阿地福韦治疗HBV的肾安全性研究（9月15日HIV&HBV）

zasxz

Renal Safety of Adefovir Dipivoxil in Patients with Chronic Hepatitis B [upload=jpg]uploadImages/20049/200491615463059539.jpg[/upload] The incidence of adefovir dipivoxil/ ADV (Hepsera) nephrotoxicity (kidney toxicity) has been previously reported with the 60 and 120 mg daily dose in HIV infection. In the present study, researchers 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. 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. Conclusions Mild nephrotoxicity was demonstrated with the dose of 30 mg daily. Nephrotoxicity, as defined by an increase >/=0.5 mg/dL from baseline in serum creatinine or a serum phosphorus value of <1.5 mg/dL on two consecutive occasions, was not observed in patients treated with ADV 10 mg for a median follow-up period of approximately 64 weeks.

zasxz

The incidence of adefovir dipivoxil/ ADV (Hepsera) nephrotoxicity (kidney toxicity) has been previously reported with the 60 and 120 mg daily dose in HIV infection. 阿地福韦的肾毒性在剂量为60和120mg的HIV治疗中已有报道。 In the present study, researchers 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. 目前研究中，研究者针对10mg治疗HBV的肾毒性进行全面报道。 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. 研究采用10mg和30mg两种剂量和安慰剂进行双盲试验，目的是检验其有效性，安全性和毒性。病人必须是慢性且没有代偿的乙肝患者。 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. 结果 48周的治疗结果显示，10mg组的血清肌氨酸酐或血清磷酸没有显著变化。 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. 30mg组中，血肌氨酸酐上升0.2mg/dL，血磷酸盐下降0.1mg/dL。 Serum creatinine increase and hypophosphatemia were more frequently observed in patients receiving ADV 30 mg daily compared with ADV 10 mg and placebo. 和10mg相比，对30mg组的患者的血肌氨酸酐和血磷酸盐必须进行更频繁的观察。 There were no grade 4 proteinuria, hematuria, or glycosuria events. 没有发现有4级蛋白尿，血尿或糖尿等症状。 Conclusions Mild nephrotoxicity was demonstrated with the dose of 30 mg daily. 结论 30mg会有轻微的肾毒性。 Nephrotoxicity, as defined by an increase >/=0.5 mg/dL from baseline in serum creatinine or a serum phosphorus value of <1.5 mg/dL on two consecutive occasions, was not observed in patients treated with ADV 10 mg for a median follow-up period of approximately 64 weeks. 连续发现血肌酐上升大于等于0.5 mg/dL或血磷酸盐小于1.5 mg/dL称之为肾毒症状。10mg组在接下来的64周内没有再进行观察。 ---译者按 如有错误，请纠正。