首页|国家集采药品孟鲁司特钠治疗儿童哮喘的临床综合评价

国家集采药品孟鲁司特钠治疗儿童哮喘的临床综合评价

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目的:对国家集采和进口原研孟鲁司特钠治疗儿童哮喘的临床综合价值进行评价.方法:从安全性、有效性、经济性、适宜性、可及性、创新性6个维度,采用专家咨询法和文献调研法初步确定临床综合评价指标体系,运用德尔菲法和层次分析法对指标体系进行筛选并确定权重;采用文献调研法、真实世界研究法、问卷调查法等构建临床综合评价证据集合体;邀请专家依据证据集合体对孟鲁司特钠进行评分,并根据指标权重计算2种药品临床综合评价总得分.结果:该研究构建了孟鲁司特钠临床综合评价指标体系,其中一级指标(安全性、有效性、适宜性、可及性、经济性、创新性)6个、二级指标14个、三级指标32个.国家集采孟鲁司特钠临床综合评价总得分为8.12分,进口原研药总得分为8.03分.进口原研药品的安全性、有效性、创新性得分略高于集采药品,而集采药品的经济性、可及性、适宜性得分略高于进口原研药.结论:国家集采孟鲁司特钠治疗儿童哮喘的临床综合价值高于进口原研药品.
Clinical evaluations of montelukast sodium in the treatment of children with asthma
OBJECTIVE To evaluate the comprehensive clinical value of domestic and imported montelukast sodium(MS)in the treatment of children with asthma.METHODS Six dimensions of safety,effectiveness,economy,suitability,accessibility and innovation,expert consultation and literature survey were employed for determining the clinical comprehensive evaluation index system.Delphi method and analytic hierarchy process were utilized for screening the index system and determine the weights of all indices.Evidence collection proceeded through literature researches,real world researches and questionnaire surveying.Experts were invited to score MS according to evidence sets.Total score of clinical comprehensive evaluation of two drugs was calculated by the weights of indices.RESULTS A comprehensive clinical evaluation index system of MS was established,including 6 primary indices(safety,effectiveness,suitability,accessibility,economy & innovation),14 secondary indices and 32 tertiary indices.Total score of MS centrally purchased domestically was 8.12 points and total score of imported original drug was 8.03 points.The scores of safety,effectiveness and innovation of imported original research drugs were slightly higher than those of pooled drugs.And the scores of economy,accessibility and suitability of pooled drugs were slightly higher than those of imported original research drugs.CONCLUSION The comprehensive clinical value of MS centrally purchased domestically for treating pediatric asthma is superior to that of imported original drugs.

montelukast sodiumasthmachildrenclinical comprehensive evaluationcollection

王钰、韩玉玲、王忠兰、郝丽娜

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山东大学附属儿童医院药学部,山东济南 250022

孟鲁司特钠 哮喘 儿童 临床综合评价 集采

山东省卫生健康委药品临床综合评价项目(第一批)

2021YZ024

2024

中国医院药学杂志
中国药学会

中国医院药学杂志

CSTPCD北大核心
影响因子:1.198
ISSN:1001-5213
年,卷(期):2024.44(10)
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