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目的:评价前蛋白转化酶枯草杆菌蛋白酶/溶菌素9(PCSK9)抑制药Alirocumab治疗血脂异常的有效性。方法:搜索数据库Pub Med、Embase、the Cochrane Library、Clinical Trials.gov、中国知网、万方数据库和国内外相关心血管会议记录,收集Alirocumab对比安慰剂和依折麦布治疗血脂异常有效性评价的2期、3期临床随机对照试验,采用RevMan 5.3软件对收集数据进行Meta分析。结果:纳入的18篇研究中包含6 748例研究对象,其中,13个研究比较了Alirocumab和依折麦布的效果,研究对象例数分别为3 606例和1 658例;5个研究比较了Alirocumab和安慰剂的效果,研究对象例数分别为864例和620例。Meta分析结果显示:与依折麦布和安慰剂相比,Alirocumab显著降低低密度脂蛋白(LDL-C)水平[依折麦布:MD=-30.51%,95%CI(-33.68%,-27.33%);安慰剂:MD=-52.25%,95%CI(-55.85%,-48.65%)]。对于已服用稳定剂量他汀类药物的患者,Alirocumab可进一步降低LDL-C水平[依折麦布:MD=-30.30%,95%CI(-34.43%,-26.17%);安慰剂:MD=-50.64%,95%CI(-54.95%,-46.33%)]。Alirocumab对其他脂质也产生有利影响:降低非高密度脂蛋白(non-HDL-C)、载脂蛋白B(Apo B)、三酰甘油(TC)和胆固醇(TG)的水平,升高高密度脂蛋白(HDL-C)和载脂蛋白A-1(Apo A-1)的水平。结论:PCSK9抑制药Alirocumab为已强化他汀治疗后LDL-C水平仍不能达标以及他汀类单药不耐受的高胆固醇血症或高危心血管疾病风险的患者提供了新的治疗选择方案。
OBJECTIVE: To evaluate the effectiveness of the proprotein convertase subtilisin / peptone 9 (PCSK9) inhibitor Alirocumab in the treatment of dyslipidemia. METHODS: The database of PubMed, Embase, the Cochrane Library, Clinical Trials.gov, CNKI, Wanfang database and relevant cardiovascular records at home and abroad were collected to evaluate the efficacy of Alirocumab in comparison with placebo and ezetimibe in the treatment of dyslipidemia Phase 2, Phase 3 clinical randomized controlled trials using RevMan 5.3 software to collect data for meta-analysis. RESULTS: Of the 18 studies included, 6 748 studies were included, of which 13 studies compared the effects of Alirocumab and ezetimibe, with 3 606 and 1 658 subjects, respectively; 5 studies compared Alirocumab and placebo effect, the number of subjects were 864 cases and 620 cases. Meta-analysis showed that Alirocumab significantly reduced LDL-C levels compared with ezetimibe and placebo [ezetimibe: MD = -30.51%, 95% CI (-33.68%, - 27.33%); placebo: MD = -52.25%, 95% CI (-55.85%, -48.65%)]. Alirocumab further reduced LDL-C levels in patients already on stable doses of statins [ezetimibe: MD = -30.30%, 95% CI (-34.43%, -26.17%); placebo: MD = 50.64%, 95% CI (-54.95%, -46.33%)]. Alirocumab also exerts beneficial effects on other lipids as well as decreasing the levels of non-HDL-C, Apo B, triglyceride (TC) and cholesterol (TG) Density lipoprotein (HDL-C) and apolipoprotein A-1 (Apo A-1). CONCLUSIONS: The PCSK9 inhibitor Alirocumab provides a new therapeutic option for patients who have not yet achieved LDL-C levels after statin therapy and those at risk for statin-naïve hypercholesterolemia or high-risk cardiovascular disease.