孟鲁司特钠片联合沙美特罗替卡松吸入气雾剂治疗老年中重度支气管哮喘有效性和安全性的系统评价  

Systematic Review of Efficacy and Safety of Montelukast Sodium Tablets Combined with Salmeterol Xinafoate and Fluticasone Propionate Inhalation Aerosol in the Treatment of Moderate and Severe Bronchial Asthma in the Elderly

作　　者：郑子恢[1] 潘慧杰[2] 张亚同[1] 马琳[1] 李文英[1] 原涵[1] 金鹏飞[1] ZHENG Zihui;PAN Huijie;ZHANG Yatong;MA Lin;LI Wenying;YUAN Han;JIN Pengfei(Dept.of Pharmacy,Beijing Hospital,National Center of Gerontology,Institute of Geriatric Medicine,Chinese Academy of Medical Science,Beijing Key Laboratory of Assessment of Clinical Drugs Risk and Individual Application(Beijing Hospital),Beijing 100730,China;Laboratory Department,Beijing Hospital,National Center of Gerontology,Institute of Geriatric Medicine,Chinese Academy of Medical Science,Beijing 100730,China)

机构地区：[1]北京医院药学部,国家老年医学中心,中国医学科学院老年医学研究院,北京市药物临床风险与个体化应用评价重点实验室(北京医院),北京100730 [2]北京医院检验科,国家老年医学中心,中国医学科学院老年医学研究院,北京100730

出　　处：《中国医院用药评价与分析》2021年第10期1227-1234,1240,共9页Evaluation and Analysis of Drug-use in Hospitals of China

基　　金：国家重点研发计划项目(No.2020YFC2009001)。

摘　　要：目的:系统评价孟鲁司特钠片联合沙美特罗替卡松吸入气雾剂治疗老年中重度支气管哮喘的有效性和安全性。方法:计算机检索Embase、PubMed、the Cochrane Library、中国知网、万方数据库和中国生物医学文献数据库,纳入孟鲁司特钠片联合沙美特罗替卡松吸入气雾剂治疗老年中重度支气管哮喘的随机对照试验(研究组治疗方案为孟鲁司特钠片与沙美特罗替卡松吸入气雾剂联合治疗,对照组为单独使用沙美特罗替卡松吸入气雾剂治疗),检索时间为建库至2021年6月。筛选文献、提取资料并评价纳入文献的偏倚风险后,采用RevMan 5.4软件进行荟萃分析(Meta分析)。结果:共纳入21项研究,包括1903患者(研究组患者958例,对照组患者945例)。Meta分析结果显示,有效性方面,研究组患者的总有效率(OR=3.95,95%CI=2.95~5.27,P<0.00001)、显效率(OR=1.52,95%CI=1.23~1.89,P<0.0001)、控制率(OR=2.05,95%CI=1.51~2.78,P<0.00001)、第1秒用力呼气容积(FEV_(1))(SMD=1.47,95%CI=0.94~2.01,P<0.00001)、哮喘控制测试量表评分(MD=4.36,95%CI=3.72~5.00,P<0.00001)、呼气峰值流速(SMD=1.02,95%CI=0.63~1.40,P<0.00001)、用力肺活量(FVC)(SMD=1.32,95%CI=0.66~1.99,P<0.0001)和FEV_(1)/FVC(SMD=2.59,95%CI=1.16~4.02,P=0.0004)均显著优于对照组,差异均有统计学意义;安全性方面,研究组患者的不良反应发生率显著低于对照组,差异有统计学意义(OR=0.24,95%CI=0.09~0.59,P=0.002)。结论:现有证据表明,孟鲁司特钠片联合沙美特罗替卡松吸入气雾剂治疗老年中重度支气管哮喘,在疗效和安全性方面较单独使用沙美特罗替卡松吸入气雾剂有显著优势。因受纳入文献数量和质量的限制,上述结论有待今后更多高质量随机对照研究予以验证。OBJECTIVE:To systematically evaluate the efficacy and safety of Montelukast sodium tablets combined with salmeterol xinafoate and fluticasone propionate inhalation aerosol in the treatment of moderate and severe bronchial asthma in the elderly.METHODS:Embase,PubMed,the Cochrane Library,CNKI,Wanfang Data and CBM database were retrieved to collect the randomized controlled trial of Montelukast sodium tablets combined with salmeterol xinafoate and fluticasone propionate inhalation aerosol in the treatment of moderate and severe bronchial asthma in the elderly(the study group was given Montelukast sodium tablets combined with salmeterol xinafoate and fluticasone propionate inhalation aerosol,while the control group received salmeterol xinafoate and fluticasone propionate inhalation aerosol alone),the retrieval time was from the establishment of the database to Jun.2021.After literature screening,data extraction and evaluation of bias risk of included literature,RevMan 5.4 software was used for meta-analysis.RESULTS:Totally 21 literature were collected,including 1903 patients(958 patients in the study group and 945 patients in the control group).Meta-analysis results show that the total effective rate(OR=3.95,95%CI=2.95-5.27,P<0.00001),significant effective rate(OR=1.52,95%CI=1.23-1.89,P<0.0001),control rate(OR=2.05,95%CI=1.51-2.78,P<0.00001),forced expiratory volume in one second(FEV_(1))(SMD=1.47,95%CI=0.94-2.01,P<0.00001),asthma control test score(MD=4.36,95%CI=3.72-5.00,P<0.00001),peak expiratory flow rate(SMD=1.02,95%CI=0.63-1.40,P<0.00001),forced vital capacity(FVC)(SMD=1.32,95%CI=0.66-1.99,P<0.0001)and FEV_(1)/FVC(SMD=2.59,95%CI=1.16-4.02,P=0.0004)in the study group were significantly better than those in the control group,the differences were statistically significant.The incidence of adverse drug reactions in the study group was significantly lower than that in the control group,and the difference was statistically significant(OR=0.24,95%CI=0.09-0.59,P=0.002).CONCLUSIONS:Available evidence indicates that Mont

关 键 词：孟鲁司特钠片 沙美特罗替卡松吸入气雾剂 支气管哮喘 Meta分析 随机对照试验 

分 类 号：R974[医药卫生—药品]