胸腺肽α1与干扰素α2b联合治疗土耳其抗HBe阳性慢性乙型肝炎

Combination thymosin-alpha 1 and interferon-alpha 2b in the treatment of anti-HBe-positive chronic hepatitis B in Turkey.

作者信息

Saruc Murat, Yuceyar Hakan, Kucukmetin Nurten, Demir Mehmet Akif, Kandiloglu Ali Riza

机构信息

Department of Gastroenterology, Celal Bayar University, School of Medicine, Manisa, Turkey.

出版信息

Hepatogastroenterology. 2002 May-Jun;49(45):798-802.

PMID:12063993

Abstract

BACKGROUND/AIMS: The most prevalent type of chronic hepatitis B in Turkey is anti-HBe-positive. No consistently effective therapy is yet available for the treatment of these patients. The aim of this study was to assess the efficacy and safety of interferon-alpha and thymosin-alpha 1 combination in the treatment of naive anti-HBe-positive and HBV DNA-positive chronic hepatitis B patients.

METHODOLOGY

Twenty-one patients were enrolled in the study. All patients had documented anti-HBe-positive, HBV DNA-positive chronic active hepatitis B without evidence of cirrhosis. Patients received a 26-week combination course of 1.6 mg thymosin-alpha 1 subcutaneously twice a week and 10 MIU interferon-alpha subcutaneously three times a week, followed by interferon-alpha monotherapy at the same dose for another 26 weeks. After treatment patients were observed for a further 26 weeks. Endpoints were a normalization of alanine aminotransferase and negativity of HBV DNA at weeks 52 and 78, as well as an improvement in liver histology at week 78.

RESULTS

Eighteen (87.7%) of the 21 patients responded by losing serum HBV DNA and normalizing alanine aminotransferase values at the end of the 52-week treatment period. Sixteen (76.2%) of these patients became sustained responders, with normal alanine aminotransferase and negative HBV DNA at the end of 78 weeks. Two patients were non-responders, two relapsed and one had a breakthrough during therapy. Significant improvements in the Knodell histological activity index were observed in the responders. No adverse events other than those seen previously with interferon monotherapy were reported.

CONCLUSIONS

Combination interferon-alpha 2b and thymosin-alpha 1 treatment may provide a safe and effective therapeutic approach for the difficult-to-treat anti-HBe-positive chronic hepatitis B patients. Further controlled studies are needed to assess the full role of this treatment strategy.

摘要

背景/目的：在土耳其，最常见的慢性乙型肝炎类型是抗-HBe阳性。目前尚无针对这些患者的持续有效的治疗方法。本研究的目的是评估α干扰素和α1胸腺素联合治疗初治抗-HBe阳性且HBV DNA阳性的慢性乙型肝炎患者的疗效和安全性。

方法

21例患者纳入本研究。所有患者均有抗-HBe阳性、HBV DNA阳性的慢性活动性乙型肝炎记录，且无肝硬化证据。患者接受为期26周的联合治疗，皮下注射α1胸腺素1.6mg，每周2次，皮下注射α干扰素10MIU，每周3次，随后以相同剂量进行α干扰素单药治疗，持续26周。治疗后对患者进行为期26周的观察。观察终点为第52周和第78周时丙氨酸转氨酶正常化和HBV DNA阴性，以及第78周时肝脏组织学改善。

结果

21例患者中有18例（87.7%）在52周治疗期结束时血清HBV DNA消失且丙氨酸转氨酶值正常，即获得应答。其中16例（76.2%）患者成为持续应答者，在78周结束时丙氨酸转氨酶正常且HBV DNA阴性。2例患者无应答，2例复发，1例在治疗期间出现突破。应答者的Knodell组织学活动指数有显著改善。除了先前在干扰素单药治疗中观察到的不良事件外，未报告其他不良事件。