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文章:

癌症治疗诱发的心脏毒性:英国黄卡药物不良反应报告分析结果

Cancer-Therapy-Induced Cardiotoxicity: Results of the Analysis of the UK Yellow Card Adverse Drug Reaction (ADR) Reporting

原文发布日期:18 December 2024

DOI: 10.3390/cancers16244223

类型: Article

开放获取: 是

 

英文摘要:

Background:Non-small cell lung cancer (NSCLC) is a predominant cause of oncological mortality in the United Kingdom. There is a diverse spectrum of therapeutic options available, such as chemotherapies, targeted therapies and immunotherapies, which have significantly advanced patient prognoses. However, despite these advancements, there is an escalating concern regarding the potential cardiotoxic effects associated with these treatments.Objectives:This study aimed to explore the association between non-small cell lung cancer treatments and cardiotoxicity.Methods:A pharmacovigilance study was conducted utilising the UK Yellow Card System. The proportional reporting ratio (PRR) and reporting odds ratio (ROR) were calculated to detect signals.Results:Among the 56 shortlisted NSCLC drugs, the total number of adverse events reported was 128,214 with 6133 reports being cardiovascular adverse reactions. Among all the drugs analysed, alectinib demonstrated the highest ROR and PRR values, indicating the strongest signal for potential cardiovascular adverse events.Conclusions:This result was comparable to previous studies which also detected a signal of alectinib related to cardiovascular events using the WHO pharmacovigilance database, VigiBase. However, clinical studies demonstrated that alectinib largely improved progression-free survival (PFS) and overall survival in patients. Therefore, it is important to continue monitoring the real-world use of alectinib, so that a benefit–risk balance can be maintained.

 

摘要翻译: 

背景:非小细胞肺癌(NSCLC)是英国肿瘤相关死亡的主要原因。目前存在多种治疗方案,如化疗、靶向治疗和免疫治疗,这些治疗显著改善了患者的预后。然而,尽管取得了这些进展,与这些治疗相关的潜在心脏毒性效应正日益引起关注。 目的:本研究旨在探讨非小细胞肺癌治疗与心脏毒性之间的关联。 方法:利用英国黄卡系统进行了一项药物警戒研究。通过计算比例报告比(PRR)和报告比值比(ROR)来检测信号。 结果:在56种候选NSCLC药物中,报告的不良事件总数为128,214例,其中6,133例为心血管不良反应。在所有分析的药物中,阿来替尼显示出最高的ROR和PRR值,表明其潜在心血管不良事件的信号最强。 结论:该结果与先前研究一致,先前研究使用世界卫生组织药物警戒数据库VigiBase也检测到阿来替尼与心血管事件相关的信号。然而,临床研究表明,阿来替尼显著改善了患者的无进展生存期(PFS)和总生存期。因此,继续监测阿来替尼在真实世界中的使用情况至关重要,以维持其获益-风险平衡。

 

原文链接:

Cancer-Therapy-Induced Cardiotoxicity: Results of the Analysis of the UK Yellow Card Adverse Drug Reaction (ADR) Reporting

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