Evaluation of Acute Kidney Injury Associated With Anticancer Drugs Used in Gastric Cancer in the Japanese Adverse Drug Event Report Database
Evaluation of Acute Kidney Injury Associated With Anticancer Drugs Used in Gastric Cancer in the Japanese Adverse Drug Event Report Database
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DOI：
10.1177/1060028019865870
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发表时间：
2019-07-26
影响因子：
2.9
通讯作者：
Hosohata, Keiko
中科院分区：
文献类型：
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作者：
Uchida, Mayako;Kondo, Yuki;Hosohata, Keiko
背景：急性肾损伤（AKI）的发生取决于肾功能障碍的严重程度、临床环境、合并症因素和地理位置。胃癌是世界上最致命的恶性肿瘤之一，在日本其发病率非常高。目的：我们使用自发报告系统数据库（日本不良药物事件报告数据库）分析了胃癌抗癌药物与 AKI 关联的排序。方法：我们利用 2004 年 4 月至 2017 年 3 月期间向药品医疗器械管理局提交的不良事件报告进行了回顾性药物警戒不成比例分析。结果：抗癌药物相关的 AKI 在 60 多岁和 70 多岁的患者中很常见（分别为 39.2% 和 43.2%）。 AKI 最常发生在服用抗癌药物后 1 个月内。使用 S-1（替加氟/吉美拉西/奥特拉西）、顺铂 (CDDP) 和卡培他滨治疗后报告 AKI 信号，显着调整的报告比值比 (95% CI) 分别为 1.50 (1.09-2.07)、3.43 (2.48-4.74) 和 1.82 (1.15-2.90)。 CDDP 诱发的 AKI 更可能发生在男性、高血压或糖尿病患者中。结论和相关性：本研究表明，大多数 AKI 病例与胃癌治疗的 S-1 和/或 CDDP 辅助化疗有关。数据还阐明，AKI 发生在 1 个月内，其临床结果比以往普通医学中药物引起的 AKI 的报道更为严重。我们的研究提供了有用的信息，以最大限度地降低对含有 S-1 和/或 CDDP 的化疗引起的 AKI 高风险患者的给药风险。
Background: Development of acute kidney injury (AKI) depends on the severity of renal dysfunction, clinical setting, comorbid factors, and geographical location. Gastric cancer is one of the deadliest malignancies worldwide, and its incidence is significantly high in Japan. Objective: We analyzed the rank-order of the association of anticancer agents for gastric cancer with AKI using a spontaneous reporting system database, the Japanese Adverse Drug Event Report database. Methods: We performed a retrospective pharmacovigilance disproportionality analysis using the adverse event reports submitted to the Pharmaceuticals and Medical Devices Agency between April 2004 and March 2017. Results: Anticancer drug-related AKI was common in patients in their 60s and 70s (39.2% and 43.2%, respectively). AKI occurred most frequently within 1 month after anticancer drug administration. The signals of AKI were reported after treatment with S-1 (tegafur/gimeracil/oteracil), cisplatin (CDDP), and capecitabine, with significant adjusted reporting odds ratios (95% CI) of 1.50 (1.09-2.07), 3.43 (2.48-4.74), and 1.82 (1.15-2.90), respectively. CDDP-induced AKI was more likely to occur in patients who were male, hypertension, or diabetes mellitus. Conclusion and Relevance: This study showed that most AKI cases were related to S-1 and/or CDDP adjuvant chemotherapy for gastric cancer treatment. The data also clarified that AKIs occurred within 1 month and that their clinical outcomes were more severe than previous reports of drug-induced AKI in general medicine. Our study provides useful information to minimize the risks of administration to patients at high risk for S-1 and/or CDDP containing chemotherapy-induced AKI.