205份抗肿瘤药物药品说明书中老年人用药信息标注情况对比  

Comparison of the Labeling of Medication Information for Elderly People in 205 Anti-Tumor Drug Manuals

作　　者：吕金涛[1] 孙霄[1] 马静 LYU Jintao;SUN Xiao;MA Jing(Liyang People's Hospital,Changzhou,Jiangsu,China 213300;Dachang Hospital of Nanjing·Jiangbei District of the Affiliated Zhongda Hospital of Southeast University,Nanjing,Jiangsu,China 210044)

机构地区：[1]江苏省溧阳市人民医院,江苏常州213300 [2]江苏省南京市大厂医院·东南大学附属中大医院江北院区,江苏南京210044

出　　处：《中国药业》2021年第15期34-37,共4页China Pharmaceuticals

基　　金：江苏省药学会-天晴医院药学基金[Q2019117]。

摘　　要：目的促进老年人抗肿瘤药物的临床合理使用。方法收集江苏省5家三级综合医院、2家老年病专科医院、1家肿瘤专科医院的抗肿瘤药物药品说明书205份,分析其中老年人用药信息的标注情况,按进口药与国产药进行对比分析。结果所有抗肿瘤药物按药理作用分为16类,按来源分为国产药(104份)和含合资的进口药(101份);按剂型分为口服制剂(64份)和注射剂(141份);所有药品说明书均未在相互作用、药物过量、药理毒理项下标注老年人用药信息,禁忌项下仅1份标注;用法用量、老年人用药、不良反应、注意事项、药理毒理、药代动力学项下分别有53份(25.85%)、183份(89.27%)、21份(10.24%)、31份(15.12%)、3份(1.46%)、23份(11.22%)标注;进口药标注静脉配制指导有47份(71.21%),多于国产药的46份(58.67%);老年人用药、用法用量标注项分别有37组(55.22%)、30组(44.78%)。结论进口药和国产药抗肿瘤药物药品说明书中关于老年人用药信息的标注差异较大,需要多部门协作监督,以促进药品生产企业进一步修订和完善药品说明书,降低医疗风险,保障老年人临床用药安全、合理。Objective To promote the rational use of anti-tumor drugs in the elderly people.Methods A total of 205 anti-tumor drug manuals were collected from five tertiary general hospitals,two specialized geriatric hospitals and one specialized oncology hospital in Jiangsu Province.The difference in the labeling of medication information for the elderly people was analyzed and compared between the imported drug manuals and domestic drug manuals.Results All anti-tumor drugs were divided into 16 categories according to their pharmacological effects.According to their sources,they were divided into domestic drugs(104 drug manuals)and imported drugs(including joint venture,101 drug manuals).According to the dosage form,they were divided into oral preparation(64 drug manuals)and injection preparation(141 drug manuals).None medication information for the elderly people was labeled in the items of interaction,drug overdose,pharmacology and toxicology of the drug manuals,and only one medication information was labeled under the item of contraindication.There were 53 drug manuals(25.85%),183 drug manuals(89.27%),21 drug manuals(10.24%),31 drug manuals(15.12%),3 drug manuals(1.46%)and 23 drug manuals(11.22%)had labeling information about usage and dosage,medication for the elderly people,adverse reactions,precautions,pharmacology and toxicology,and pharmacokinetics respectively.A total of 47 drug manuals(71.21%)of imported anti-tumor drugs were marked with intravenous preparation guidance,which was more than 46 drug manuals(58.67%)of domestic anti-tumor drugs.There were 37 groups(55.22%)and 30 groups(44.78%)of labeling items about medication for the elderly and usage and dosage in the drug manuals of imported and domestic drugs.Conclusion There are great differences in the labeling of medication information for the elderly people between the import anti-tumor drug manuals and the domestic anti-tumor drug manuals,and the cooperation and supervision of multi-department are needed to promote the drug manufacturers to further revise and

关 键 词：抗肿瘤药物 药品说明书 老年人 用药信息 药事管理 

分 类 号：R95[医药卫生—药学] R979.1