四川大学华西第二医院儿科门诊处方超药品说明书用药情况调查  

A Survey of Off-label Drug Use Prescriptions in Pediatric Outpatient Department of West China Second University Hospital

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

机构地区：[1]四川大学华西第二医院药剂科,成都610041 [2]四川大学华西医院中国循证医学中心,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》2011年第10期1120-1124,共5页Chinese Journal of Evidence-based Medicine

摘　　要：目的调查四川大学华西第二医院儿科超药品说明书用药的情况,并分析其原因与处置情况,为促进我国儿科合理用药提供基线数据。方法分层随机抽取四川大学华西第二医院2008年5月至2009年4月儿科门诊处方,根据药品说明书内容,判断是否超说明书用药;并分析超说明书用药的类型,不同年龄段超说明书用药发生率及药品种类等。结果共抽取2400份处方,含6028条用药记录。其中超说明书用药处方1398张,占58.25%;超说明书用药记录1923条,占31.90%。超说明书用药类型中居前三位的是:给药剂量(45.98%),给药频次(21.17%)及年龄(18.19%)。各年龄段处方超说明书用药发生率居前三位的有学龄期(61.56%)、学龄前(60.77%)和婴幼儿(57.66%)。各类药物超说明书用药发生率居前五类的药物为抗变态反应药(49.45%),消化系统用药(49.32%),外用药(41.49%),中成药(34.60%)和神经系统用药(33.78%)。结论儿科门诊处方中超药品说明书用药情况普遍。严格按照药品说明书规定的用法、用量,选择适宜患儿的药物剂型是减少超说明书用药,提高用药安全性的有效途径。Objective To investigate the off-label prescriptions in pediatrics in West China Second University Hospital and to analyze the reasons and performance,so as to provide the baseline data for improving the rationality drug use in pediatrics in China.Methods The prescriptions of pediatrics outpatient department were randomly selected from May 2008 to April 2009;and the off-label use was analyzed according to the package inserts in the following aspects,the types of off-label use,the rate of off-label use in different age groups and categories of medicine.Results Of the total 2 400 prescriptions,1 398（58.25%） involving off-label use.All sample prescriptions contained 6028 records,1 923（31.90%） involving off-label use.The problems such as dosage（45.98%）,frequency（21.17%） and age（18.19%） were the top-three types of off-label use.The rate in different age groups ranked as the top-three were school-age（61.56%）,followed by preschool（60.77%） and infants（57.56）.The top-five categories of medicines in off-label use were anti-allergy drugs（49.45%）,digestive system drugs（49.32%）,externally applied drugs（41.49%）,Chinese patent drugs（34.60%） and nervous system drugs（33.78%）.Conclusion The off-label drug use is widespread in pediatrics outpatient department.It is an effective approach to reduce off-label use and improve drug safety through strictly abiding by the instruction of usage and dosage as well as selecting a suitable dosage form.

关 键 词：儿科门诊 儿童用药 儿童用药风险 超药品说明书用药 

分 类 号：R95[医药卫生—药学]