基于FAERS数据库西地那非不同适应症的不良事件信号挖掘

Data Mining of Adverse Events for Sildenafil Under Different Indications Based On The FAERS Database

关键词:  西地那非  不良事件  勃起功能障碍  肺动脉高压  数据挖掘

Key words:  sildenafil  adverse drug reactions  erectile dysfunction  pulmonary arterial hypertension  data mining

摘要:

目的 基于美国FDA不良事件报告系统(FAERS)数据库,挖掘西地那非不同适应症的不良事件(ADE)信号,为临床安全用药提供参考。方法 从FAER中提取2004年第一季度至2024年第三季度西地那非不同适应症的的不良事件报告数据,采用报告比值比(ROR)法、贝叶斯置信区间递进神经网络(BCPNN)法进行 ADE 信号检测。结果 得到适应症为勃起功能障碍的ADE报告数6502例,适应症为肺动脉高压ADE报告数10031例。采用ROR和BCPNN法挖掘,西地那非适应症为勃起功能障碍中阳性信号PT有97个,ADE报告数最多依次为恶性黑色素瘤、勃起增强、射精障碍等；适应症为肺动脉高压阳性信号PT有278个,ADE报告数最多依次为死亡、心力衰竭、充血性心力衰竭等。在适应症为勃起功能障碍中,我们发现了说明书中未提及SOC是良性、恶性及性质不明的肿瘤,其中报告数最多且信号强度最高的PT为恶性黑色素瘤和原位恶性黑色素瘤,而这在勃起功能障碍患者中报告数却较少。在两适应症中,眼器官和耳及迷路系统的不良反应报告数量和信号强度较高,需要密切关注这两个系统的不良反应,如视力损害和听力减退等。结论 西地那非不同适应证其ADE报告数存在区别,对于勃起功能障碍的患者,恶性黑色素瘤的报告例数和信号强度均较强,而肺动脉高压患者中的报告数却非常低,需进一步的临床随机对照研究证实。在两种适应症中,都需要密切关注眼器官和耳部及迷路系统的不良反应,如视力损害和听力减退等。

Abstract:

OBJECTIVE To explore the adverse drug event (ADE) signals of sildenafil under different indications based on the U.S. FDA Adverse Event Reporting System (FAERS) database, providing references for safe clinical medication use. Methods Data on ADE reports of sildenafil under different indications from the first quarter of 2004 to the third quarter of 2024 were extracted from the FAERS database. ADE signal detection was performed using the Reporting Odds Ratio (ROR) method and the Bayesian Confidence Propagation Neural Network (BCPNN) method. Results A total of 6,502 ADE reports were obtained for the indication of erectile dysfunction (ED), and 10,031 reports for pulmonary arterial hypertension (PAH). Using the ROR and BCPNN methods, 97 positive signal PTs (Preferred Terms) were identified for ED, with the highest number of ADE reports being for malignant melanoma, enhanced erection, and ejaculation disorder, etc. For PAH, 278 positive signal PTs were identified, with the highest number of ADE reports being for death, heart failure, and congestive heart failure, etc. In the ED indication, we identified an SOC (System Organ Class) of benign, malignant, and unspecified tumors that was not mentioned in the product insert. Among these, the PTs with the highest report numbers and signal strengths were malignant melanoma and in situ malignant melanoma, which had relatively low report numbers in ED patients. In both indications, the number of ADE reports and signal strengths were relatively high for the eye organs and ear and labyrinth systems, indicating a need to closely monitor adverse reactions in these systems, such as visual impairment and hearing loss. Conclusion The number of ADE reports for sildenafil varies between different indications. For ED patients, the report numbers and signal strengths for malignant melanoma were relatively high, while they were very low for PAH patients. Further clinical randomized controlled studies are needed to confirm these findings. In both indications, close attention should be paid to adverse reactions in the eye organs and ear and labyrinth systems, such as visual impairment and hearing loss.