国家基本药物目录(2018年版)中抗菌药物适应证用法用量比对分析

Comparative analysis of indications usage and dosage of antibacterial agents in 2018 Edition of National Essential Medicine List

目的通过比对和分析《国家基本药物目录》(2018版)(2018版基药目录)中抗菌药物适应证、用法用量与国内外参考资料的差异,了解差异类型和产生原因,同时为药品说明书修订提供参考,促进基本药物的合理使用。方法2018版基药目录中抗菌药物按规定剂型展开,以药品国内说明书适应证和用法用量为基础,与美国食品药品监督管理局(FDA)药品说明书和国内外5部权威药学专著进行比对,采用Excel 2007软件进行数据统计分析。结果按规定剂型展开药品93种,与各参考资料相比,适应证完全一致的比例为17%~45%,差异主要类型有适应证有增减;用法用量完全一致的比例为0~45%,差异主要类型为国外参考资料中肌肉注射和静脉滴注的剂量相同,而国内参考资料中多为不一致;适应人群用药详细信息不同;单次剂量不同;给药频次不同。结论2018版基药目录中抗菌药物说明书适应证和用法用量与国内外参考资料相比差异较大,产生原因多样,亟待采取有效的管理措施,以保障基本药物的合理使用。

Objective To compare and analyze the differences in indications,usage and dosage of antibacterial agents between National Essential Medicine List(2018 Edition)(NEML)and several drug information published in China or other countries,so as to investigate the types and causes of differences,provide suggestion for future revision of drug labels,and promote rational use of essential medicine.Methods The indications,dosage and usage of antibacterial agents in 2018 Edition NEML,categorized by uniform preparation formulation,were compared with descriptions in FDA drug labels and five reputed domestic books,using Excel 2007 for data calculation and statistical analysis.Results In total,93 antibacterial agents categorized by uniform preparation formulation in 2018 Edition NEML,were compared with the reference materials.The rate of complete consistency in indications was 17%-45%,with differences chiefly resulting from addition and/or withdrawal of indications.The rate of complete consistency in dosage and usage was 0-45%,with differences chiefly in the intramuscular and intravenous injection dosage which was identical to international descriptions but varied substantially with Chinese drug labels,the detailed dosage information for target population,the single dose,and dosing intervals.Conclusion The indications,dosage and usage of antibacterial agents in 2018 Edition NEML are significantly different from the information in other Chinese or international counterparts due to multiple reasons.Effective managerial measures should be adopted to ensure rational use of essential medicine.