四川大学华西第二医院2010年儿科门诊患儿超说明书用药情况调查  

Survey on Off-Label Drug Use in Pediatric Outpatients of West China Second University Hospital in 2010

作　　者：张伶俐[1,2] 李幼平[1] 黄亮[2] 胡蝶[2,3] 曾力楠[2] 杨春松[2] 陈敏[2,3] 

机构地区：[1]四川大学华西医院中国循证医学中心,成都610041 [2]四川大学华西第二医院药剂科,成都610041 [3]四川大学华西药学院,成都610041

出　　处：《中国循证医学杂志》2012年第3期267-273,共7页Chinese Journal of Evidence-based Medicine

基　　金：十一五国家科技支撑计划重点项目"乡镇卫生院药物配置与物流关键技术研究与产品开发"(编号:2008BAI65B22)

摘　　要：目的回顾性调查2010年四川大学华西第二医院儿科门诊患儿超说明书用药现状,分析相关危险因素,为了解我国儿科超说明书用药现状和制订超说明书用药政策提供基线数据。方法分层随机抽取该院2010年儿科门诊患儿的处方,依据药品说明书,判断其用药医嘱是否超说明书,分析各超说明书用药类型、各年龄段儿童各类药品超说明书用药情况以及超说明书用药与年龄、性别和基本药物、非处方药物分类的关系。结果共抽取门诊儿科处方2 640张,分析处方用药医嘱8 588条,涉及药品329种。按处方、用药医嘱与药品种类计,超说明书用药发生率分别为76.59%、40.88%、83.89%。超说明书用药类型主要包括未提及儿童用药信息(35.57%)、适应症(25.44%)和剂量(25.31%)3种。超说明书用药发生率居前2位的年龄段为新生儿(54.35%)和青少年(49.64%)。用药医嘱数居前4位的超说明书用药种类依次为:呼吸系统用药(48.12%)、中成药(48.12%)、消化和代谢系统用药(33.36%)、全身用抗感染药(16.27%)。全院门诊各年龄段患儿超说明书用药的风险无差异,基本药物、处方药物可能存在更高的超说明书用药风险。结论 2010年四川大学华西第二医院儿科门诊患儿超说明书用药情况普遍,并呈增长趋势。这一方面反映了药品说明书中儿科用药信息缺乏,另一方面也提示急需国家出台相关法律法规或指南,以规范我国可能日趋严重的超说明书用药行为,并通过促进儿童药物临床试验以提供更多用药证据,鼓励研发和生产儿童适用药品和剂型,建立我国儿童基本药物目录等多种手段,保障儿童用药安全和规避医师职业风险。To determine the extent of off-label drug use in pediatric outpatients of West China Second University Hospital in 2010, and to analyze its possible risk factors, so as to provide baseline data for getting acquainted with the extent of off-label drug use in pediatrics in China and developing policy of off-label drug use. Method The stratified random sampling was conducted to select prescriptions of children aged 0 to 18 years in pediatric outpatients of the West China Second University Hospital in 2010. According to drug instructions, off-label drug use of prescriptions of all selected children was analyzed in the following aspects, the category of off-label drug use, age, category of drugs. In ad- dition, an analysis was conducted to check the relationship between off-label use and following possible risk factors： age, sex, essential medicines and over-the-counter drugs. Result A total of 2 640 prescriptions with 8 588 medical advices involving 329 drugs were extracted and analyzed, with incidence rates of off-label drug use accounting for 76.59%, 40.88% and 83.89%, respectively. The main categories of off-label drug use were no pediatric information （35.57%）, indication （25.44%）, and dosage （25.31%）. The top 2 age groups with highest incidence rate of off-label drug were neonates （54.35%） and adolescents （49.64%）. The top 4 drugs with highest incidence rate of off-label drug were respiratory system medicines （48.12%）, Chinese patent medicines （48.12%）, digestive and metabolic system medicines （33.36%）, and systemic anti-in- fectives （16.27%）. The off-label use risks in all age groups in the hospital were indifferent, and the essential medicines andprescription medicines were likely to present higher risks of drug off-label. Conclusion Off-label drug use in pediatric outpatients is common with growth trend in pediatric outpatients of the West China Second University Hospital. On the one hand, drug instructions lack pediatric information, and on the other hand, it＇s badly i

关 键 词：超说明书用药 儿科 儿科门诊 危险因素分析 用药安全 

分 类 号：R95[医药卫生—药学]