Evolocumab治疗高胆固醇血症患者安全性的Meta分析

Meta-analysis of the safety of Evolocumab/AGM145 on treatment to hypercholesterolemia patients

目的：Evolocumab,也称AGM145,做为一种抑制PCSK9的全人源单克隆抗体,做为一种新型降脂药已经被FDA批准上市。本文讨论Evolocumab与对照组降低高胆固醇患者血脂的安全性。方法：以计算机检索Pub Med、Medline、Cochrane、EMBASE、BIOSIS Preview、Sci Finder Scholar数据库、中国生物医学文献数据库、维普中文数据库、万方数据库、中国知网数据库,将符合标准的文章纳入研究,使用Review Manager 5.3对入选研究进行Meta分析,并对偏倚进行分析。结果：纳入研究文献9篇,共计4 435人,Meta分析结果显示Evolocumab不良反应与安慰剂比较无显著增多（OR 1.08,95%CI 0.88～1.33）,Evolocumab的任意不良反应较依折麦布发生较少（OR 0.84,95%CI 0.68～1.03）,Evolocumab的严重不良反应较依折麦布无显著增多（OR 1.4,95%CI 0.61～3.17）。结论：Evolocumab作为一种新型降脂药物,降低血浆LDL-C浓度疗效显著,其不良反应较对照组无明显增多,严重不良反应少见。

AIM：Evolocumab,also called AGM145,a fully human monoclonal antibody of proprotein convertase subtilisin-like/kexin type 9 （PC-SK9）,has been approved by the FDA as a new lipid-lowering drug.We discussed the safety of Evolocumab treatment to hypercholesterolemia patients versus control groups.METHODS：The articles that met the inclusion criteria were retrieved from PubMed,Medline,Cochrane,EMBASE,BIOSIS Preview,SciFinder Scholar database,the Chinese biomedical literature database,VIP database,Wanfang database and CKNI database by computer and all these articles were studied using Review Manager 5.3 for meta-analysis and analysis of bias.RESULTS：9 articles and totally 4435 patients were included in this study.Meta-analysis results showed that there was no significant increasing of Evolocumab adverse events compared with placebo （OR 1.08,95% CI 0.88-1.33）.The any adverse events of Evolocumab were less than ezetimibe （OR 0.84,95% CI 0.68-1.03）,the serious adverse events of Evolocumab were no significant increasing than ezetimibe （OR 1.4,95% CI 0.61-3.17）.CONCLUSION：As a new lipid-lowering drug,Evolocumab significantly reduced low-density lipoprotein （LDL） cholesterol levels and showed no significant increasing on side effects compared with control groups and its serious side effects were rare.