中国药物警戒 ›› 2019, Vol. 16 ›› Issue (9): 555-560.
DOI: 10.19803/j.1672-8629.2019.09.07

• 安全性评价与合理用药 • 上一篇    下一篇

抗肿瘤药品说明书中儿童用药信息分析

赵爽, 宋燕青, 王相峰, 金芳, 苗秋丽*   

  1. 吉林大学第一医院药学部,吉林 长春 130021
  • 收稿日期:2018-05-30 修回日期:2019-10-21 出版日期:2019-09-20 发布日期:2019-10-21
  • 通讯作者: *苗秋丽,女,硕士,主管药师,临床药学。E-mail：miaoql365@163.com
  • 作者简介:赵爽,女,硕士,临床药学。

Analysis of Pediatric Use Information in Package Inserts of Antineoplastic Drugs

ZHAO Shuang, SONG Yanqing, WANG Xiangfeng, JINFang, MIAO Qiuli*   

  1. Department of Pharmacy, the First Hospital of Jilin University, Jilin Changchun 130021, China
  • Received:2018-05-30 Revised:2019-10-21 Online:2019-09-20 Published:2019-10-21

PDF (PC)

190

摘要： 目的 调查抗肿瘤药品说明书中儿童用药标示情况,为合理使用及规范管理提供参考。方法 收集抗肿瘤药品说明书141份,将说明书中提及儿童用药剂量和儿童用药标示内容列成Excel表,对其相关内容进行统计分析。结果 141份抗肿瘤药品说明书中,标示儿童用药剂量信息19份（13.47%）,标示儿童用药指导信息47份（33.33%）。结论 抗肿瘤药品说明书中,儿童用药剂量和指导性内容仍需进一步完善,建议药品生产企业应加强儿童用药相关研究及儿童药品不良反应报告的收集,及时补充、完善药品说明书中儿童用药信息相关内容。

关键词: 药品说明书, 抗肿瘤药品, 儿童, 标示信息

Abstract: Objective To investigate the pediatric use information in the package inserts of antineoplastic drugs, so as to provide reference for rational use and standardized management. Methods 141 package inserts of antineoplastic drugs were collected, the dosage and directions for pediatric in the package inserts were organized and analyzed by Excel. Results Among the 141 package inserts, 19（13.47%） were labeled with pediatric dosage, and 47 （33.33%） were labeled with directions for pediatric use. Conclusion In the package inserts of antineoplastic drugs, the information of dosage and directions for pediatric need to be further improved. It is suggested that manufacturers should strengthen the research and track safety issues in pediatric and update the information in the package inserts timely .

Key words: package insert, antineoplastic drug, pediatric, labeling information

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