摘要
目的:分析已上市国产儿童用药批准情况,为其新药研制及临床使用提供参考。方法:对国家人口健康科学数据中心提供的儿童用药数据进行整理挖掘,对其剂型、治疗领域分布进行分析。结果:中成药在我国儿童专用药方面具有一定的发展潜力。片剂和颗粒剂是儿童用药接受度高、生产工艺相对成熟的剂型;不经胃肠道给药的剂型在儿童专用剂型上具有一定的发展潜力。在儿童临床用药中,化学药研制较多;中成药研制在儿童常见病方面比较集中,研制儿童用中成药在消化系统和解热镇痛用药方面更有潜力。结论:我国应在鼓励儿童用药研制的前提下,借鉴国外先进经验,尽早完善儿童用药体系。
Objective:To analyze the approval of children’s drug use in China and explore its basic attributes to provide reference for guiding the development of children’s drug use and clinical drug use.Methods:In this study,data mining was conducted based on the2014—2019 effective approval data of domestic children’s drug use provided by the information center of the National Population Health Data Center,to explore the overall situation of domestic children’s drug use,to systematically analyze the dosage form and treatment field distribution of domestic children’s drug use,and to draw conclusions based on the comparative analysis of domestic and foreign policies.Results:At present,traditional Chinese medicine has a certain development potential in children’s only medicine.At present,tablets and granules are the most accepted and relatively mature dosage forms for children.The dosage forms without gastrointestinal administration have certain development potential in the only dosage forms for children.There are many chemical drugs developed in children’s clinical medication.Traditional Chinese medicine is concentrated in children’s common diseases.Traditional Chinese medicine for children has more potential and opportunity in the development of digestive system and antipyretic and analgesic drugs.Conclusion:On the premise of vigorously developing the development of children’s drug use,China should learn from the advanced experience of foreign countries,improve the basic catalogue of children’s drug use as soon as possible based on evidence,compile the authoritative guidelines for children’s drug use in China,and improve the safety system of children’s drug use.
作者
王树月
贾玉芹
陈明珠
王俊彦
程全
王俊豪
牛浩然
宫建
WANG Shu-yue;JIA Yu-qin;CHEN Ming-zhu;WANG Jun-yan;CHENG Quan;WANG Jun-hao;NIU Hao-ran;GONG Jian(Research Group of Jian Gong on Pharmcoepidemiology and Clinical Drug Evaluation,Shenyang Pharmaceutical University,Liaoning Shenyang 110016,China;Weihai Hospital of Traditional Chinese Medicine,Shandong Weihai 264205,China;Department of Pharmacy,Heping Campus of General Hospital of the Northern War Zone of the Chinese People′s Liberation Army,China Medical University,Liaoning Shenyang,110055,China;Shanghai Biomass Pharmaceutical Product Evaluation Professional Public Service Platform,Center for Pharmacological Evaluation and Research,China State Institute of Pharmaceutical Industry,Shanghai 200437,China)
出处
《中国药物评价》
2021年第2期169-173,共5页
Chinese Journal of Drug Evaluation
基金
沈阳药科大学创新创业训练计划项目(201910163170)。
关键词
儿童专用药
国产药品
剂型
适应证
Children’s drug use
Domestic drug
Evidence-based medicine
Rational drug use
