原研与国产仿制抗菌药物药品说明书的对比分析

Comparison Analysis of Package Inserts between Brand Name and Domestic Generic Antibacterial Drugs

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。

OBJECTIVE： To provide reference for further standardizing package inserts of domestic generic antibacterial drugs. METHODS： 68 pieces of package inserts for 34 kinds of brand name and generic antibacterial drugs were analyzed comparatively, including ADR, precautions, drug interaction, pharmacology and toxicology and pharmacokinetics, according to Regulation for Drug Package Inserts and Label Management and Regulatory Guidelines for Chemicals and Biologicals and other references. RE- SULTS ＆ CONCLUSIONS： The labelling rate of pharmacological effects in 68 drug package inserts is relatively high, but the la- belling rate of clinical trial data on ADR and its proportion or frequency in package inserts of domestic generic antibacterial drugs is lower than that of brand name drugs. The package inserts are not labeled or marked in detail in the case of need for caution and the need to observe medication course; for influential factors of therapeutic efficacy and the effect of medication on clinical test, the labelling rate was also in low level relatively; the labelling rate of precautions about drug interaction and combination is significantly lower than brand name drugs. The labelling proportion of toxicological explanation is not high, especially the majority of domestic package inserts only contain pharmacological effects but not involve non-clinical toxicology research. In package inserts of domestic generic antibacterial drug, the labelling rate of items about absorption, distribution, metabolism, pharmacokinetic parameters of special populations, pharmacokinetic parameters in liver and kidney damage patients is lower or incomplete. Drug administration departments are suggested to strengthen the labelling management in terms of ADR, precautions, drug interactions, pharmacology and toxicology, pharmacokinetics and so on, so as to standardize and improve drug package inserts as soon as possible.