Division of Gastroenterology and Hepatology, Taichung Veterans General Hospital, Taichung, Taiwan.
Division of Nephrology, Taichung Veterans General Hospital, Taichung, Taiwan.
Aliment Pharmacol Ther. 2018 Jun;47(12):1673-1681. doi: 10.1111/apt.14682. Epub 2018 Apr 25.
Renal dysfunction remains an issue in tenofovir disoproxil fumarate (TDF) for chronic hepatitis B (CHB) patients.
To evaluate renal safety of TDF according to the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines.
We retrospectively recruited CHB patients who received either TDF or entecavir (ETV) monotherapy from January 2008 to August 2015. After excluding confounding conditions, 253 patients who received TDF were randomly matched 1:2 with 506 patients who received ETV through the propensity scores, which consisted of age, gender, cirrhosis, chronic kidney disease (CKD) and estimated glomerular filtration rate (eGFR). Renal function deterioration was defined as a drop in GFR category accompanied with a ≥25% eGFR decline. Cumulative incidences of and hazard ratios (HRs) for renal dysfunction were analysed.
The mean eGFR decline was significantly greater in the TDF group over 48 months (TDF vs ETV: 15.73 mL/min/1.73 m , 95% confidence interval [CI]: 13.76-17.70 vs 5.96 mL/min/1.73 m , 95% CI: 4.72-7.19; P < 0.001). The cumulative incidence of renal function deterioration was significantly higher in the TDF group (TDF vs ETV: 11.1%, 95% CI: 7.4-14.8 vs 1.7%, 95% CI: 1.0-2.4; P < 0.001). After adjusting for age, pre-existing CKD and diabetes, TDF was independently associated with an increased risk of renal function deterioration (HR 5.36, 95% CI: 2.16-13.35; P < 0.001). Pre-existing CKD (HR 6.71, 95% CI: 2.25-17.65), proteinuria (HR 3.39, 95% CI: 1.23-9.39), and haematuria (HR 4.25, 95% CI: 1.32-13.68) were also independent factors of renal dysfunction.
By following the KDIGO guidelines, we confirmed that TDF was associated with a higher risk of renal dysfunction as compared to ETV.
替诺福韦二吡呋酯（TDF）治疗慢性乙型肝炎（CHB）患者仍存在肾功能障碍问题。
根据肾脏病：改善全球预后（KDIGO）指南评估 TDF 的肾脏安全性。
我们回顾性招募了 2008 年 1 月至 2015 年 8 月接受 TDF 或恩替卡韦（ETV）单药治疗的 CHB 患者。排除混杂因素后，通过倾向评分将 253 例接受 TDF 治疗的患者随机匹配 1:2 与 506 例接受 ETV 治疗的患者，倾向评分包括年龄、性别、肝硬化、慢性肾脏病（CKD）和估算肾小球滤过率（eGFR）。肾功能恶化定义为 GFR 类别下降伴有≥25%的 eGFR 下降。分析肾功能障碍的累积发生率和风险比（HRs）。
在 48 个月内，TDF 组的 eGFR 下降明显更大（TDF 与 ETV：15.73 mL/min/1.73 m ，95%置信区间 [CI]：13.76-17.70 与 5.96 mL/min/1.73 m ，95% CI：4.72-7.19；P <0.001）。TDF 组肾功能恶化的累积发生率明显更高（TDF 与 ETV：11.1%，95% CI：7.4-14.8%与 1.7%，95% CI：1.0-2.4%；P <0.001）。在调整年龄、预先存在的 CKD 和糖尿病后，TDF 与肾功能恶化的风险增加独立相关（HR 5.36，95% CI：2.16-13.35；P <0.001）。预先存在的 CKD（HR 6.71，95% CI：2.25-17.65）、蛋白尿（HR 3.39，95% CI：1.23-9.39）和血尿（HR 4.25，95% CI：1.32-13.68）也是肾功能障碍的独立因素。
根据 KDIGO 指南，我们证实 TDF 与 ETV 相比，肾功能障碍的风险更高。
