《中国药典》收载儿科用中成药临床应用现状分析

Research on Clinical Application of Chinese Patent Medicines for Pediatrics Included in Chinese Pharmacopoeia

目的:剖析我国儿科用中成药临床应用的现状及其相关问题,为我国中成药在儿科的合理应用提出建议。方法:统计2010年版《中国药典》收录的176个儿科用中成药的功能主治、剂型和剂量,与国家公布的非处方药目录比较,并查阅相关近期的临床研究报道,统计、分析临床应用的情况。结果与结论:此次统计范围中,共有104个儿科用中成药被遴选为非处方药,存在治疗病症比较集中、部分品种未公布处方药味剂量、有1/2的儿科用中成药未见临床应用研究报道等问题。应深入儿科用中成药临床应用研究,建立安全性、必要性再评价机制,为儿科用中成药合理使用提供参考,并加强药品标准建设,淘汰临床不适宜品种。

OBJECTIVE： To analyze the clinical application and the related problems of Chinese patent medicines for pediatrics in China, and to give the suggestion on rational use of it in pediatric department. METHODS： 176 Chinese patent medicines for pediatrics were collected from Chinese Pharmacopoeia （2010 edition） and we analyzed the information about the main functions, dosage form and drug dosage, and comparing with list of OTC. Relevant clinical reports were reviewed, and clinical application of Chinese patent medicines for pediatrics was analyzed statistically. RESULTS＆CONCLUSION： 104 Chinese patent medicines for pediatrics are the OTC, and the major problems existing in it are treatment of disease single, dosage of prescription drug unpublished, few clinical applications and so on. It is suggested to in-depth study clinical application of Chinese patent medicines for pediatrics, establish the safety and necessity re-evaluation, provide reference for rational use of Chinese patent medicines for pediatrics, perfect the national drug standards and die out unsuitable drugs in the clinic.