摘要
目的:以丙酸氟替卡松(FP)雾化吸入用混悬液为核心开展吸入性糖皮质激素(ICS)类药物应用于儿童哮喘急性期治疗的临床综合评价。方法:系统梳理国内外相关指南、文献等资料并开展经济学分析,从有效性、安全性、经济性、适宜性、可及性、创新性多维度开展综合评价。结果:(1)有效性,FP与双倍剂量布地奈德(BUD)混悬液相比,可明显改善晨间最大呼气峰流量(PEF),而双倍剂量吸入用BUD混悬液则在夜间无哮喘发作率方面更优。(2)安全性,儿童哮喘急性期应用FP与BUD混悬液在晨间血清皮质醇水平、夜间尿皮质醇水平、不良事件发生率、促肾上腺素激素、血清糖化血红蛋白、身高及体质量增长等方面比较差异均无统计学意义。(3)经济性,成本效果分析和最小成本分析显示,以晨间/夜间PEF、第1秒用力呼气量(FEV1)、用力肺活量(FVC)、日间无哮喘发作率、日间/夜间应急缓解药使用率作为效果指标,FP比BUD混悬液具有更优的经济性;以夜间无哮喘发作率作为效果指标,BUD经济性优于FP,但当意愿支付值(WTP)<160.00元时,FP则具有更优经济性。(4)适宜性,相比于丙酸倍氯米松(BDP),FP与BUD具有较好药理学优势。FP雾化吸入用混悬液是儿童专用药品,适用于>4岁儿童,有效期最长,可降低基层医疗机构的药品管理成本,适宜慢性疾病长期治疗管理。吸入用BUD混悬液有多种仿制药,可用于>6个月儿童。吸入用BDP混悬液适用于>2岁儿童。(5)可及性,医疗机构覆盖率BUD>BDP>FP(原研),部分BUD仿制药因进入集采目录机构覆盖率较高。可负担性,疗程费用FP4岁儿童,且可及性(医疗机构覆盖率)低于BUD和BDP。鉴于FP雾化吸入用混悬液为新上市药品,现有文献证据有限,研究结果需定期更新和长期论证。
Objective:To comprehensive evaluate the effect of inhaled corticosteroids(ICS)suspensions in children with acute asthma with nebulized fluticasone propionate(FP)as the core drug.Methods:Systematic review of relevant literature and economic analysis were conducted to comprehensively evaluate the effectiveness,safety,economy,suitability,accessibility and innovation.Results:(1)Effectiveness,FP significantly improved morning peak expiratory flow(PEF)compared with double-dose budesonide(BUD)suspension,while double-dose BUD significantly reduced the absence of asthma attack at night.(2)Safety,there were no significant differences between FP and BUD suspension in children with acute asthma in the aspects of serum cortisol levels in the morning,urine cortisol levels at night,incidence of adverse events,adrenotropic hormone levels,glycocated hemoglobin,height and body weight.(3)Economy,cost-effectiveness analysis and minimum cost analysis showed that FP was more economical than BUD with morning/night PEF,forced expiratory volume at one second(FEV1),forced vital capacity(FVC),daytime absence of asthma attack,daytime/night emergency reliever as the effect indicators.Taking the absence of asthma attack at night as effect indicator,BUD was more cost-effective than FP.When the willingness-to-pay(WTP)was less than 160.00 yuan,FP was more economical than BUD.(4)Suitability,compared with beclomethasone(BDP),FP and BUD had more pharmacological advantages.FP was the child-specific medication of ICS for children over 4 years old.FP had the longest drug validity date,which could reduce the cost of drug management in primary medical institutions and was conducive to long-term treatment of disease management.Inhaled BUD was available in a variety of generic versions and could be used in children over 6 months old.Inhaled BDP suspension could be used in children over 2 years old.(5)Accessibility,the coverage rate of medical institutions was BUD>BDP>FP(original).Most generic BUD had higher coverage rate of medical institutions due to the
作者
尉耘翠
王舒
何晓静
向莉
董名扬
曹旺
崔伊婷
胡利华
刘小会
菅凌燕
王晓玲
Yu Yuncui;Wang Shu;He Xiaojing;Xiang Li;Dong Mingyang;Cao Wang;Cui Yiting;Hu Lihua;Liu Xiaohui;Jian Lingyan;Wang Xiaoling(National Center for Children’s Health,China,Beijing Children’s Hospital,Capital Medical University,Beijing 100045,China;Shengjing Hospital of China Medical University,Shenyang 110801,China)
出处
《儿科药学杂志》
CAS
2023年第11期35-43,共9页
Journal of Pediatric Pharmacy
基金
国家呼吸系统疾病临床医学研究中心呼吸专项,编号HXZX-202107
北京医药卫生经济研究会委托项目“儿童药品临床综合评价指南开发及哮喘用药临床综合评价试点研究”。
关键词
吸入性糖皮质激素
急性发作
儿童
哮喘
综合评价
inhaled corticosteroids
acute attacks
children
asthma
comprehensive evaluation
