替诺福韦与恩替卡韦在慢性乙型肝炎患者中的肾安全性比较

StephenW

World J Gastroenterol. 2019 Jun 21;25(23):2961-2972. doi: 10.3748/wjg.v25.i23.2961.
Comparison of renal safety of tenofovir and entecavir in patients with chronic hepatitis B: Systematic review with meta-analysis.
Lee HY1, Oh H1, Park CH2, Yeo YH3, Nguyen MH3, Jun DW4.
Author information

1
    Department of Internal Medicine, Hanyang University College of Medicine, Seoul 04763, South Korea.
2
    Department of Internal Medicine, Hanyang University Guri Hospital, Hanyang University College of Medicine, Guri 11923, South Korea.
3
    Division of Gastroenterology and Hepatology, Stanford University Medical Center, Stanford University, Stanford 94305, CA, United States.
4
    Department of Internal Medicine, Hanyang University College of Medicine, Seoul 04763, South Korea. [email protected].

Abstract
BACKGROUND:

Recently, the American Association for the Study of Liver Disease suggested no preference between tenofovir (TDF) and entecavir (ETV) regarding potential long-term risks of renal complications. Over the years, renal safety has become a critical concern in nucleos(t)ide analog-treated patients due to the long-term use of these drugs. However, existing studies do not show significant differences in renal dysfunction between these two drugs. Further, there is a paucity of studies comparing the long-term renal effects of TDF and ETV.
AIM:

To investigate the effects of TDF and ETV on renal function, we performed systematic review and meta-analysis.
METHODS:

Two investigators independently searched the Cochrane Library, MEDLINE, and Embase databases for randomized controlled trials and nonrandomized studies (NRSs) using the keywords "CHB", "Tenofovir", and "Entecavir", and additional references were obtained from the bibliographies of relevant articles published through December 2017. The quality of each study was assessed using the Newcastle-Ottawa scale and the Grading of Recommendations Assessment, Development and Evaluation criteria. The primary outcome was the change in serum creatinine level in the TDF and ETV groups at baseline, 6 mo, 12 mo and 24 mo.
RESULTS:

Nine NRSs comprising 2263 participants met the inclusion criteria. Changes in creatinine levels were higher in the TDF group than in the ETV group at 6 mo [mean difference (MD) = 0.03 mg/dL; 95%CI: 0.02-0.04; I 2 = 0%], 12 mo (MD = 0.05 mg/dL; 95%CI: 0.02-0.08; I 2 = 78%), and 24 mo (MD = 0.07 mg/dL; 95%CI: 0.01-0.13; I 2 = 93%). The change in estimated glomerular filtration rate (eGFR) was significantly higher in the TDF group than in the ETV group at 6 mo [standardized mean difference (SMD), -0.22; 95%Cl: -0.36--0.08; I 2 = 0%], 12 mo (SMD = -0.24; 95%Cl: -0.43--0.05; I 2 = 50%), and 24 mo (-0.35; 95%Cl: -0.61- -0.09; I 2 = 67%).
CONCLUSION:

TDF statistically significantly increased serum creatinine levels and decreased the eGFR in 6-24 mo compared to ETV, with moderate to low quality of evidence. However, the differences are negligible.
KEYWORDS:

Chronic; Entecavir; Hepatitis B; Meta-analysis; Review; Safety; Systematic; Tenofovir

PMID:
    31249453
PMCID:
    PMC6589741
DOI:
    10.3748/wjg.v25.i23.2961

StephenW

World J Gastroenterol。 2019年6月21日; 25（23）：2961-2972。 doi：10.3748 / wjg.v25.i23.2961。
替诺福韦与恩替卡韦在慢性乙型肝炎患者中的肾安全性比较：荟萃分析的系统评价。
Lee HY1，Oh H1，Park CH2，Yeo YH3，Nguyen MH3，Jun DW4。
作者信息

1
汉阳大学医学院内科，韩国首尔04763
2
汉阳大学医学院内科，汉阳大学医学院，韩国古里11923。
3
斯坦福大学斯坦福大学医学中心消化内科和肝脏病学科，斯坦福大学94305，CA，美国。
4
汉阳大学医学院内科，韩国首尔04763 [email protected]。

抽象
背景：

最近，美国肝病研究协会建议替诺福韦（TDF）和恩替卡韦（ETV）之间没有关于潜在的肾脏并发症长期风险的偏好。多年来，由于长期使用这些药物，肾脏安全已经成为核心（t）类似物治疗患者的关键问题。然而，现有研究未显示这两种药物之间肾功能不全的显着差异。此外，缺乏比较TDF和ETV的长期肾脏影响的研究。
目标：

为了研究TDF和ETV对肾功能的影响，我们进行了系统评价和荟萃分析。
方法：

两名研究人员使用关键词“CHB”，“替诺福韦”和“恩替卡韦”独立搜索Cochrane图书馆，MEDLINE和Embase数据库进行随机对照试验和非随机研究（NRS），并从相关文章的参考书目中获得其他参考文献。 2017年12月出版。使用纽卡斯尔 - 渥太华量表和建议评估，发展和评估标准评估每项研究的质量。主要结果是TDF和ETV组在基线，6 Mo，12 mo和24 mo时血清肌酐水平的变化。
结果：

九个NRS包括2263个参与者符合纳入标准。 TDF组肌酐水平的变化高于ETV组6个月[平均差异（MD）= 0.03 mg / dL; 95％CI：0.02-0.04; I 2 = 0％]，12个月（MD = 0.05 mg / dL; 95％CI：0.02-0.08; I 2 = 78％），和24个月（MD = 0.07 mg / dL; 95％CI：0.01-0.13 ; 2 = 93％）。 TDF组的估计肾小球滤过率（eGFR）的变化在6个月时显着高于ETV组[标准化平均差异（SMD）， -  0.22; 95％Cl：-0.36-- 0.08; I 2 = 0％]，12 mo（SMD = -0.24; 95％Cl：-0.43-0.05; I 2 = 50％），和24 mo（-0.35; 95％Cl：-0.61- -0.09; I 2 = 67％）。
结论：

与ETV相比，TDF在6-24个月时具有统计学上显着的血清肌酐水平升高和eGFR降低，具有中等至低质量的证据。但是，差异可以忽略不计。
关键词：

慢性;恩替卡韦;乙型肝炎; Meta分析;评论;安全;系统;替诺福韦

结论：
31249453
PMCID：
PMC6589741
DOI：
10.3748 / wjg.v25.i23.2961

StephenW

https://www.wjgnet.com/1007-9327/full/v25/i23/2961.htm