原研与国产仿制左氧氟沙星注射液说明书的对比分析 点击下载
论文标题： 原研与国产仿制左氧氟沙星注射液说明书的对比分析
英文标题：
中文摘要： 目的：为提高国产仿制左氧氟沙星注射液说明书的信息质量提供建议。方法：将原研左氧氟沙星注射液药品说明书与20份3种不同酸根的国产仿制左氧氟沙星注射液药品说明书中警告、适应证、用法用量、儿童用药、药物相互作用、毒理学、药动学等内容进行对比分析。结果与结论：21份药品说明书中适应证、用法用量和药动学的标注率较高，均为100％。国产仿制盐酸盐、乳酸盐、甲磺酸盐左氧氟沙星注射液药品说明书警告中肌腱损伤的标注率分别为30.00％、0、33.33％，适应证中抗菌谱的标注率分别为10.00％、0、33.33％，药物相互作用的具体结果标注率分别为10.00％、0、66.67％，毒理学标注率分别为70.00％、85.71％、33.33％，均低于原研药100％的标注率。3种国产仿制左氧氟沙星注射液药品说明书用法用量、儿童用药及毒理学项目均缺少临床试验数据，药动学项目缺少肝肾功能损伤者及特殊人群药动学参数。建议左氧氟沙星注射液国产仿制药企业完善药品说明书的具体内容；药品说明书监管部门应完善对药品说明书的审批管理；医师和药师应严格按相应药品说明书的信息对照使用。
英文摘要： OBJECTIVE： To provide suggestions for improving the quality of the instructions of domestic generic Levofloxacin injections. METHODS： A set of instructions of original Levofloxacin injection and 20 sets of instructions of domestic generic Levofloxacin injections （with three kinds of acid radicals） were compared and analyzed in warning， indications， dosage and administration， medication for children， drug interactions， toxicology， pharmacokinetics， etc. RESULTS & CONCLUSIONS： The rate of recording indications， dosage and administration and pharmacokinetics among the 21 sets of instructions is high， up to 100％. Among the instructions of domestic generic Levofloxacin hydrochloride injection， Levofloxacin lactate injection and Levofloxacin mesylate injection， the rates of mentioning a tendon injury in the warning section are 30.00％， 0 and 33.33％ respectively； those of recording antibacterial spectrum in the indications section are 10.00％， 0 and 33.33％ respectively； those of recording the specific results of drug interactions are 10.00％， 0 and 66.67％ respectively； and those of recording toxicological information are 70.00％， 85.71％ and 33.33％ respectively， all of which are lower than the recording rates of 100％ for the instructions of original one. In the instructions of domestic generic Levofloxacin injection， there is a lack of clinical trial data in the sections of dosage and administration， medication for children and toxicology and of pharmacokinetic parameters for patients with impaired liver/kidney function and special population in the pharmacokinetics section. It is suggested that the manufacturers of domestic generic Levofloxacin injections should improve the specific contents of the instructions； the instructions regulatory authorities should improve the administration of instructions examination and approval； and doctors and pharmacists should strictly follow the instructions.
期刊： 2016年第27卷第25期
作者： 李桂丹，何心
英文作者： LI Guidan，HE Xin
关键字： 左氧氟沙星；说明书；原研药；仿制药；对比分析
KEYWORDS： Levofloxacin； Instructions； Original drug； Generic drug； Comparative analysis
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