儿童未经许可和超说明书用药现状分析  

Unlicensed and Off-Label Drug in Pediatric Patients

作　　者：李慧[1] 叶小飞[1] 郭晓晶[1] 钱维[1] 贺佳[1] 

机构地区：[1]第二军医大学卫勤系卫生统计学教研室,上海200433

出　　处：《中国药物警戒》2012年第9期523-527,共5页Chinese Journal of Pharmacovigilance

基　　金：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)

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。Objective To introduce the conception and pediatric use of unlicensed/off-label medicines, and explore the relationship between them and adverse drug reactions in children. Methods A number of native and international literatures involved from 2000 till now was collected, analyzed and reviewed. Results The 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 drag reactions. Further studies are needed to evaluate it in the future. Conclusion Unlicensed 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 chnical trials for children＇s medicines.

关 键 词：未经许可用药 超说明书用药 药品不良反应 儿童 

分 类 号：R951[医药卫生—药学] R969.3