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.