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接受替诺福韦或恩替卡韦治疗的慢性乙型肝炎患者发生肾脏事件的风险相似。

Similar risk of renal events among patients treated with tenofovir or entecavir for chronic hepatitis B.

机构信息

University of California at San Diego, 200 W. Arbor Drive, San Diego, CA 92103, USA.

出版信息

Clin Gastroenterol Hepatol. 2012 Aug;10(8):941-6; quiz e68. doi: 10.1016/j.cgh.2012.04.008. Epub 2012 Apr 13.

DOI:10.1016/j.cgh.2012.04.008
PMID:22507876
Abstract

BACKGROUND & AIMS: Tenofovir is a nucleotide reverse-transcriptase inhibitor approved for treatment of human immunodeficiency virus infection, as well as chronic hepatitis B (CHB). We evaluated nephrotoxicity among patients with CHB treated with tenofovir.

METHODS

We performed a community-based, retrospective cohort study of 80 patients with CHB who received tenofovir, alone or in a combination regimen; they were matched for age and sex with 80 CHB patients who received only entecavir. Incidences of serum creatinine (SCr) increase ≥0.2 mg/dL and new SCr levels of 1.5, 2.0, or 2.5 mg/dL were assessed. Patients with an estimated glomerular filtration rate (eGFR) <60 mL/min, calculated using the Modification of Diet in Renal Disease or Cockcroft-Gault formula, or who had ≥20% decrease in eGFR were also recorded.

RESULTS

More patients given entecavir had increases in SCr ≥2.5 mg/dL (1 vs 6; P = .053), whereas more patients given tenofovir had a new Cockcroft-Gault eGFR of <60 mL/min (15 vs 6; P = .022) and at least 1 dose adjustment (13 vs 4; P = .021). By multivariate analysis, the only significant factors associated with an increase in SCr were a history of organ transplantation (adjusted odds ratio, 6.740; 95% confidence interval, 1.799-28.250; P = .005) and pre-existing renal insufficiency (adjusted odds ratio, 10.960; 95% confidence interval, 2.419-48.850; P = .002). No factors, including therapy assignment, were associated with a new eGFR <60 mL/min.

CONCLUSIONS

Markers of renal function indicated that patients who received tenofovir were no more likely to have changes in renal function than patients treated with entecavir. History of transplant and pre-existing renal insufficiency were the only factors independently associated with increases in SCr.

摘要

背景与目的

替诺福韦是一种核苷酸逆转录酶抑制剂,已被批准用于治疗人类免疫缺陷病毒感染和慢性乙型肝炎(CHB)。我们评估了接受替诺福韦治疗的 CHB 患者的肾毒性。

方法

我们进行了一项基于社区的回顾性队列研究,共纳入 80 例接受替诺福韦单药或联合治疗的 CHB 患者,并按年龄和性别与 80 例仅接受恩替卡韦治疗的 CHB 患者进行匹配。评估血清肌酐(SCr)升高≥0.2mg/dL 和新的 SCr 水平 1.5、2.0 或 2.5mg/dL 的发生率。还记录了估算肾小球滤过率(eGFR)<60mL/min 的患者(使用肾脏病饮食改良公式或 Cockcroft-Gault 公式计算)或 eGFR 下降≥20%的患者。

结果

更多接受恩替卡韦治疗的患者出现 SCr 升高≥2.5mg/dL(1 例比 6 例;P=0.053),而更多接受替诺福韦治疗的患者新的 Cockcroft-Gault eGFR<60mL/min(15 例比 6 例;P=0.022)和至少 1 次剂量调整(13 例比 4 例;P=0.021)。多变量分析显示,与 SCr 升高相关的唯一显著因素是器官移植史(调整后的优势比,6.740;95%置信区间,1.799-28.250;P=0.005)和预先存在的肾功能不全(调整后的优势比,10.960;95%置信区间,2.419-48.850;P=0.002)。包括治疗分配在内的任何因素均与新的 eGFR<60mL/min 无关。

结论

肾功能标志物表明,接受替诺福韦治疗的患者肾功能变化的可能性并不高于接受恩替卡韦治疗的患者。移植史和预先存在的肾功能不全是与 SCr 升高相关的唯一独立因素。

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