【作者】 杨蓉；

【导师】 张焕萍；

【作者基本信息】 山西医科大学 ， 内科学（专业学位）， 2022， 硕士

【摘要】 目的:本研究的目的在于评估使用美泊利单抗对于重症嗜酸性细胞哮喘患者的疗效及安全性。方法:通过计算机检索中国知网、万方、维普、Pubmed、Cochrane图书馆、Embase、Clinical Trials.gov等数据库,收集自建库至2022年2月之前发表的关于美泊利单抗治疗重症嗜酸性粒细胞哮喘患者的随机对照研究（Randomized Controlled Trials、RCT）,Clinicaltrails.gov平台已完成但尚未发表的RCT也纳入其中,使用End Note文献管理器对检索到的所有文献进行筛选,对纳入的文献进行数据提取并进行质量评价,采用Rev Man5.3软件进行统计分析并绘制森林图。结果:1.文献检索结果:使用Endnote文献管理器对检索到的所有文献进行初步去重,通过阅读文献标题、摘要及全文去除会议摘要、综述、非RCT及与美泊利单抗治疗重症嗜酸性粒细胞哮喘无关的文献,最终共纳入了8项研究,均为RCT,共包含2632例受试者,其中美泊利单抗治疗组1642例,对照组990例。2.结果显示:与安慰剂组相比,使用美泊利单抗治疗可以使研究期间至少发生1次哮喘急性发作的患者比例减少（RR=0.47,95%CI:0.42～0.53,P<0.00001）,而且使患者哮喘急性发作频率显著降低（RR=-0.90,95%CI:-1.21～-0.59,P<0.00001）,血液中及痰中嗜酸性粒细胞计数较安慰剂组明显减少（MD=-0.23,95%CI:-0.26～-0.20,P<0.00001;MD=-6.37,95%CI:-9.68～-3.06,P=0.0002）,第一秒用力呼气量（forced expiratory volume in first second,FEV₁）、哮喘控制问卷评分（Asthma Control Questionnaire,ACQ评分）较对照组均得到了明显改善（MD=0.10,95%CI:0.09～0.11,P<0.00001;MD=-0.34,95%CI:-0.54～-0.15,P=0.0006）,且美泊利单抗治疗组不良反应发生率与安慰剂组相当（RR=0.98,95%CI:0.94～1.02,P=0.29）,美泊利单抗治疗组严重不良反应发生率较安慰剂组降低（RR=0.69,95%CI:0.48～0.99,P=0.04）。结论:使用美泊利单抗治疗可以显著减少研究期间患者的哮喘急性发作频率、减少患者血中及痰中嗜酸性粒细胞计数,改善FEV₁、ACQ评分、且总体安全性良好。更多还原

【Abstract】 Objective:The purpose of this study was to evaluate the efficacy and safety of mepolizumab in patients with severe eosinophilic asthma.Methods:By searching CNKI,Wanfang,VIP,Pubmed,Cochrane Library,Embase,Clinicaltrials.gov and other databases,a randomized controlled trial of mepolizumab in the treatment of severe eosinophilic asthma was collected and published until February2022.The RCT,completed but not yet published by the Clinicaltrails.gov was included,using End Note document manager to screen all retrieved literature,extract data from the included literature,and evaluate quality,using the software revman 5.3 to carry on the statistical analysis and draw the forest map.Results:1.Document retrieval results:Using Endnote document manager to carry out preliminary duplication removal for all documents,and remove conference abstracts,reviews,non-RCT and unrelated to mepolizumab treatment of severe eosinophilic asthma by reading literature titles,abstracts and full texts Literatures.finally included in8 studies,all of which were RCTs,including a total of 2632 subjects,including 1642 in the mepolizumab treatment group and 990in the control group.2.The results showed:compared with the placebo group,the use of mepolizumab treatment reduced the proportion of patients with at least one asthma exacerbation during the study period（RR=0.47,95%CI:0.42～0.53,P<0.00001）,In addition,the frequency of acute attacks in asthma patients was significantly reduced（RR=-0.90,95%CI:-1.21～-0.59,P<0.00001）,and the counts of eosinophils in blood and sputum were significantly lower than those in the placebo group（MD=-0.23,95%CI:-0.26～-0.20,P<0.00001;MD=-6.37,95%CI:-9.68～-3.06,P=0.0002）,FEV₁and ACQ score were significantly improved compared with the control group（MD=0.10,95%CI:0.09-0.11,P<0.00001;MD=-0.34,95%CI:-0.54～-0.15,P=0.0006）,and the incidence of adverse reactions in the mepolizumab treatment group was comparable to that in the placebo group（RR=0.98,95%CI:0.94～1.02,P=0.29）,The incidence of serious adverse reactions in the monoclonal antibody treatment group was lower than that in the placebo group（RR=0.69,95%CI:0.48-0.99,P=0.04）.Conclusion:Treatment with mepolizumab significantly reduced the frequency of asthma exacerbations,decreased blood and sputum eosinophil counts,and improved FEV₁and ACQ scores during the study period,with a good overall safety profile.更多还原