，汇总风险比更接近1。
根据现有证据，ACS发作后14天内开始他汀类药物治疗在4个月内不会降低死亡、MI或中风风险。
