脂必泰与阿托伐他汀比较治疗高脂血症疗效及安全性的系统评价

Efectiveness and Safety of Zhibitai versus Atorvastatin for Hyperlipidemia:A Systematic Review

目的系统评价脂必泰与阿托伐他汀比较治疗高脂血症的临床疗效和安全性。方法计算机检索PubMed、CENTRAL(2010年第7期)、CBM、CNKI、VIP及WanFang Data数据库,全面收集脂必泰与阿托伐他汀比较治疗高脂血症的随机对照试验(RCT),检索时限均为从建库至2012年7月,并追溯纳入研究的参考文献。由两位研究者按照纳入与排除标准独立筛选文献、提取资料和评价质量后,采用RevMan 5.2软件进行Meta分析。结果共纳入4个RCT,519例患者。Meta分析结果显示:治疗后8周脂必泰组较阿托伐他汀组更能降低TG[MD=–0.12,95%CI(–0.23,–0.01),P=0.03]和升高HDL-C水平[MD=–0.16,95%CI(–0.22,–0.11),P=0.000 01],但在4周和8周TC、LDL-C和4周TG水平方面,两组差异无统计学意义。两组均无明显毒副作用,但阿托伐他汀有损害肝功能的倾向。结论目前的较弱证据表明,治疗后8周脂必泰组较阿托伐他汀组更能降低TG和升高HDL-C水平,但两组在其他血脂指标和安全性方面,差异无统计学意义。因受纳入研究的质量和数量限制,尚需更多高质量RCT结果验证。

Objective To systematically review the effectiveness and safety of Zhibitai vs. atorvastatin in the treatment of hyperlipidemia. Methods Randomized controlled trials （RCTs） about Zhibitai vs. atorvastatin for hyperlipidemia were electronically retrieved in databases of PubMed, CENTRAL （Issue 7, 2010）, CBM,CNKI, VIP and WanFang Data from inception to July, 2012. Two reviewers independently screened literature, extracted data, and assessed methodological quality. Then, meta-analysis was conducted using RevMan 5.2 software. Results A total of 4 RCTs involving 519 cases were included. The results of meta-analysis showed, Zhibitai was superior to atorvastatin in reducing TG levels after 8-week treatment （MD= ？0.12, 95%CI ？0.23 to ？0.01, P=0.03） and increasing HDL-C levels after 8-week treatment （MD= ？0.16, 95%CI ？0.22 to ？0.11, P=0.000 01）. But there was no significant difference in decreasing TC levels and LDL-C levels after 4-week treatment and 8-week treatment as well as decreasing TG levels after 4-week treatment between the two groups. No obvious adverse reaction occurred in the two groups, but atorvastatin may impair liver function. Conclusion Current evidence with weak strength shows that, Zhibitai is superior to atorvastatin in reducing TG levels, and increasing HDL-C levels after 8 weeks. However, they are alike in other blood-fat index and safety. Due to the limited quantity and quality of the included studies, more high quality RCTs are needed to verify the above conclusion.