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临床常用抗感染药说明书中有关儿童用药的调查
作者：林津晶 黄文龙 徐伟 来源：《中国医药导报》2015年第20期
[摘要] 目的 调查常用抗感染药说明书中关于儿童用药的阐述，发现问题并提出合理性建议，为完善抗感染药说明书中儿童用药信息，促进儿童用药安全提供参考。 方法 选取2013年临床常用抗感染药物，对368份药物说明书中有关儿童用药项进行统计分析。 结果 绝大部分制剂的儿童剂量换算方式为按体重进行折算，比例达80.1%；关于儿童用药项，不同剂型的标注情况差异不大；儿童药理药动学等信息的缺项率极高，缺项率在56%～100%之间；总体而言，外资药说明书中儿童用药项的标注情况优于国产药品。 结论 常用抗感染药说明书中有关儿童用药项的标注情况不容乐观，提示相关部门应引起重视，保障儿童用药安全。 [关键词] 抗感染药；药品说明书；儿童用药；调查分析
[中图分类号] R969.3 [文献标识码] A [文章编号] 1673-7210（2015）07（b）-0031-06 [Abstract] Objective To investigate pediatric drug use stated in package inserts of commonly used antibiotics and analyze the problems， so as to complete the content of labeling in package inserts and promote clinical rational drug use in children. Methods A total of 368 package inserts of antibiotics commonly prescribed in hospitals in 2013 were randomly sampled for the investigation of the contents and limitations about pediatric drug use. Results The dose conversion of majority drugs was by weight， accounting for 80.1%. There was little different in the contents of different dosage forms about pediatric drug use. The information of prescribed pharmacology and pharmacokinetics was highly poor， accounting for 56% to 100%. The annotation ratio of application for children from foreign capitaled and domestic manufacturers had significant difference. Conclusion Labeling of pediatric drug use in package inserts of commonly used antibiotics is not very optimistic. Great
importance should be attached to the incomplete mark of drug use for children， and ensure the safety of pediatric drug use.
[Key words] Antibiotics； Drug package inserts； Pediatric drug use； Investigation and statistics
药品是既具有治疗作用又有毒副作用的特殊商品。药品说明书是药品包装的一部分，应当包含药品安全性、有效性等重要科学数据、结论和信息，用以指导安全合理用药。药品说明书是医生、药师及患者正确使用药品的首要依据，也是有关部门鉴定医疗责任的法律依据。中国第6次人口普查结果显示，我国0～14岁儿童超过2.2亿人，约占人口总数的16.6%[1]。每年的患儿数量约占总患病数的20%[2]。与之相比，儿童专用药稀缺，数量占比不到2%，用药“成人化”现象普遍[3]。儿童正处于生长发育期，身体各系统、器官功能尚未完善，肝酶分泌不
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