alirocumab添加治疗血脂异常随机对照临床试验的系统评价

A systematic review of randomized controlled trials of alirocumab as add on treatment for dyslipidemia

目的系统评价alirocumab添加治疗血脂异常的有效性和安全性。方法计算机检索Pub Med、Sciencedirect、Embase、Cochrane Library、中国生物医学文献数据库、中国期刊全文数据库、万方数据库、维普数据库中筛选alirocumab添加治疗血脂异常的随机对照试验。由两位研究人员根据纳入和排除标准筛选文献、提取数据并对文献进行质量评价,采用RevMan 5.3和Stata 12软件进行Meta分析。结果共纳入13项研究,包括5 051例患者。Meta分析结果显示alirocumab添加治疗血脂异常在降低低密度脂蛋白胆固醇(LDL-C)、三酰甘油(TG)、总胆固醇(TC)、载脂蛋白B(Apo B)、脂蛋白a(Lpa)、非高密度脂蛋白胆固醇(non-HDL-C)水平和升高HDL-C水平方面均优于安慰剂。alirocumab在降低LDL-C、TC、Apo B、Lpa和non-HDL-C水平和升高HDL-C水平方面均优于依折麦布,在降低TG方面与依折麦布相当。alirocumab在降低LDL-C、TC、Apo B、Lpa和non-HDL-C水平方面均优于他汀类,在降低TG和升高HDL-C水平方面与他汀类相当。在总不良反应发生率方面,试验组和对照组无显著差异,但alirocumab引起注射部位挫伤高于对照组。结论当前证据显示,alirocumab添加治疗血脂异常安全、有效,但其对临床心血管终点事件的影响仍有待论证。

AIM To assess the effects and safety of alirocumab as add on treatment for dyslipidemia. METHODS The databases of PubMed, Sciencedirect, Embase, Cochrane Library, CBM, CNKI, Wanfang, VIP database were retrieved with computers for searching randomized controlled trials. Two reviewers independently screened literature according to the inclusion and exclusion criteria, extracted information, and assessed the methodological quality of included studies. Meta- analysis of the data was performed by using RevMan 5.3 software and Stata 12 software. RESULTS Thirteen randomized controlled trials involving 5 051 patients were analyzed. Compared with the placebo group, the levels of low density lipoprotein cholesterol （LDL-C）, triglyceride （TG）, total cholesterol （TC）, apolipoprotein B （ApoB）, lipoprotein （Lpa） and non- high density lipoprotein cholesterol （non- HDL-C） were significantly decreased and the HDL-C levels were increased in the alirocumab group. Compared with ezetimibe, the levels of LDL-C, TC, ApoB, Lpa, and non- HDL-C were significantly decreased and HDL-C levels were increased in the alirocumab group. And in the TG levels, two groups had a similar reduction. Compared with the statins, alirocumab significantly decreased the levels of LDL-C, TC, ApoB, Lpa and non-HDL-C. In the TG and HDL-C levels, two groups were similar. CONCLUSION The present evidences showed alirocumab was safe and effective for treatment in dyslipidemia, meanwhile the impact of clinical cardiovascular endpoints remains to be demonstrated.