中国呼吸与危重监护杂志

中国呼吸与危重监护杂志

美泊利单抗治疗嗜酸性粒细胞性哮喘疗效与安全性的系统评价

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目的 系统评价美泊利单抗治疗嗜酸性粒细胞性哮喘的疗效与安全性。 方法 计算机检索 PubMed、Embase、ISI Web of Science、Cochrane CENTRAL、MEDLINE、VIP、CNKI 等数据库,收集美泊利单抗治疗嗜酸性粒细胞性哮喘的随机对照试验(RCT),检索时限均为从建库至 2016 年 10 月,并追溯纳入研究的参考文献和手工检索相关会议资料。由两位研究者按照纳入与排除标准独立筛选文献、提取资料和评价质量后,采用 RevMan 5.1 软件进行 Meta 分析。 结果 共纳入了 9 个 RCT,2 273 例患者。Meta 分析结果显示,与对照组比较,试验组治疗期间哮喘急性发作率降低[RR=0.67,95%CI(0.53,0.85),P=0.000 9],血液中嗜酸性粒细胞计数明显减少[MD=–0.22,95%CI(–0.29,–0.15),P<0.000 01],痰中嗜酸性粒细胞计数明显减少[MD=–6.37,95%CI(–9.68,–3.06),P<0.000 2],哮喘相关生活质量(ACQ)总分提高的患者比例也明显增加。两组间总不良反应发生率相似[RR=0.90,95%CI(0.71,1.14),P=0.39];严重不良反应发生率方面,美泊利单抗优于安慰剂[RR=0.45,95%CI(0.23,0.89),P=0.02];总心血管事件发生率方面,美泊利单抗与安慰剂治疗相当[RR=0.95,95%CI(0.40,2.22),P=0.90]。对于能否改善肺功能,美泊利单抗可能有一定作用,但目前观察到的效果不明显。 结论 美泊利单抗在哮喘治疗中可降低哮喘患者血液及痰中嗜酸性粒细胞数,减轻哮喘患者急性发作率,提高生活质量,且有较好的安全性。

Objective To systematically evaluate the effectiveness and safety of mepolizumab in treating eosinophilic asthma. Methods Databases including PubMed, Embase, ISI Web of Science, Cochrane CENTRAL, MEDLINE, VIP and CNKI were searched to collect randomized controlled trials (RCTs) about mepolizumab for eosinophilic asthma from inception to October 2016. The references of these articles and relevant conference information were also manually retrieved. Meta-analysis was performed by RevMan 5.1 software after two researchers independently selected the literatures, extracted data and evaluated the quality according to the inclusion and exclusion criteria. Results A total of 9 RCTs involving 2273 patients were included. Compared with the control group, the acute exacerbation rate of asthma was decreased significantly in the mepolizumab treatment group [RR=0.67, 95%CI (0.53, 0.85), P=0.0009], eosinophil count in blood was significantly reduced [MD=–0.22, 95%CI (–0.29, –0.15), P<0.00001], eosinophil count in sputum was also significantly reduced [MD=–6.37, 95%CI (–9.68, –3.06), P<0.0002], and the proportion of patients with increased asthma-related quality of life (ACQ) score was higher significantly. The overall incidence of adverse reactions was similar between two groups [RR=0.90, 95%CI (0.71, 1.14), P=0.39]. The incidence of serious adverse reactions of mepolizumab treatment was superior to that of placebo [RR=0.45, 95%CI (0.23, 0.89), P=0.02]. The overall incidence of cardiovascular events was comparable between placebo and mepolizumab treatment [RR=0.95, 95%CI(0.40, 2.22), P=0.90]. Mepolizumab treatment may have a role in improving lung function, but the effect was not obvious. Conclusion Mepolizumab treatment can reduce the number of eosinophils in blood and sputum, reduce the exacerbation rate, and improve the quality of life of asthmatic patients with better safety.

关键词: 美泊利单抗; 抗白细胞介素5; 嗜酸性粒细胞性哮喘; 系统评价; Meta 分析; 随机对照试验

Key words: Mepolizumab; Anti-IL-5; Eosinophilic asthma; Systematic review; Meta-analysis; Randomized controlled trial

引用本文: 江训盛, 周娜, 董必文, 张艳霞, 康庆鑫, 习慧明, 戴玲丽, 焦深山. 美泊利单抗治疗嗜酸性粒细胞性哮喘疗效与安全性的系统评价. 中国呼吸与危重监护杂志, 2018, 17(1): 6-14. doi: 10.7507/1671-6205.201611032 复制

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