| 鲍志伟,崔朝,马静,等.抗肿瘤药物说明书 166份妊娠及哺乳期妇女用药标注情况分析[J].安徽医药,2021,25(4):842-845. |
| 抗肿瘤药物说明书 166份妊娠及哺乳期妇女用药标注情况分析 |
| Analysis of drug labeling of 166 pregnant and lactating women in anti-cancer drugs manual |
| |
| DOI：10.3969/j.issn.1009-6469.2021.04.051 |
| 中文关键词: 说明书 抗肿瘤药物 孕妇 哺乳期妇女 分析 |
| 英文关键词: Prospectuses Antitumor drugs Pregnant women Lactating women Analysis |
| 基金项目:江苏省药学会 -奥赛康医院药学基金(A201626) |
|
| 摘要点击次数: 1312 |
| 全文下载次数: 394 |
| 中文摘要: |
| 目的了解常用抗肿瘤药物说明书中妊娠及哺乳期妇女用药的标注情况，为规范药品说明书的标注提供参考。方法 2019年 1—2月收集江苏省五家三甲医院抗肿瘤药物的药品说明书， 2019年 3—9月对其中关于妊娠及哺乳期妇女用药信息的标注情况进行调查分析。结果共收集 166份抗肿瘤药物说明书，按来源分为国产药(84份)、进口药(82份)，按药品剂型分为口服制剂(52份)、注射剂(114份)。说明书中有关妊娠分级、哺乳分级及妊娠和哺乳期妇女用药信息标注率均不高，且用药信息标注的位置分散，同一成分的不同厂家药品的说明书差异也较大。结论抗肿瘤药物说明书中关于妊娠及哺乳期妇女用药的标注，有待进一步规范、完善。建议相关部门强制药品生产企业定期修订说明书，以保障临床用药安全、合理。 |
| 英文摘要: |
| Objective To understand the information for pregnant and lactating women of commonly used antitumor drug in Jiangsu,and to provide a reference for the labeling of standardized drug instructions.Methods The package inserts of anticancer drugs in fiveGrade Class A hospitals in Jiangsu From January to February 2019 were collected, and the information for pregnant and lactating women was investigated and analyzed.Results A total of 166 package inserts for anticancer drugs were collected, which were assigned intodomestic drugs (84 pieces) and imported drugs (82 pieces) according to the source, and assigned into oral preparation (52 pieces) andinjection (114 pieces) according to their dosage forms. The labeling rate of pregnancy classification, lactation classification and the information for pregnant and lactating women in the items was not high, and the location of the information was scattered, and the instructions for different manufacturers of the same ingredient were different.Conclusion The information for pregnant and lactating womenin package inserts of the antitumor drug needs to be further regulated and improved. It is recommended that relevant departments forcedrug manufacturers to periodically revise the instructions to ensure the safety and rationality of clinical drug use. |
|
查看全文
查看/发表评论 下载PDF阅读器 |
| 关闭 |
