Health Sciences Faculty, University of Beira Interior (FCS-UBI), 6200-506 Covilhã, Portugal.
Health Sciences Research Center, University of Beira Interior (CICS-UBI), 6200-506 Covilhã, Portugal.
Curr Oncol. 2023 Jul 7;30(7):6533-6545. doi: 10.3390/curroncol30070479.
Poly (ADP-Ribose) polymerase inhibitors (PARPi) have emerged as a targeted therapy in cancer treatment with promising results in various types of cancer. This work aims to investigate the profile of adverse drug reactions (ADRs) associated with PARPi through the reports provided by the Eudravigilance (EV) database. We also intend to analyze the potential association of peripheral neuropathy to PARPi. Data on individual case safety reports (ICSRs) were obtained by accessing the European spontaneous reporting system via the EV website. A total of 12,762 ICSRs were collected from the EV database. Serious cases of nervous system disorders were analyzed providing strong evidence that peripheral neuropathy was reported in a higher frequency in patients treated with niraparib. Most cases reported a not recovered/not resolved outcome and involved drug withdrawal. However, several studies suggest that PARPi attenuate chemotherapy-induced painful neuropathy. Unexpected ADRs such as peripheral neuropathy may also occur, mostly in patients taking niraparib. Further pharmacovigilance studies should be conducted in this area to clarify with more precision the toxicity profile of these drugs.
聚（ADP-核糖）聚合酶抑制剂（PARPi）已成为癌症治疗中的一种靶向疗法，在多种类型的癌症中取得了有希望的结果。本研究旨在通过 Eudravigilance（EV）数据库中提供的报告，调查与 PARPi 相关的不良药物反应（ADR）的特征。我们还旨在分析 PARPi 与周围神经病变的潜在关联。通过访问 EV 网站上的欧洲自发报告系统，从 EV 数据库中获得了关于个别病例安全报告（ICSR）的数据。从 EV 数据库中收集了 12762 份 ICSR。对神经系统疾病严重病例的分析提供了有力的证据，表明尼拉帕利治疗的患者中报告周围神经病的频率更高。大多数报告的结果为未恢复/未解决，且涉及药物停用。然而，一些研究表明，PARPi 可减轻化疗引起的痛性神经病。也可能发生意想不到的 ADR，如周围神经病变，主要发生在服用尼拉帕利的患者中。应在该领域开展进一步的药物警戒研究，以更精确地阐明这些药物的毒性特征。
