700例药品不良反应报告超说明书用药情况分析.PDFVIP

·药品未注册用法 · 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 中图分类号：R969.3 文献标志码：B 文章编号：1007-7693(2016)11-1474-04 DOI: 10.13748/ki.issn1007-7693.2016.11.027 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 超说明书用药也称药品未注册用法，是指药 行登记，使用 Microsoft Excel 2007 登记及统计数 品使用的适应证、给药方法或剂量不在药品监督