沙美特罗/丙酸氟替卡松与丙酸氟替卡松在儿童哮喘升阶梯治疗中有效性及安全性的系统评价和Meta分析  

Effectiveness and safety of fluticasone propionate plus salmeterol versus fluticasone propionate alone in the step-up treatment for children with asthma:A systematic review and meta-analysis

作　　者：黄莉萍 卢姝亚 彭东红[3,4] HUANG Liping;LU Shuya;PENG Donghong(Neijiang Maternal and Child Health Hospital,Neijiang 641199,China;School of Nursing,Hong Kong Polytechnic University,Hong Kong 100872,China;Department of Respiratory Medicine,Children's Hospital of Chongqing Medical University,National Clinical Research Center for Child Health and Disorders,Ministry of Education Key Laboratory of Child Development and Disorders,Chongqing Key Laboratory of Pediatrics,Chongqing 400014,China;Department of Pediatrics,Jiangxi Hospital,Children's Hospital of Chongqing Medical University,Nanchang 330038,China)

机构地区：[1]四川省内江市妇幼保健院,内江641199 [2]香港理工大学护理学院,中国香港100872 [3]重庆医科大学附属儿童医院呼吸科,国家儿童健康与疾病临床研究中心,儿童发育疾病研究教育部重点实验室,儿科学重庆市重点实验室,重庆400014 [4]重庆医科大学附属儿童医院江西医院儿内科,南昌330038

出　　处：《中国循证儿科杂志》2023年第5期355-361,共7页Chinese Journal of Evidence Based Pediatrics

摘　　要：背景在成人哮喘研究中,沙美特罗/丙酸氟替卡松(FSC)联合用药已被证实较单用丙酸氟替卡松(FP)疗效更好且安全性相当,但在儿童哮喘人群中仍缺乏可靠的临床研究证据。目的对FSC组和单用FP组在哮喘患儿升阶梯治疗中的文献行系统评价/Meta分析,探讨两组用药的有效性及安全性。设计系统评价/Meta分析。方法检索时间为数据库建库至2023年9月,在Cochrane、MEDLINE(通过PubMed)、Embase、Web of Science、中国生物医学文献数据库、中国知网数据库和万方数据库中检索以FSC和单用FP治疗哮喘患儿的RCT。2名研究者独立进行文献筛选、数据提取、偏倚风险评估和证据质量总结,通过R Studio1.4.1717进行数据分析。主要结局指标哮喘恶化、与吸入性糖皮质激素(ICS)和FSC相关的不良事件。结果共纳入11篇RCT中的9438例哮喘患儿。Meta分析结果显示,FSC组较FP组在治疗前后用力呼出50%肺活量时的瞬间流量(MEF50)MD=0.17(95%CI:0.16~0.18,P<0.0001)、晨间呼气峰流速(PEF)MD=4.84(95%CI:4.53~5.15,P<0.0001)、治疗前后无哮喘症状天数%MD=1.39(95%CI:1.36~1.41,P<0.05)、无沙丁胺醇使用天数%MD=1.09(95%CI:1.06~1.12,P<0.05)的改善情况差异均有统计学意义。在减少哮喘恶化发生RR=0.87(95%CI:0.70~1.09,P=0.22)、减少与ICS和FSC相关的不良事件RR=0.99(95%CI:0.61~1.60,P=0.95)和其他不良事件RR=0.98(95%CI:0.91~1.05,P=0.55)的发生率差异均无统计学意义。结论在儿童哮喘升阶梯治疗中,FSC组与FP组在减少哮喘恶化的发生率差异无统计学意义,两组用药安全性相当,没有因沙美特罗的添加而带来额外的药物相关不良事件,也没有增加其他不良事件;但FSC更能改善肺功能(MEF50、晨间PEF)和哮喘症状,并能减少治疗中沙丁胺醇的使用。Background In adult asthma studies,salmeterol/fluticasone propionate combination(FSC)has been shown to achieve better efficacy and comparable safety than fluticasone propionate alone(FP),but reliable clinical evidence is still lacking in children with asthma.Objective To conduct a systematic review and meta-analysis on salmeterol/fluticasone propionate combination and fluticasone propionate alone in the step-up treatment of children with asthma,and to explore the efficacy and safety of the two groups.Design Systematic review and meta-analysis.Methods Randomized controlled trials(RCTs)of salmeterol/fluticasone propionate combination versus fluticasone propionate alone were systematically searched in Cochrane,MEDLINE(via PubMed),Embase,Web of Science,CBM,CNKI and Wanfang databases from the inception to September 2023.Two researchers independently finished literature screening,data extraction,risk of bias assessment,and evidence quality summary.Data analysis was completed through R Studio1.4.1717.Main outcome measures Asthma exacerbations and adverse events related to inhaled corticosteroids(ICS)and FSC.Results A total of 11 RCTs with 9438 children with asthma were included.The comparison between fluticasone propionate/salmeterol combination and fluticasone propionate alone showed a statistical difference in the improvement in maximal expiratory flow at 50%vital capacity(MEF50)(MD=0.17,95%CI:0.16-0.18,P<0.0001),mean morning peak expiratory flow(PEF)(MD=4.84,95%CI:4.53-5.15,P<0.0001)before and after treatment,improved percentage of symptom-free days(MD=1.39,95%CI:1.36-1.41,P<0.05)and albuterol-free days(MD=1.09,95%CI:1.06-1.12,P<0.05)before and after treatment.But there was no statistically significant difference in the reduction in asthma exacerbations(RR=0.87,95%CI:0.70-1.09,P=0.22),the incidence of reduced ICS and FSC-related adverse events(RR=0.99,95%CI:0.61-1.60,P=0.95)and other adverse events(RR=0.98,95%CI:0.91-1.05,P=0.55).Conclusions Compared with fluticasone propionate,salmeterol/Fluticasone propionate combi

关 键 词：支气管哮喘 儿童 沙美特罗 丙酸氟替卡松 META分析 

分 类 号：R725.6[医药卫生—儿科]