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基于大型理赔数据库的癌症患者使用质子泵抑制剂或钾离子竞争性酸阻滞剂后发生急性肾损伤的自我对照病例系列研究。

Self-controlled Case Series Study for Acute Kidney Injury after Starting Proton Pump Inhibitors or Potassium-Competitive Acid Blocker in Patients with Cancer Using a Large Claims Database.

机构信息

Department of Hospital Pharmaceutics, School of Pharmacy, Showa University.

Department of Pharmacy, Showa University Hospital.

出版信息

Biol Pharm Bull. 2024;47(2):518-526. doi: 10.1248/bpb.b23-00676.

Abstract

To investigate the risk of acute kidney injury (AKI) in patients with cancer following the initiation of proton pump inhibitors (PPIs) and potassium-competitive acid blocker (PCAB), considering sex and anti-cancer drug use. We conducted a self-controlled case-series study using the Japan Medical Data Center claims data from 12422 patients with cancer who were prescribed PPIs or PCAB between January 2017 and December 2019. Considering the timing of PPI or PCAB, control period (days -120 to -1), risk period 1 (days 0 to +30), and risk period 2 (days +31 to +365) were defined. To assess the incidence rate ratio (IRR) and 95% confidence interval (CI) as the risk ratio, we adjusted for anti-cancer drugs to assess the risk of AKI. Additionally, we also examined sex differences to identify the risk of AKI. AKI was observed in risk period 1 [2.05 (1.12-3.72), p = 0.0192], but a slight reduction was noted in risk period 2 [0.60 (0.36-1.00), p = 0.0481]. A sex-specific increase in the risk of AKI was observed only in males during risk period 1 [2.18 (1.10-4.32), p = 0.0260], with a reduction in risk period 2 [0.48 (0.26-0.89), p = 0.0200]. We identified an increased risk of AKI in patients with cancer starting PPIs or PCAB particularly in males within 30 d after PPI or PCAB initiation, emphasizing the need for vigilant monitoring and management of AKI in this patient population.

摘要

为了研究质子泵抑制剂(PPIs)和钾竞争性酸阻滞剂(PCAB)起始后癌症患者发生急性肾损伤(AKI)的风险,我们考虑了性别和抗癌药物的使用。我们使用日本医疗数据中心 2017 年 1 月至 2019 年 12 月期间开具 PPI 或 PCAB 的 12422 例癌症患者的索赔数据进行了自身对照病例系列研究。考虑到 PPI 或 PCAB 的时间,定义了对照期(-120 至-1 天)、风险期 1(0 至+30 天)和风险期 2(+31 至+365 天)。为了评估发病率比(IRR)和 95%置信区间(CI)作为风险比,我们调整了抗癌药物以评估 AKI 的风险。此外,我们还检查了性别差异,以确定 AKI 的风险。在风险期 1 观察到 AKI [2.05(1.12-3.72),p=0.0192],但在风险期 2 观察到略有减少[0.60(0.36-1.00),p=0.0481]。仅在男性中观察到在风险期 1 时 AKI 的风险增加[2.18(1.10-4.32),p=0.0260],在风险期 2 时风险降低[0.48(0.26-0.89),p=0.0200]。我们发现,在开始使用 PPI 或 PCAB 后,特别是在开始使用 PPI 或 PCAB 后 30 天内,癌症患者发生 AKI 的风险增加,这强调了在这一患者群体中需要警惕 AKI 的监测和管理。

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