Renal safety of adefovir dipivoxil in patients with chronic hepatitis B: Two double-blind, randomized, placebo-controlled studies
Renal safety of adefovir dipivoxil in patients with chronic hepatitis B: Two double-blind, randomized, placebo-controlled studies
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DOI：
10.1111/j.1523-1755.2004.00866.x
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发表时间：
2004-09-01
影响因子：
19.6
通讯作者：
Deray, G
中科院分区：
文献类型：
--
作者：
Izzedine, H;Hulot, JS;Deray, G
背景。此前曾报道过阿德福韦酯 (ADV) 每日剂量 60 和 120 mg 对人类免疫缺陷病毒 (HIV) 的肾毒性发生率。我们报告了对目前批准的每天 10 毫克剂量的 ADV 治疗慢性乙型肝炎的肾耐受性的完整分析。方法。为了调查两种 ADV 给药方案（每日 10 毫克或每日 30 毫克）的有效性、安全性和耐受性，对未接受当前治疗且有乙型肝炎病毒 (HBV) 复制证据的慢性乙型肝炎和代偿性肝病患者进行了两项双盲、安慰剂对照研究。结果。 ADV 10 mg 组的血清肌酐或血清磷水平与第 48 周时的基线相比没有总体中位变化。在第 48 周，ADV 30 mg 组的中位血清肌酐水平略有增加 0.2 mg/dL，血清磷水平下降 0.1 mg/dL。与 ADV 10 mg 和安慰剂相比，每天接受 ADV 30 mg 治疗的患者更容易观察到血清肌酐升高和低磷血症。没有出现 4 级蛋白尿、血尿或糖尿事件。结论。每天 30 mg 的剂量显示出轻度肾毒性。肾毒性，定义为血清肌酐或血清磷值较基线增加大于或等于 0.5 mg/dL
Background. The incidence of adefovir dipivoxil (ADV) nephrotoxicity has been previously reported with the 60 and 120 mg daily dose in human immunodeficiency virus (HIV). We report a complete analysis on the renal tolerance of ADV at the currently approved dose of 10 mg daily for the treatment of chronic hepatitis B.Methods. To investigate the efficacy, safety, and the tolerability of two dosing regimens of ADV (10 mg daily or 30 mg daily), two double-blind, placebo-controlled studies were performed in patients with chronic hepatitis B and compensated liver disease who were not undergoing current treatment and who had evidence of hepatitis B virus (HBV) replication.Results. There was no overall median change from baseline at week 48 in serum creatinine or serum phosphorus levels in the ADV 10 mg group. In the ADV 30 mg group there was a slight increase of 0.2 mg/dL in median serum creatinine levels, and decrease of 0.1 mg/dL in serum phosphorus levels at week 48. Serum creatinine increase and hypophosphatemia were more frequently observed in patients receiving ADV 30 mg daily compared with ADV 10 mg and placebo. There were no grade 4 proteinuria, hematuria, or glycosuria events.Conclusion. Mild nephrotoxicity was demonstrated with the dose of 30 mg daily. Nephrotoxicity, as defined by an increase greater than or equal to0.5 mg/dL from baseline in serum creatinine or a serum phosphorus value of