某院门诊奥美拉唑超说明书用药情况调查分析
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篇名: 某院门诊奥美拉唑超说明书用药情况调查分析
TITLE:
摘要: 目的:调查门诊奥美拉唑超说明书用药情况,为临床合理用药提供参考。方法: 采用回顾性调查的方法,并用随机数字表法抽取某院门诊2014年6月-2017年5月使用奥美拉唑的处方1 838张,根据最新版药品说明书,判断是否超说明书用药;通过查阅国内外指南、文献和Micromedex数据库等对超说明书用药进行分析。结果:1 838张处方中,超说明书用药处方有1 750张(95.21%),涉及3种类型、13项超说明书用药内容。超说明书用药类型主要为超适应证用药,共1 747张(96.47%)。消化内科和非消化内科超说明书用药发生率、不同级别医师超说明书用药发生率比较,差异均无统计学意义(P>0.05)。13项超说明书用药内容中,7项有国内外指南、专家共识/建议或文献报道等不同级别的循证医学证据支持,但其中仅有1项被Micromedex的Thomson分级系统收录,其余6项均无任何循证医学证据。结论:该院门诊奥美拉唑超说明书用药现象普遍,部分超说明书用药有证据支持,但各证据质量存在差异。临床应规范说明书应用以避免法律风险,确保患者安全用药。
ABSTRACT: OBJECTIVE: To investigate the omeprazole off-label use and provide reference for rational drug use in clinic. METHODS: In retrospective survey, 1 838 omeprazole prescriptions were selected from outpatient department during Jun. 2014 to May 2017 by random number table. According to the latest drug instruction, whether the off-label use or not was determined. Off-label use was determined by reviewing domestic and foreign guidelines, literatures and Micromedex database. RESULTS: Among 1 838 prescriptions, there were 1 750 prescriptions of off-label drug use (95.21%), involving 13 items and 3 types of off-label drug use. Main type of off-label drug use was over-indication medication, involving 1 747 prescriptions (96.47%). There was no statistical significance in the incidence of off-label drug use between digestive department and non-digestive department or among physicians at different levels (P>0.05). Among 13 items of off-label drug use, 7 items were supported by evidence-based medicine evidence of domestic and foreign guideline, expert consensus/suggestion or literature reports, etc.; among which 1 item of off-label drug use were included in Micromedex grading system and other 6 items had no evidence-based medicine evidence. CONCLUSIONS: The phenomenon of omeprazole off-label use is widespread in outpatient department of the hospital, and some off-label drug use are supported by evidences. There are differences in the quality of those evidences. It is suggested to standardize the off-label drug use to avoid legal risks and guarantee the safety of drug use for patients.
期刊: 2017年第28卷第35期
作者: 蒋炜,吴晓玲,周敏华,谢奕丹,王艳,黄光鸿
AUTHORS: JIANG Wei,WU Xiaoling,ZHOU Minhua,XIE Yidan,WANG Yan,HUANG Guanghong
关键字: 门诊;奥美拉唑;超说明书用药;分析
KEYWORDS: Outpatient department; Omeprazole; Off-label drug use;Analysis
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