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中国循证儿科杂志

中国循证儿科杂志 ›› 2023, Vol. 18 ›› Issue (5): 355-361.DOI: 10.3969/j.issn.1673-5501.2023.05.005

• 论著 • 上一篇    下一篇

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

黄莉萍1,卢姝亚2,彭东红3   

  1. 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；重庆医科大学附属儿童医院江西医院儿内科（目前带教单位）南昌，330038


  • 收稿日期:2022-04-29 修回日期:2022-06-10 出版日期:2023-10-25 发布日期:2023-10-25
  • 通讯作者: 彭东红

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

HUANG Liping1，LU Shuya2，PENG Donghong3   

  1. 1 Neijiang Maternal and Child Health Hospital, Neijiang 641199, China; 2 School of Nursing, Hong Kong Polytechnic University,Hong Kong 100872, China;3 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

  • Received:2022-04-29 Revised:2022-06-10 Online:2023-10-25 Published:2023-10-25
  • Contact: PENG Donghong, email: pdhdxy@163.com

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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9 438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<0.000 1）、晨间呼气峰流速（PEF）MD=4.84（95%CI：4.53~5.15，P<0.000 1）、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。

关键词: 支气管哮喘, 儿童, 沙美特罗/丙酸氟替卡松, 丙酸氟替卡松, Meta分析

Abstract: 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 9 438 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<0.000 1), mean morning peak expiratory flow(PEF) (MD=4.84, 95%CI: 4.53-5.15,P<0.000 1) 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 combined therapy significantly improved lung function (MEF50, mean morning PEF) and asthma symptoms, and reduced the use of salbutamol in treatment, but there was no difference in the reduction in asthma exacerbations. The safety was similar in both groups, with no additional drug-related adverse events or increased incidence of adverse events due to the addition of salmeterol.

Key words: Concentrated cod liver oil, Children, Salmeterol combination, Fluticasone propionate, Meta-analysis