Abstract：
BACKGROUND: Real-world big data studies on drug-reduced male semen quality are few and far between, with most studies based on animal trials, small scale retrospective studies, or a limited number of pre-market clinical trials.
METHODS: This study aimed to identify culprit drugs that reduced male semen quality based on the United States Food and Drug Administration adverse event reporting system. The Medical Dictionary for Regulatory Activities preferred terms and standardized Medical Dictionary for Regulatory Activities queries were used to define reduced male semen quality. Adverse events related to drug-reduced male semen quality were then analyzed by disproportionality analysis using the United States Food and Drug Administration adverse event reporting system data between 2004 and 2023.
RESULTS: At the preferred term level, 59 drugs with risk signals were detected to be associated with drug-reduced male semen quality, with the three most frequently reported second-level Anatomical Therapeutic Chemical groups being antineoplastic agents (n = 16, 27.12%), psychoanaleptics (n = 9, 15.25%), and psycholeptics (n = 6, 10.17%). At the standardized Medical Dictionary for Regulatory Activities queries level, the five drugs with the greatest number of cases were finasteride (845 cases, IC025 = 7.72), dutasteride (163 cases, IC025 = 7.22), tamsulosin (148 cases, IC025 = 5.99), testosterone (101 cases, IC025 = 4.08), and valproic acid (54 cases, IC025 = 2.44). Additionally, clinical information about drug-reduced male semen quality is absent from the Summary of Product Characteristics of 41 drugs in our study.
CONCLUSIONS: Using the United States Food and Drug Administration adverse event reporting system database, we offer a list of drugs with risk signals for reducing male semen quality. In the future, there is still a need for more studies on drugs whose effects on male semen quality are not fully understood.
METHODS: This study aimed to identify culprit drugs that reduced male semen quality based on the United States Food and Drug Administration adverse event reporting system. The Medical Dictionary for Regulatory Activities preferred terms and standardized Medical Dictionary for Regulatory Activities queries were used to define reduced male semen quality. Adverse events related to drug-reduced male semen quality were then analyzed by disproportionality analysis using the United States Food and Drug Administration adverse event reporting system data between 2004 and 2023.
RESULTS: At the preferred term level, 59 drugs with risk signals were detected to be associated with drug-reduced male semen quality, with the three most frequently reported second-level Anatomical Therapeutic Chemical groups being antineoplastic agents (n = 16, 27.12%), psychoanaleptics (n = 9, 15.25%), and psycholeptics (n = 6, 10.17%). At the standardized Medical Dictionary for Regulatory Activities queries level, the five drugs with the greatest number of cases were finasteride (845 cases, IC025 = 7.72), dutasteride (163 cases, IC025 = 7.22), tamsulosin (148 cases, IC025 = 5.99), testosterone (101 cases, IC025 = 4.08), and valproic acid (54 cases, IC025 = 2.44). Additionally, clinical information about drug-reduced male semen quality is absent from the Summary of Product Characteristics of 41 drugs in our study.
CONCLUSIONS: Using the United States Food and Drug Administration adverse event reporting system database, we offer a list of drugs with risk signals for reducing male semen quality. In the future, there is still a need for more studies on drugs whose effects on male semen quality are not fully understood.
摘要：
背景：关于药物减少的男性精液质量的真实世界大数据研究很少，大多数研究都是基于动物试验，小规模回顾性研究，或有限数量的上市前临床试验。
方法：本研究旨在根据美国食品和药物管理局不良事件报告系统确定降低男性精液质量的罪魁祸首药物。监管活动医学词典首选术语和监管活动标准化医学词典查询用于定义男性精液质量降低。然后使用2004年至2023年之间的美国食品和药物管理局不良事件报告系统数据，通过不成比例分析对与药物降低的男性精液质量相关的不良事件进行分析。
结果：在首选术语级别，检测到59种具有风险信号的药物与药物减少的男性精液质量有关，三个最常报告的二级解剖治疗化学组是抗肿瘤药（n=16，27.12％），精神病患者（n=9，15.25％），和精神病患者（n=6，10.17％）。在标准化的监管活动医学词典查询级别，病例最多的五种药物是非那雄胺(845例，IC025=7.72),杜他雄胺(163例，IC025=7.22),坦索罗辛(148例，IC025=5.99),睾酮（101例，IC025=4.08),和丙戊酸(54例，IC025=2.44)。此外,在我们的研究中,41种药物的产品特征摘要中没有关于药物降低男性精液质量的临床信息.
结论：使用美国食品和药物管理局不良事件报告系统数据库，我们提供了一系列具有降低男性精液质量的风险信号的药物。在未来,对于那些对男性精液质量的影响尚未完全了解的药物，仍需要更多的研究。
方法：本研究旨在根据美国食品和药物管理局不良事件报告系统确定降低男性精液质量的罪魁祸首药物。监管活动医学词典首选术语和监管活动标准化医学词典查询用于定义男性精液质量降低。然后使用2004年至2023年之间的美国食品和药物管理局不良事件报告系统数据，通过不成比例分析对与药物降低的男性精液质量相关的不良事件进行分析。
结果：在首选术语级别，检测到59种具有风险信号的药物与药物减少的男性精液质量有关，三个最常报告的二级解剖治疗化学组是抗肿瘤药（n=16，27.12％），精神病患者（n=9，15.25％），和精神病患者（n=6，10.17％）。在标准化的监管活动医学词典查询级别，病例最多的五种药物是非那雄胺(845例，IC025=7.72),杜他雄胺(163例，IC025=7.22),坦索罗辛(148例，IC025=5.99),睾酮（101例，IC025=4.08),和丙戊酸(54例，IC025=2.44)。此外,在我们的研究中,41种药物的产品特征摘要中没有关于药物降低男性精液质量的临床信息.
结论：使用美国食品和药物管理局不良事件报告系统数据库，我们提供了一系列具有降低男性精液质量的风险信号的药物。在未来,对于那些对男性精液质量的影响尚未完全了解的药物，仍需要更多的研究。
