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引用本文:任燕萍,芦小燕,周菲,龚燕波,张灵灵.700例药品不良反应报告超说明书用药情况分析[J].中国现代应用药学,2016,33(11):1474-1477.
REN Yanping,LU Xiaoyan,ZHOU Fei,GONG Yanbo,ZHANG Lingling.Analysis of Off-label Drug Uses of 700 Cases of Adverse Drug Reaction Reports[J].Chin J Mod Appl Pharm(中国现代应用药学),2016,33(11):1474-1477.
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700例药品不良反应报告超说明书用药情况分析
任燕萍, 芦小燕, 周菲, 龚燕波, 张灵灵
宁波市第二医院, 浙江 宁波 315010
摘要:
目的 了解药品不良反应(adverse drug reactions,ADR)报告中超说明书用药的情况,为临床合理用药提供参考。方法 对2014年1~12月收集的药品不良反应报告共700例进行回顾性分析,根据药品说明书对超说明书用药情况进行分析。结果 700例ADR报告中,共有医嘱1 605条,有267份超说明书用药报告(38.1%),有416条超说明书医嘱(25.9%),类型主要为超给药频次、超给药剂量和超适应症,超说明书用药构成比居前3位的药物依次为银杏达莫注射液、前列地尔注射液和注射用美洛西林钠。结论 ADR报告中超说明书用药情况普遍存在,需加强监管,促进临床合理用药,减少ADR的发生。
关键词:  药品不良反应  超说明书用药
DOI:10.13748/j.cnki.issn1007-7693.2016.11.027
分类号:R284.1;R917.101
基金项目:
Analysis of Off-label Drug Uses of 700 Cases of Adverse Drug Reaction Reports
REN Yanping, LU Xiaoyan, ZHOU Fei, GONG Yanbo, ZHANG Lingling
Ningbo No. 2 Hospital, Ningbo 315010, China
Abstract:
OBJECTIVE To investigate the situation of off-label drug uses of drug adverse reaction reports, and to promote clinical rational drug use. METHODS A retrospective analysis was conducted on 700 cases of adverse drug reactions reported in our hospital in 2014, according to the drug instructions. RESULTS A total of 1 605 drug prescriptions was recorded in 700 cases of ADR reports, 267 ADR reports involved off-label drug uses(38.1%), 416 drug prescriptions involved off-label drug uses(25.9%). The top three types of off-label uses were off-label administration frequency, overdose, and off-indication use; and the top three drugs were Ginkgo Dipyidamolum, Alprostadil injection, and mezlocillin sodium for injection. CONCLUSION Off-label drug uses are common in ADR reports in our hospital. It is important to tighten monitoring on the off-label drug uses and to promote clinical rational drug uses so as to reduce the incidence of ADR.
Key words:  adverse drug reactions  off-label drug uses
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