性功能障碍(SD)是一个问题,可以影响性反应周期的任何阶段(例如性欲,唤醒和高潮)和任何年龄的个人。SD可能是由身体原因引起的,比如医疗条件,酗酒或药物滥用;心理因素,如压力和焦虑;和不同的药物,如选择性5-羟色胺再摄取抑制剂(SSRIs),及其相关的不利影响。
这项研究的目的是描述怀疑导致患者SD药物不良反应(ADR)的药物的特征。通过基于药物警戒报告进行描述性研究。
2003年1月至2019年12月提交给荷兰药物警戒中心Lareb的报告用于调查药物引起的性障碍。选定的报告中至少有一个ADR报告在“监管活动医学词典”(MedDRA®)系统器官分类(SOC)“生殖系统和乳房疾病”和“与性疾病有关的SOC“精神疾病”中,并纠正了荷兰人口的药物使用(支出)。
在观察期间,共报告了2815例SDADR。数据根据三个变量进行划分:药物治疗组,药物本身,和性爱。总共观察到722个不同的SD/药物治疗组对。SD报告频率最高的药物治疗组是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,男性患勃起功能障碍更多,性欲下降和射精障碍,而在女性中,性欲障碍,性交困难和SD是最常见的不良反应。
在两性之间检测到不同的反应和不成比例的反应。抗抑郁药,抗高血压药,口服避孕药,α-阻断剂,和抗雄激素是药物治疗组,SD报告数量和相应的高比值比最高。
BACKGROUND: 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.
OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.