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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Pub Med、EMBASE、CENTRAL、Clinical Trial、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10mg·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。
OBJECTIVE: To systematically evaluate the anti-atherosclerosis effects of atorvastatin at 10 mg · d ~ (-1) and 80 mg · d ~ (-1) in Chinese population. METHODS: The databases of Pub Med, EMBASE, CENTRAL, Clinical Trial, CBM, CNKI, VIP and Wanfang were searched by computer (as of December 2014). Randomized controlled trials of different doses of atorvastatin on atherosclerosis were included in the Chinese population . The direct and indirect effects of hepatic dysfunction 10 mg · d -1 and 80 mg · d -1 were calculated respectively by using STATA software and Indirect Treatment Comparisons software Relative risk (RR) and 95% confidence interval (95% CI). Results: A total of 27 articles were included, with 2 507 cases and the longest treatment time was 5 years. There were 2 direct comparisons between 10 mg · d -1 and 80 mg · d -1, and the direct effect of two doses on liver dysfunction was 0.44 (95% CI: 0.07-2.95) . The effects of 10 mg · d -1 and 20 mg · d -1, 20 mg · d -1 and 80 mg · d -1, 10 mg · d -1 and The direct comparison of 40 mg · d -1, 40 mg · d -1 with 80 mg · d -1 was 15, 2, 9 and 1, respectively, with 20 mg · d -1, (-1) and 40 mg · d ~ (-1) as intermediate bridges. ITC analysis showed that hepatic dysfunction caused by 10 mg · d -1 compared with 80 mg · d -1 Indirect effect values RR were 0.584 (95% CI: 0.034 to 9.987) and 0.437 (95% CI: 0.008 to 22.811). Subgroup analysis by treatment time <6 months and ≥6 months also showed no significant difference in the effect of liver dysfunction between 10 mg · d -1 and 80 mg · d -1 ( P> 0.05). CONCLUSION: Based on the direct and indirect effects of 10 mg · d ~ (-1) and 80 mg · d ~ (-1), patients with atherosclerosis in China took 10 mg · d ~ (-1) or 80 mg · D ~ (-1) atorvastatin in liver dysfunction after the difference was not statistically significant.