新型口服抗凝药物的中国_美国以及欧盟说明书对比分析_卢琳.pdfVIP

新视野 New Horizons 新型口服抗凝药物的中国、美国以及欧盟说明书对比分析 1 1* 2 2* 3 3* 卢琳 ,马满玲 ，柳鑫 ，赵志刚 ，徐露珍 ，黎月玲 1.哈尔滨医科大学附属第一医院药学部,黑龙江哈尔滨150000;2.首都医科大学附属北京天坛医院,北京100050;3.广州市红十字会医院，广州 510000 [摘要] 目的：为临床更加全面了解新型口服抗凝药物，进而合理、安全的应用于临床提供参考。方法：对已在我国上市的五种新型口服抗 凝药物的中国、美国、欧盟说明书进行对比分析，并着重对不良反应、注意事项、药物的相互作用、药理毒理、药动学以及特殊人群用药 等相关安全性项目进行对比分析。结果和结论：我国药品说明书与美国说明书和欧盟说明书结构类似，基本项目内容一致，但存在部分项 目标注简单或缺失。不良反应、注意事项、药物相互作用、药理毒理、药动学、特殊人群用药等关键的安全性项目存在标注不够详细等问 题。建议临床工作者加强对新型口服抗凝药物的说明书学习，同时建议生产企业等相关部门不断完善说明书内容，以保证临床使用新型口 服抗凝药物的安全性、有效性。 [关键词] 新型口服抗凝药物；药品说明书；安全性；对比分析 [中图分类号] R973+.2　　[文献标识码]　A　　[文章编号]　1672-2809(2018)08-0008-09　 Comparative Analysis of the Instructions of New Oral Anticoagulant Listed in China, America and European Unions 1 1* 2 2* 3 3* LU Lin , MA Man-ling , LIU Xin , ZHAO Zhi-gang , XU Lu-zhen , LI Yue-ling 1.First affiliated hospital of Harbin Medical University medicine division, Harbin Heilongjiang 150000, China; 2.Beijing Tian Tan affiliated hospital of Capital Medical University, Beijing 100050, China; 3.The Red Cross hospital in Guangzhou, Guangzhou Guangdong 510000 , China [Abstract] Objective: To provide reference for further reasonable and safe application of new oral anticoagulant and provide reference for clinical practice. Methods: Instructions of five new anticoagulants listed in China, American and the Europeans were analyzed and ADR, precautions, drug interaction, pharmacology and toxicology, pharmacokinetics and the use in specific populations were emphasized. ResuitsConciusions: The structure and items of the domestic, American and the European ’s instructions were similar, but some projects were not marked or too sample. On security items of ADR, precautions, drug interaction, pharmacology and toxicology, pharmacokinetics and the use in specific populations were not marked in detail. It is suggested that medical care personnel should study the management of drug instructions and drug m