药品说明书中终末期肾病血液透析患者剂量调整信息标注情况分析  

Analysis of Labeling Situation of Drug Instructions for Drug Dose Adjustment in Hemodialysis Patients with End-Stage Renal Disease

作　　者：李思妍 沈江华[1] 曾艳[1] 邱雨婕 邵晨 闫素英[1] LI Siyan;SHEN Jianghua;ZENG Yan;QIU Yujie;SHAO Chen;YAN Suying(Department of Pharmacy,Capital Medical University Xuanwu Hospital,Beijing 100053,China;Department of Clinical Pharmacy,School of Pharmaceutical Sciences,Capital Medical University,Beijing 100069,China)

机构地区：[1]首都医科大学宣武医院药学部,北京100053 [2]首都医科大学药学院临床药学系,北京100069

出　　处：《医药导报》2025年第3期491-496,共6页Herald of Medicine

基　　金：北京老年人健康评估及维护关键技术研究(D181100000218002);首都医科大学“本科生科研创新”项目(XSKY2023399)。

摘　　要：目的调查全身使用药品的说明书中对终末期肾病血液透析患者透析相关信息标注情况,为进一步规范和完善药品说明书提供参考。方法2023年1—3月收集宣武医院药品目录中全身使用化学药品及生物制剂药品的说明书中终末期肾病血液透析患者药动学及药物剂量调整信息,分类比较原研药与仿制药、进口药与国产药药物相应信息的标注率;将通过非肾脏途径消除、或分子量≥5000、或与血浆蛋白结合率≥60%、或药物分布容积>360 L的药品归类为“不可透析组”,其他药物归类于“可透析组”,分组比较“可透析组”与“不可透析组”药物相应信息的标注率;并与Lexicomp、Micromedex中相应药物相应信息的标注率和内容比较。结果930种药品说明书中,药物透析清除情况、药物调整方案及明确的药物调整方案标注率分别为16.67%、25.16%和24.52%。原研药与仿制药、进口药与国产药透析相关信息标注率差异无统计学意义。“可透析组”与“不可透析组”透析相关信息标注率差异有统计学意义(P<0.01)。被调查的药品说明书与Lexicomp或Micromedex中相应药品透析相关信息标注率差异有统计学意义(P<0.01)。结论被调查的药品说明书存在终末期肾病血液透析患者相关信息缺失与标注不明确的问题,应引起有关部门重视。Objective To investigate the labeling of dialysis-related information in the instructions of drugs for systemic use in patients with end-stage renal disease undergoing hemodialysis,and to provide reference for further standardization and improvement of drug instructions.Methods Collected the information on pharmacokinetics and drug dose adjustment in hemodialysis patients with end-stage renal disease from the instructions of chemicals and biologics used systemically in XuanWu hospital's formulary from January to March 2023.Classified and compared the labeling rates of the corresponding information of the originally developed drugs and generic drugs,imported drugs and domestic drugs;Drugs eliminated by non-renal route,or with molecular weight≥5000,or binding rate of plasma protein≥60%,or drug distribution volume>360L were classified as“non-dialysis group”,and other drugs were classified as“dialysis group”,compared the labeling rate of corresponding information of drugs in“dialysis group”and“non-dialysis group”;and compared the labeling rate and content with relevant information in Lexicomp and Micromedex.Results Among the 930 drug instructions,the labeling rates of drug dialysis clearance,drug adjustment,and explicit drug adjustment plan were 16.67%,25.16%,and 24.52%.There was no significant difference in the labeling rate of dialysis-related information between original and generic drugs,and imported and domestic drugs.There was a significant difference in the labeling rate of dialysis-related information between the"dialyzable group"and the"non-dialyzable group"(P<0.01).The difference in the labeling rate of dialysis related information between the investigated drug instructions and the corresponding drugs in Lexicomp or Micromedex was statistically significant(P<0.01).Conclusion Attention should be paid to the lack of information and unclear labeling of hemodialysis patients with end-stage renal disease in the drug instructions by relevant departments.

关 键 词：药品说明书 终末期肾病 血液透析 Micromedex Lexicomp 

分 类 号：R95[医药卫生—药学]