PCSK9单抗AMG145降脂疗效及安全性的Meta分析

A Meta-analysis of Efficacy and Safety of PCSK9 Antibody AMG145 on Lipid-lowering

目的系统评价PCSK9单抗AMG145在降脂治疗中的疗效和安全性。方法检索2003年至2015年3月13日Pub Med、Cochrane Library、EMBase、Web of Science、中国学术期刊数据库(CNKI)、中国生物医学文献数据库(CBM)。纳入AMG145与安慰剂降脂治疗的临床随机对照试验,由两名评价者独立评价研究质量,提取资料,交叉核对后,采用Rev Man5.3软件进行Meta分析。结果纳入9项研究2965例,其中二期临床试验5项,三期临床试验4项,均为英文文献。Meta分析结果显示与PBO(安慰剂)相比,AMG145在干预治疗12周后可显著降低低密度脂蛋白胆固醇(LDLC)、脂蛋白(a)、Apo B/Apo A1,升高高密度脂蛋白胆固醇(HDLC),且差异有统计学意义(P<0.01),而不良事件总的发生率、肌痛、注射部位反应、鼻咽炎、头痛、ALT/AST升高>3倍等的发生率AMG145与PBO相比差异无统计学意义(P>0.05)。结论 AMG145在降脂治疗中具有较好疗效和安全性。

Aim To assess the efficacy and safety of PCSK9 antibody AMG145 on lipid-lowering by a meta-analysis. Methods Such database as Pub Med,Cochrane Library,EMBase,Web of Science,CNKI,CBM were searched from 2003 to Mar 13,2015 for randomly collecting case-control clinical trial of AMG145 on lipid-lowering. Assessment and data extraction were conducted by two reviewers independently,meta-analysis was performed by Rev Man5. 3 software.Results 9 studies involving 2965 patients were included,including 5 Phase 2 and 4 Phase 3 clinical trials,all literatures were published by English. The results of meta-analysis showed that： compared with PBO AMG145 can significantly lower LDLC,Lp（ a）,Apo B / Apo A1 and elevate HDLC after 12 weeks medication（ P〈0. 01）; there were no significant differences of total adverse events,myodynia,nasopharyngitis,injection sites reaction,headache and ALT / AST≥3 times ULN between AMG145 and PBO（ P〉0. 05）. Conclusion AMG145 can lower lipid effectively and safely.