Abstract：
To identify which medications are mostly associated with ejaculatory disorders through a disproportionality analysis.
The Food and Drug Administration Adverse Event Reporting System (FDA-FAERS) and the Eudra-Vigilance (EV) database were queried to identify medications more commonly associated to ejaculatory disorders from September 10, 2012 to June 1, 2023. Proportional Reported Ratios (PRRs) were computed for all the selected drugs.
Overall, 7404 reports of ejaculatory disorders reports were identified, and of these, 6854 cases (92.6%) were attributed to ten specific medications. On FDA-FAERS and EV databases, Paroxetine and Tamsulosin were the main responsible of delayed ejaculation (103/448 events, 23.0%) and retrograde ejaculation (366/1033 events, 35.4%), respectively. Finasteride was mostly related to painful ejaculation and ejaculation failure, with 150 events (7.8%) and 735 events (38.4%) respectively. Within the group of high-risk medications, Sildenafil presented higher risk of ejaculatory disorders than Tadalafil (PRR=5.85 (95%CI 5.09-6.78), P < .01).
Ten drugs were recognized to display significant reporting levels of ejaculatory disorders. Among them, Finasteride and Sildenafil were responsible for the most reports in FDA-FAERS and in EV databases, respectively. Physicians should thoroughly counsel patients treated with these drugs about the risk of ejaculatory disorders. Further integration into clinical trials is needed to enhance the applicability and significance of these results.
The Food and Drug Administration Adverse Event Reporting System (FDA-FAERS) and the Eudra-Vigilance (EV) database were queried to identify medications more commonly associated to ejaculatory disorders from September 10, 2012 to June 1, 2023. Proportional Reported Ratios (PRRs) were computed for all the selected drugs.
Overall, 7404 reports of ejaculatory disorders reports were identified, and of these, 6854 cases (92.6%) were attributed to ten specific medications. On FDA-FAERS and EV databases, Paroxetine and Tamsulosin were the main responsible of delayed ejaculation (103/448 events, 23.0%) and retrograde ejaculation (366/1033 events, 35.4%), respectively. Finasteride was mostly related to painful ejaculation and ejaculation failure, with 150 events (7.8%) and 735 events (38.4%) respectively. Within the group of high-risk medications, Sildenafil presented higher risk of ejaculatory disorders than Tadalafil (PRR=5.85 (95%CI 5.09-6.78), P < .01).
Ten drugs were recognized to display significant reporting levels of ejaculatory disorders. Among them, Finasteride and Sildenafil were responsible for the most reports in FDA-FAERS and in EV databases, respectively. Physicians should thoroughly counsel patients treated with these drugs about the risk of ejaculatory disorders. Further integration into clinical trials is needed to enhance the applicability and significance of these results.
摘要：
目的：通过不成比例分析确定哪些药物与射精障碍主要相关。
方法：从2012年9月10日至2023年6月1日，对食品和药物管理局不良事件报告系统（FDA-FAERS）和Eudra-Vigilance（EV）数据库进行了查询，以确定与射精障碍更常见相关的药物。计算所有选定药物的比例报告比率(PRR)。
结果：总体而言，确定了7404例射精障碍报告，其中，6854例（92,6％）归因于十种特定药物。在FDA-FAERS和EV数据库上，帕罗西汀和坦索罗辛是射精延迟的主要原因（103/448事件，23,0%)和逆行射精(366/1033事件，35,4%)，分别。非那雄胺主要与疼痛性射精和射精失败有关，分别有150个事件（7,8%）和735个事件（38,4%）。在高风险药物组中，西地那非出现射精障碍的风险高于他达拉非（PRR=5.85（95CI5.09-6.78），p<0,01)。
结论：10种药物被认为表现出显著的射精障碍报告水平。其中,非那雄胺和西地那非在FDA-FAERS和EV数据库中报告最多，分别。医生应彻底告知接受这些药物治疗的患者射精障碍的风险。需要进一步整合到临床试验中以增强这些结果的适用性和重要性。
方法：从2012年9月10日至2023年6月1日，对食品和药物管理局不良事件报告系统（FDA-FAERS）和Eudra-Vigilance（EV）数据库进行了查询，以确定与射精障碍更常见相关的药物。计算所有选定药物的比例报告比率(PRR)。
结果：总体而言，确定了7404例射精障碍报告，其中，6854例（92,6％）归因于十种特定药物。在FDA-FAERS和EV数据库上，帕罗西汀和坦索罗辛是射精延迟的主要原因（103/448事件，23,0%)和逆行射精(366/1033事件，35,4%)，分别。非那雄胺主要与疼痛性射精和射精失败有关，分别有150个事件（7,8%）和735个事件（38,4%）。在高风险药物组中，西地那非出现射精障碍的风险高于他达拉非（PRR=5.85（95CI5.09-6.78），p<0,01)。
结论：10种药物被认为表现出显著的射精障碍报告水平。其中,非那雄胺和西地那非在FDA-FAERS和EV数据库中报告最多，分别。医生应彻底告知接受这些药物治疗的患者射精障碍的风险。需要进一步整合到临床试验中以增强这些结果的适用性和重要性。
