Division of Hepato-Gastroenterology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, No. 123, Dapi Rd., Niaosong Dist, Kaohsiung City, 83301, Taiwan.
Department of Health Care Management, College of Management; and Healthy Aging Research Center, Chang Gung University, Taoyuan, Taiwan.
Hepatol Int. 2021 Apr;15(2):310-317. doi: 10.1007/s12072-021-10148-z. Epub 2021 Apr 27.
Tenofovir disoproxil fumarate (TDF) and Entecavir (ETV) are commonly used for patients with chronic hepatitis B (CHB), and renal or bone toxicity are possible concerns. This study is to evaluate the renal and bone effect of TDF compared with ETV in CHB patients.
This is a retrospective study at Kaohsiung Chung-Gung memorial hospital, Taiwan, from June 2013 to December 2018. Patients with CHB were prescribed with TDF or ETV for 3 years or above. Renal function was assessed at 12-week intervals. Dual-energy X-ray absorptiometry scans of the spine and femurs were performed at 48-week intervals. The propensity score analysis was conducted to balance the baseline characteristics of patients in both treatment groups.
A total of 258 patients were included in this study: TDF (n = 135) and ETV (n = 123). The prevalence of osteopenia was much higher in the TDF group at week 48 and week 96. The TDF group showed significant mean percentage decrease from baseline in bone mineral density throughout the treatment course. Logistic regression analysis adjusted for the propensity score demonstrated that the use of TDF was the only predictive factor of significant bone density loss at week 144. The mean percentage decline of estimated glomerular filtration rate was significant in the TDF group at all time points. Renal threshold phosphate concentration was similar among both treatment groups.
This study suggested CHB patients treated with TDF may experience increased risks of bone loss and renal deficits compared to those treated with ETV.
富马酸替诺福韦二吡呋酯（TDF）和恩替卡韦（ETV）常用于治疗慢性乙型肝炎（CHB）患者，可能存在肾毒性和骨毒性等问题。本研究旨在评估 TDF 相较于 ETV 对 CHB 患者的肾和骨效应。
这是一项回顾性研究，于 2013 年 6 月至 2018 年 12 月在台湾高雄荣民总医院进行。CHB 患者接受 TDF 或 ETV 治疗 3 年以上。每 12 周评估一次肾功能，每 48 周进行一次脊柱和股骨的双能 X 线吸收法骨密度扫描。采用倾向性评分分析平衡两组患者的基线特征。
本研究共纳入 258 例患者：TDF 组（n=135）和 ETV 组（n=123）。在第 48 周和第 96 周，TDF 组的骨质疏松症患病率明显更高。TDF 组在整个治疗过程中，骨密度的平均百分比从基线开始显著下降。经倾向性评分调整的逻辑回归分析表明，使用 TDF 是第 144 周时骨密度显著下降的唯一预测因素。在所有时间点，TDF 组的估算肾小球滤过率的平均百分比下降均有统计学意义。两组的肾磷阈浓度相似。
本研究表明，与接受 ETV 治疗的患者相比，接受 TDF 治疗的 CHB 患者发生骨丢失和肾损伤的风险可能增加。
