父亲接触药物对生育、怀孕和后代的安全问题:基于美国食品和药物管理局不良事件报告系统的分析。

IF 3.2 2区 医学 Q1 ANDROLOGY
Andrology Pub Date : 2024-10-26 DOI:10.1111/andr.13790
Yanbin Zeng, Wanlong Lin, Wei Zhuang
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引用次数: 0

摘要

背景:越来越多的证据表明,父亲的身体状况对妊娠结局和后代的健康有重大影响。然而,通过随机对照试验评估父亲药物暴露的安全性在伦理方面存在挑战,而且相关的临床研究耗费了大量资源,只能评估少数几种药物。目前,有关父亲药物暴露的安全性数据很少:研究父方药物暴露对生育能力、妊娠结局和后代健康的影响:对来自美国食品药物管理局不良事件报告系统(FAERS)的数据进行了分析(2010-2022 年)。结果:在161805例药物不良事件中,有4例与父亲的药物暴露有关:在16,180,533份报告中,有3210份与父亲的药物暴露有关,包括7808例伴随不良事件。治疗类风湿性关节炎、癌症和感染的药物是父亲暴露的主要来源。分析确定了 115 个与生殖健康有关的信号。值得注意的是,地西泮-小枣婴儿和非那雄胺-隐睾症的信号尤为显著(报告几率比,ROR > 800,N > 10)。此外,治疗免疫炎症的生物制剂也经常出现自然流产信号;使用免疫抑制剂与先天性畸形数量最多有关,其中贝拉替塞-骨骼发育不良和他克莫司-胫骨的信号最强。只有霉酚酸、雌激素和伊马替尼对男性生育能力有影响。抗肿瘤药物对生殖毒性的影响较高,其中依托泊苷和顺铂的13三体综合征信号值最高:这是首次全面评估父亲接触大多数药物对生殖安全性的研究。临床和科研人员应密切关注本研究中的风险药物清单,尤其是以下关联组合:用于治疗炎症性疾病的生物制剂-流产、地西泮-小枣婴儿、非那雄胺-隐睾症、依托泊苷和顺铂-13 三体综合征。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Safety concerns of paternal drug exposure on fertility, pregnancy and offspring: An analysis based on the FDA adverse event reporting system.

Background: Growing evidence indicates that paternal condition significantly influences pregnancy outcomes and offspring health. However, assessing the safety of paternal drug exposure via randomized controlled trials poses ethical challenges, and relevant clinical studies consume a lot of resources to evaluate only a few drugs. Currently, safety data on paternal drug exposure are scarce.

Objectives: To investigate the impact of paternal drug exposure on fertility, pregnancy outcomes, and offspring health.

Materials and methods: Data from the FDA adverse event reporting system (FAERS) were analyzed (2010-2022). Disproportionality analyses were used to identify signals of each drug-adverse event pair associated with paternal drug exposure in a different hierarchical manner.

Results: Out of the 16,180,533 reports, 3210 were related to paternal exposure, encompassing 7808 concomitant adverse events. Drugs used to treat rheumatoid arthritis, cancer, and infections were primary sources of paternal exposure. Analysis identified 115 signals concerning reproductive health. Notably, the signals of diazepam-small for dates baby and finasteride-cryptorchidism were particularly significant (reporting odds ratio, ROR > 800, N > 10). Moreover, spontaneous abortion signals occur frequently in biologics for the treatment of immune inflammation; the use of immunosuppressive drugs was associated with the highest number of congenital anomalies, with the strongest signals for belatacept-skeletal dysplasia, and tacrolimus-talipes. Only mycophenolic acid, estrogen and imatinib have signals on male fertility. Anti-tumor agents had high numbers of each reproductive toxicity, with the highest values of trisomy 13 signals associated with etoposide and cisplatin.

Conclusions: This is the first research to fully assess the safety of paternal exposure to the majority of medications in terms of reproduction. Clinical and scientific researchers should pay close attention to the list of risk medications included in this study, particularly the following association combinations: biologics used to treat inflammatory diseases-abortion, diazepam-small for date baby, finasteride-cryptorchidism, etoposide and cisplatin-13 trisomy.

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来源期刊
Andrology
Andrology ANDROLOGY-
CiteScore
9.10
自引率
6.70%
发文量
200
期刊介绍: Andrology is the study of the male reproductive system and other male gender related health issues. Andrology deals with basic and clinical aspects of the male reproductive system (gonads, endocrine and accessory organs) in all species, including the diagnosis and treatment of medical problems associated with sexual development, infertility, sexual dysfunction, sex hormone action and other urological problems. In medicine, Andrology as a specialty is a recent development, as it had previously been considered a subspecialty of urology or endocrinology
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