王昭蓉,刘璐,李琳琳,等.中美药品说明书中关于解热镇痛药物干扰检验内容比较研究[J].安徽医药,2017,21(10):1936-1937. |
中美药品说明书中关于解热镇痛药物干扰检验内容比较研究 |
Comparison of the information of drug impairing laboratory tests of antipyretic and analgesic drug labels in US and China WANG Zhaorong1,LIU Lu1,LI Linlin1,DING Hongxia2,FAN Jianying1,LI Haibo1 (1.Department of clinical laboratory,Nantong Maternity and Child Health Hospital,Nantong, Jiangsu 226018,China;2.Pharmacodia(Beijing) Co.,LTD,Beijing 100085,China) Abstract:Objective |
投稿时间:2016-10-07 |
DOI: |
中文关键词: 解热镇痛药 临床检验 干扰 药品说明书 |
英文关键词: Antipyretic and analgesic drugs Clinical assay Interference Drug labels |
基金项目:江苏省卫生国际(地区)交流支撑计划资助项目(2012-036) |
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中文摘要: |
目的 对比美国和中国解热镇痛药物说明书中有关药物干扰检验的内容。 方法 以美国和中国国家食品药品监督管理局收录的解热镇痛药物说明书为研究对象,检索其中药物干扰检验的相关内容。 结果 在美国上市的解热镇痛药物中,二氟尼柳、依托度酸、甲芬那酸、萘普生、奥沙普秦、柳氮磺吡啶、托美丁钠等七种药物会干扰临床检验结果,而中国相应药物的说明书中均未提及相关内容。 结论 我国药品生产企业及药品监督部门需规范及完善药品说明书内容,为患者及医务工作者提供更多有用的信息。 |
英文摘要: |
Objective To compare the information of antipyretic and analgesic drugs impairing laboratory tests from US and China prescription drug labels. Methods The labels for prescription antipyretic and analgesic drugs were collected and reviewed manually for their information related to the drug impairing laboratory tests. Results According to the information provided by US drug labels,seven antipyretic and analgesic drugs,namely diflunisal,etodolac,mefenamic acid,naproxen,oxaprozin,sulfasalazine and tolmetin sodium could affect the laboratory assays.But there wereno any related information in China antipyretic and analgesic drug labels. Conclusions For the government regulatory agency and the drugs manufactures,standardization of the drug labelsis needed to provide more useful information for the patients and medical professional staff. |
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