今日药学

2016, v.26(07) 515-518

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心血管系统药物超说明书用药现状调查
Analysis of Off-Label Drug Use in Cardiovascular Drugs

杜美欣;刘晓琦;杨敏;劳海燕;曾英彤;张晓娟;
DU Meixin;LIU Xiaoqi;YANG Min;LAO Haiyan;ZENG Yingtong;ZHANG Xiaojuan;Department of Pharmacy,Guangdong General Hospital,Guangdong Academy of Medical Sciences;

摘要(Abstract):

目的调查某三甲医院2014-01~12心内科住院患者心血管系统药物超说明书用药情况,为加强超药品说明书用药管理提供依据。方法分层随机抽取该院心内科住院患者的出院带药医嘱,根据药品说明书按适应证、剂量、年龄等指标计算超说明书用药比例,并根据临床指南、专家共识、或文献等判断其合理性。结果共纳入心内科住院患者479例,分析用药医嘱1 153条,涉及药品57种。超说明书用药主要类型为超适应证用药,发生率为23.07%(266/1 153),超剂量用药发生率为0.17%(2/1 153),无超年龄用药。超说明书的发生率最高的一类药物为血脂调节剂40.32%(125/310)。此次调查无因药物超说明书应用导致的不良反应而再次入院患者。结论心血管系统药物超说明用药情况普遍存在,但存在合理性,有必要对超说明书用药进行分级管理。
OBJECTIVE To provide the basis for medication management of off-label drug use by analyzing the off-label drug use inpatient medical order from department of cardiology,from January 2014 to December. METHODS The stratified random sampling was conducted to select discharge medication for patient in department of cardiology.The situation of drugs used was calculated according to medicine operation instructions,such as indications,dosage,suitable groups; the rationalisation was judged according to clinical guidelines,expert consensus,evidence-based medicine orliterature. RESULTS The total of 479 inpatients were selected,and 1 153 prescriptions involved 57 drugs were analyzed. The main categories of off-label drug use were surpass indication,the rate was 23. 07%( 266/1 153),the categories of off-label drug use were everyday total dosage,the rate was 0.17%( 2/1 153),and no suitable groups. The main categories of off-label drug use were blood lipid regulating drugs( 40.33%)( 125 / 310). This survey without off-label drug uses patients led to the hospital again due to adverse drug reactions. CONCLUSION The off-label drug use of cardiovascular drugs were universal,but has its rationality. Level-to-level administration of off-label drugs use will be necessary.

关键词(KeyWords): 心血管药物;超说明书用药;用药分析
cardiovascular agents;off-label drug use;countermeasures analysis

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作者(Author): 杜美欣;刘晓琦;杨敏;劳海燕;曾英彤;张晓娟;
DU Meixin;LIU Xiaoqi;YANG Min;LAO Haiyan;ZENG Yingtong;ZHANG Xiaojuan;Department of Pharmacy,Guangdong General Hospital,Guangdong Academy of Medical Sciences;

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