药品说明书中儿童用药信息标注情况与儿童用药风险  

Medicine information annotation about package inserts of pediatric drugs and children's risk in medication

作　　者：阚淑月[1] 于庆坤[1] 王慧丽[1] 钱坤[1] 

机构地区：[1]唐山市妇幼保健院,河北唐山063000

出　　处：《中国医院药学杂志》2016年第20期1801-1804,共4页Chinese Journal of Hospital Pharmacy

摘　　要：目的:调查药品说明书关于儿童用药信息标注情况,了解儿童用药风险。方法:收集医院儿科常用药品说明书521份,对儿童用药信息标注情况进行调查分析。结果:儿童专用药品86份,占16.5%。药品辅料标注率38.8%。外资、国产药品中有儿童临床试验和药动学数据的比率分别为17.5%,2.5%和40.0%,8.4%,儿童用法用量标注率为82.5%和73.8%,国产药低于外资药;涉外西药、国产西药、中成药有儿童药代动力学数据的比率分别为39.5%,10.5%,0,中成药低于西药(P<0.05);儿童用法用量标注率分别为81.4%,80.0%,62.0%。其他儿童常用药品中有儿童临床试验比率和儿童用法用量标注率明显低于儿童专用药品(P<0.05)。中药不良反应、禁忌、相互作用等项缺省超过50%。结论:儿童专用药品少,儿童常用药品说明书中儿童用药信息标注不充分,儿童用药存在风险隐患。OBJECTIVE To learn children＇s medication risks by investigating medicine information annotation about package inserts of pediatric drugs.METHODS A total of 521 package inserts from our hospital were investigated and analyzed for child medication.RESULTS There were 86 special pediatric drugs（16.5%）,38.8% of them had annotation of pharmaceutical excipients.Of foreign and domestic drugs,17.5%,2.5% had clinical trial information,40.0%,8.4% had information of pharmacokinetics,82.5%and 73.8% had usage and dosage information in children,and all these percentages were lower in domestic drugs than foreign countries（P〈0.05）.Of foreign western drugs,domestic drugs and Chinese patent drugs,39.5%,10.5% and 0had pharmacokinetic data,lower in Chinese patent drugs than western drugs（P〈0.05）,and 81.4%,80.0%and 62.0% had annotations of usage and dosage in children.Annotation rates of clinical trials,usage and dosage of other drugs were significantly lower than pediatric drugs（P〈0.05）.More than50%traditional Chinese medicine drugs had no information on adverse reactions,contraindications and interactions.CONCLUSION Pediatric drugs are less,common pediatric drugs have no sufficiently annotated data,and pediatric medication has certain potential risks.

关 键 词：药品说明书 儿童 信息 风险 调查 

分 类 号：R969[医药卫生—药理学]