Construction and application of a comprehensive evaluation system for oral Chinese patent medicines in children
- VernacularTitle:儿童口服中成药综合评价体系的构建与应用
- Author:
Sichao YAN
1
;
Jingtai CHEN
2
;
Weixin ZENG
3
;
Tao YANG
1
;
Jianliang LI
4
;
Ying CHEN
5
;
Guofeng PAN
1
Author Information
1. Beijing Shijitan Hospital，Capital Medical University，Beijing 100038，China
2. Beijing Sifang Traditional Chinese Medicine Yinpian Co.，Ltd.，Beijing 102502，China
3. Eye Hospital，China Academy of Chinese Medical Sciences，Beijing 100040，China
4. Sichuan Academy of Chinese Medicine Sciences，Chengdu 610041，China
5. Institute of Chinese Materia Medica，China Academy of Chinese Medical Sciences，Beijing 100073，China
- Publication Type:Journal Article
- Keywords:
Children;
oral Chinese patent medicines;
comprehensive clinical evaluation;
Evaluation system;
Medication safety;
Rational drug use
- From:
China Pharmacy
2026;37(18):2357-2362
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To construct a comprehensive evaluation system for oral Chinese patent medicines in children that is compatible with pediatric physiological characteristics and the features of traditional Chinese medicine （TCM）， and provide a basis for the selection， pharmaceutical management， and medical insurance procurement of oral Chinese patent medicines in children.METHODS According to the Guidelines for the Management of Comprehensive Clinical Evaluation of Drugs （ 2021 Trial Edition ） and related policy documents and literatures， six first-level indicators were determined： safety， efficacy， suitability， economy， accessibility， and innovation. An initial indicator pool was constructed through literature retrieval， policy text analysis， and semi-structured expert interviews. A preliminary survey using a 5-point Likert scale was conducted to determine the primary indicator list. Two rounds of Delphi expert consultation were carried out. The analytic hierarchy process （AHP） was used to determine the weights and scores of indicators at all levels， and the methodological quality of the questionnaire and reliability were evaluated. Five oral Chinese patent medicines for pediatric respiratory diseases were selected for empirical evaluation. Two independent blinded reviewers scored the medicines， and the Kappa value was calculated to evaluate inter-rater consistency.RESULTS Both rounds of Delphi consulting had 21 experts， with a positive coefficient of 100% and an authoritative coefficient of 0.89. The Kendall’s W coefficients of concordance for the first and second rounds of Delphi expert consultation were 0.812 and 0.856， respectively （ P ＜0.01）. The consistency ratios of all AHP judgment matrices ranged from 0.032 to 0.087 （all ＜0.10）. The Cronbach’s α coefficient was 0.847. A comprehensive evaluation system for oral Chinese patent medicines in children was established， comprising 6 first-level indicators， 25 second-level indicators， and 78 third-level indicators. The weights of the first-level indicators were 0.32， 0.24， 0.16， 0.13， 0.10 and 0.05， respectively， for safety， effectiveness， suitability， economy， accessibility and innovation. The empirical evaluation showed that Xiao’er chiqiao qingre granules obtained the highest comprehensive score （90.8 points）， followed by Xiao’er feire kechuan oral liquid （86.3 points）， Ertong qingfei oral liquid （82.8 points）， Xiao’er xiaoji zhike oral liquid （82.0 points）， and Jinzhen oral liquid （81.5 points）. The inter-rater consistency Kappa value was 0.91.CONCLUSIONS The comprehensive evaluation system for oral Chinese patent medicines in children constructed in this study， includes 12 pediatric-specific third-level indicators and integrates key evaluation points of both traditional Chinese and Western medicine. It demonstrates good consistency and reliability， with good operability and reproducibility.
