CFDA和FDA标准下我院精神专科药物超适应证使用比较分析  

Comparison and Analysis about Off-indication Use of Psychiatric Drugs in Our Hospital by the Standards of CFDA and FDA

作　　者：贾晓妮[1] 权伟[1] 陈建波[1] 岳丹萍[2] 支媗[1] 张晓红[1] 

机构地区：[1]西安市精神卫生中心药剂科,西安710061 [2]西安市精神卫生中心人事科,西安710061

出　　处：《中国药房》2017年第14期1899-1903,共5页China Pharmacy

摘　　要：目的:了解精神专科医院住院患者在我国食品药品监督管理总局(CFDA)和FDA标准下口服化学药医嘱超适应证用药情况,比较两种标准的差异性,分析原因和用药合理性,为医院制订超适应证用药管理制度提供参考。方法:统计并分析我院2016年1-6月住院患者的口服化学药医嘱,分别以CFDA和FDA批准的适应证为标准,判断超适应证用药情况。结果:共收集到符合本研究要求的口服化学药医嘱507条,CFDA和FDA标准下的超适应证医嘱比例都相对较高,分别为58.58%和55.82%。CFDA标准下,喹硫平和阿立哌唑的超适应证发生率都明显高于FDA标准下的结果,差异均有统计学意义(P<0.05);构成比居前3位者分别为丙戊酸镁(54.03%)、草酸艾司西酞普兰(10.45%)和喹硫平(10.15%);超适应证医嘱中没有循证医学依据的有7条,占超适应证医嘱总数的2.36%。结论:我院多数超适应证医嘱能提供相关依据及文献支持,但仍有少部分超适应证用药证据不够充分。医院应建立相应的管理制度,以保证患者的用药安全和医师的合法权益。OBJECTIVE： To investigate off-indication use of oral chemical drugs medical orders by the standards of CFDA and FDA, and to compare the differences between the two standards, analyzereasons and rationality of drug use, so as to pro- vide reference for establishing off-indications use management system. METHODS： The oral chemical drugs medical orders of inpatients were analyzed statistically during Jan.-Jun. 2016. Off-label uses was judged according to the standards of CFDA and FDA. RESULTS： Totally 507 oral chemical drugs medical orders were collected, the percentage of off-indications use were in high level, being 58.58% and 55.82% respectively by the standards of CFDA and FDA. The incidence of off-indication use of quetiapine and aripiprazole by the CFDA standards were significantly higher than the results of FDA standards, with statistical significance （P〈0.05）. Magnesium valproate （54.03%）, escitalopram oxalate （10.45%） and quetiapine （10.15%） occupied the top 3 places in the list of constituent ratio. Among off-indication medical orders, 7 orders had no evidence-based medicine, ac- counting for 2.36% of total. CONCLUSIONS： Most off-indication medical orders of our hospital could provide the basis and lit- erature support, while there are still a few off-indication use with insufficient evidence. The corresponding management system of the hospital should be formulated to guarantee the medication safety of the patients and legitimate rights and interests of the doctors.

关 键 词：精神专科药物 超适应证用药 医嘱 合理用药 

分 类 号：R969.3[医药卫生—药理学]