Abstract：
UNASSIGNED: Ospemifene has been authorized for the treatment of vulvovaginal atrophy (VVA). This study wasto evaluate adverse events (AEs) associated with ospemifene by data mining the US Food and Drug Administration Adverse Event Reporting System (FAERS).
UNASSIGNED: The signals of AEs linked to ospemifene were measured using disproportionality analyses, such as the reporting odds ratio (ROR), the proportional reporting ratio (PRR), the Bayesian confidence propagation neural network (BCPNN), and the multi-item gamma Poisson shrinker (MGPS) algorithms.
UNASSIGNED: There were 2283 events of ospemifene being the \'primary suspected (PS)\' AE out of the 12,692,824 reports from the FAERS database. Ospemifene-induced AEs hit 25 organ systems. There were 726 severely disproportional preferred terms (PTs) that complied with the four algorithms. The investigation turned up a number of anticipated adverse drug reactions (ADRs), and significant unanticipated ADRs linked to eye and renal problems were found, indicating potential side effects not yet included in the prescription instructions.
UNASSIGNED: We detected novel AEs signals for ospemifene, and the results of our investigation were compatible with clinical observations. This suggests that further prospective clinical trials are required to confirm these findings and demonstrate their link. Our findings might be useful supporting data for ospemifene safety research in the future.
UNASSIGNED: The signals of AEs linked to ospemifene were measured using disproportionality analyses, such as the reporting odds ratio (ROR), the proportional reporting ratio (PRR), the Bayesian confidence propagation neural network (BCPNN), and the multi-item gamma Poisson shrinker (MGPS) algorithms.
UNASSIGNED: There were 2283 events of ospemifene being the \'primary suspected (PS)\' AE out of the 12,692,824 reports from the FAERS database. Ospemifene-induced AEs hit 25 organ systems. There were 726 severely disproportional preferred terms (PTs) that complied with the four algorithms. The investigation turned up a number of anticipated adverse drug reactions (ADRs), and significant unanticipated ADRs linked to eye and renal problems were found, indicating potential side effects not yet included in the prescription instructions.
UNASSIGNED: We detected novel AEs signals for ospemifene, and the results of our investigation were compatible with clinical observations. This suggests that further prospective clinical trials are required to confirm these findings and demonstrate their link. Our findings might be useful supporting data for ospemifene safety research in the future.
摘要：
■Ospemifene已被授权用于治疗外阴阴道萎缩（VVA）。本研究通过数据挖掘美国食品和药物管理局不良事件报告系统（FAERS）来评估与ospemifene相关的不良事件（AE）。
■与ospemifene相关的AE的信号使用歧化分析进行测量，例如报告赔率比(ROR)，比例报告比(PRR)，贝叶斯置信度传播神经网络(BCPNN)，和多项目伽马泊松收缩器(MGPS)算法。
■在FAERS数据库的12,692,824个报告中，有2283个事件是\'主要可疑（PS）\'AE。Ospemifene诱导的AE击中25个器官系统。有726个严重不成比例的首选项（PT）符合这四种算法。调查发现了一些预期的药物不良反应(ADR)，发现了与眼睛和肾脏问题相关的大量意外不良反应，表明潜在的副作用尚未包含在处方说明中。
■我们检测到新的AE信号forospemifene，我们的研究结果与临床观察一致.这表明需要进一步的前瞻性临床试验来证实这些发现并证明它们之间的联系。我们的发现可能是未来ospemifene安全性研究的有用支持数据。
■与ospemifene相关的AE的信号使用歧化分析进行测量，例如报告赔率比(ROR)，比例报告比(PRR)，贝叶斯置信度传播神经网络(BCPNN)，和多项目伽马泊松收缩器(MGPS)算法。
■在FAERS数据库的12,692,824个报告中，有2283个事件是\'主要可疑（PS）\'AE。Ospemifene诱导的AE击中25个器官系统。有726个严重不成比例的首选项（PT）符合这四种算法。调查发现了一些预期的药物不良反应(ADR)，发现了与眼睛和肾脏问题相关的大量意外不良反应，表明潜在的副作用尚未包含在处方说明中。
■我们检测到新的AE信号forospemifene，我们的研究结果与临床观察一致.这表明需要进一步的前瞻性临床试验来证实这些发现并证明它们之间的联系。我们的发现可能是未来ospemifene安全性研究的有用支持数据。
