我院常用抗菌药物说明书中儿童用药项目表述情况的调查分析  

Investigation and Analysis of Children Medication Item Description in Package Inserts of Commonly Used Antibacterial in Our Hospital

作　　者：姚晖[1] 黄志恩[1] 李晓莹[1] 何小凤[1] 李炳光[1] 

机构地区：[1]佛山市第二人民医院药剂科,广东佛山528000

出　　处：《中国药房》2012年第36期3374-3376,共3页China Pharmacy

基　　金：广东省药学会医院药学研究基金资助项目(2012A04)

摘　　要：目的:为完善和修订抗菌药物说明书提供参考。方法:收集我院常用抗菌药物说明书110份,摘录和统计有关儿童用药项目的表述。结果:标注儿童用法用量的占70.9%;儿童用药事项标注率为100.0%,其中详细标注占21.8%,标注儿童用药"尚不明确"的占40.0%,标注"儿童慎用"或"儿童禁用"占33.7%,标注"遵医嘱"或"用量酌减"占4.5%;标注儿童药动学仅占27.3%。国、内外不同厂家的儿童用药标注情况相近。结论:国家相关部门应加强对抗菌药品说明书的安全监管,完善说明书中儿童用药项目的表述,增强儿童使用抗菌药物的指引,以减少不合理用药和不良反应的发生。OBJECTIVE： To give some reference for the writing and improvement of package inserts. METHODS： 110 pack- age inserts of commonly used antibacterials were collected, and the description of children medication item were extracted and ana- lyzed statistically. RESULTS： The marked rate of usage and dosage for children medication was 70.9%. The marked rate of an- nouncements for children was 100.0%. The package inserts with the mark of ＂for children＂ was 21.8%, and with the mark of ＂not clear＂ was 40.0%, and with the mark of ＂children caution＂ or ＂children prohibition＂ was 33.7%, at last with the mark of ＂under supervision of a physician＂ or ＂dosage discount＂ was 4.5%. The marked rate of children pharmacokinetics was only 27.3%. The de- scription of Children medication item of different manufacturers at home and abroad is similar. CONCLUSIONS： Government and relevant departments in China should strengthen security control and upgrade of package inserts, especially the drug use for chil- dren, and enhance the guidance of antibacterials use for children, so that it could reduce the occurrence of irrational use of drugs and adverse drug reaction.

关 键 词：抗菌药物 药品说明书 儿童用药 

分 类 号：R95[医药卫生—药学]