PDF(Pubmed)
Abstract：
OBJECTIVE: This study aims to conduct an exhaustive evaluation of Vilazodone\'s safety in clinical application and to unearth the potential adverse event (AE) risks associated with its utilization based on FDA Adverse Event Reporting System (FAERS) database.
METHODS: This research employed data spanning from the first quarter of 2011 to the third quarter of 2023 from the FAERS database. Various signal detection methodologies, including the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayesian Geometric Mean (EBGM), were utilized to ascertain the correlation between Vilazodone and specific AEs.
RESULTS: The study compiled a total of 17,439,268 reports of drug AEs, out of which 5,375 were related to Vilazodone. Through signal mining, 125 Preferred Terms (PTs) encompassing 27 System Organ Classes (SOCs) were identified. The findings indicated a higher prevalence among females and patients within the 45 to 65 age bracket. The principal categories of AEs included Psychiatric disorders, Nervous system disorders, and Gastrointestinal disorders, with prevalent incidents of Diarrhoea, Nausea, and Insomnia. Moreover, the study identified robust signals of novel potential AEs, notably in areas such as sleep disturbances (Sleep paralysis, Hypnagogic hallucination, Rapid eye movements sleep abnormal, Sleep terror, Terminal insomnia, Tachyphrenia), sexual dysfunctions (Female orgasmic disorder, Orgasm abnormal, Disturbance in sexual arousal, Spontaneous penile erection, Anorgasmia, Sexual dysfunction, Ejaculation delayed), and other symptoms and injuries (Electric shock sensation, Violence-related symptom, Gun shot wound).
CONCLUSIONS: Although Vilazodone presents a positive prospect in the management of MDD, the discovery of AEs linked to its use, particularly the newly identified potential risks such as sleep and sexual dysfunctions, necessitates heightened vigilance among clinicians.
METHODS: This research employed data spanning from the first quarter of 2011 to the third quarter of 2023 from the FAERS database. Various signal detection methodologies, including the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayesian Geometric Mean (EBGM), were utilized to ascertain the correlation between Vilazodone and specific AEs.
RESULTS: The study compiled a total of 17,439,268 reports of drug AEs, out of which 5,375 were related to Vilazodone. Through signal mining, 125 Preferred Terms (PTs) encompassing 27 System Organ Classes (SOCs) were identified. The findings indicated a higher prevalence among females and patients within the 45 to 65 age bracket. The principal categories of AEs included Psychiatric disorders, Nervous system disorders, and Gastrointestinal disorders, with prevalent incidents of Diarrhoea, Nausea, and Insomnia. Moreover, the study identified robust signals of novel potential AEs, notably in areas such as sleep disturbances (Sleep paralysis, Hypnagogic hallucination, Rapid eye movements sleep abnormal, Sleep terror, Terminal insomnia, Tachyphrenia), sexual dysfunctions (Female orgasmic disorder, Orgasm abnormal, Disturbance in sexual arousal, Spontaneous penile erection, Anorgasmia, Sexual dysfunction, Ejaculation delayed), and other symptoms and injuries (Electric shock sensation, Violence-related symptom, Gun shot wound).
CONCLUSIONS: Although Vilazodone presents a positive prospect in the management of MDD, the discovery of AEs linked to its use, particularly the newly identified potential risks such as sleep and sexual dysfunctions, necessitates heightened vigilance among clinicians.
摘要：
目的：本研究旨在基于FDA不良事件报告系统（FAERS）数据库，对维拉佐酮的临床应用安全性进行详尽评估，并揭示与其使用相关的潜在不良事件（AE）风险。
方法：这项研究采用了FAERS数据库中2011年第一季度至2023年第三季度的数据。各种信号检测方法，包括报告赔率比(ROR)，比例报告比率(PRR)，贝叶斯置信传播神经网络(BCPNN)，和经验贝叶斯几何均值(EBGM)，用于确定维拉唑酮与特定AE之间的相关性。
结果：该研究共收集了17,439,268份药物不良事件报告，其中5375人与维拉佐酮有关。通过信号挖掘，确定了125个包含27个系统器官类别（SOC）的首选术语（PT）。研究结果表明，女性和45至65岁年龄段的患者的患病率更高。AEs的主要类别包括精神疾病，神经系统疾病,和胃肠道疾病，随着腹泻的流行，恶心，和失眠。此外，这项研究确定了新的潜在AE的稳健信号，特别是在睡眠障碍等领域(睡眠瘫痪，催眠幻觉,快速眼动睡眠异常，睡眠恐怖，终端失眠，心动过速)，性功能障碍（女性性高潮障碍，性高潮异常,性唤起的障碍，自发性阴茎勃起,性高潮,性功能障碍,射精延迟)，和其他症状和伤害(电击感觉，与暴力有关的症状，枪伤）。
结论：尽管维拉佐酮在MDD的管理中具有积极的前景，与它的使用相关的AE的发现，特别是新发现的潜在风险，如睡眠和性功能障碍，临床医生必须提高警惕。
方法：这项研究采用了FAERS数据库中2011年第一季度至2023年第三季度的数据。各种信号检测方法，包括报告赔率比(ROR)，比例报告比率(PRR)，贝叶斯置信传播神经网络(BCPNN)，和经验贝叶斯几何均值(EBGM)，用于确定维拉唑酮与特定AE之间的相关性。
结果：该研究共收集了17,439,268份药物不良事件报告，其中5375人与维拉佐酮有关。通过信号挖掘，确定了125个包含27个系统器官类别（SOC）的首选术语（PT）。研究结果表明，女性和45至65岁年龄段的患者的患病率更高。AEs的主要类别包括精神疾病，神经系统疾病,和胃肠道疾病，随着腹泻的流行，恶心，和失眠。此外，这项研究确定了新的潜在AE的稳健信号，特别是在睡眠障碍等领域(睡眠瘫痪，催眠幻觉,快速眼动睡眠异常，睡眠恐怖，终端失眠，心动过速)，性功能障碍（女性性高潮障碍，性高潮异常,性唤起的障碍，自发性阴茎勃起,性高潮,性功能障碍,射精延迟)，和其他症状和伤害(电击感觉，与暴力有关的症状，枪伤）。
结论：尽管维拉佐酮在MDD的管理中具有积极的前景，与它的使用相关的AE的发现，特别是新发现的潜在风险，如睡眠和性功能障碍，临床医生必须提高警惕。
