Department of Pharmacy, Women and Children's Hospital, School of Medicine, Xiamen University, 10# Zhenhai Road, Xiamen, China.
BMC Infect Dis. 2024 May 9;24(1):446. doi: 10.1186/s12879-024-09339-4.
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.
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.
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].
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.
在流感治疗选择有限的情况下，评估奥司他韦和巴洛沙韦的安全性至关重要，尤其是考虑到它们的疗效相当。本研究调查了上市后安全性概况，探讨了不良事件（AE）及其与药物的关联，为临床提供重要参考。
对 2004 年第一季度至 2022 年第四季度 FDA 不良事件报告系统（FAERS）数据进行了细致分析。使用数据挖掘技术，如报告比值比（ROR）、比例报告比、贝叶斯置信传播神经网络和多元伽马泊松收缩，研究了奥司他韦和巴洛沙韦相关的 AE。Venn 分析比较并选择了与每种药物相关的特定 AE。
纳入 15104 例奥司他韦病例和 1594 例巴洛沙韦病例，Wain 分析揭示了 21 种在神经、精神、胃肠道、皮肤、呼吸和感染领域共同出现的 AE。奥司他韦表现出 221 种显著的特异性 AE，包括阑尾结石[ROR（95%CI），459.53（340.88619.47）]、婴儿痤疮[ROR（95%CI），368.65（118.891143.09）]、急性黄斑神经视网膜病变[ROR（95%CI），294.92（97.88888.64）]、直肠炎[ROR（95%CI），245.74（101.47595.31）]和老年紫癜[ROR（95%CI），154.02（81.96289.43）]。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（8.3017.72），n=27]、心室颤动[ROR（95%CI），7.68（6.019.83），n=64]、中毒性表皮坏死松解症[ROR（95%CI），7.21（5.749.05），n=75]。巴洛沙韦表现出 34 种特异性 AE，包括黑便[ROR（95%CI），21.34（14.1532.18），n=23]、出血性膀胱炎[ROR（95%CI），20.22（7.5754.00），n=4]、麻痹性肠梗阻[ROR（95%CI），18.57（5.9857.71），n=3]和出血性素质[ROR（95%CI），16.86（5.4352.40），n=3]。与巴洛沙韦相关的 DME 包括横纹肌溶解症[ROR（95%CI），15.50（10.53~22.80），n=26]。
在奥司他韦治疗期间，特别是在有肝脏疾病的患者中，监测暴发性肝炎至关重要。奥司他韦有引起异常行为的潜力，尤其是在青少年中，需要特别关注。巴洛沙韦的肝毒性较低，可能成为肝脏疾病患者的潜在替代药物。在使用巴洛沙韦治疗期间，建议密切关注横纹肌溶解症的发生，需要及时监测有临床表现的相关指标。综合数据旨在为临床医生和医疗保健专业人员提供有价值的见解，帮助他们在真实世界场景中了解这些流感治疗方法的安全性概况。
