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Abstract：
OBJECTIVE: Amidst limited influenza treatment options, evaluating the safety of Oseltamivir and Baloxavir Marboxil is crucial, particularly given their comparable efficacy. This study investigates post-market safety profiles, exploring adverse events (AEs) and their drug associations to provide essential clinical references.
METHODS: A meticulous analysis of FDA Adverse Event Reporting System (FAERS) data spanning the first quarter of 2004 to the fourth quarter of 2022 was conducted. Using data mining techniques like reporting odds ratio (ROR), proportional reporting ratio, Bayesian Confidence Propagation Neural Network, and Multiple Gamma Poisson Shrinkage, AEs related to Oseltamivir and Baloxavir Marboxil were examined. Venn analysis compared and selected specific AEs associated with each drug.
RESULTS: Incorporating 15,104 Oseltamivir cases and 1,594 Baloxavir Marboxil cases, Wain analysis unveiled 21 common AEs across neurological, psychiatric, gastrointestinal, dermatological, respiratory, and infectious domains. Oseltamivir exhibited 221 significantly specific AEs, including appendicolith [ROR (95% CI), 459.53 (340.88 ∼ 619.47)], acne infantile [ROR (95% CI, 368.65 (118.89 ∼ 1143.09)], acute macular neuroretinopathy [ROR (95% CI), 294.92 (97.88 ∼ 888.64)], proctitis [ROR (95% CI), 245.74 (101.47 ∼ 595.31)], and Purpura senile [ROR (95% CI), 154.02 (81.96 ∼ 289.43)]. designated adverse events (DMEs) associated with Oseltamivir included fulminant hepatitis [ROR (95% CI), 12.12 (8.30-17.72), n=27], ventricular fibrillation [ROR (95% CI), 7.68 (6.01-9.83), n=64], toxic epidermal necrolysis [ROR (95% CI), 7.21 (5.74-9.05), n=75]. Baloxavir Marboxil exhibited 34 specific AEs, including Melaena [ROR (95% CI), 21.34 (14.15-32.18), n = 23], cystitis haemorrhagic [ROR (95% CI), 20.22 (7.57-54.00), n = 4], ileus paralytic [ROR (95% CI), 18.57 (5.98-57.71), n = 3], and haemorrhagic diathesis [ROR (95% CI), 16.86 (5.43-52.40)), n = 3]. DMEs associated with Baloxavir Marboxil included rhabdomyolysis [ROR (95% CI), 15.50 (10.53 ∼ 22.80), n = 26].
CONCLUSIONS: Monitoring fulminant hepatitis during Oseltamivir treatment, especially in patients with liver-related diseases, is crucial. Oseltamivir\'s potential to induce abnormal behavior, especially in adolescents, necessitates special attention. Baloxavir Marboxil, with lower hepatic toxicity, emerges as a potential alternative for patients with liver diseases. During Baloxavir Marboxil treatment, focused attention on the occurrence of rhabdomyolysis is advised, necessitating timely monitoring of relevant indicators for those with clinical manifestations. The comprehensive data aims to provide valuable insights for clinicians and healthcare practitioners, facilitating an understanding of the safety profiles of these influenza treatments in real-world scenarios.
METHODS: A meticulous analysis of FDA Adverse Event Reporting System (FAERS) data spanning the first quarter of 2004 to the fourth quarter of 2022 was conducted. Using data mining techniques like reporting odds ratio (ROR), proportional reporting ratio, Bayesian Confidence Propagation Neural Network, and Multiple Gamma Poisson Shrinkage, AEs related to Oseltamivir and Baloxavir Marboxil were examined. Venn analysis compared and selected specific AEs associated with each drug.
RESULTS: Incorporating 15,104 Oseltamivir cases and 1,594 Baloxavir Marboxil cases, Wain analysis unveiled 21 common AEs across neurological, psychiatric, gastrointestinal, dermatological, respiratory, and infectious domains. Oseltamivir exhibited 221 significantly specific AEs, including appendicolith [ROR (95% CI), 459.53 (340.88 ∼ 619.47)], acne infantile [ROR (95% CI, 368.65 (118.89 ∼ 1143.09)], acute macular neuroretinopathy [ROR (95% CI), 294.92 (97.88 ∼ 888.64)], proctitis [ROR (95% CI), 245.74 (101.47 ∼ 595.31)], and Purpura senile [ROR (95% CI), 154.02 (81.96 ∼ 289.43)]. designated adverse events (DMEs) associated with Oseltamivir included fulminant hepatitis [ROR (95% CI), 12.12 (8.30-17.72), n=27], ventricular fibrillation [ROR (95% CI), 7.68 (6.01-9.83), n=64], toxic epidermal necrolysis [ROR (95% CI), 7.21 (5.74-9.05), n=75]. Baloxavir Marboxil exhibited 34 specific AEs, including Melaena [ROR (95% CI), 21.34 (14.15-32.18), n = 23], cystitis haemorrhagic [ROR (95% CI), 20.22 (7.57-54.00), n = 4], ileus paralytic [ROR (95% CI), 18.57 (5.98-57.71), n = 3], and haemorrhagic diathesis [ROR (95% CI), 16.86 (5.43-52.40)), n = 3]. DMEs associated with Baloxavir Marboxil included rhabdomyolysis [ROR (95% CI), 15.50 (10.53 ∼ 22.80), n = 26].
CONCLUSIONS: Monitoring fulminant hepatitis during Oseltamivir treatment, especially in patients with liver-related diseases, is crucial. Oseltamivir\'s potential to induce abnormal behavior, especially in adolescents, necessitates special attention. Baloxavir Marboxil, with lower hepatic toxicity, emerges as a potential alternative for patients with liver diseases. During Baloxavir Marboxil treatment, focused attention on the occurrence of rhabdomyolysis is advised, necessitating timely monitoring of relevant indicators for those with clinical manifestations. The comprehensive data aims to provide valuable insights for clinicians and healthcare practitioners, facilitating an understanding of the safety profiles of these influenza treatments in real-world scenarios.
摘要：
目标：在有限的流感治疗选择中，评估奥司他韦和BaloxavirMarboxil的安全性至关重要，特别是考虑到它们的可比功效。这项研究调查了上市后的安全概况，探索不良事件（AE）及其药物关联，以提供必要的临床参考。
方法：对2004年第一季度至2022年第四季度的FDA不良事件报告系统（FAERS）数据进行了细致的分析。使用数据挖掘技术，如报告赔率比(ROR)，比例报告比率，贝叶斯置信传播神经网络，和多重伽玛泊松收缩，检查了与奥司他韦和BaloxavirMarboxil相关的AE。Venn分析比较并选择与每种药物相关的特定AE。
结果：纳入了15,104例奥司他韦病例和1,594例巴洛沙韦马波西尔病例，Wain分析揭示了神经系统中21种常见的AE，精神病学,胃肠,皮肤病学,呼吸,和传染性领域。奥司他韦表现出221个显著的特异性AE，包括阑尾石[ROR（95%CI），459.53(340.88~619.47)]，痤疮婴儿[ROR（95%CI，368.65（118.89~1143.09）]，急性黄斑神经视网膜病变[ROR（95%CI），294.92(97.88≈888.64)]，直肠炎[ROR（95%CI），245.74(101.47~595.31)]，和老年性紫癜[ROR（95%CI），154.02（81.96~289.43）]。与奥司他韦相关的指定不良事件（DME）包括暴发性肝炎[ROR（95％CI），12.12(8.30-17.72),n=27]，心室纤颤[ROR（95%CI），7.68(6.01-9.83),n=64]，中毒性表皮坏死溶解[ROR（95%CI），7.21(5.74-9.05),n=75]。BaloxavirMarboxil表现出34种特定的AE，包括Melaena[ROR（95%CI），21.34（14.15-32.18），n=23]，出血性膀胱炎[ROR（95%CI），20.22（7.57-54.00），n=4]，肠梗阻麻痹性[ROR（95%CI），18.57（5.98-57.71），n=3]，和出血性素质[ROR（95%CI），16.86（5.43-52.40）），n=3]。与BaloxavirMarboxil相关的DME包括横纹肌溶解[ROR（95%CI），15.50(10.53~22.80)，n=26]。
结论：在奥司他韦治疗期间监测暴发性肝炎，尤其是肝脏相关疾病的患者，至关重要。奥司他韦诱导异常行为的潜力，尤其是青少年,需要特别注意。BaloxavirMarboxil,具有较低的肝毒性，成为肝病患者的潜在替代品。在BaloxavirMarboxil治疗期间，建议重点关注横纹肌溶解症的发生，有临床表现者需及时监测相关指标。全面的数据旨在为临床医生和医疗保健从业人员提供有价值的见解，有助于理解这些流感治疗在现实世界中的安全性。
方法：对2004年第一季度至2022年第四季度的FDA不良事件报告系统（FAERS）数据进行了细致的分析。使用数据挖掘技术，如报告赔率比(ROR)，比例报告比率，贝叶斯置信传播神经网络，和多重伽玛泊松收缩，检查了与奥司他韦和BaloxavirMarboxil相关的AE。Venn分析比较并选择与每种药物相关的特定AE。
结果：纳入了15,104例奥司他韦病例和1,594例巴洛沙韦马波西尔病例，Wain分析揭示了神经系统中21种常见的AE，精神病学,胃肠,皮肤病学,呼吸,和传染性领域。奥司他韦表现出221个显著的特异性AE，包括阑尾石[ROR（95%CI），459.53(340.88~619.47)]，痤疮婴儿[ROR（95%CI，368.65（118.89~1143.09）]，急性黄斑神经视网膜病变[ROR（95%CI），294.92(97.88≈888.64)]，直肠炎[ROR（95%CI），245.74(101.47~595.31)]，和老年性紫癜[ROR（95%CI），154.02（81.96~289.43）]。与奥司他韦相关的指定不良事件（DME）包括暴发性肝炎[ROR（95％CI），12.12(8.30-17.72),n=27]，心室纤颤[ROR（95%CI），7.68(6.01-9.83),n=64]，中毒性表皮坏死溶解[ROR（95%CI），7.21(5.74-9.05),n=75]。BaloxavirMarboxil表现出34种特定的AE，包括Melaena[ROR（95%CI），21.34（14.15-32.18），n=23]，出血性膀胱炎[ROR（95%CI），20.22（7.57-54.00），n=4]，肠梗阻麻痹性[ROR（95%CI），18.57（5.98-57.71），n=3]，和出血性素质[ROR（95%CI），16.86（5.43-52.40）），n=3]。与BaloxavirMarboxil相关的DME包括横纹肌溶解[ROR（95%CI），15.50(10.53~22.80)，n=26]。
结论：在奥司他韦治疗期间监测暴发性肝炎，尤其是肝脏相关疾病的患者，至关重要。奥司他韦诱导异常行为的潜力，尤其是青少年,需要特别注意。BaloxavirMarboxil,具有较低的肝毒性，成为肝病患者的潜在替代品。在BaloxavirMarboxil治疗期间，建议重点关注横纹肌溶解症的发生，有临床表现者需及时监测相关指标。全面的数据旨在为临床医生和医疗保健从业人员提供有价值的见解，有助于理解这些流感治疗在现实世界中的安全性。
