依折麦布联合辛伐他汀降脂疗效和安全性的Meta分析

A Meta-analysis on lipid-lowering effect and safety of ezetimibe combining simvatatin therapy

目的评价依折麦布联合辛伐他汀降脂治疗的疗效与安全性。方法计算机检索Cochrane library,Pubmed,Embase,万方数据库(Wanfang),中国学术期刊全文数据库(CNKI),中国生物医学文献数据库(CBM),维普数据库(VIP)至2012年9月30日,收集依折麦布联合辛伐他汀治疗高脂血症的随机对照试验(RCTs),由两名作者独立阅读所有文献,按入选标准纳入试验,提取资料,交叉核对并进行方法学质量评估,使用RevMan5.2软件进行Meta分析。结果最终纳入10项研究,纳入研究对象3367例。Meta分析结果:与单独口服辛伐他汀相比,依折麦布联合辛伐他汀显著降低血浆低密度脂蛋白-胆固醇(LDL-C)水平(SMD=-0.87,95%CI:-1.10～-0.64,P<0.001)、血浆胆固醇(TC)水平(SMD=-0.81,95%CI:-1.03～-0.59,P<0.001)、血浆甘油三酯(TG)水平(SMD=-0.41,95%CI:-0.66～-0.17,P<0.05),与单独口服辛伐他汀相比,依折麦布联合辛伐他汀显著升高血浆高密度脂蛋白-胆固醇(HDL-C)水平(SMD=0.15,95%CI:0.04～0.26,P<0.05);依折麦布联合辛伐他汀导致转氨酶升高、肌酸激酶升高及总的药物相关的不良事件的发生率与单用辛伐他汀比较,差异无统计学意义。结论依折麦布联合辛伐他汀较单独应用辛伐他汀能更有效的降低血脂水平,且安全性和耐受性良好,但上述结果尚需要更多高质量、大样本随机对照实验进一步证实。

Objective To review the lipid-lowering effect and safety of ezetimibe combining simvatatin therapy. Methods The databases of Cochrane Library, PubMed, Embase, WangFang Database, CNKI, CBM and VIP Database were retrieved with computers for collecting randomized controlled trials （ RCT ） about ezetimibe combining simvatatin in lipid-lowering treatment until Sept. 30, 2012. All literature was read and selected by two researchers independently according to inclusion and exclusion criterions, and materials were extracted, checked crossly and given methodological quality evaluation. The Meta-analysis was conducted by using RevMan 5.2 software. Results There were totally 10 RCT included involving 3367 cases, and the results of Meta-analysis showed that ezetimibe combining simvatatin therapy decreased significantly the levels of plasma low-density lipoprotein-cholesterol （LDL-C, SMD=-0.87, 95%CI： -1.10--0.64, P〈0.001 ） , total cholesterol （TC, SMD=-0.81, 95%CI： -1.03- -0.59, P〈0.001 ） and triglyeeride （ TG, SMD=-0.41, 95%CI： -0.66- -0.17, P 〈0.05 ） , and increased significantly the level of high-density lipoprotein-cholesterol （ HDL-C, SMD=0.15, 95%CI： 0.04-0.26, P〈0.05 ） compared with simvatatin monotherapy. The increase of transaminase and creatine kinase and incidence of adverse events induced by ezetimibe combining simvatatin therapy had no statistical significance compared with simvatatin monotherapy. Conclusion Zetimibe combining simvatatin therapy can reduce the level of blood fat with higher safety and tolerance compared with simvatatin monotherapy, while more muhiple-center and large-sample RCT with higher quality are required for further identifying the results.