奥马珠单抗治疗难治性哮喘疗效的Meta分析  

The Efficacy of Omalizumab in Patients with Severe Allergic Asthma:A Meta-analysis

作　　者：苗伟伟[1,2] 汪凤凤[1] 陈子[1] 马元[1] 谢林艳[3,4] 宋丽丽[3,4] 陈宇平[3,4] 黄茂[1] 周林福[1,3,4] 

机构地区：[1]南京医科大学第一附属医院呼吸内科,江苏南京210029 [2]胜利油田中心医院呼吸内科,山东东营257000 [3]江苏盛泽医院 [4]江苏省人民医院盛泽分院呼吸内科,江苏苏州215228

出　　处：《中国呼吸与危重监护杂志》2015年第5期449-455,共7页Chinese Journal of Respiratory and Critical Care Medicine

基　　金：国家自然科学基金(编号:81370133;81170018);江苏省医学重点人才项目(编号:RC2011066);江苏省高校自然科学研究项目(编号:11KJB320008);江苏省临床医学科技专项(编号:BL2012012);江苏省社会发展重点研发专项(编号:BE2015651);江苏省中医药科技项目(编号:YB2015110);苏州市科技计划项目(编号:SYS201402)

摘　　要：目的系统评价奥马珠单抗对12~75岁难治性哮喘患者的治疗效果及临床应用。方法计算机检索Pubmed、Web of Science、Embase等数据库,纳入研究奥马珠单抗辅助治疗过敏性哮喘效果的随机对照试验,由两位研究者进行资料提取和质量评价后,采用Review Manage 5.1软件进行Meta分析。结果共纳入10个随机对照试验。与对照组比较,奥马珠单抗组能显著降低12~75岁难治性哮喘患者的激素稳定期急性发作率[RR=0.56,95%CI（0.42,0.75）,P〈0.000 1]以及激素减量期急性发作率[RR=0.53,95%CI（0.48,0.60）,P〈0.000 01],显著减少至少急性恶化发作1次患者的比例[RR=0.71,95%CI（0.61,0.84）,P〈0.000 01],并显著降低糖皮质激素用量（≥50%）[RR=1.51,95%CI（1.24,1.84）,P〈0.001]。另外,奥马珠单抗能显著改善哮喘患者生活质量[RR=1.25,95%CI（1.13,1.38）,P〈0.000 01];但对难治性哮喘患者急诊就诊率无显著影响[RR=0.63,95%CI（0.28,1.44）,P〈0.001]。结论在哮喘指南常规治疗基础上加用奥马珠单抗,可减少难治性哮喘患者急性发作率并降低糖皮质激素用量,改善患者生活质量。Objective To determine the efficacy of omalizumab in patients（ 12 - 75 years of age）with severe allergic asthma,and guide its clinical application.Methods Databases,including Pubmed,Web of Science and Embase,were searched to collect randomized controlled trials（ RCTs）.Data were extracted,and the quality of included RCTs was assessed by two reviewers,followed by meta-analyses using Review Manage 5.1 software.Results Meta-analyses of ten included RCTs showed that,compared with placebo,omalizumab reduced the rate of exacerbation per patient during both stable-steroid phase [RR = 0.56,95%CI（ 0.42,0.75）,P〈0.000 1] and steroid-reduction phase for patients with severe asthma [ RR = 0.53,95% CI（ 0.48,0.60）,P〈0.000 01],reduced the number of patients experienced at least one exacerbation[RR = 0.71,95% CI（ 0.61,0.84）,P〈0.000 01],and significantly reduced the dosage of beclomethasone dipropionate（ ≥50%） [RR = 1.51,95% CI（ 1.24,1.84）,P〈0.001].Omalizumab significantly improved asthma-related quality of life [RR = 1.25,95% CI（ 1.13,1.38）,P〈0.000 01],albeit no indications of omalizumab reducing the rate of emergency visits [RR = 0.63,95% CI（ 0.28,1.44）,P〈0.001].Conclusion The addition of omalizumab to standard asthma therapy reduces asthma exacerbations,decreases inhaled corticosteroid and rescue medication use,and improves the quality of life in severe asthma patients.

关 键 词：难治性哮喘 奥马珠单抗 IG E 抗Ig E抗体 META分析 

分 类 号：R562.25[医药卫生—呼吸系统]