静脉用抗菌药物药品说明书配制方法的对比分析  

Comparative analysis of preparation methods of intravenous antibacterial drug instructions

作　　者：冯新奥 刘水 宋雨婷 杜雅薇[1] FENG Xin'ao;LIU Shui;SONG Yuting;DU Yawei(Department of Pharmacy,Peking University Third Hospital,Beijing 100191,China;Department of Pharmacy,Emergency General Hospital,Beijing 100028,China)

机构地区：[1]北京大学第三医院药学部,北京100191 [2]应急总医院药学部,北京100028

出　　处：《临床药物治疗杂志》2024年第S1期95-99,共5页Clinical Medication Journal

摘　　要：目的 探讨静脉用抗菌药物说明书中配制方法描述的规范性,比较其存在的差异。方法 收集北京市2家三级医院所使用的静脉用抗菌药物的纸质说明书,比较配制方法、配伍禁忌、保存条件中的单次剂量、用药频次、配制浓度、可用溶媒、振荡时间、静置时间、输注速度、串输要求、冲管要求及原药、复溶液、成品的保存条件等,计算标注率、详细率及标注位置;对相同通用名下不同厂家的8组说明书进行详细比较。结果 共提取298条静脉用抗菌药物配制方法及相关标注信息,其中用药频次标注最为完整、明确,可用溶媒、单次剂量、配伍禁忌、输注速度标注较为详细,振荡时间、静置时间、冲管要求的标注率较低且详细率极低;配制方法多在说明书用法用量中标注,配伍禁忌及保存条件的标注位置较为分散;相同通用名下不同厂家的药品说明书差异较小,头孢呋辛、替考拉宁存在较大差异。结论 静脉用药说明书较前有明显改善,但配伍禁忌和成品药液保存条件的标注位置仍需规范,振荡时间、静置时间、滴注速度、冲管要求的标注率、详细率还可进一步完善。Objective The study aimed to investigate the standardization of preparation instructions described in package inserts for intravenous antibiotics and compare existing differences.Methods Package inserts for intravenous antibacterial from two tertiary hospitals were collected and analyzed for preparation methods,contraindications,single dosage,dosing frequency,preparation concentration,compatible solvents,shaking time,resting time,infusion rate,sequential infusion requirements,flushing requirements,as well as storage conditions for the original drug,reconstituted solutions,and final products.Annotation rates,level of detail and position of information were evaluated.a detailed comparison was made among 8 groups of instructions with the same generic name from different manufacturers.Results A total of 298 entries on preparation methods and related information were extracted.Dosing frequency annotations were most complete,while compatible solvents,single dosage,compatibility contraindications,and infusion rates were also detailed.However,information on shaking time,resting time,and flushing requirements was sparse and lacked detailed instructions.Preparation methods primarily listed in the dosage and administration section,while compatibility contraindications and storage conditions were inconsistently placed.Minimal differences were observed among inserts from different manufacturers of the same generic drugs,with notable variations found for cefuroxime and teicoplanin.Conclusion There has been marked improvement in the labeling of intravenous drug package inserts;however,standardization is still needed for labeling positions of compatibility contraindications and storage conditions of final preparations.The inclusion and detailing of shaking time,resting time,infusion rate,and flushing requirements require further refinement.

关 键 词：抗菌药物 静脉用药 说明书用法 配制方法 

分 类 号：R944.11[医药卫生—药剂学]