Instituto Politécnico De Coimbra, ESTESC-Coimbra Health School, Farmácia, Coimbra, Portugal.
Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands.
Drug Saf. 2022 Jun;45(6):639-650. doi: 10.1007/s40264-022-01174-3. Epub 2022 Apr 7.
Sexual dysfunction (SD) is a problem that can affect any phase of the sexual response cycle (such as sexual desire, arousal and orgasm) and individuals of any age. SD can be caused by physical reasons, such as medical conditions, alcoholism or drug abuse; psychological factors, such as stress and anxiety; and different medicines, such as selective serotonin reuptake inhibitors (SSRIs), and their associated adverse effects.
The aim of this study was to characterise drugs suspected to have caused SD adverse drug reactions (ADRs) in patients, by conducting a descriptive study based on pharmacovigilance reports.
Reports submitted to the Netherlands Pharmacovigilance Centre Lareb from January 2003 to December 2019 were used to investigate drug-induced sexual disorders. Selected reports had at least one ADR reported in the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) 'Reproductive system and breast disorders' and the SOC 'Psychiatric disorders' relating to sexual disorders and corrected for drug utilisation (expenditure) for the Dutch population.
A total of 2815 SD ADRs were reported in the observed period. Data were divided according to three variables: pharmacotherapeutic group, the drug itself, and sex. A total of 722 different SD/pharmacotherapeutic group pairs were observed. The pharmacotherapeutic groups with the highest frequency of SD reports were SSRIs (n = 488, 17.58%), other antidepressants (n = 172, 6.20%) and HMG-CoA reductase inhibitors (n = 149, 5.37%). Distinguishing ADRs by sex, men suffered more from erectile dysfunction, decreased libido and ejaculation disorders, while among women, libido disorders, dyspareunia and SD were the most common ADRs.
Different reactions and disproportionality of reactions were detected between the sexes. Antidepressants, antihypertensives, oral contraceptives, α-blockers, and anti-androgens were the pharmacotherapeutic groups with the highest number of SD reports and corresponding high odds ratios.
性障碍（SD）是一种可能影响性反应周期任何阶段（如性欲、唤起和高潮）的问题，并且可能影响任何年龄段的个体。SD 可能由身体原因引起，例如医疗状况、酗酒或药物滥用；心理因素，如压力和焦虑；以及不同的药物，如选择性 5-羟色胺再摄取抑制剂（SSRIs）及其相关的不良反应。
本研究旨在通过基于药物警戒报告的描述性研究，描述导致患者出现 SD 不良反应（ADR）的可疑药物。
使用从 2003 年 1 月至 2019 年 12 月向荷兰药物警戒中心 Lareb 提交的报告，调查药物引起的性功能障碍。选择的报告至少有一个 ADR 在《监管活动医学词典》（MedDRA）系统器官类别（SOC）“生殖系统和乳房疾病”和 SOC“精神障碍”中报告与性功能障碍相关，并针对荷兰人口的药物使用（支出）进行校正。
在观察期间共报告了 2815 例 SD ADR。根据三个变量对数据进行了分类：治疗组、药物本身和性别。观察到总共 722 种不同的 SD/治疗组组合。SD 报告频率最高的治疗组是 SSRIs（n=488，17.58%）、其他抗抑郁药（n=172，6.20%）和 HMG-CoA 还原酶抑制剂（n=149，5.37%）。按性别区分 ADR，男性更多地患有勃起功能障碍、性欲减退和射精障碍，而女性中，性欲障碍、性交疼痛和 SD 是最常见的 ADR。
检测到不同性别之间存在不同的反应和反应比例失调。抗抑郁药、抗高血压药、口服避孕药、α-受体阻滞剂和抗雄激素是报告 SD 数量最多的治疗组，相应的比值比也较高。
