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替诺福韦和恩替卡韦的一线单药治疗在乙肝治疗中具有相当的疗效。

First-line monotherapies of tenofovir and entecavir have comparable efficacies in hepatitis B treatment.

作者信息

Ozaras Resat, Mete Bilgul, Ceylan Bahadir, Ozgunes Nail, Gunduz Alper, Karaosmanoglu Hayat, Cagatay Atahan, Gokturk Kadir, Erdem Levent, Kocak Funda, Senates Ebubekir, Tabak Fehmi

机构信息

aDepartment of Infectious Diseases, Cerrahpasa Medical School bDepartment of Infectious Diseases, Istanbul Medical School, Istanbul University cDepartment of Infectious Diseases, Bezmialem Vakif University dDepartment of Infectious Diseases, Medeniyet University eInfectious Diseases Unit, Sisli Etfal Research and Education Hospital fInfectious Diseases Unit, Haseki Research and Education Hospital gInfectious Diseases Unit, Buyukcekmece Research and Education Hospital hDepartment of Infectious Diseases, Bilim University iInfectious Diseases Unit, Basaksehir State Hospital jInfectious Diseases Unit, Haydarpasa Research and Education Hospital, Istanbul, Turkey.

出版信息

Eur J Gastroenterol Hepatol. 2014 Jul;26(7):774-80. doi: 10.1097/MEG.0000000000000099.

Abstract

BACKGROUND

Hepatitis B virus (HBV) infection is a health problem worldwide. Current treatment options for chronic hepatitis B (CHB) are nucleoside or nucleotide analogues and pegylated interferons. Tenofovir and entecavir are much more commonly used as they have better efficacy, tolerability, and high genetic barriers to resistance.

AIM

The aim of this study was to assess the efficacies of tenofovir and entecavir in previously untreated CHB patients in a treatment cohort.

PATIENTS AND METHODS

We included CHB patients in a cohort including previously untreated HBeAg-positive and HBeAg-negative patients from 10 centers in Istanbul, Turkey. The patients were compared in terms of baseline characteristics, decrease in alanine transaminase (ALT), decrease in HBV-DNA to undetectable levels, HBeAg loss and anti-HBe development (among baseline HBeAg-positive patients), interventions to therapy because of lack of efficacy, side effects, severe side effects, and side effects that required change in treatment.

RESULTS

The study included 121 patients who were administered tenofovir and 130 patients who were administered entecavir. The majority of patients were men, with mild to moderate histology in both treatment groups. The mean duration of follow-up was 18 and 20 months for tenofovir and entecavir, respectively. Patients receiving both drugs showed comparable rates of HBeAg loss, rates of undetectable HBV-DNA levels, rates of ALT normalization, ALT decrease, and decrease in HBV-DNA. Both drugs were well tolerated.

CONCLUSION

This study shows that although the baseline characteristics did not match, tenofovir and entecavir sustained comparable virological efficacies. More patients discontinued entecavir during follow-up. Both drugs provided effective viral control, with few side effects.

摘要

背景

乙型肝炎病毒(HBV)感染是一个全球性的健康问题。目前慢性乙型肝炎(CHB)的治疗选择是核苷或核苷酸类似物以及聚乙二醇化干扰素。替诺福韦和恩替卡韦因其疗效更好、耐受性佳以及对耐药性具有较高的基因屏障而更为常用。

目的

本研究的目的是评估替诺福韦和恩替卡韦在一个治疗队列中既往未接受治疗的CHB患者中的疗效。

患者与方法

我们纳入了一个队列中的CHB患者,这些患者来自土耳其伊斯坦布尔10个中心,包括既往未接受治疗的HBeAg阳性和HBeAg阴性患者。对患者的基线特征、丙氨酸转氨酶(ALT)下降情况、HBV-DNA降至不可检测水平、HBeAg消失和抗-HBe产生(基线HBeAg阳性患者中)、因疗效不佳、副作用、严重副作用以及需要改变治疗的副作用而进行的治疗干预等方面进行比较。

结果

该研究纳入了121例接受替诺福韦治疗的患者和130例接受恩替卡韦治疗的患者。大多数患者为男性,两个治疗组的组织学表现均为轻度至中度。替诺福韦和恩替卡韦的平均随访时间分别为18个月和20个月。接受两种药物治疗的患者在HBeAg消失率、HBV-DNA不可检测水平率、ALT正常化率、ALT下降以及HBV-DNA下降方面表现相当。两种药物耐受性均良好。

结论

本研究表明,尽管基线特征不匹配,但替诺福韦和恩替卡韦的病毒学疗效相当。随访期间更多患者停用了恩替卡韦。两种药物均能有效控制病毒,副作用较少。

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