580份处方药说明书中儿童用药信息的调查分析_郭慧蕾.pdf

580份处方药说明书中儿童用药信息的调查分析 ＊ # 郭慧蕾 ，徐 进，许 静，张 永（南京医科大学附属南京儿童医院，南京 210008） 中图分类号 R985；R969.3 文献标志码 A 文章编号 1001-0408（2015）32-4497-04 DOI 10.6039/j.issn.1001-0408.2015.32.12 摘 要 目的：为儿童安全合理用药提供参考。方法：抽取我院近5年内有使用记录的化学药品与治疗用生物制品处方药说明书 580份，对说明书儿童专用药品儿童信息、专科药物儿童信息，以及用法用量、临床试验、药动学等项目中儿童信息的标注情况，采 用比率分析及顺位分析法进行统计分析。结果：处方药儿童专用药品少、剂型以注射剂为主，专科药物儿童信息少，用法用量依据 单一，药动学参数不完整、儿童临床试验参考数据少。结论：我国儿童在用药品的说明书标注情况不容乐观，规范说明书、补充完 善儿童用药信息势在必行，以确保儿童用药安全有效。 关键词 儿童用药剂型；药品说明书；儿童用药信息调查 Investigation and Analysis of Children Medication Information in 580Drug Instructions GUO Hui-lei ，XU Jin ，XU Jing ，ZHANG Yong （Nanjing Children ’s Hospital Affiliated to Nanjing Medical Univer- sity ，Nanjing 210008，China ） ABSTRACT OBJECTIVE ：To provide reference for reasonable and safe use of drugs in children. METHODS ：580 prescription drug instructions of chemical drugs and chemical product for treatment were collected from our hospital. Children information stated in drug instruction of exclusive drugs for children and special drugs ，and in dosage and usage ，clinical trial ，pharmacokinetics and other items were all analyzed statistically ratio analysis and sequence analysis. RESULTS ：The exclusive drugs for children were few ，and major dosage form were injection. The instruction of special drugs were lack of children ’s information. Usage and dosage based on monotonous evidence. The pharmacokinetic parameters were incomplete ，and there were slender amount of data about chil- dren clinical trials. CONCLUSIONS ：The drug instruction of drugs for children are looking blue. It is urgent to standard drug in- struction and complete medication information for children ，so as to ensure safe and effective of drug use. KEYWORDS Children dosage form ；Drug instruction ；Children medication information investigation 儿童患者是用药的特殊群体，其正处于生长发育旺盛时 童信息以及用法用量、临床试验和药动学项目中的儿童信息 期