OBJECTIVE:To investigate the pediatric drug marking in drug instruction in Xiamen Children’s Hospital ( hereinafter referred to as “our hospital”) , so as to provide reference for the standardizing pediatric drug use in drug instruction.METHODS: Instructions of 310 drugs ( 91 kinds of injections, 37 kinds of skin preparation, 34 kinds of ophthalmic preparation, 11 kinds of inhalation and aerosol and 137 kinds of oral preparation ) were collected in our hospital from Feb.to Apr.2016 to conduct the statistical analysis, in terms of the safety of pediatric drugs and dosage and administration for children, dosage and administration for newborns and pharmacokinetics for children.RESULTS:The annotation ratio of the safety of pediatric drugs, dosage and administration for children and pharmacokinetics for children from domestic produced drugs were lower than those of foreign produced drugs, respectively with significant difference(P<0.05).The annotation ratio of the safety of pediatric drugs from western drugs were higher than that of Chinese patent drugs, with significant difference(P<0.05).As for the dosage form, the annotation ratio of the safety of pediatric drugs and dosage and administration for children for inhalation and aerosol was the highest;and the annotation ratio of dosage and administration for newborns, and pharmacokinetics for children were commonly low.CONCLUSIONS:There are few categories of pediatric drugs in our hospital, the annotation ratio of pediatric drug marking in drug instruction is relatively low, which commonly lead to the off-label use of drugs.Clinical experiment should be advocated to improve the basic data for completing the pediatric drug marking in drug instruction.%目的：了解厦门市儿童医院（以下简称“我院”）常用药品的说明书中有关儿童用药的标注情况，为规范药品说明书中儿童用药内容提供参考。方法：收集我院2016年2—4月常用的310种药品（其中注射剂91种，皮肤给药制剂37种，眼用制剂34种，吸入和喷雾剂11种，口服制剂137种）的说明书，对药品说明书中儿童用药的安全性、儿童用法与用量、新生儿用法与用量、儿童药动学参数标注情况等进行统计分析。结果：国产药品说明书中儿童用药安全性、儿童用法与用量、儿童药动学参数标注率均明显低于涉外药品，差异均有统计学意义（ P＜0．05）；化学药说明书中儿童用药安全性标注率明显高于中成药，差异有统计学意义（ P＜0．05）；剂型方面，吸入和喷雾剂说明书中儿童用药安全性、儿童用法与用量标注率最高；所有调查药品的说明书中，新生儿用法与用量、儿童药动学参数标注率普遍较低。结论：我院儿童专用药物的品种数较少，常用药品说明书中儿童用药相关内容标注率较低，导致临床超说明书用药现象较普遍。应加强儿童用药的临床试验，完善药品说明书中儿童用药标示项。
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