Ross S D, Allen I E, Connelly J E, Korenblat B M, Smith M E, Bishop D, Luo D
MetaWorks Inc, Boston, MA 02210, USA.
Arch Intern Med. 1999;159(15):1793-802. doi: 10.1001/archinte.159.15.1793.
To determine the risk of cardiovascular events and death in patients receiving statin treatment for cholesterol regulation.
Systematic review and meta-analysis of all randomized controlled trials that were published as of April 15, 1997. Primary or secondary prevention trials or regression trials were eligible.
All-cause mortality, fatal myocardial infarction (MI) or stroke, nonfatal MI or stroke, angina, and withdrawal from the studies. Both random- and fixed-effects models were run for the outcomes of interests, and results are expressed as odds ratios (ORs). Sensitivity analyses tested the impact of the study type and duration, statin treatment type, and control arm event rates. Intent-to-treat denominators were used whenever they were available, and the number needed to treat was calculated when appropriate.
Seventeen studies (21 303 patients) were included (2 secondary prevention studies, 5 mixed primary-secondary prevention population studies, and 10 regression trials). Treatment groups included lovastatin (t = 5), pravastatin (t = 10), and simvastatin (t = 3). For all-cause mortality, the OR was 0.76 (95% confidence interval [CI], 0.67-0.86) in favor of receiving statin treatment; for fatal MI, the OR was 0.61 (95% CI, 0.48-0.78); for nonfatal MI, the OR was 0.69 (0.54-0.88); for fatal stroke, the OR was 0.77 (95% CI, 0.57-1.04); for nonfatal stroke, the OR was 0.69 (95% CI, 0.54-0.88); and for angina, the OR was 0.70 (95% CI, 0.65-0.76).
Patients who received statin treatment demonstrated a 20% to 30% reduction in death and major cardiovascular events compared with patients who received placebo. This advantage was generally present across study types and statin treatment types and for patients with less severe dyslipidemias. The benefit in clinical outcomes was noticeable as early as 1 year.
确定接受他汀类药物治疗以调节胆固醇的患者发生心血管事件和死亡的风险。
对截至1997年4月15日发表的所有随机对照试验进行系统评价和荟萃分析。一级或二级预防试验或回归试验均符合条件。
全因死亡率、致命性心肌梗死（MI）或中风、非致命性MI或中风、心绞痛以及退出研究情况。对感兴趣的结局采用随机效应模型和固定效应模型进行分析，结果以比值比（OR）表示。敏感性分析检验了研究类型和持续时间、他汀类药物治疗类型以及对照臂事件发生率的影响。只要有可用的意向性治疗分母，就使用该分母，并在适当的时候计算需治疗人数。
纳入了17项研究（21303例患者）（2项二级预防研究、5项一级-二级预防混合人群研究和10项回归试验）。治疗组包括洛伐他汀（t = 5）、普伐他汀（t = 10）和辛伐他汀（t = 3）。对于全因死亡率，接受他汀类药物治疗的优势比为0.76（95%置信区间[CI]，0.67 - 0.86）；对于致命性MI，优势比为0.61（95%CI，0.48 - 0.78）；对于非致命性MI，优势比为0.69（0.54 - 0.88）；对于致命性中风，优势比为0.77（95%CI，0.57 - 1.04）；对于非致命性中风，优势比为0.69（95%CI，0.54 - 0.88）；对于心绞痛，优势比为0.70（95%CI，0.65 - 0.76）。
与接受安慰剂的患者相比，接受他汀类药物治疗的患者死亡和主要心血管事件减少了20%至30%。这种优势在不同研究类型和他汀类药物治疗类型中普遍存在，并且在血脂异常较轻的患者中也存在。临床结局的益处早在1年时就很明显。
