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一项随机、初步试验,旨在评估替诺福韦/恩曲他滨联合阿扎那韦/利托那韦或依非韦伦治疗后初治 HIV 感染患者的血肌酐或胱抑素 C 估算肾小球滤过率。

A randomized, pilot trial to evaluate glomerular filtration rate by creatinine or cystatin C in naive HIV-infected patients after tenofovir/emtricitabine in combination with atazanavir/ritonavir or efavirenz.

机构信息

Department of Materno Infantile e Tecnologie Biomediche, Institute of Infectious and Tropical Diseases, University of Brescia, Italy.

出版信息

J Acquir Immune Defic Syndr. 2012 Jan 1;59(1):18-30. doi: 10.1097/QAI.0b013e31823a6124.

DOI:10.1097/QAI.0b013e31823a6124
PMID:21992924
Abstract

BACKGROUND

Glomerular filtration rate (GFR) estimated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation based on creatinine or cystatine C may be more accurate methods especially in patients without chronic kidney disease. There is lack of data on GFR estimated by these methods in patients on highly active antiretroviral therapy.

METHODS

Antiretroviral-naive HIV-infected patients were randomized to tenofovir/emtricitabine in association with atazanavir/ritonavir (ATV/r) or efavirenz (EFV) Patients had to have an actual creatinine clearance >50 mL/minute (24-hour urine collection) and were followed for 48 weeks.

RESULTS

Ninety-one patients (48 ATV/r, 43 EFV) were recruited. Using the CKD-EPI creatinine formula, there was a significant decrease in GFR up to week 48 in patients receiving ATV/r (4.9 mL/minute/m(2), P = 0.02) compared with a not statistically significant increment in patients prescribed EFV. Using the cystatin C-based equation, we found greater decrease in GFR in both arms, although, in the EFV arm, the decrease was not statistically significant (5.8 mL/minute/m(2), P = 0.92). At multivariable analysis, ATV/r was a significant predictor of greater decrease in estimated glomerular filtration rate (eGFR) (P = 0.0046) only with CKD-EPI creatinine.

CONCLUSIONS

ATV/r plus tenofovir caused greater GFR decreases compared with EFV. The evaluation of eGFR by cystatin C confirmed this result, but this method seemed to be more stringent, probably precluding the possibility to detect a significant difference in the pattern of eGFR evolution between the two arms over time. More studies are needed to understand the clinical relevance of these alterations and whether cystatin C is a more appropriate method for monitoring GFR in clinical practice.

摘要

背景

基于肌酐或胱抑素 C 的慢性肾脏病流行病学合作组(CKD-EPI)方程估算的肾小球滤过率(GFR)可能是更准确的方法,尤其是在无慢性肾脏病的患者中。在接受高效抗逆转录病毒治疗的患者中,这些方法估算的 GFR 数据缺乏。

方法

抗逆转录病毒初治的 HIV 感染者随机分为替诺福韦/恩曲他滨联合阿扎那韦/利托那韦(ATV/r)或依非韦伦(EFV)组。患者必须有实际的肌酐清除率>50 mL/min(24 小时尿液收集),并随访 48 周。

结果

91 例患者(48 例 ATV/r,43 例 EFV)入选。使用 CKD-EPI 肌酐公式,与接受 EFV 治疗的患者相比,接受 ATV/r 治疗的患者在第 48 周时 GFR 显著下降(4.9 mL/min/㎡,P = 0.02),但差异无统计学意义。使用基于胱抑素 C 的方程,我们发现两个治疗组的 GFR 均有较大下降,尽管在 EFV 组,下降无统计学意义(5.8 mL/min/㎡,P = 0.92)。多变量分析显示,仅在 CKD-EPI 肌酐方程中,ATV/r 是估算肾小球滤过率(eGFR)较大下降的显著预测因素(P = 0.0046)。

结论

与 EFV 相比,ATV/r 加替诺福韦导致 GFR 下降更大。胱抑素 C 评估 eGFR 证实了这一结果,但该方法似乎更为严格,可能排除了在这两个治疗组之间随着时间的推移 eGFR 演变模式发生显著差异的可能性。需要更多的研究来了解这些改变的临床意义,以及胱抑素 C 是否是监测临床实践中 GFR 的更合适方法。

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