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1. 国家儿童医学 中心,首都医科大学附属北京儿童医院,北京,100045
2. 中国医科大学附属盛京医院,沈阳,110801
纸质出版日期:2023,
网络出版日期:2023-11-10,
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尉耘翠, 王舒, 何晓静, 等. 糖皮质激素雾化吸入混悬液应用于儿童哮喘急性期综合评价[J]. 儿科药学杂志, 2023,29(11):35-43.
Yu Yuncui, Wang Shu, He Xiaojing, et al. Comprehensive Evaluation of Inhaled Corticosteroids Suspensionin Children with Acute Asthma[J]. 2023,29(11):35-43.
尉耘翠, 王舒, 何晓静, 等. 糖皮质激素雾化吸入混悬液应用于儿童哮喘急性期综合评价[J]. 儿科药学杂志, 2023,29(11):35-43. DOI: 10.13407/j.cnki.jpp.1672-108X.2023.11.011.
Yu Yuncui, Wang Shu, He Xiaojing, et al. Comprehensive Evaluation of Inhaled Corticosteroids Suspensionin Children with Acute Asthma[J]. 2023,29(11):35-43. DOI: 10.13407/j.cnki.jpp.1672-108X.2023.11.011.
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 entry into the collection catalog in China. From the perspective of affordability
the treatment course cost was FP
吸入性糖皮质激素急性发作儿童哮喘综合评价
]inhaled corticosteroidsacute attackschildrenasthmacomprehensive evaluation
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