中国药物警戒 ›› 2012, Vol. 9 ›› Issue (9): 523-527.

• 政策与法规研究 • 上一篇    下一篇

儿童未经许可和超说明书用药现状分析

李慧, 叶小飞, 郭晓晶, 钱维, 贺佳*   

  1. 第二军医大学卫勤系卫生统计学教研室,上海 200433
  • 收稿日期:2011-07-06 出版日期:2012-09-10 发布日期:2015-08-07
  • 通讯作者: 贺佳,女,博士生导师,药物流行病学与新药评价的统计分析。E-mail:hejia@smmu.edu.cn
  • 作者简介:李慧,女,硕士研究生在读,数据挖掘在药物警戒中的应用。
  • 基金资助:
    国家自然科学基金资助项目（No.30872186,No.81072388）,上海市优秀学科带头人计划（A类）（No.09XD1405500）; 上海市领军人才培养计划（No.022）

Unlicensed and Off-Label Drug in Pediatric Patients

LI Hui, YE Xiao-fei, GUO Xiao-jing, QIAN Wei, HE Jia*   

  1. Department of Health Statistics, Faculty of Health Service, Second Military Medical University, Shanghai 200433, China
  • Received:2011-07-06 Online:2012-09-10 Published:2015-08-07

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摘要： 目的介绍未经许可用药和超说明书用药的概念及在儿童中的应用现状,并探讨其与药品不良反应发生的关系。方法检索2000年至今的国内外文献,进行整理,分析和归纳。结果未经许可/超说明书用药在不同的儿童人群中有着不同的特点,总体发生率存在较大差异。超说明书用药处方数高于未经许可用药。住院儿童中至少接受一种未经许可/超说明书用药的患者比例高于非住院儿童,且在新生儿中发生率较高,大都是超出说明书规定的年龄和剂量使用。各研究对其是否会使药品不良反应发生的风险增加这一问题,结论存在差异,尚需进一步验证。结论未经许可/超说明书用药在儿童用药中广泛存在,应客观面对,认识其在临床治疗活动中的积极作用的同时,也要重视其引发的不良反应。国家建立健全医疗机构规章制度,推动儿童药物临床试验的发展,确保儿童用药安全。

关键词: 未经许可用药, 超说明书用药, 药品不良反应, 儿童

Abstract: ObjectiveTo introduce the conception and pediatric use of unlicensed/off-label medicines, and explore the relationship between them and adverse drug reactions in children. MethodsA number of native and international literatures involved from 2000 till now was collected, analyzed and reviewed. ResultsThe results indicated that different children population has different characteristic. In general, off-label/unlicensed prescription rates ranged widely, and higher rates were found in hospital versus community patients, especially in neonates. The most common category of off-label use were age and dose. There was no consensus about whether off-label/unlicensed medicines would increase the risk of adverse drug reactions. Further studies are needed to evaluate it in the future. ConclusionUnlicensed and off-label medicines are widely used in pediatric patients and we should look at the issue objectively. To ensure that children are not exposed to unnecessary risks, the state shall establish rules and regulations of health care organizations and promote the development of controlled clinical trials for children's medicines.

Key words: unlicensed drug use, off-label drug use, adverse drug reactions, pediatric