Department of Gastroenterology, University of São Paulo School of Medicine, Av. Dr. Enéas Carvalho de Aguiar, 255 ICHC, 9th floor, Office 9159, São Paulo, SP, 05403-000, Brazil.
IMED School of Medicine, Passo Fundo, RS, Brazil.
J Gastroenterol. 2020 May;55(5):496-514. doi: 10.1007/s00535-020-01680-0. Epub 2020 Mar 17.
Nucleos(t)ide analogues (NAs) are the main drug category used in chronic hepatitis B (CHB) treatment. Despite the fact that NAs have a favourable safety profile, undesired adverse events (AEs) may occur during the treatment of CHB. Given the eminent number of patients currently receiving NAs, even a small risk of any of these toxicities can represent a major medical issue. The main objective of this review was to analyse information available on AEs associated with the use of NAs in published studies. We choose the following MesH terms for this systematic review: chronic hepatitis B, side effects and treatment. All articles published from 1 January 1990 up to 19 February 2018 in MEDLINE of PubMed, EMBASE, the Cochrane Library and LILACS databases were searched. A total of 120 articles were selected for analysis, comprising 6419 patients treated with lamivudine (LAM), 5947 with entecavir (ETV), 3566 with tenofovir disoproxil fumarate (TDF), 3096 with telbivudine (LdT), 1178 with adefovir dipivoxil (ADV) and 876 with tenofovir alafenamide (TAF). The most common AEs in all NAs assessed were abdominal pain/discomfort, nasopharyngitis/upper respiratory tract infections, fatigue, and headache. TAF displays the highest density of AEs per patient treated among NAs (1.14 AE/treated patient). In conclusion, treatment of CHB with NAs is safe, with a low incidence of AEs. Despite the general understanding TAF being safer than TDF, the number of patients treated with TAF still is too small in comparison to other NAs to consolidate an accurate safety profile. PROSPERO Registration No. CRD42018086471.
核苷（酸）类似物（NAs）是慢性乙型肝炎（CHB）治疗的主要药物类别。尽管 NAs 具有良好的安全性，但在 CHB 治疗期间仍可能发生不良事件（AE）。鉴于目前接受 NAs 治疗的患者数量众多，即使这些毒性作用的风险很小，也可能成为一个主要的医疗问题。本综述的主要目的是分析已发表研究中与 NAs 使用相关的 AE 信息。我们为这个系统综述选择了以下 MeSH 术语：慢性乙型肝炎，副作用和治疗。从 1990 年 1 月 1 日到 2018 年 2 月 19 日，我们在 PubMed 的 MEDLINE、EMBASE、Cochrane 图书馆和 LILACS 数据库中搜索了所有已发表的文章。共选择了 120 篇文章进行分析，其中包括 6419 例接受拉米夫定（LAM）治疗、5947 例接受恩替卡韦（ETV）治疗、3566 例接受替诺福韦二吡呋酯（TDF）治疗、3096 例接受替比夫定（LdT）治疗、1178 例接受阿德福韦酯（ADV）治疗和 876 例接受替诺福韦艾拉酚胺（TAF）治疗。所有评估的 NAs 中最常见的 AE 是腹痛/不适、鼻咽炎/上呼吸道感染、疲劳和头痛。在 NAs 中，TAF 每治疗 1 例患者发生 AE 的密度最高（1.14 AE/治疗患者）。总之，NAs 治疗 CHB 是安全的，AE 发生率低。尽管普遍认为 TAF 比 TDF 更安全，但与其他 NAs 相比，接受 TAF 治疗的患者数量仍然太少，无法确定其准确的安全性。PROSPERO 注册号：CRD42018086471。
