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我国儿童药品在临床使用中存在的问题及对策分析
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| 篇名： | 我国儿童药品在临床使用中存在的问题及对策分析 |
| TITLE： | |
| 摘要： | 目的：分析我国儿童药品在临床使用中存在的问题，并提出相关对策与建议。方法：以“儿童”或“小儿”为检索词检索国家食品药品监督管理总局网站中已注册的药品信息，再分别检索9家医院处方系统中儿童用药处方数据，国家药品数据管理系统中所有在产药品信息，中国知网数据库、万方数据库中超说明书用药调查及医疗机构儿科用药情况的文献（5家具有代表性的三级综合性医疗机构），以了解我国儿童临床用药的基本情况及存在的问题。结果：共检索到已注册药品信息170 009条，其中标注“儿童”或“小儿”的药品信息2 784条，约占1.64％。9家医院处方系统共收集32万张儿童用药处方，涉及儿童药品1 186种，覆盖22个治疗领域，仅有51种剂型。所有在产药品信息中，适宜儿童用药规格的药品仅占10％。各数据库检索结果显示，5家医院门诊处方中超说明书用药发生率较高，以无儿童用药信息、超适应证、超给药剂量为主。我国儿童临床用药存在儿童药品品种少、剂型及规格单一、超说明书用药现象普遍、缺乏科学用药依据、儿童药物临床试验开展困难等问题。结论：尽管我国相继出台了保障儿童临床用药的相关政策，但是目前我国儿童临床用药面临的问题仍然十分严峻，在进一步实施和落实相关政策的同时，需要建立一个由政府部门主导，社会、企业、医疗机构、患者全面参与、相互配合的联动管理体系以保障临床儿童用药安全。 |
| ABSTRACT： | OBJECTIVE： Te analyze the problems of clinical use in pediatric drug in China， and to put forward related countermeasures and suggestions. METHODS： Using “children” and “pediatrics” as retrieval words， registered drug information were retrieved from the website of China Food and Drug Administration； the data of pediatric drug use prescription was retrieved from hospital prescription system of 9 hospitals； all drug information were retrieved from national drug data management system； off-label drug use investigation and the literatures of pediatric drug use in medical institutions （5 representative third grade general medical institutions） were retrieved from CNKI and Wanfang database. General information and problems of pediatric drug use in China were investigated. RESULTS： A total of 170 009 items of registered drug information were retrieved， including 2 784 drug information items labeled with ”children” or ”pediatrics”， accounting for 1.64％；320 000 drug prescriptions from hospital prescription system of 9 hospitals covered 22 treatment areas involving 1 186 drugs and 51 dosage forms. Only 10％ suitable for children. The retrieval results of database showed that the incidence of children off-label drug use in outpatients prescriptions of 5 hospitals was in high level， mainly manifesting as without the information of pediatric drug use， hyper-indication drug use， hyper-dosage drug use. There were many problems in clinical pediatric drug use in China， such as less variety for children， single dosage form and specification， widespread off-label drug use， lack of scientific reference for drug use， difficulty in developing pediatric drug clinical trials， etc. CONCLUSIONS： Although the policies to protect children’s clinical drug use have been introduced in China， the problems facing children’s clinical drug use in China are still very serious. While further implementing relevant policies， it is necessary to establish a linkage management system led by government departments， with the full participation and mutual cooperation of society， enterprises， medical institutions and patients so as to guaratee the safety of pediatric drug use in clinic. |
| 期刊： | 2019年第30卷第2期 |
| 作者： | 王雪韵，苏巍巍，丁宏，郭文，华雪蔚 |
| AUTHORS： | WANG Xueyun，SU Weiwei，DING Hong，GUO Wen，HUA Xuewei |
| 关键字： | 儿童用药；临床使用；问题；对策 |
| KEYWORDS： | Pediatric drug use； Clinical use； Problems； Countermeasures |
| 阅读数： | 685 次 |
| 本月下载数： | 39 次 |
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