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某“三甲”医院2015－2016年超说明书用药调查分析
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| 篇名： | 某“三甲”医院2015－2016年超说明书用药调查分析 |
| TITLE： | |
| 摘要： | 目的：控制超说明书用药风险，为合理用药提供参考。方法：采用分层等比例抽样法抽取某“三甲”医院2015年6月－2016年6月门诊处方，根据国家食品药品监督管理总局发布的最新版药品说明书，筛查出全部超说明书用药处方并进行统计。依据Micromedex工具及相关文献报道、指南，分析超说明书用药的类型、疾病诊断、证据来源及级别，以及相关的严重的药品不良反应（ADR）。结果：在抽取的3 025 张门诊处方中，11.2％（339 张）的处方涉及超说明书用药，包括超适应证（88.7％）、超给药剂量（6.0％）、超给药途径（3.2％）和超适应人群（2.1％）；涉及疾病诊断以胃食管反流病为主（16.0％）。证据主要来源于美国FDA批准的说明书（1.5％）、国际国内指南（83.8％）、专家共识（12.4％）和其他（文献报道等）（2.4％）。13项超说明书用药用法已被Micromedex收录，推荐等级、证据强度各有不同。8种超说明书用药药品有致严重的ADR的报道。结论：该院门诊超说明书用药均有循证医学证据支持，但证据质量有差异。在实践中，医师、药师还应充分权衡超说明书用药利弊。 |
| ABSTRACT： | OBJECTIVE： To control the risk of off-label drug use，and to provide reference for rational drug use. METHODS： Outpatient prescriptions were selected by stratified equal proportion sampling method from a third grade class A hospital during Jun. 2015-Jun. 2016. According to the latest edition of drug instruction issued by CFDA， the off-label prescriptions were screened and analyzed statistically. According to Micromedex tools and literatures report， guidelines， off-label drug use and related severe ADR were analyzed. RESULTS： Of 3 025 outpatient prescriptions， 11.2％ of prescriptions （339 pieces） were considered as off-label prescriptions， including without indication （88.7％）， over dose （6.0％）， beyond route of administration （3.2％） and beyond adapt-to-the-crowd （2.1％）. Gastroesophagedal reflux was the main diagosis （16.0％）. 1.5％ of off-label drug use were supported by FDA-approved labels， 83.8％ of them were supported by international and national guidelines， 12.4％ of them were supported by expert consensus， and 2.4％ of them were supported by other literature report. Thirteen items of off-label drug use had been included in Micromedex， recommendation grade and evidence intensity of which varied. Eight drugs of off-label drug use were reported to result in serious ADR. CONCLUSIONS： All off-label drug use in outpatient department of this hospital is supported by evidence-based medical evidence. But the quality of evidence varies. In the practice， physicians and pharmacists should balance the benefit and risk of off-labed drug use carefully. |
| 期刊： | 2017年第28卷第29期 |
| 作者： | 张翠翠，张镭，陆进 |
| AUTHORS： | ZHANG Cuicui，ZHANG Lei，LU Jin |
| 关键字： | 超说明书用药；药品不良反应；风险 |
| KEYWORDS： | Off-label drug use； ADR； Risk |
| 阅读数： | 373 次 |
| 本月下载数： | 27 次 |
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