某精神专科医院儿童青少年患者超说明书用药情况分析  

Add to Favorite Investigation of off-label drug use in children and adolescents in a psychiatric hospital

作　　者：贾晓妮[1] 李甜[2] 陈建波 李欢 支丽娟 张晓红[2] JIA Xiaoni;LI Tian;CHEN Jianbo(Xi'an Mental Health Center,Xi'an 710010,China)

机构地区：[1]西安市精神卫生中心,陕西西安710010 [2]西安医学院

出　　处：《精神医学杂志》2023年第6期600-604,共5页Journal of Psychiatry

基　　金：陕西省自然科学基础研究计划项目(编号:2022JQ-861);西安市科技计划项目(编号:21YXYJ0078,22YXYJ0028,23YXYJ0079)。

摘　　要：目的 调查某精神专科医院儿童及青少年患者在我国国家药品监督管理局(NMPA)和美国食品药品监督管理局(FDA)标准下的超说明书用药(OLDU)情况。方法 统计某精神专科医院儿少心理科2022年4月~2023年3月的住院医嘱,分别根据NMPA和FDA标准下的最新药品说明书判断其OLDU情况。结果 共调查511例住院患者的医嘱,含医嘱条数1 869条,涉及精神科药品34种。NMPA和FDA标准下入组患者OLDU发生率分别为85.55%和67.52%,NMPA标准OLDU比例高于FDA标准(P<0.01)。其中NMPA标准超适应人群及超适应证总用药比例均高于FDA标准(P<0.05),NMPA标准超剂量总用药比例低于FDA标准(P<0.01);NMPA标准抗精神病药和抗抑郁药总用药比例高于FDA标准(P<0.01)。NMPA标准喹硫平、阿立哌唑、奥氮平、鲁拉西酮的总OLDU比例均高于FDA标准(P<0.05),NMPA标准喹硫平、奥氮平、鲁拉西酮超适应人群OLDU比例高于FDA标准(P<0.01),NMPA标准阿立哌唑超适应证OLDU比例高于FDA标准(P<0.01)。结论 NMPA和FDA标准下某院精神科儿童青少年患者处方中OLDU现象普遍存在。我国相关部门应尽快完善OLDU法律法规,促进儿童青少年合理用药,减少医疗纠纷的发生。Objective To investigate off-label drug use(OLDU)in children and adolescents of a psychiatric hospital under the standards of National Medical Products Administration(NMPA)and the United States Food and Drug Administration(FDA).Methods The inpatient medical orders of the pediatric psychology department of the hospital from April 2022 to March 2023 were collected,and the OLDU was judged according to the latest drug instructions under the NMPA and FDA standards.Results A total of 511 hospitalized patients'medical orders were investigated,including 1869 medical orders with 34 psychiatric drugs.The incidence of OLDU under NMPA criteria(85.55%)was higher than that under FDA criteria(67.52%)(P<0.01).The proportions of unapproved indication use,off-label population,antipsychotics and antidepressants under NMPA criteria were all higher than those under FDA criteria(P<0.05);the proportion of overdose under NMPA criteria was lower than that under FDA criteria(P<0.01).The overall OLDU proportions of quetiapine,aripiprazole,olanzapine and lurasidone under NMPA criteria were all higher than those under FDA criteria(P<0.05).The proportions of off-label population of quetiapine,olanzapine and lurasidone under NMPA criteria were all higher than those under FDA criteria(P<0.01).The proportion of unapproved indication use of aripiprazole under NMPA criteria was higher than that under FDA criteria(P<0.01).Conclusion OLDU is common in psychiatric prescriptions for children and adolescents in the hospital under the NMPA and FDA standards.Relevant departments should improve laws and regulations on OLDU as soon as possible,to promote rational drug use among children and adolescents,and to reduce the occurrence of medical disputes.

关 键 词：精神科 超说明书用药 儿童青少年 NMPA FDA 

分 类 号：R749.94[医药卫生—神经病学与精神病学]