Institute of Digestive Disease, The Chinese University of Hong Kong, Hong Kong SAR, China.
Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong SAR, China.
Aliment Pharmacol Ther. 2018 Nov;48(9):984-992. doi: 10.1111/apt.14945. Epub 2018 Aug 20.
In clinical trials involving patients with preserved renal function, tenofovir disoproxil fumarate (TDF) use was associated with mild renal impairment in 1% of patients.
To compare serial renal function of entecavir (ETV)-treated, TDF-treated, and untreated patients with chronic hepatitis B.
We studied the risk of chronic kidney disease (CKD) progression in a territory-wide cohort of patients with chronic hepatitis B without treatment and of those on ETV or TDF treatment. Estimated glomerular filtration rate (eGFR) was determined by the CKD Epidemiology Collaboration equation and was classified into five CKD stages. CKD progression, defined as an increase of at least one CKD stage, was compared among treated and untreated patients.
After propensity score matching, 2254 ETV-treated, 2254 TDF-treated, and 2254 untreated patients were included in the analysis. Their mean baseline eGFR was 90.3 ± 19.6, 91.3 ± 20.6, and 92.2 ± 20.0 mL/min/1.73 m , respectively. During a mean follow-up of 2.4 ± 1.5 years, 639 ETV-treated, 706 TDF-treated, and 564 untreated patients exhibited CKD progression ≥1 stage. The 5-year cumulative incidence (95% confidence interval) of CKD progression was 43% (40%-46%) in ETV-treated, 48% (45%-51%) in TDF-treated, and 43% (39%-47%) in untreated patients (reference group), respectively (P = 0.267 and <0.001, respectively). The number of patients who exhibited CKD progression ≥2 stages was 92 (4.1%) in the untreated cohort, 95 (4.2%) in the ETV-treated cohort, and 51 (2.3%) in the TDF-treated cohort.
The use of TDF was associated with mild renal impairment in a minority of patients; those treated with ETV had a similar risk compared to untreated patients.
在涉及肾功能正常的患者的临床试验中，替诺福韦酯富马酸（TDF）的使用导致 1%的患者出现轻度肾功能损害。
比较恩替卡韦（ETV）治疗、TDF 治疗和未治疗的慢性乙型肝炎患者的连续肾功能。
我们研究了未治疗的慢性乙型肝炎患者以及接受 ETV 或 TDF 治疗的患者中慢性肾脏病（CKD）进展的风险。通过 CKD 协作组方程确定肾小球滤过率估计值（eGFR），并将其分为五个 CKD 阶段。比较治疗和未治疗患者之间的 CKD 进展情况，定义为至少增加一个 CKD 阶段。
经过倾向评分匹配后，纳入了 2254 例 ETV 治疗、2254 例 TDF 治疗和 2254 例未治疗的患者进行分析。他们的平均基线 eGFR 分别为 90.3±19.6、91.3±20.6 和 92.2±20.0 mL/min/1.73m。在平均 2.4±1.5 年的随访期间，639 例 ETV 治疗、706 例 TDF 治疗和 564 例未治疗的患者出现 CKD 进展≥1 期。CKD 进展的 5 年累积发生率（95%置信区间）分别为 ETV 治疗组 43%（40%-46%）、TDF 治疗组 48%（45%-51%）和未治疗组 43%（39%-47%）（参考组）（P=0.267 和 <0.001）。未治疗组有 92 例（4.1%）、ETV 治疗组有 95 例（4.2%）和 TDF 治疗组有 51 例（2.3%）患者出现 CKD 进展≥2 期。
TDF 的使用导致少数患者出现轻度肾功能损害；与未治疗的患者相比，接受 ETV 治疗的患者风险相似。
