药品说明书对男性生育力影响信息的标注情况调研  

Research of the medication information labeling on the impact of male fertility

作　　者：杨佳 曾珠 陈诚 李文军 黄贵丽 董杰 吕凤 刘松青 奚鑫 YANG Jia;ZENG Zhu;CHEN Cheng;LI Wenjun;HUANG Guili;DONG Jie;LYU Feng;LIU Songqing;XI Xin(Department of Pharmacy,the Third Affiliated Hospital of Chongqing Medical University,Chongqing 401120,China;School of Chinese Medicine,Hong Kong Baptist University,Hong Kong 999077,China)

机构地区：[1]重庆医科大学附属第三医院药剂科,重庆401120 [2]香港浸会大学中医药学院,中国香港999077

出　　处：《中国医院药学杂志》2025年第5期580-586,共7页Chinese Journal of Hospital Pharmacy

基　　金：重庆市临床药学重点专科建设项目[编号:委办(2024-81)]。

摘　　要：目的:统计分析药品说明书中男性生育信息标注情况,为有生育计划男性的临床用药提供参考。方法:收集《国家基本药品目录(2023)》《全国药品集中采购中选结果表(2022)》以及重庆医科大学附属第三医院在院使用的药品说明书,采用逐一阅读的方式,对男性生育力标注信息进行提取、统计和分析。以PubMed、Web of Science、中国知网(CNKI)、万方数据库、维普中文期刊数据库(VIP)为数据源,检索有关药物对男性生育力影响的研究,对有文献报道了生殖毒性而未在说明书中载明的药品进行整理归纳。结果:共收集药品说明书2823份,其中西药说明书1644份,标注了男性生育力相关信息的占476份;中成药说明书1179份,仅7份标注了男性生育力相关内容,总标注率为17.11%。在西药说明书中,标注率最高的药物分类为抗肿瘤药(60.45%);进口药的标注率为48.01%,其中标注在“生育力/不孕”项下的占48.07%;国产药品说明书标注率为23.28%,其中标注在“生育力/不孕”项下的占29.83%。在所有调研说明书中,30个药品有文献报道生育毒性而未在说明书中阐明。结论:说明书中有关男性生育力信息总体标注率不高,绝大多数缺乏人类数据和用药指导,需要更多的循证医学证据来完善药品说明书,为医务人员、患者提供可靠的信息。OBJECTIVE To provide references for clinical medication for men with family planning through the statistical analysis of male fertility information labeled in drug instructions.METHODM Drug instructions were collected from the“National Essential Medicines List(2023)”“National Drug Centralized Procurement Selection Results Table(2022)”and Phar⁃macy of the Third Affiliated Hospital of Chongqing Medical University,and male fertility labeling information was statistically ana⁃lyzed by reading them one by one.Studies on the effects of drugs on male fertility were searched in the PubMed,Web of Science,China National Knowledge Infrastructure(CNKI),Wanfang Database and VIP.Drugs that reported reproductive toxicity in lit⁃eratures but were not included in the instructions were summarized.RESULTS A total of 2823 drug instructions were collected,including 1644 Western medicine instructions(476 indicated information related to male fertility)and 1179 instructions of tradi⁃tional Chinese patent medicines(7 were marked with male fertility related content).The total labeling rate was 17.11%.In West⁃ern medicine instructions,anti-tumor drugs(60.45%)showed the highest labeling rate.The labeling rate of imported drugs was 48.01%,of which 48.07%were labeled under the category of"fertility/infertility".The labeling rate of domestic drug instructions was 23.28%,of which 29.83%were labeled under the category of"fertility/infertility".Among all the investigated instructions,30 drugs had literature reporting on reproductive toxicity but were not explicitly stated in the instructions.CONCLUSION The overall labeling rate of male fertility information is not high,and there is a lack of human data and medication guidance informa⁃tion.The impact of drugs on male fertility requires more evidence-based medicine to improve drug instructions,in order to pro⁃vide reliable information for healthcare workers and patients.

关 键 词：药品说明书 男性生殖 精子 男性不育 

分 类 号：R926[医药卫生—药学]