儿童医院常用药物说明书中儿童用药标项分析

Annotation for Children Analysis of Commonly Used Medicines in Children's Hospital

目的:调查我院常用药品说明书中儿童用药项的标注情况,分析儿童用药现状,对儿童合理用药提出建议。方法:选取我院目前使用频率较高药品的说明书338份,其中口服制剂、注射剂、吸入剂及喷剂294份,五官、皮肤科外用药44份。按照有儿童用法用量、儿童慎用禁用提示、儿童用药尚不明确及儿童用药项缺省等标注情况进行统计分析。结果:294份说明书按厂家分类调查,外资、国产药品中有儿童用法用量的标注率分别为78%,65.7%,国产药儿童用法标注率明显低于外资药;按西药和中成药进行分类调查,涉外西药、国产西药、中成药中有儿童用法的标注率分别为79%,64.9%,47.4%,儿童用法的标注率涉外西药最高,中成药最低;按剂型进行调查分析,口服制剂、注射剂、吸入与喷剂、外用制剂中有儿童用法的标注率分别为68.1%,55.6%,78.9%,13.6%,外用制剂儿童用法缺省严重。结论:儿童常用药品的说明书中儿童用法项标注率太低,针对儿童的药品太少,应当引起相关部门的重视。

Objective： To analyze the annotation for children of commonly used medicines in our hospital in order to understand the utilization of drugs and improve rational drug use for children. Method： 338 frequently used package inserts were chosen, in which 294 ones were about oral preparations, injection preparations and inhalation/spray preparations,44 ones were on external preaprations involving otolaryngologic preparations and dermatologic preparations. The annotations including dosage and administration for children, caution use and prohibition for children, indefinite use for children and without any annotation for children were investigated. Result： Firstly,294 package inserts were classified according to the manufacturers. Among them, the annotation ratio of application for children from foreign capitaled and domestic manufacturers was 78% and 65.7%, respectively with significant difference. Then the package inserts were studied according to the medicine properties, and the annotation ratio of application for children was 79%, 64. 9% and 47.4% for foreign western medicines, domestic western medicines and Chinese patent medicines, respectively. Lastly, the package in- serts were investigated according to dosage forms, and the results were 68. 1% ,55.6% ,78.9% and 13.6% for oral, injection, inhalation/spray and external preparations, respectively, showing the severe annotation lack in external preparations. Conclusion： The annotation ratio of application for children in the package inserts is much low, especially in domestic western medicines, Chinese patent medicines and external preparations, which must attract attention from relevant departments.