聚乙二醇化干扰素α与阿德福韦联合应用对中国慢性乙型肝

StephenW

Medicine (Baltimore). 2018 Aug;97(34):e12089. doi: 10.1097/MD.0000000000012089.
Combined effect of pegylated interferon α with adefovir on renal function in Chinese patients with chronic hepatitis B.
Su Q1, Liu Y1, Li J1,2.
Author information

1
    Department of Infectious Diseases, First Affiliated Hospital of Anhui Medical University.
2
    Department of Infectious Diseases, Chaohu Affiliated Hospital of Anhui Medical University, Hefei, China.

Abstract
BACKGROUND:

Long-term safety of treatment with hepatitis B virus (HBV) polymerase inhibitors is a concern. Adefovir dipivoxil (ADV) and/or interferon alfa (IFN-α) therapies have previously been associated with impairment of renal function. Limited data are available on the safety of combination therapy with nucleos (t)ide analogues (NAs) and IFN-α. The aim of this analysis was to assess the renal function during combined therapy with pegylated interferon α-2b (PEG-IFN-α-2b) and ADV versus PEG-IFN-α-2b alone in patients with chronic hepatitis B (CHB).
METHODS:

We performed a multicenter, prospective, open-label, randomized-controlled trial of renal function data to investigate the efficacy of 48 weeks of therapy with PEG-IFN-α-2b and ADV versus PEG-IFN-α-2b alone in 102 patients with CHB in Anhui, China. Glomerular filtration rates (GFRs) were calculated by Cockcroft-Gault (CG), abbreviated Modification of Diet in Renal Disease (MDRD) study, and Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation, and were tested by repeated-measures 1-way analysis of variance within groups. A linear mixed effects model for repeated measures was also used to evaluate the association between baseline information and estimated glomerular filtration rate (eGFR) changes overtime in all enrolled patients. The model considered the baseline age, sex, HBV DNA, aminotransferase, treatment group, time, and group-by-time interaction as fixed effects and incorporated random effects for individual subjects.
RESULTS:

After 48 weeks of therapy and further 24 weeks of follow-up, the eGFR decreased both in patients given PEG-IFN-α-2b single therapy and combined therapy. Age, HBV DNA, and combined therapy were significant negative predictive factors for eGFR changes.
CONCLUSION:

The incidence of renal adverse events in both groups was low, and the combination therapy may have delayed, but reversible renal impairment.

PMID:
    30142868
DOI:
    10.1097/MD.0000000000012089

StephenW

医学（巴尔的摩）。 2018年8月; 97（34）：e12089。 doi：10.1097 / MD.0000000000012089。
聚乙二醇化干扰素α与阿德福韦联合应用对中国慢性乙型肝炎患者肾功能的影响
Su Q1，Liu Y1，Li J1,2。
作者信息

1
    安徽医科大学第一附属医院感染科。
2
    安徽医科大学附属巢湖附属医院感染科，合肥

抽象
背景：

用乙型肝炎病毒（HBV）聚合酶抑制剂治疗的长期安全性是一个问题。阿德福韦酯（ADV）和/或干扰素α（IFN-α）治疗先前已与肾功能损害相关。有关核苷（t）ide类似物（NAs）和IFN-α联合治疗安全性的数据有限。该分析的目的是评估聚乙二醇化干扰素α-2b（PEG-IFN-α-2b）和ADV与PEG-IFN-α-2b联合治疗慢性乙型肝炎（CHB）患者的肾功能。
方法：

我们进行了一项多中心，前瞻性，开放标签，随机对照的肾功能数据试验，以研究单独使用PEG-IFN-α-2b和ADV与PEG-IFN-α-2b治疗48周的疗效。 CHB在中国安徽。肾小球滤过率（GFR）由Cockcroft-Gault（CG），缩写为肾脏疾病饮食改良（MDRD）研究和慢性肾病流行病学协作（CKD-EPI）方程计算，并通过重复测量1-测试组内方差分析方法。用于重复测量的线性混合效应模型也用于评估所有登记患者中基线信息与估计的肾小球滤过率（eGFR）随时间变化之间的关联。该模型将基线年龄，性别，HBV DNA，氨基转移酶，治疗组，时间和逐组时间相互作用视为固定效应，并将个体受试者纳入随机效应。
结果：

在治疗48周和进一步24周的随访后，给予PEG-IFN-α-2b单一疗法和联合疗法的患者的eGFR均下降。年龄，HBV DNA和联合治疗是eGFR变化的重要阴性预测因素。
结论：

两组肾脏不良事件的发生率较低，联合治疗可能有延迟但可逆的肾功能损害。

结论：
    30142868
DOI：
    10.1097 / MD.0000000000012089