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首页> 美国卫生研究院文献>Medicina >Retrospective Toxicological Profiling of Radium-223 Dichloride for the Treatment of Bone Metastases in Prostate Cancer Using Adverse Event Data
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Retrospective Toxicological Profiling of Radium-223 Dichloride for the Treatment of Bone Metastases in Prostate Cancer Using Adverse Event Data

机译：使用不良事件数据回顾性研究223氯化镭治疗前列腺癌骨转移的毒理学分析

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Background and Objective: Radium-223 dichloride (Xofigo®) is a calcium mimetic agent approved for the treatment of castration-resistant prostate cancer patients with symptomatic bone metastases and no known visceral metastatic disease. This targeted, α-particle-emitting therapy has demonstrated significant survival benefit accompanied by a favorable safety profile. Nevertheless, recent evidence suggests that its combined use with abiraterone and prednisone/prednisolone may be associated with increased risk of death and fractures. While the precise pathophysiologic mechanisms of these events are not yet clear, collecting evidence from more clinical trials and translational studies is necessary. The aim of our present study is to assess whether accessible sources of patient outcome data can help gain additional clinical insights to radium-223 dichloride’s safety profile. Materials and Methods: We performed a retrospective analysis of cases extracted from the FDA Adverse Event Reporting System and characterized side effect occurrence by using reporting ratios. Results: A total of ~1500 prostate cancer patients treated with radium-223 dichloride was identified, and side effects reported with the use of radium-223 dichloride alone or in combination with other therapeutic agents were extracted. Our analysis demonstrates that radium-223 dichloride may often come with hematological-related reactions, and that, when administered together with other drugs, its safety profile may differ. Conclusions: While more prospective studies are needed to fully characterize the toxicological profile of radium-223 dichloride, the present work constitutes perhaps the first effort to examine its safety when administered alone and in combination with other agents based on computational evidence from public real-world post marketing data.
机译：背景与目的：镭223（Xofigo ®）是一种钙模拟剂，已被批准用于治疗去势抵抗的有症状骨转移且无内脏转移性疾病的前列腺癌患者。这种靶向性的，发射α粒子的疗法已显示出显着的生存获益，并具有良好的安全性。然而，最近的证据表明，将其与阿比特龙和泼尼松/泼尼松龙联合使用可能会增加死亡和骨折的风险。尽管这些事件的确切病理生理机制尚不清楚，但有必要从更多的临床试验和转化研究中收集证据。我们当前研究的目的是评估患者结果数据的可访问来源是否可以帮助获得更多的临床信息，以了解二氯化镭223的安全性。材料和方法：我们对从FDA不良事件报告系统中提取的病例进行了回顾性分析，并通过使用报告比率来表征副作用的发生。结果：总共鉴定出约1500名接受二氯化镭223治疗的前列腺癌患者，并提取了单独使用或与其他治疗剂联合使用的报告的副作用。我们的分析表明，二氯化铀223可能经常伴随血液学相关反应，并且与其他药物一起给药时，其安全性可能会有所不同。结论：尽管需要更多前瞻性研究来全面表征223氯化镭的毒理学特征，但本工作可能是根据公共现实世界的计算证据，单独或与其他药物合用时检查其安全性的第一项努力。发布营销数据。

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