| 摘要: |
| 目的:以《中成药临床综合评价指南(2022 版试行)》为指导,探索王氏保赤丸治疗儿童功能性消化不良(FD) 的疗效,并
开展临床综合评价方法体系研究,为儿科合理用药提供参考。方法:基于文献资料、相关数据平台、指南共识等信息,从有效性、
安全性、经济性、适宜性、可及性、创新性及中医药特色7 个维度,依据药品临床综合评价体系,对王氏保赤丸进行临床综合评
价。结果:王氏保赤丸与双歧杆菌三联活菌治疗儿童FD 疗效相当,与双歧杆菌乳杆菌三联活菌、多潘立酮比较,总有效率更
高。应用王氏保赤丸发生不良反应/ 事件概率低于双歧杆菌三联活菌,安全性佳。王氏保赤丸的微丸剂型尤其适用于婴幼儿,
与对照药相比经济性居中,市场可及性好,且具有鲜明的中医药特色。结论:王氏保赤丸治疗儿童FD 疗效确切,安全可靠;综
合评价认为其具有较高的临床价值,为其临床合理使用提供了参考。 |
| 关键词: 功能性消化不良 儿童 王氏保赤丸 临床综合评价 中成药 |
| DOI：10.13407/j.cnki.jpp.1672-108X.2025.12.001 |
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| 基金项目:中医药传承与创新“百千万”人才工程(岐黄工程)项目,国中医药人教函〔2021〕204 号。 |
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| Comprehensive Clinical Evaluation of Wangshi Baochi Pills in the Treatment of Functional Dyspepsia in Children Based on the Guideline for Clinical Comprehensive Evaluation of Chinese Patent Medicine (2022Version) |
| Wang Yangyang1, Cao Wang2, Ma Xinling1, Nie Lianghui3, Rong Ping3, Wang Xiaoling2 |
| (1. Tianjin Children’ s Hospital / Children’s Hospital, Tianjin University, Tianjin 300134, China; 2. Beijing Children’s Hospital, Capital Medical University,Beijing 100045, China; 3. First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China) |
| Abstract: |
| Objective: To evaluate the clinical efficacy of Wangshi Baochi pills in the treatment of functional dyspepsia (FD) in
children based on the Guideline for Clinical Comprehensive Evaluation of Chinese Patent Medicine (2022 Version), and to provide
reference for rational drug use in children. Methods: Based on literature, relevant data platforms, guideline consensus, and other
information, seven dimensions such as safety, effectiveness, economy, suitability, innovation accessibility and traditional Chinese
medicine characteristics of Wangshi Baochi pills were comprehensively evaluated according to the clinical comprehensive evaluation
technology system. Results: Wangshi Baochi pills were not inferior to Bifidobacterium triple viable bacteria in the treatment of FD in
children, and had a higher total effective rate compared with Bifidobacterium triple viable bacteria and domperidone. The incidence of
adverse drug reactions/ events with Wangshi Baochi pills was lower than Bifidobacterium triple viable bacteria, indicating good safety.
The micro-pill formulation of Wangshi Baochi pills was particularly suitable for infants, compared with the reference medicine, Wangshi
Baochi pills had medium economy, good market accessibility and distinct traditional Chinese medicine characteristics. Conclusion:
Wangshi Baochi pills has proven to be highly effective and safe in the treatment of children with FD. The comprehensive evaluation
indicates that it has significant clinical value and provides reference for the rational clinical application. |
| Key words: functional dyspepsia children Wangshi Baochi pills comprehensive clinical evaluation traditional Chinese medicine |
