PCSK9单抗AMG145降脂疗效及安全性的Meta分析
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(1.石河子大学医学院,新疆石河子市832002;2.石河子大学医学院第一附属医院心内二科,新疆石河子市832008)

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樊刚,硕士研究生,研究方向为心血管病,E-mail为nfgcardiology@126.com。

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A Meta-analysis of Efficacy and Safety of PCSK9 Antibody AMG145 on Lipid-lowering
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1.Medical College of Shihezi University, Shihezi, Xinjiang 832002, China;2.First Affiliated Hospital, College of Medicine, Shihezi University, Shihezi, Xinjiang 832008, China)

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    摘要:

    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PubMed、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RevMan5.3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)、ApoB/ApoA1,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。

    Abstract:

    Aim To assess the efficacy and safety of PCSK9 antibody AMG145 on lipid-lowering by a meta-analysis. Methods Such database as PubMed, 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 RevMan5.3 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), ApoB/ApoA1 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.

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樊刚,王忠,段军仓,黄磊,李小雷. PCSK9单抗AMG145降脂疗效及安全性的Meta分析[J].中国动脉硬化杂志,2016,24(3):297~305.

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  • 收稿日期:2015-04-30
  • 最后修改日期:2015-07-16
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  • 在线发布日期: 2016-04-15