徐伏莲,温预关,陈伟家,何佩华,林悦甜,余松喜,胡晋卿
XU Fulian,WEN Yuguan,CHEN Weijia,HE Peihua,LIN Yuetian,YU Songxi,HU Jinqing

• 1:江门市第三人民医院
• 2:广州医科大学附属脑科医院(广州市惠爱医院)
• 3:江门市新会区第三人民医院

摘要(Abstract)：

目的了解精神药物在儿童青少年患者中超说明书用药的情况,为今后制定儿童青少年精神药物超说明书用药政策提供基线数据。方法调查广东省3家不同级别的精神专科医院儿童青少年患者门诊处方和住院用药医嘱,根据国家食品药品监督管理总局批准的药品说明书判断患者各条用药医嘱是否超说明书用药,统计门诊处方及住院医嘱的超说明书用药比例、各类精神药物超说明书用药发生率、超说明书用药类型、"有儿童用药信息"与"无儿童用药信息"情况下超说明书用药发生频率前3位的药品,并采用χ~2检验分析医院级别、处方医生职称与超说明书用药的发生是否相关。结果本研究共纳入4 745项超说明书用药,发生率为73.76%,共涉及21个精神药物。各类药物的超说明书的发生率分别为抗精神病药物86.43%、抗抑郁药62.46%、镇静安眠药54.55%。超说明书用药类型排名前3名是:超"无儿童用药信息"、超年龄和超适应证用药。在"有儿童用药信息"的情况下,超说明书发生频次前3名是利培酮片、地西泮注射液、盐酸舍曲林片;在"无儿童用药信息"中排名前3的是富马酸喹硫平片、奥氮平片、阿立哌唑片。超说明书用药的发生率与医院级别及处方医生职称有显著的相关性(P<0.05)。结论儿童青少年精神药物超说明书用药现象普遍存在,建议尽快制定精神药物儿童青少年超说明书用药相关规定、专家共识及指南,规范儿童青少年患者精神药物的使用,保障患儿用药安全,减少临床用药风险。
OBJECTIVE To investigate the status quo of off-label drug use in child and adolescent psychiatric patients,so as to provide baseline data for making policies of off-label psychiatric drug use in child and adolescent psychiatric patients.METHODS Medical orders for child and adolescent psychiatric patients were selected from three psychiatric hospitals with different grades in Guangdong.According to the State Food and Drug Administration approved judgment with the prescriptions of off-label drug use in the drug instructions,the rate of off-label drug use,the categories of off-label drug use,the category of drugs and the top 3 drugs with or without pediatric information of off-label use was calculated,and the off-label drug relationship between the hospital grade and the doctor prescription title was analyzed by using χ~2 test.RESULTS Totally 4 745 medication records,including 21 psychotropic drugs were analyzed,73.76% of them were off-label drug use.The rate of off-label drug use was 86.43%,62.46% and 54.55% in antipsychotic drugs,antidepressants and sedative-hypnotics.The main categories of off-label drug use were "no pediatric information",age and indication.The top 3 drugs with pediatric information of off-label use were risperidone tablet,diazepam injection,sertraline tablet and top 3 drugs with no pediatric information of off-label use were quetiapine tablet,olanzapine tablet and aripiprazole tablet.In addition,the hospital grade and the doctor prescription title were closely related to the rates of off-label drug.CONCLUSION The off-label drug use in child and adolescent psychiatric patients is common.It is urgent to develop related laws and regulations or guidelines to regulate off-label drug use in order to ensure the safety of drug use in child and adolescent psychiatric patients.

关键词(KeyWords)： 精神科;超说明书用药;儿童青少年;用药安全;多中心调查
psychiatric;off-label drug use;child and adolescent;drug safety;multicenter study

Abstract:

Keywords:

基金项目(Foundation): 广东省医院药学研究基金(2017A14);; 广州市医药卫生科技项目(20171A010281)

作者(Author): 徐伏莲,温预关,陈伟家,何佩华,林悦甜,余松喜,胡晋卿
XU Fulian,WEN Yuguan,CHEN Weijia,HE Peihua,LIN Yuetian,YU Songxi,HU Jinqing

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