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中国人群不同剂量阿托伐他汀抗动脉粥样硬化致肝功能异常的系统评价

ystematic Review of Abnormal Liver Function in Chinese Atherosclerosis Patients with Different Dose of Atorvastatin

DOI：

中文关键词: 阿托伐他汀动脉粥样硬化肝功能异常间接比较系统评价

英文关键词:Atorvastatin Atherosclerosis Abnormal liver function Indirect comparisons Systematic review

基金项目:

作者	单位
李建平	北京大学第一医院心内科（北京 100134）；
陈诗娴	南京医科大学流行病学系；
杨智荣	北京大学循证医学中心
孙凤	北京大学循证医学中心
唐少文	南京医科大学流行病学系；

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中文摘要:

摘要目的:系统评价中国人群使用10mg·d^-1和80mg·d^-1阿托伐他汀抗动脉粥样硬化致肝功能异常的差异。方法：计算机检索PubMed、EMBASE、CENTRAL、ClinicalTrial、CBM、CNKI、VIP、万方等数据库（截止2014年12月），纳入中国人群不同剂量阿托伐他汀抗动脉粥样硬化的随机对照试验。运用STATA软件和间接治疗比较（Indirect Treatment Comparisons，ITC）软件分别计算10 mg·d^-1与80 mg·d^-1相比引起肝功能异常的直接效应和间接效应，以相对危险度（RR）及95%可信区间（95%CI）表示。结果：共纳入27篇文献，病例数2 507例，治疗时间最长为5年。10 mg·d^-1与80 mg·d^-1直接比较的研究有2个，两剂量相比致肝功能异常的直接效应RR=0.44（95%CI：0.07~2.95）。10 mg·d^-1与20 mg·d^-1，20 mg·d^-1与80 mg·d^-1，10 mg·d^-1与40 mg·d^-1，40 mg·d^-1与80 mg·d^-1直接比较的研究为15，2，9和1个，分别以20 mg·d^-1和40 mg·d^-1为中间桥梁，ITC分析显示10 mg·d^-1与80 mg·d^-1相比引起肝功能异常的间接效应值RR为0.584（95%CI：0.034~9.987）和0.437（95%CI：0.008~22.811）。按治疗时间<6个月和≥6个月进行亚组分析也显示10 mg·d^-1与80 mg·d^-1引起肝功能异常的效应值差异无统计学意义（P＞0.05）。 结论：基于10 mg·d^-1与80 mg·d^-1相比的直接效应和间接效应结果，中国动脉粥样硬化患者服用10 mg·d^-1或80 mg·d^-1阿托伐他汀后在肝功能异常方面的差异无统计学意义。

英文摘要:

ABSTRACT Objective: To compare the safety profile of abnormal liver function in Chinese atherosclerosis patients with atorvastatin 10 mg·d^-1 versus 80 mg·d^-1 based on systematic review. Methods: Literatures were retrieved from PubMed, EMBASE, CENTRAL, ClinicalTrial, CBM, CNKI, VIP and Wanfang database (December 2014). STATA and Indirect Treatment Comparisons (ITC) software were applied to compute direct and indirect effects of abnormal liver function, and the results were described by relative risk (RR) and 95% confidence intervals (95%CI). Results: In total 27 qualified literatures with 2 507 atherosclerosis patients were included. The maximum treatment period was 5 years. The numbers of direct comparisons in abnormal liver function of 10 mg·d^-1 vs 80 mg·d^-1, 10 mg·d^-1 vs 20 mg·d^-1, 20 mg·d^-1 vs 80 mg·d^-1, 10 mg·d^-1 vs 40mg·d^-1 and 40mg·d^-1 vs 80mg·d^-1 were 2, 15, 2, 9, and 1, respectively. The RR of direct effect of abnormal liver function in comparisons of 10mg·d^-1 vs 80mg·d^-1 was 0.44(95%CI: 0.07 2.95). Setting 20 mg·d^-1 and 40 mg·d^-1 as a common comparator in ITC, the RR of indirect effect in 10 mg·d^-1 vs 80 mg·d^-1 group were 0.584(95%CI: 0.034 9.987), 0.437(95%CI: 0.008 22.811), respectively. The direct effect and indirect effect in 10 mg·d^-1 vs 80 mg·d^-1 group also showed no statistical difference based on treatment time <6 months and ≥6 months. Conclusion:Our results did not find significant differences between 10 mg·d^-1 and 80 mg·d^-1 group in Chinese atherosclerosis patients treated with atorvastatin for abnormal liver function based on the results of direct and indirect comparison.

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