摘要
目的系统评价国产与进口辛伐他汀调脂疗效和安全性的差异。方法采用循证医学的文献分析评价方法,计算机检索中国生物医学文献数据库(CBMdisc)、中国期刊全文数据库(CNKI)、Medline、EMbase、Cochrane图书馆临床对照试验资料库(CCTR)等数据库,收集国产与进口辛伐他汀调脂疗效和安全性比较的随机对照试验。评价纳入研究的方法学质量,提取有效数据,采用RevMan5.0软件对数据进行Meta分析。结果共纳入11篇随机对照试验。Meta分析结果显示,国产与进口辛伐他汀在降低血清总胆固醇(TC)、三酰甘油(TG)、低密度脂蛋白胆固醇(LDL-C)及升高高密度脂蛋白胆固醇(HDL-C)水平等指标方面的比较,差异均无统计学意义(MD=0.06,95%CI:-0.06～0.17,P>0.05)、(MD=0.04,95%CI:-0.18～0.26,P>0.05)、(MD=0.11,95%CI:-0.04～0.26,P>0.05)、(MD=0.00,95%CI:-0.05～0.05,P>0.05)。2者的不良反应比较,差异也无统计学意义(OR=0.85,95%CI:0.55～1.32,P>0.05)。结论国产与进口辛伐他汀在降低TC、TG、LDL-C及升高HDL-C水平等指标方面无显著性差异,且2者不良反应相当。
Objective To compare the lipid-regulating efficacy and safety of domestic and imported simvastatin. Methods Literature analysis based on evidence-based medicine was performed. The literatures of randomized controlled trials on the lipid-regulatory efficacy and safety of domestic and imported simvastatin were retrieved from CBMdisc, CNKI, Medline, EMbase and CCTR. The quality of involving studies was evaluated. Data were extracted into a specially designed extraction form. Data analysis was performed by the Cochrane collaboration＇s RevMan5.0 software. Results The Meta-analysis of involving 11 RCTs showed that the effect of reducing TC, TG, LDL-C and rising HDL-C of domestic and imported simvastatin had no significant differences, （MD=0.06, 95% CI -0.06-0.17, P〉0.05）, （MD=0.04,95% CI -0.18-0.26, P〉0.05）, （MD=0.11, 95% CI -0.04-0.26, P〉0.05）, （MD=0.00, 95% CI -0.05-0.05, P〉0.05）, and ADR of domestic and imported simvastatin was similar （OR=0.85, 95% CI 0.55-1.32, P〉0.05）. Conclusion Both domestic and imported simvastatin had the similar effects on TC, TG, LDL-C, HDL-C and ADR.
出处
《临床药物治疗杂志》
2012年第3期14-18,共5页
Clinical Medication Journal
