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儿童口服中成药综合评价体系的构建与应用
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| 篇名： | 儿童口服中成药综合评价体系的构建与应用 |
| TITLE： | Construction and application of a comprehensive evaluation system for oral Chinese patent medicines in children |
| 摘要： | 目的 构建适配儿童生理特征与中医药特色的儿童口服中成药临床综合评价体系，为儿童口服中成药的遴选、药事管理、医保采购提供依据。方法依据《药品临床综合评价管理指南（2021年版试行）》及相关政策文件、文献，确定安全性、有效性、适宜性、经济性、可及性、创新性6项一级指标；通过文献检索与政策文本分析、专家半结构化访谈构建初始指标池；采用Likert5级评分进行预调研，确定初级指标清单；开展两轮德尔菲专家咨询，结合层次分析法（AHP）确定各级指标权重及得分，并进行问卷质量评价与信度检验。以5种儿童呼吸系统口服中成药为例开展实证评价，采用双人独立盲法评分并计算Kappa值以评价评分者间的一致性。结果两轮德尔菲咨询专家均为21位，专家积极系数均为100%，专家权威系数均为0.89；第1、2轮德尔菲专家咨询的肯德尔和谐系数分别为0.812、0.856（P＜0.01）；全部AHP判断矩阵一致性比率为0.032～0.087；Cronbach’sα为0.847。最终确立了包含6项一级指标、25项二级指标、78项三级指标的儿童口服中成药综合评价体系，其中一级指标（安全性、有效性、适宜性、经济性、可及性、创新性）的权重分别为0.32、0.24、0.16、0.13、0.10、0.05。实证评价显示，小儿豉翘清热颗粒综合得分最高（90.8分），其次为小儿肺热咳喘口服液（86.3分）、儿童清肺口服液（82.8分）、小儿消积止咳口服液（82.0分）、金振口服液（81.5分）；评价者间一致性Kappa值为0.91。结论本研究构建的儿童口服中成药综合评价体系，特别设立12项儿科专属三级评价指标，融合了中西医评价要点，一致性和信度检验良好，具备较好的可操作性与可复现性。 |
| 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. |
| 期刊： | 2026年第37卷第18期 |
| 作者： | 闫思超；陈井太；曾蔚欣；杨涛；李建良；陈颖；潘国凤 |
| AUTHORS： | YAN Sichao，CHEN Jingtai，ZENG Weixin，YANG Tao，LI Jianliang，CHEN Ying，PAN Guofeng |
| 关键字： | 儿童;口服中成药;临床综合评价;评价体系;用药安全;合理用药 |
| KEYWORDS： | Children;oral Chinese patent medicines;comprehensive clinical evaluation;Evaluation system;Medication safety;Rational drug use |
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