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| 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 |
| 尉耘翠1,王舒2,何晓静2,向莉1,董名扬2,曹旺1,崔伊婷2,胡利华1,刘小会1,菅凌燕2,王晓玲 |
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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) |
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| 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。 |
| 关键词: 吸入性糖皮质激素 急性发作 儿童 哮喘 综合评价 |
| DOI：10.13407/j.cnki.jpp.1672-108X.2023.11.011 |
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| 基金项目::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” |
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| Comprehensive Evaluation of Inhaled Corticosteroids Suspensionin Children with Acute Asthma |
| Yu Yuncui1 , Wang Shu2 , He Xiaojing2 , Xiang Li1 , Dong Mingyang2 , Cao Wang1 , Cui Yiting2 , Hu Lihua1 , Liu Xiaohui1 , Jian Lingyan2 , Wang Xiaoling1 |
| (1. National Center for Children’s Health, China, Beijing Children’s Hospital, Capital Medical University, Beijing 100045, China; 2. Shengjing Hospital of China Medical University, Shenyang 110801, China) |
| Abstract: |
| 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
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| Key words: ]inhaled corticosteroids acute attacks children asthma comprehensive evaluation |
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