四川省儿童用药品研发生产和使用现状调查  

The development,production and use of medicine for children in Sichuan province:a across-sectional study

作　　者：陈哲 李思雨[1,2,3,4,6] 李海龙 邹锟[1,2,3,4] 曾力楠 贾知军[1,2,3,4,5] 成果 唐永[9] 赵绍阳 蒋永穆 张伶俐 CHEN Zhe;LI Siyu;LI Hailong;ZOU Kun;ZENG Linan;JIA Zhijun;CHENG Guo;TANG Yong;ZHAO Shaoyang;JIANG Yongmu;ZHANG Lingli(Department of Pharmacy,West China Second University Hospital,Sichuan University,Chengdu 610041,P.R.China;Evidence-Based Pharmacy Center,West China Second University Hospital,Sichuan University,Chengdu 610041,P.R.China;NMPA Key Laboratory for Technical Research on Drug Products in vitro and in vivo Correlation,Chengdu 610041,P.R.China;Key Laboratory of Birth Defects and Related Diseases of Women and Children,Sichuan University,Ministry of Education,Chengdu 610041,P.R.China;West China School of Pharmacy,Sichuan University,Chengdu 610041,P.R.China;West China School of Medicine,Sichuan University,Chengdu 610041,P.R.China;Department of Pediatrics,West China Second University Hospital,Sichuan University,Chengdu 610041,P.R.China;Laboratory of Molecular Translational Medicine,Center for Translational Medicine,Sichuan University,Chengdu 610041,P.R.China;School of Economics,Sichuan University,Chengdu 610041,P.R.China;Chinese Evidence-based Medicine Center,West China Hospital,Sichuan University,Chengdu 610041,P.R.China)

机构地区：[1]四川大学华西第二医院药学部,成都610041 [2]四川大学华西第二医院循证药学中心,成都610041 [3]国家药品监督管理局药物制剂体内外相关性技术研究重点实验室,成都610041 [4]出生缺陷与相关妇儿疾病教育部重点实验室,成都610041 [5]四川大学华西药学院,成都610041 [6]四川大学华西临床医学院,成都610041 [7]四川大学华西第二医院儿科,成都610041 [8]四川大学转化医学中心分子转化医学实验室,成都610041 [9]四川大学经济学院,成都610041 [10]四川大学华西医院中国循证医学中心,成都610041

出　　处：《中国循证医学杂志》2023年第5期497-503,共7页Chinese Journal of Evidence-based Medicine

基　　金：四川省科技计划项目(编号:2020YFS0035)。

摘　　要：目的调查四川省儿童用药品的研发生产和使用现状,剖析儿童用药品生产使用过程中存在的问题,为保障儿童用药品提供建议。方法使用自填式电子问卷调研四川省内14家研发生产儿童药品的生产企业和20家设立儿科的综合医院或儿童专科医院的儿童用药品研发生产、配备和使用情况。结果接受调研的14家生产企业共报告正研发/生产儿童用药品116个(有确切儿童用药信息的第一类儿童用药品75个,说明书中仅标示为儿童酌情减量或遵循医嘱使用的第二类儿童用药品41个),其中已获批上市药品109个(93.97%),21个(18.10%)为国家基本药物,76个(65.52%)为医保报销药品。第一类儿童药品剂型多为片剂(28个,37.34%)和颗粒剂(19个,25.34%),但口服溶液剂(3个,4.00%)和糖浆剂(5个,6.67%)等适合儿童使用剂型较少。医疗机构儿童药品配备使用情况调研结果显示,每家医院需分剂量的儿童用药品平均为57种,药师将分剂量的方法告知临床医务人员或患者及家属由其自行分剂量是最常见的操作方式。结论医疗机构药品个体化分剂量调配需求大,部分儿童用药品有待进一步研发和改良,以满足儿童临床用药需求。应进一步增加儿童药物研发生产投入和政策支持,促进儿童药物临床试验,激励儿童专用药品研发。Objective To investigate the development,production and use of children’s drugs in Sichuan Province,analyze the problems existing in these links,and provide suggestions for ensuring that children’s needs for drugs are met.Methods The self-filling electronic questionnaire was used to investigate the production,procurement and use of children’s drugs in 14 pharmaceutical companies producing children’s drugs and 20 general hospitals with pediatric departments or children’s hospitals in Sichuan province.Results The 14 surveyed pharmaceutical companies reported that 116 children’s drugs were being developed or produced(75 first-class children’s drugs with exact medication information for children,41 second-class children’s drugs only noted as children's discretionary reduction or use according to clinician’s instructions),out of which 109(93.97%)drugs had been approved for marketing,21(18.10%)were national essential medicines and 76(65.52%)were covered by national basic medical insurance.The dosage forms of first-class children's drugs were mainly tablets(28,37.34%)and granules(19,25.34%),while oral solution(3,4.00%),syrup(5,6.67%)and other dosage forms suitable for children were less.According to the surveyed results on the use of children's drugs in hospitals,there were 57 children’s drugs whose minimum use units needed to be manually divided into smaller ones on average in each hospital,and it was the most common operation pattern that pharmacists informed nurses,patients or patients’family members of the dose splitting methods and then splitting drugs’minimum use units by themselves.Conclusion There is a great demand for splitting minimum use units of drugs whose strength is too big for children in medical institutions,and some children’s drugs need to be developed and further modified to meet the clinical children’s drug needs.We should further increase investments and policy supports for the children’s drugs,promote children’s clinical trials,and encourage the research and develop

关 键 词：儿童 药品 研发 生产 使用 横断面调查 

分 类 号：R95[医药卫生—药学]