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瑞利珠单抗治疗血嗜酸性粒细胞计数升高的控制不佳哮喘的疗效和安全性:一项系统评价和荟萃分析。

The efficacy and safety of reslizumab for inadequately controlled asthma with elevated blood eosinophil counts: A systematic review and meta-analysis.

作者信息

Li Jinfeng, Wang Fangfang, Lin Cunzhi, Du Jianxin, Xiao Baohong, Du Chunhua, Sun Jiaxing

机构信息

a Department of Respiratory Medicine , The Affiliated Hospital of Qingdao University , Qingdao , China.

出版信息

J Asthma. 2017 Apr;54(3):300-307. doi: 10.1080/02770903.2016.1212371. Epub 2016 Jul 19.

DOI:10.1080/02770903.2016.1212371
PMID:27435534
Abstract

CONTEXT

Reslizumab is a humanised anti-interleukin 5 monoclonal antibody that disrupts eosinophil maturation and promotes programmed cell death.

OBJECTIVE

We carried out a systematic review and meta-analysis to assess the efficacy and safety of the drug in patients with inadequately controlled, eosinophilic asthma.

DATA SOURCES

The search included the following databases: MEDLINE, EMBASE, and the Cochrane Controlled Trials Register.

STUDY SELECTION

A literature review was performed to identify all published randomized double-blind, placebo-controlled trials of reslizumab for the treatment of inadequately controlled, eosinophilic asthma.

DATA EXTRACTION

Two reviewers independently extracted and verified pre-defined data fields.

RESULTS

Four publications including 5 RCTs that compared reslizumab with placebo. For the comparison of reslizumab with placebo, asthma exacerbation (odds ratio (OR) = 0.46, 95% confidence interval (CI) = 0.35 to 0.59, p <0.00001); a forced expiratory volume in 1 s (FEV1) (the standardized mean difference (SMD) = 0.16, 95%CI = 0.10 to 0.23, p <0.00001); Asthma Control Questionnaire (ACQ) score (the SMD = -0.26, 95%CI= -0.36 to -0.16, p <0.00001); blood eosinophil counts (the SMD = -475.62, 95%CI = -528.41 to -422.83, p <0.00001). Safety assessments included the proportion of individuals who withdrawn due to adverse event (AE) (OR = 0.60 95%CI = 0.38 to 1.17, p = 0.16) indicated that reslizumab was well tolerated.

LIMITATIONS

The article didn't research the safety, efficacy of reslizumab with longer term.

CONCLUSIONS

This meta-analysis indicates that reslizumab to be an effective and safe treatment for inadequately controlled, eosinophilic asthma.

摘要

背景

瑞利珠单抗是一种人源化抗白细胞介素5单克隆抗体,可破坏嗜酸性粒细胞成熟并促进程序性细胞死亡。

目的

我们进行了一项系统评价和荟萃分析,以评估该药物在控制不佳的嗜酸性粒细胞性哮喘患者中的疗效和安全性。

数据来源

检索包括以下数据库:MEDLINE、EMBASE和Cochrane对照试验注册库。

研究选择

进行文献综述,以确定所有已发表的关于瑞利珠单抗治疗控制不佳的嗜酸性粒细胞性哮喘的随机双盲、安慰剂对照试验。

数据提取

两名评价者独立提取并核实预先定义的数据字段。

结果

四项出版物包括5项将瑞利珠单抗与安慰剂进行比较的随机对照试验。对于瑞利珠单抗与安慰剂的比较,哮喘加重(比值比(OR)=0.46,95%置信区间(CI)=0.35至0.59,p<0.00001);第1秒用力呼气量(FEV1)(标准化均数差(SMD)=0.16,95%CI=0.10至0.23,p<0.00001);哮喘控制问卷(ACQ)评分(SMD=-0.26,95%CI=-0.36至-0.16,p<0.00001);血液嗜酸性粒细胞计数(SMD=-475.62,95%CI=-528.41至-422.83,p<0.00001)。安全性评估包括因不良事件(AE)退出的个体比例(OR=0.60,95%CI=0.38至1.17,p=0.16),表明瑞利珠单抗耐受性良好。

局限性

该文章未对瑞利珠单抗的长期安全性和疗效进行研究。

结论

这项荟萃分析表明,瑞利珠单抗是治疗控制不佳的嗜酸性粒细胞性哮喘的一种有效且安全的疗法。

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