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探索和比较PARP抑制剂之间的脏不良影响,基于对市场营销后监测数据的现实分析

Qiuyu Xu¹, Lin Jiang², Gang Chen¹

¹Department of Nephrology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.

Frontiers in medicine

|November 4, 2024

概括

多 (ADP-ribose) 聚合酶抑制剂 (PARPis) 可能导致损伤,特别是在老年人中. 维利帕里布的风险较高,因此在PARPi治疗期间需要仔细监测功能.

科学领域:

在瘤学瘤学.
腎臟病學 (nephrology) 是一種醫學專業.
药物监督药物监督药物监督

背景情况:

多 (ADP-ribose) 聚合酶抑制剂 (PARPis) 是卵巢和乳腺癌的关键向治疗方法.
急性损伤 (AKI) 是PARPi治疗的已知风险,但缺乏比较分析.
需要现实世界的数据来描述不同PARP的脏不良影响 (RAE).

研究的目的:

综合评估和比较与各种多 (ADP-ribose) 聚合酶抑制剂 (PARPis) 相关的脏不良影响 (RAE),使用现实数据.
调查与PARPi相关的RAE的发病率,发病时间和临床结果 (住院治疗,死亡).
确定具有较高RAE风险概况的特定PARP.

主要方法:

在FDA不良事件报告系统 (FAERS) 数据库 (2004年1月 - 2023年9月) 中使用了不成比例和贝叶斯分析.
确定了与不同PARP相关的RAE疑似病例.
分析了已确定的RAE的发病时间,住院率和死亡率.

主要成果:

确定了1696个与PARPi相关的RAE,其中56.31%发生在85岁以上的患者中.
维利帕里布与RAE的相关性显著更高 (ROR=29.20,PRR=19.80,EBGM=19.80).
平均RAE发病时间为15天;住院和死亡率分别为28.15%和4.34%.

结论:

虽然PARPi相关的RAE往往是可逆的,但由于潜在的严重程度,需要大量的临床关注.
早期识别面临不可逆转损伤风险的个体至关重要.
建议对PARPi患者进行密切的功能监测,特别是老年人和有先前存在病的患者.

关键词:

不良事件报告系统不良事件报告系统毒性毒性毒性瘤脏病学瘤脏病学卵巢癌是发生在卵巢的癌症.功能功能功能

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