依折麦布联合他汀与单纯他汀强化对冠心病高危/极高危患者的调脂疗效和不良反应的荟萃分析  

Comparing the efficacy and safety of ezetimibe and statin combination therapy versus statin intensive monotherapy in patients with a high/very high risk of coronary heart disease:a meta-analysis

作　　者：施方园 崔翰斌[2] SHI Fangyuan;CUI Hanbin(Medical School of Ningbo University,Ningbo,Zhejiang,315211,China;Department of Cardiology,The First Hospital of Ningbo,Ningbo,Zhejiang,315010,China)

机构地区：[1]宁波大学医学院,浙江宁波315211 [2]宁波市第一医院心血管内科

出　　处：《临床心血管病杂志》2019年第11期983-991,共9页Journal of Clinical Cardiology

摘　　要：目的:评价依折麦布联合他汀与单纯他汀强化对冠心病高危/极高危患者的调脂疗效和安全性。方法:采用Cochrane系统评价方法,通过计算机检索Pubmed、Embase、The Cochrane Library电子数据库中的随机对照临床试验,检索时限为1997年1月至2019年3月。均为随机对照研究,随访时间均≥6周,采用RevMan5.3及Stata12.0软件对所纳入的文献进行研究。结果:共纳入15项研究,包括5 391例患者。依折麦布与不同剂量他汀联合强化治疗与单纯双倍剂量他汀强化治疗的分析显示,联合治疗组调脂疗效明显高于单纯他汀组,其中低密度脂蛋白胆固醇(LDL-C)(SMD=-0.67,95%CI:-0.81^-0.54,P<0.01)、总胆固醇(TC)(SMD=-0.63,95%CI:-0.78^-0.48,P<0.01)、TG(SMD=-0.23,95%CI:-0.29^-0.17,P<0.01)、Non-HDL-C(SMD=-10.73,95%CI:-16.32^-5.14,P<0.01);联合治疗组显著提高高密度脂蛋白胆固醇(HDL-C)(SMD=0.08,95%CI:0.02~0.13,P=0.007);两者对降低高敏C反应蛋白(hs-CRP)水平无显著差异(SMD=-0.10,95%CI:-0.23~0.03,P=0.13);联合治疗组不同危险等级患者的LDL-C的达标率明显高于单纯他汀组(RR=1.73,95%CI:1.43~2.08,P<0.01)。不良反应方面,联合治疗组与单纯他汀组患者发生谷丙转氨酶(ALT)≥正常值上限3倍的情况无差异(RR=0.62,95%CI:0.23~1.64,P=0.33),发生肌酸激酶(CK)≥10倍基线值的情况也无差异(RR=0.33,95%CI:0.05~2.12,P=0.25)。结论:依折麦布联合他汀强化治疗较单纯他汀强化治疗能更显著降低LDL-C、TC、TG、Non-HDL-C,联合治疗组显著提高HDL-C水平,两者对降低hs-CRP水平无差异,两组之间不良反应无明显差别。Objective:Decreasing LDL-C reduces the risk of major adverse cardiovascular events.We aimed to evaluate the efficacy and safety of ezetimibe and statin combination therapy vs statin monotherapy.Method:We performed electronic searches using tools such as PubMed,Embase and the Cochrane Library,and all literature with related language was retrieved to March 2019.All articles were randomized controlled studies,and follow-up time was ≥ 6 weeks.Meta-analysis was performed using RevMan5.1 and the stata 12.0 software.Result:Fifteen studies involving 5 391 individuals were included in this review.Compared with statin intensive monotherapy,the overall efficacy of ezetimibe and statin combination therapy was better at lowering lipid levels as determined from the LDL-C(SMD:-0.67[-0.81,-0.54],P<0.01),TC(SMD:-0.63[-0.78,-0.48],P<0.01),TG(SMD:-0.23[-0.29,-0.17],P<0.01),and non-HDL-C(SMD:-10.73[-16.32,5.14],P<0.01).Moreover,combination therapy significantly elevated HDL-C levels(SMD:0.08,[0.02,0.13],P=0.007).There were no significant differences for the decreasing levels of hs-CRP(SMD:-0.10,[-0.23,0.03],P=0.13).Combination therapy showed a significantly higher achievement of LDL-C goals than that of statin monotherapy(RR:1.73[1.43,2.08],P<0.01).There was no significant difference in the incidence of adverse effects between the combination treatment group and statin monotherapy group,with ALT≥3 ULN(RR:0.62[0.23,1.64],P=0.33)and CK≥3 ULN(RR:0.33[0.05,2.12],P=0.25).Conclusion:Compared with statin monotherapy,ezetimibe and statin combination therapy can significantly reduce blood lipids and elevate HDL-C levels.There is no significant difference in decreasing hs-CRP levels and safety between the two groups.

关 键 词：依折麦布 他汀类药物 不良反应 Meta分析 

分 类 号：R541.4[医药卫生—心血管疾病]