Pozzato G, Moretti M, Crocé L S, Sasso F, Kaneko S, Unoura M, Kobayashi K, Crovatto M, Santini G, Tiribelli C
Istituto Patologia Medica, Trieste, Italy.
J Med Virol. 1995 Apr;45(4):445-50. doi: 10.1002/jmv.1890450416.
The aim of the study was to assess the role of different viral strains of hepatitis C virus (HCV) in determining the outcome of the alpha-interferon (IFN) therapy. Fifty-seven patients (34 from Italy and 23 from Japan) with HCV-positive liver disease were enrolled in the study. The NS4 region of HCV was amplified in sera by "nested" polymerase chain reaction (PCR) using a primer pair synthesized according to the sequence of JK-1. The NS4 region was positive in 14 (41%) Italian and in 13 (56%) Japanese patients. In positive patients the sequence of the NS4 region was also obtained. Subsequently, HCV genotype was determined in all patients by PCR amplification of the core region. All patients received recombinant alpha 2a-interferon (IFN), 6 million units 3 times a week for 1 month followed by 3 million units 3 times a week for 5 months. The patients were followed for 1 year after the end of treatment. At the end of the follow-up, 17 (30%) had sustained normal levels of serum alanine aminotransferase (ALT). The outcome of treatment was not correlated with race, age, sex, histology, and pretreatment ALT level, but was significantly (P < 0.00001) associated with the presence of both the NS4-JK-1 region and HCV type II. Among the 27 NS4-positive patients, only 1 patient (3.7%) achieved a complete response, whereas the remaining 26 patients (95.3%) either were non-responders or relapsed after IFN was discontinued.(ABSTRACT TRUNCATED AT 250 WORDS)
本研究的目的是评估丙型肝炎病毒（HCV）不同毒株在决定α干扰素（IFN）治疗结果中的作用。57例HCV阳性肝病患者（34例来自意大利，23例来自日本）纳入本研究。使用根据JK - 1序列合成的引物对，通过“巢式”聚合酶链反应（PCR）在血清中扩增HCV的NS4区域。14例（41%）意大利患者和13例（56%）日本患者的NS4区域呈阳性。在阳性患者中也获得了NS4区域的序列。随后，通过核心区域的PCR扩增在所有患者中确定HCV基因型。所有患者均接受重组α2a干扰素（IFN）治疗，600万单位，每周3次，共1个月，随后300万单位，每周3次，共5个月。治疗结束后对患者随访1年。随访结束时，17例（30%）患者血清丙氨酸氨基转移酶（ALT）水平持续正常。治疗结果与种族、年龄、性别、组织学及治疗前ALT水平无关，但与NS4 - JK - 1区域和HCV II型的存在显著相关（P < 0.00001）。在27例NS4阳性患者中，仅1例（3.7%）获得完全缓解，而其余26例（95.3%）患者要么无反应，要么在停用IFN后复发。（摘要截短至250字）
