美国精神科药物说明书中药物干扰实验室检验内容的分析  

Analysis of drug-related laboratory test interference in psychotropic drug instructions in USA

作　　者：鲍欣欣[1] 朱海霞[1] 王文玉[1] 王姣娇 李海波[1] 

机构地区：[1]南通市妇幼保健院检验科,江苏南通226018

出　　处：《中国新药与临床杂志》2016年第10期718-721,共4页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：目的分析美国精神科药物说明书中有关药物干扰检验的信息,以期对我国说明书的撰写和监管有所借鉴。方法从美国食品和药物管理局药品说明书官方网站Daily Med中下载收录的所有药品说明书建立数据库,手工检索其中精神科药物干扰检验的相关内容。结果在美国已上市的精神科药物中,检索到盐酸安非他酮等13种药物能够干扰临床检验,对检验结果的解释造成不利的影响。这些药物使尿液中其他药物呈假阳性,而且多采用了免疫学方法的测定,提示可能是由于检测试剂中所用抗体的非特异性反应所致。结论药品说明书是临床上药物干扰检验的良好信息来源。我国药品生产企业及药品监督部门应规范、完善药品说明书内容,以便为临床合理用药提供更多的帮助。AIM To analyse the drug- related laboratory test interference in psychotropic drug instructions in USA, in order to give reference to the compiling and supervision of drug instructions in China. METHODS From DailyMed, the drug instruction official website of United States Food and Drug Administration, all drug instructions were downloaded to establish a database. And the information about psychotropic drug-related laboratory test interference were manually searched. RESULTS Totally 13 psychotropic drugs, such as bupropion hydrochloride, were retrieved with detailed information about drug-related laboratory tests. These drugs make the urine determination of the other drugs a false positive and most of the tests were taken by immunoassay methods. It was indicated that this interference may be due to the nonspecificity of antibody caused by the detection reagent. There was no any information about drug related laboratory test interference for these psychotropic drugs in Chinese labels. CONCLUSION Drug instructions are a goodinformation source for in our country should clinical drug interference test. The drug supervision departments and the drug manufactures standardize and improve the contents of the drug instrctions in order to provide more help for clinical rational drug use.

关 键 词：精神治疗药物 药物标签 假阳性反应 美国食品和药物管理局 

分 类 号：R749[医药卫生—神经病学与精神病学]