肠外营养治疗药品说明书中儿童用药信息标注情况:基于20家儿童专科医院的调研结果  

Labeling of Children’s Medication Information in Drug Instructions of Parenteral Nutrition Treatment:Based on Survey Results of 20 Children’s Hospitals

作　　者：王祯 蔡和平 王晓玲[2] 阮文懿 Wang Zhen;Cai Heping;Wang Xiaoling;Ruan Wenyi(Anhui Provincial Children’s Hospital,Hefei 230032,China;Beijing Children’s Hospital,Capital Medical University,Beijing 100045,China)

机构地区：[1]安徽省儿童医院,合肥230032 [2]首都医科大学附属北京儿童医院,北京100045

出　　处：《儿科药学杂志》2024年第5期12-15,共4页Journal of Pediatric Pharmacy

摘　　要：目的:调查分析儿童专科医院在用肠外营养治疗药品说明书中儿童用药信息标注可能存在的问题,为促进我国药品说明书中儿童用药信息标注的完善和规范提供方向。方法:收集20家儿童专科医院在用的肠外营养治疗药品说明书,对说明书中“儿童用法与用量”“儿童临床适应证”“儿童用药”“药动学参数”“禁忌”“不良反应”“注意事项”项下儿童用药信息的标注情况进行统计和分析。结果:共收集调查59种肠外营养治疗药品说明书,儿童专用品种12种;标注“儿童用法与用量”的占49.2%,标注“儿童临床适应证”的占28.8%,标注“儿童用药”项的占30.5%;不同成分肠外营养治疗药品说明书中儿童用药标注率亦存在差异,氨基酸类标注率低、维生素及微量元素类标注率较高;在“儿童用药”“注意事项”“不良反应”“禁忌”“药动学参数”项下肠外营养治疗药品说明书中儿童用药相关信息都存在不同程度地缺失。结论:说明书中儿童用药相关信息偏差大、用药信息标注不完善、临床实用价值低的情况在肠外营养治疗药品中较普遍,应积极完善肠外营养治疗药品说明书中儿童用药信息。Objective:To investigate and analyze the possible problems in the labeling of children’s medication information in drug instructions of parenteral nutrition treatment in children’s hospitals,so as to provide directions for improving and standardizing the labeling of children’s medication information in drug instructions in China.Methods:Drug instructions of parenteral nutrition in 20 children’s hospitals were collected,statistical analysis was carried out on the data concerning the labeling of information on children’s medication under the items of“usage and dosage for children”“clinical indication for children”“medication for children”“pharmacokinetic parameters”“contraindications”“adverse drug reactions”and“matters for attention”.Results:A total of 59 kinds of drug instructions of parenteral nutrition were collected and investigated,including 12 special varieties for children.And 49.2%were labeled with“usage and dosage for children”,28.8%with“clinical indication for children”and 30.5%with“medication for children”.There were differences in the labeling rate of children’s medication in different components of drug instructions of parenteral nutrition,with low labeling rate of amino acids and high labeling rate of vitamins and trace elements.In drug instructions of parenteral nutrition under the items of“medication for children”“matters for attention”“adverse drug reactions”“contraindications”and“pharmacokinetic parameters”,there were different degrees of labeling missing in the information related to medication for children.Conclusion:The deviation of information related to children’s medication in drug instructions of parenteral nutrition is great,the labeling of medication information is incomplete,and the clinical application value is low,which is more common in parenteral nutrition therapeutic drugs,and the information on children’s medication in drug instructions of parenteral nutrition should be actively improved.

关 键 词：肠外营养治疗药品 儿童 药品说明书 儿童用药信息 

分 类 号：R969.3[医药卫生—药理学]