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

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。

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

Objective: To investigate and analyze the possible problems in the labeling of children’s medication information in druginstructions of parenteral nutrition treatment in children’ s hospitals, so as to provide directions for improving and standardizing thelabeling of children’s medication information in drug instructions in China. Methods: Drug instructions of parenteral nutrition in 20children’s hospitals were collected, statistical analysis was carried out on the data concerning the labeling of information on children’smedication 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 ofdrug instructions of parenteral nutrition were collected and investigated, including 12 special varieties for children. And 49. 2% werelabeled with “usage and dosage for children”, 28. 8% with “ clinical indication for children” and 30. 5% with “ medication forchildren”. There were differences in the labeling rate of children’s medication in different components of drug instructions of parenteralnutrition, with low labeling rate of amino acids and high labeling rate of vitamins and trace elements. In drug instructions of parenteralnutrition 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, thelabeling of medication information is incomplete, and the clinical application value is low, which is more common in parenteral nutritiontherapeutic drugs, and the information on children’s medication in drug instructions of parenteral nutrition should be actively improved.