沙美特罗替卡松吸入粉雾剂与布地奈德福莫特罗吸入粉雾剂治疗儿童支气管哮喘的临床综合评价

Clinical Comprehensive Evaluation of Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation Versus Budesonide and Formoterol Fumarate Powder for Inhalation in the Treatment of Bronchial Asthma in Children

目的:评价沙美特罗替卡松吸入粉雾剂与布地奈德福莫特罗吸入粉雾剂治疗儿童支气管哮喘的临床综合价值,为医院药品遴选及临床用药决策提供参考。方法:检索国内外文献数据库,纳入随机对照试验,开展有效性及安全性评价;回顾性分析某三甲医院儿童支气管哮喘患儿直接医疗成本数据,开展经济性评价;通过问卷调研及搜集相关药品采购及销售数据、药品说明书,开展创新性、适宜性及可及性评价。结果:共检索出326篇文献,最终纳入3篇,共298例患者,其中干预组(沙美特罗替卡松吸入粉雾剂)148例,对照组(布地奈德福莫特罗吸入粉雾剂)150例。Meta分析结果显示,沙美特罗替卡松吸入粉雾剂与布地奈德福莫特罗吸入粉雾剂治疗儿童支气管哮喘后的不良反应发生率比较无统计学差异[OR=1.03,95%CI(0.62,1.73),P=0.91];沙美特罗替卡松吸入粉雾剂治疗后有效率低于布地奈德福莫特罗吸入粉雾剂[OR=0.49,95%CI(0.25,0.97),P=0.04]。经济性评价结果显示,沙美特罗替卡松吸入粉雾剂治疗儿童支气管哮喘较布地奈德福莫特罗吸入粉雾剂不具有经济性。共回收问卷52份,结果显示,沙美特罗替卡松吸入粉雾剂与布地奈德福莫特罗吸入粉雾剂相比不具有明显的创新性、适宜性和可及性。结论:沙美特罗替卡松吸入粉雾剂治疗儿童支气管哮喘临床价值较低,且其未纳入《国家基本药物目录》,不具有临床优势。

Objective:To evaluate the clinical comprehensive value of salmeterol xinafoate and fluticasone propionate powder for inhalation versus budesonide and formoterol fumarate powder for inhalation in the treatment of bronchial asthma in children so as to provide reference for drug selection and clinical medication decision in hospital.Methods:Data of randomized controlled trials were retrieved from domestic and foreign literature databases to perform the efficacy and safety evaluation.Direct medical costs of children with bronchial asthma in a tertiary hospital were retrospectively analyzed and economic evaluation was performed.Innovation,suitability and accessibility evaluation were carried out through questionnaire investigation and collection of relevant drug procurement and sales data as well as package inserts.Results:A total of 326 articles were retrieved,and 3 articles were finally included,including a total of 298 patients,with 148 patients in the intervention group(salmeterol xinafoate and fluticasone propionate powder for inhalation)and 150 patients in the control group(budesonide and formoterol fumarate powder for inhalation).Meta-analysis showed that there was no statistically significant difference in the incidence of adverse reactions between salmeterol xinafoate and fluticasone propionate powder for inhalation and budesonide and formoterol fumarate powder for inhalation in the treatment of bronchial asthma in children[OR=1.03,95%CI(0.62,1.73),P=0.91].The response rate with salmeterol xinafoate and fluticasone propionate powder for inhalation was lower than that with budesonide and formoterol fumarate powder for inhalation[OR=0.49,95%CI(0.25,0.97),P=0.04].The results of economic evaluation showed that salmeterol xinafoate and fluticasone propionate powder for inhalation was not more economic as compared with budesonide and formoterol fumarate powder for inhalation in the treatment of bronchial asthma in children. A total of 52 questionnaires were collected, and the results showed that salmeterol xinafoate and fluticasone propionate powder for inhalation was not significantly more innovative, suitable and accessible as compared with budesonide and formoterol fumarate powder for inhalation. Conclusion: Salmeterol xinafoate and fluticasone propionate powder for inhalation has low clinical value in the treatment of bronchial asthma in children, has not been included in the Essential Drug List of China, and exhibits no clinical advantages.