Scott James D, Wolfe Peter R, Bolan Robert K, Guyer Bill
Western University of Health Sciences College of Pharmacy, Pomona, California 91766, USA.
HIV Clin Trials. 2006 Mar-Apr;7(2):55-8. doi: 10.1310/2taj-qpd1-tyae-qak5.
The purpose of this study was to evaluate the short-term effects (up to 6 months) of tenofovir disoproxil fumarate (DF) use on renal function in patients being treated for HIV-1 infection.
The charts of 447 HIV-1-infected patients who received at least three months of tenofovir DF treatment were reviewed. Data collected included demographics, concurrent antiretrovirals, other concurrent medications, CD4 counts and HIV-1 viral loads, and serum creatinine values while on tenofovir DF. Data collection was truncated at 6 months.
Baseline serum creatinine (SCr) was 1.0 mg/dL, with a calculated creatinine clearance (CLCr) of 95.2 mL/min (using the Cockroft-Gault equation). There was no significant change in SCr or CLCr at 12 weeks (1.1 mg/dL and 92.7 mL/min, respectively) or 24 weeks (1.1 mg/dL and 92.9 mL/min, respectively). All three patients with grade 2 increases in SCr had other medical reasons for an increased SCr (one patient each had indinavir-associated nephrolithiasis, lactic acidosis, and pancreatitis). No patients experienced any complications from these increases in SCr.
Increases in SCr and CLCr within the first 6 months of tenofovir DF therapy were rare. Although no clinical nephrotoxicity was observed, continued observation of renal function is warranted in patients predisposed to renal impairment.
本研究旨在评估富马酸替诺福韦二吡呋酯(DF)用于治疗HIV-1感染患者时对肾功能的短期影响(最长6个月)。
回顾了447例接受至少3个月富马酸替诺福韦治疗的HIV-1感染患者的病历。收集的数据包括人口统计学信息、同时使用的抗逆转录病毒药物、其他同时使用的药物、CD4细胞计数和HIV-1病毒载量,以及服用富马酸替诺福韦期间的血清肌酐值。数据收集在6个月时截止。
基线血清肌酐(SCr)为1.0mg/dL,计算得出的肌酐清除率(CLCr)为95.2mL/分钟(使用Cockcroft-Gault公式)。在12周时(分别为1.1mg/dL和92.7mL/分钟)或24周时(分别为1.1mg/dL和92.9mL/分钟),SCr或CLCr无显著变化。所有3例SCr升高2级的患者均有其他导致SCr升高的医学原因(1例患者分别患有茚地那韦相关肾结石、乳酸性酸中毒和胰腺炎)。没有患者因这些SCr升高而出现任何并发症。
在富马酸替诺福韦治疗的前6个月内,SCr和CLCr升高很少见。虽然未观察到临床肾毒性,但对于有肾功能损害倾向的患者,仍有必要持续观察肾功能。