吸入用布地奈德混悬液治疗儿童喘息性疾病的临床综合评价指标体系构建

Construction of clinical comprehensive evaluation index system of inhaled budesonide suspension in the treatment of children with asthmatic diseases

关键词:  吸入用布地奈德混悬液  临床综合评价  指标体系

Key words:  budesonide suspension  clinical comprehensive evaluation  index system

摘要:

目的? 建吸入用布地奈德混悬液治疗儿童喘息性疾病的临床综合评价指标体系,为全面评估儿童药品临床综合评价标准化、规范化、科学化提供方法学参考。方法? 依据《儿童临床药品综合评价技术指南(2022年版试行)》,通过文献研究、头脑风暴等方法进行主题选定,初步拟定指标框架,建立指标池；通过德尔菲专家法邀请15位相关领域专家进行问卷调查,依据专家意见、界值法对评价指标进行优化和筛选,运用直接打分法、层次分析法计算各级指标的权重,构建客观、科学的吸入用布地奈德混悬液治疗儿童喘息性疾病的临床综合评价指标体系。结果? 从有效性、安全性、经济性、适宜性、创新性和可及性六个维度构建了吸入用布地奈德混悬液的临床综合评价指标体系,包括6个一级指标,12个二级指标,28个三级指标。结论 构建的吸入用布地奈德混悬液治疗儿童喘息性疾病的综合评价指标体系具有较高的权威性和科学性,可为医疗机构药品遴选及临床合理用药提供指标构建方法的可信依据。

Abstract:

OBJECTIVE To establish a comprehensive clinical evaluation index system of inhaled budesonide suspension, and to provide methodological reference for the standardization, normalization and scientific evaluation of comprehensive clinical evaluation of children's drugs. METHODS Based on the Guidelines for the Management of Comprehensive Clinical Evaluation of Drugs （2021 edition for trial use）, through literature review, brainstorming and other methods to select the theme, initially formulate the index framework, establish the index pool; Invite 15 experts in related fields to conduct a questionnaire survey through Delphi method, based on the expert opinions and bounding value method, the evaluation indicators are optimized and selected, the weights of each index were calculated by the direct scoring method and the analytic hierarchy process, and an objective and scientific clinical comprehensive evaluation index system of inhaled budesonide inhalation suspension was established. RESULTS 3-level index system was established with six dimensions of effectiveness, safety, economy, suitability, innovation and accessibility, including 6 first-level indicators , 12 second-level indicators and 28 third-level indicators. . CONCLUSION The constructed comprehensive evaluation index system of inhaled budesonide suspension has high authenticity and scientificity, which can provide a credible basis for index construction methods for drug selection and clinical rational drug use in medical institutions.