他汀类药物引起肝功能异常的系统评价

目的:系统评价他汀类药物引起肝功能异常的风险。方法:计算机检索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、PubMed、EMBase、Medline、Cochrane Library、康健数据库中有关他汀类药物引起肝功能异常的随机对照试验(RCT),评价纳入研究的文献质量,提取有效数据后,采用Rev Man 5.0统计软件对数据进行Mate分析。结果:共纳入9项研究,合计9 084例患者。研究包含药物有辛伐他汀、阿托伐他汀、氟伐他汀、瑞舒伐他汀、洛伐他汀。Meta分析结果显示,使用他汀类药物治疗的患者肝功能异常发生率显著高于使用安慰剂治疗的患者,差异有统计学意义[OR=2.00,95%CI(1.23,3.25),P=0.005];并且他汀类药物高剂量组患者肝功能异常发生率显著高于低剂量组,差异亦有统计学意义[OR=1.84,95%CI(1.04,3.27),P=0.04]。结论:使用他汀类药物有引起患者肝功能异常的风险,且高剂量较易发生肝功能异常,临床应谨慎用药。由于纳入研究数量较少,该结论尚需大样本、高质量的RCT进一步证实。

Systematic Review of Statins-induced Abnormal Liver Function

OBJECTIVE： To evaluate the effects of statins on liver function. METHODS： Retrieved from CBM, CNKI, Wanfang database, PubMed, EMBase, Medline, Cochrane Library and Kangjian database, randomized controlled trials （RCT） about statins-induced abnormal liver function were collected. The quality of included literatures was evaluated, and valid data were extracted. Meta-analysis was conducted using Rev Man 5.0 software. RESULTS： A total of 9 literatures were included, involving 9 084 patients. The research involved simvastatin, atorvastatin, fluvastatin, rosuvastatin and lovastatin. Meta-analysis results showed that the incidence of abnormal liver function in patients receiving statins was significantly higher than that of patients receiving placbo; there was statistical significance [OR-2.00,95%CI （1.23,3.25）,P=0.005]; that of statins high-dose group was significantly higher than that of statins low-dose group; there was statistical significance [OR-1.84, 95% CI （1,04, 3.27）, P=0.04]. CONCLUSIONS： Statins may cause liver dysfunction, especially high dose. The drugs should be used carefully. Due to small-scale and low quality included studies, large-scale high quality RCT are required.