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用于治疗乙型肝炎的DNA聚合酶抑制剂:安全性评估

DNA polymerase inhibitors for treating hepatitis B: a safety evaluation.

作者信息

Mak Lung-Yi, Seto Wai-Kay, Lai Ching-Lung, Yuen Man-Fung

机构信息

a Division of Gastroenterology and Hepatology, Department of Medicine , Queen Mary Hospital , Hong Kong , Hong Kong.

出版信息

Expert Opin Drug Saf. 2016;15(3):383-92. doi: 10.1517/14740338.2016.1139573. Epub 2016 Feb 1.

Abstract

INTRODUCTION

Oral nucleoside/ nucleotide analogues (NAs) are currently the mainstay of treatment for patients with chronic hepatitis B virus (HBV) infection. They are generally safe to use. However, since their approval in the last decade and a half, the literature has reported adverse effects associated with the use of NA in HBV patients. A comprehensive review on the drug safety is lacking.

AREAS COVERED

Significant adverse effects associated with NA use in HBV patients including muscle toxicity, peripheral neuropathy, nephrotoxicity and lactic acidosis are discussed. The reported prevalence of each adverse effect, as well as their predictive factors, reversibility and their use in pregnancy and lactating mothers are covered in this review. Novel data regarding reno-protective effect of telbivudine are also discussed.

EXPERT OPINION

Use of NA in HBV is generally safe. Uncommon adverse effects can be minimized or detected early if clinicians exercise adequate precautions when using NA for at-risk populations with regular monitoring.

摘要

引言

口服核苷/核苷酸类似物(NAs)是目前慢性乙型肝炎病毒(HBV)感染患者治疗的主要药物。它们通常使用安全。然而,自过去十五年前获批以来,文献报道了HBV患者使用NA相关的不良反应。目前缺乏关于药物安全性的全面综述。

涵盖领域

讨论了HBV患者使用NA相关的重大不良反应,包括肌肉毒性、周围神经病变、肾毒性和乳酸性酸中毒。本综述涵盖了每种不良反应的报告患病率,以及它们的预测因素、可逆性及其在妊娠和哺乳期母亲中的使用情况。还讨论了关于替比夫定肾脏保护作用的新数据。

专家意见

HBV患者使用NA总体安全。如果临床医生在为高危人群使用NA时采取充分预防措施并定期监测,罕见的不良反应可以最小化或早期发现。

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