新疆某“三甲”医院儿科住院患儿超说明书用药情况调查与分析

Investigation and Analysis of Off-label Drug Use in Pediatric Inpatients from a Third Grade Class A Hospital of Xinjiang

目的：为促进患儿合理用药和进一步开展超说明书用药相关研究提供基线数据。方法：分层随机抽取新疆某“三甲”医院2014年3月-2015年2月期间的儿科住院病历（患儿年龄≤18岁）,依据药品说明书内容,由基金课题组成员和临床药师判断是否存在超说明书用药情况,对超说明书用药类型、患儿年龄段和药品种类等进行统计分析。结果：共抽取住院病历864份,按病历数和用药记录数计,超说明书用药发生率分别为87.85%和46.94%;超说明书用药类型主要集中在超给药频次（39.33%）和超适应证（33.01%）方面;该院超说明书用药主要发生在幼儿（1-3岁,69.01%）及儿童（4-11岁,28.44%）;超说明书用药情况在各类药品中都普遍存在,其中营养类药物、呼吸系统用药和神经系统用药的超说明书发生率较高,均超过50%。结论：该院儿科住院患儿超说明书用药现象较为普遍。执法部门、执业人员、临床药师及生产企业应从各自角度对超说明书用药进行干预,以促进儿科合理用药。

OBJECTIVE： To provide baseline data for promoting rational drug use in children and further develop relevant study of off-label drug use. METHODS ： Medical records of pediatrics inpatients aged below 18 years were randomly selected from a third grade class a hospital of Xinjiang during Mar. 2014 to Feb. 2015, to judge the drug use behavior according to the drug pack-age inserts, and analyze the types of off-label drug use, age groups and drug varieties statistically by fund research group members and clinical pharmacists. RESULTS： According to the number of medical orders and medication records, 864 inpatients medical re- cords were selected and the incidence of off-label drug use were 87.85% and 46.94%. The types of off-label drug use mainly con- centrated in the super frequency （39.33%） and super indications （33.01% ）. The off-label drug use in the hospital mainly occurred in young children aged 1-3 years （69.01%） and children aged 4-11 years （28.44%）. The off-label drug use was widely found in various drugs. The incidence of off-label drug use for nutritional drug, respiratory system drugs and nervous system drugs were all in high level and higher than 50%. CONCLUSIONS： The phenomenon of off-label drug use is widespread in pediatric inpatients. Rational use of pediatric drugs shonld be promoted throagh off-label drug use intervention by authorties, epproved persons, clinical pharmacists and manufacturing enterprises.