临床常用头孢菌素类抗菌药物药品说明书评价

Evaluation of Instructions of Clinical Common Cephalosporin Antibacterial Drugs

目的将临床常用的头孢菌素类抗菌药物说明书进行对比分析,为药品说明书的完善和合理使用提供参考。方法收集整理临床常用的14种头孢菌素类原研药和仿制药共计28份药品说明书,依据相关法律法规和参考资料为评价标准对其进行对比分析。结果28份药品说明书中,主要在注意事项、药物相互作用、特殊人群用药、贮藏条件、修订日期等方面存在差异。此外,亦存在适应证范围不一、同一说明书对应多种规格、用法用量存在差异、不良反应存在差异、药物过量描述不一、药动学描述不一等问题。结论头孢菌素类抗菌药物,尤其是仿制药药品说明书的内容完整度有待提高,说明书修订有待加强,建议不断完善头孢菌素类抗菌药物药品说明书,以保证患者用药安全。

OBJECTIVE To compare the common clinical cephalosporin antibiotics instructions,and provide reference for the improvement and rational use of the drug instructions.METHODS A total of 28 drug instructions for 14 kinds of common clinical cephalosporin original research drugs and generic drugs were collected and compared according to relevant laws,regulations and references.RESULTS There were main problems such as differences in precautions,drug interactions,drug use of specific populations,storage conditions and revision date among the 28 drug instructions.In addition,there were problems such as different indications,specifications corresponding to the same instruction,usage and dosage,adverse reactions,descriptions of drug overdose,and pharmacokinetic descriptions.CONCLUSION The content integrity of the cephalosporin instructions,especially generic drug instructions needs to be improved,and the revision of the instructions needs to be strengthened.It is recommended to continuously improve the cephalosporin instructions to ensure the medication safety of patients.