原研与国产仿制抗菌药物药品说明书的对比分析

发布时间：2018-03-12 12:00

本文选题：抗菌药物　切入点：药品说明书　出处：《中国药房》2015年01期 　论文类型：期刊论文

【摘要】：目的:为进一步规范国产仿制抗菌药物药品说明书提供参考。方法:依据《药品说明书和标签管理规定》《化学药品和生物制品说明书规范细则》及其他参考资料对34种原研与国产仿制抗菌药物的68份药品说明书中不良反应、注意事项、药物相互作用、药理毒理、药动学等相关项目的标注情况进行对比分析。结果与结论:68份药品说明书中药理作用标注率都相对较高,但国产仿制抗菌药药品说明书关于不良反应的临床试验数据说明及其比例或频率方面的标注率明显低于原研药品;在需要慎用及用药过程中需观察的情况等方面没有标注或者标注不够详细;在影响药物疗效的因素和用药对于临床检验的影响方面标注率较低;在药物相互作用的结果和合并用药的注意事项标注率明显低于原研药品;涉及毒理说明的标注比例不高,尤其是国内大部分药品说明书只有药理作用而没有非临床毒理研究的相关信息;在吸收、分布、代谢、特殊人群药动学参数、肝肾损害患者药动学参数等方面标注率比原研抗菌药品低,或者标注不完整。建议药监部门加强国产仿制抗菌药物药品说明书在不良反应、注意事项、药物相互作用、药理毒理、药动学等方面标注的管理,尽快规范和完善药品说明书。
[Abstract]:Objective: to provide reference for further standardization of generic antimicrobial drug instructions made in China. Methods: according to the regulations for the Administration of Drug instructions and labelling, the specifications for Chemical and Biological products and other reference materials. Adverse reactions were observed in 68 drug instructions of 34 original and domestic imitated antimicrobial agents. The results showed that the labeling rate of pharmacological action in 68 drug instructions was higher than that in 68 drug instructions. However, the labeling rate of the clinical trial data and the proportion or frequency of adverse drug reactions in the instruction book of domestic imitation antimicrobial drugs was obviously lower than that of the original drugs. In need of careful use and the situation to be observed in the course of medication, there is no marking or labeling in detail, in the factors affecting the efficacy of drugs and the effect of medication on clinical testing, the labeling rate is low. The results of drug interaction and the attention rate of the combined drug were significantly lower than those of the original drug, and the proportion of the labels involved in the toxicological description was not high. In particular, most drug instructions in China have only pharmacological effects and no relevant information for non-clinical toxicological studies; pharmacokinetic parameters in absorption, distribution, metabolism, and special population. The labeling rate of pharmacokinetic parameters in patients with liver and kidney damage is lower than that of the original antibacterial drugs, or the labeling is incomplete. It is suggested that the drug supervision department strengthen the adverse reactions, precautions, and drug interactions in the drug instructions of domestic imitation antimicrobial drugs. Pharmacological toxicology, pharmacokinetics and other aspects of label management, as soon as possible to standardize and improve drug instructions.
【作者单位】：福建医科大学附属泉州第一医院药剂科;
【分类号】：R95

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