普伐他汀对血脂异常患者调脂治疗安全性的Meta分析

Efficacy and safety of pravastatin on lipid-lowing therapy in hyperlipidemia patients:A Meta-analysis

目的探讨长期使用普伐他汀对血脂异常患者肝功能损害、肌病、脑卒中、肿瘤发生率的影响,并评价其安全性。方法计算机检索MEDLINE、EMBASE、Cochrane Central Register of Controlled Trials(CENTRAL)、中国生物医学文献数据库、中国期刊全文数据库、万方数据库中关于普伐他汀、高脂血症、冠心病的随机对照试验(RCT),同时筛检纳入文献的参考文献。对文献质量进行严格评价和资料提取,对符合质量标准的RCT进行Meta分析。结果检索到15篇相关文献,研究表明普伐他汀治疗后患者肝功能异常发生率无显著差异(OR=1.03,95%CI 0.86～1.23,p=0.76),肌病发生率无显著差异(OR=1.17,95%CI 0.84～1.63,P=0.35),脑卒中发生率显著下降(OR=0.85,95%CI 0.76～0.94,P=0.002),肿瘤发生率无显著差异(OR=1.06,95%CI 0.99～1.14,P=0.12),普伐他汀40 mg总死亡事件发生率无显著差异(OR=0.87,95%CI为0.72～1.06,P=0.17);普伐他汀20 mg总死亡事件发生率显著下降(OR=0.76,95%CI 0.60～0.90,P=0.02)。结论普伐他汀可以降低患者脑卒中的发生率,并且其与对照组相比,未发现明显肝功能异常或肌病等不良反应,肿瘤的发生率也未见明显增加。

Objective To explore the effect on incidence of liver dysfunction, cardiomyopathy, stroke and cancer in patients which long-term applied pravastatin in hyperlipidemia patients. Methods A Meta-analysis of randomized, placebo- controlled trials（RCT） was performed with a database search of the MEDLINE, EMBASE Pub reed, Cochrane Central Register of Controlled Trials （ CENTRAL）, China biological medical literature database, China journal full-text database and Wanfang data on pravastatin, hyperlipemia, coronary heart disease. Results Totally 15 articles were screened. The results showed that there was no significant differences between patients applied pravastatin and placebo on their liver dysfunction （ OR = 1.03, 95% CI 0.86 - 1.23, P = 0.76）, incidence of cardiomyopathy （ OR = 1.17, 95% CI 0.84 - 1.63, P = 0. 35 ）, and incidence of cancer （OR = 1.06, 95% CI 0.99 - 1.14, P = 0.12）, and pravastatin were superior to placebo for decreasing the stroke incidence （ OR =0.85, 95% CI 0.76 -0.94, P =0. 002） , pravastatin 20mg lower total deaths （ OR =0.76, 95% CI 0.60 - 0.90, P = 0.02）, more obvious than pravastatin 40mg （ OR = 0.87, 95% CI 0.72 - 1.06, P = 0.17）. Conclu- sion It demonstrated that the pravastatin could decrease the incidence of stroke, and there was no signifieiant side effect on liver function, eardiomyopathy and cancer incidence.