评论性文章：在HBV-monoinfected患者核苷和核苷酸类似物的长期

StephenW

Aliment Pharmacol Ther. 2016 May 19. doi: 10.1111/apt.13659. [Epub ahead of print]
Review article: long-term safety of nucleoside and nucleotide analogues in HBV-monoinfected patients.
Lampertico P1, Chan HL2, Janssen HL3, Strasser SI4, Schindler R5, Berg T6.
Author information

    1Division of Gastroenterology and Hepatology, "A.M. and A. Migliavacca" Center for Liver Disease, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano, Milan, Italy.
    2Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong.
    3Toronto Centre for Liver Diseases, University Health Network, Toronto, ON, Canada.
    4AW Morrow Gastroenterology and Liver Centre, Royal Prince Alfred Hospital, Sydney, NSW, Australia.
    5Department of Nephrology and Intensive Care, Campus Virchow, Charité - Universitätsmedizin, Berlin, Germany.
    6Section Hepatology, Clinic for Gastroenterology and Rheumatology, University Hospital Leipzig, Leipzig, Germany.

Abstract
BACKGROUND:

Nucleos(t)ide analogues (NUCs) for chronic hepatitis B treatment achieve high rates of viral suppression and are generally well tolerated. Entecavir (ETV) and tenofovir disoproxil fumarate (TDF) are the currently preferred first-line agents. The safety of these agents in clinical practice is particularly relevant since long-term treatment is usually required.
AIM:

To summarise and critically discuss recent real-world evidence on the safety of treatment with ETV or TDF in hepatitis B virus (HBV)-monoinfected patients.
METHODS:

PubMed and conference proceedings up to 15th June 2015 were searched using the terms ((((Hepatitis_B) OR HBV) AND ((tenofovir) OR entecavir)) AND (((lactic_acidosis) OR bone) OR renal)).
RESULTS:

In selected populations included in registration studies, both ETV and TDF were well tolerated with no clinically significant renal toxicity or lactic acidosis. Growing 'real-world' clinical experience with these agents includes some reports of ETV-associated lactic acidosis and TDF-associated renal impairment; however, evidence from cohort studies appears to be conflicting. In the case of ETV-related lactic acidosis, a small number of cases have been reported, all in patients with decompensated cirrhosis. The degree of association between TDF treatment and changes in markers of renal function varies between studies: discrepancies may result from the use of different definitions and cut-offs for reporting renal toxicities, and differences in patient populations.
CONCLUSIONS:

Pre-treatment and on-treatment monitoring of eGFR and phosphorus, with prompt appropriate dose adjustment or treatment switch can minimise the impact of NUC renal toxicity. Standardisation of measures of renal impairment and identification of early molecular markers remain an unmet need.

© 2016 John Wiley & Sons Ltd.

StephenW

滋养品药理疗法。 2016年5月19日DOI：10.1111 / apt.13659。 [打印EPUB提前]
评论性文章：在HBV-monoinfected患者核苷和核苷酸类似物的长期安全性。
Lampertico P1，陈HL2，HL3扬森，斯特拉瑟SI4，迅达R5，伯格T6。
作者信息

    胃肠病学和肝病，“上午和A. Migliavacca”中心肝病基金会IRCCS钙'格兰达Ospedale马焦雷位于Policlinico，UNIVERSITA阿布鲁Studi住宅米兰，意大利米兰的1区。
    中国的香港大学，香港威尔斯亲王医院的2Prince。
    3Toronto中心肝病大学健康网络，多伦多，加拿大。
    4AW莫罗胃肠病学和肝病中心，皇家阿尔弗雷德王子医院，悉尼，新南威尔士，澳大利亚。
    Universitätsmedizin，德国柏林 - 肾脏病和重症监护，校园啸，查理特的5Department。
    6Section肝病诊所胃肠病学和风湿病，大学医院莱比锡，德国莱比锡。

抽象
背景：

核苷（酸）类似物（NUCs）用于慢性乙型肝炎治疗达到病毒抑制率较高，一般耐受性良好。恩替卡韦（ETV）和富马酸替诺福韦酯（TDF）是目前优选的一线药物。在临床实践中，这些药物的安全性是特别相关的，因为通常需要长期治疗。
目标：

为了总结和批判性讨论治疗与ETV或TDF在乙型肝炎病毒（HBV）-monoinfected病人的安全最近真实世界的证据。
方法：

考研和会议记录达2015年6月15日进行了使用条款（（（（Hepatitis_​​B）或HBV）AND（（替诺福韦）或恩替卡韦））AND（（（lactic_acidosis）或骨）或肾））搜索。
结果：

在纳入注册研究选择的人群，ETV和TDF两人都很好，没有临床显著肾毒性或乳酸性酸中毒的耐受性。不断增长的“真实世界”这些药物的临床经验，包括ETV相关的乳酸性酸中毒和TDF相关的肾功能损害的一些报告;然而，从队列研究的证据似乎是相互矛盾的。在ETV相关乳酸性酸中毒的情况下，病例少数已报道，所有患者的失代偿性肝硬化。 TDF治疗和变化之间的关联性的肾功能的标志物的程度的研究之间变化：可能会导致从使用不同的定义和切割取舍报告肾毒性，和在患者群体差异的差异。
结论：

前处理和治疗监测的eGFR和磷，以提示适当调整剂量或治疗开关可以最小NUC肾毒性的影响。肾损害和早期分子标记鉴定的标准化措施仍然是一个尚未满足的需求。

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