Wright T L, Combs C, Kim M, Ferrell L, Bacchetti P, Ascher N, Roberts J, Wilber J, Sheridan P, Urdea M
Department of Veterans Affairs Medical Center, San Francisco, California 94121.
Hepatology. 1994 Oct;20(4 Pt 1):773-9. doi: 10.1002/hep.1840200402.
The aims of this pilot study were to evaluate the safety and efficacy of interferon-alpha 2b for treatment of hepatitis C virus infection in liver transplant recipients, to monitor changes in hepatitis C virus RNA levels with treatment and to determine pretreatment parameters predictive of a complete response. Eighteen patients with documented hepatitis C virus viremia and histological evidence of hepatitis after liver transplantation received 3 million units of alpha interferon three times weekly for at least 4 mo. Pretreatment serum aminotransferase levels were at least 1.5 times the upper limit of normal and no patient had concomitant hepatitis B virus infection. Response to therapy was defined as normalization of both aspartate and alanine aminotransferase at the end of treatment. Five patients (28%) had a complete response, whereas 13 (72%) had persistent elevation of one or both aminotransferases (nonresponders). At the end of therapy, hepatitis C virus RNA levels were reduced in both responders and nonresponders (p = 0.043 and 0.039, respectively by Wilcoxon signed rank test). After cessation of treatment, aminotransferases remained normal in four of five responders but serum hepatitis C virus RNA levels returned to pretreatment levels in responders and nonresponders. There was no significant change in histological score with therapy. Responders were more likely than nonresponders to have low pretreatment hepatitis C virus RNA levels and low serum bilirubin (p = 0.0004 and 0.0077, respectively). Responders tended to have a prolonged interval between transplantation and initiation of therapy (p = 0.10 by rank logistic regression analysis). Side effects resulted in early cessation of therapy in two patients and dose reduction in six.(ABSTRACT TRUNCATED AT 250 WORDS)
这项初步研究的目的是评估干扰素-α 2b治疗肝移植受者丙型肝炎病毒感染的安全性和疗效，监测治疗过程中丙型肝炎病毒RNA水平的变化，并确定预测完全缓解的预处理参数。18例有丙型肝炎病毒血症记录且肝移植后有肝炎组织学证据的患者，接受300万单位的α干扰素，每周3次，至少治疗4个月。预处理时血清氨基转移酶水平至少为正常上限的1.5倍，且无患者合并乙型肝炎病毒感染。治疗反应定义为治疗结束时天冬氨酸和丙氨酸氨基转移酶均恢复正常。5例患者（28%）完全缓解，而13例（72%）一种或两种氨基转移酶持续升高（无反应者）。治疗结束时，反应者和无反应者的丙型肝炎病毒RNA水平均降低（分别经Wilcoxon符号秩检验，p = 0.043和0.039）。治疗停止后，5例反应者中有4例氨基转移酶仍保持正常，但反应者和无反应者的血清丙型肝炎病毒RNA水平均恢复到预处理水平。治疗后组织学评分无显著变化。反应者比无反应者更可能预处理时丙型肝炎病毒RNA水平低和血清胆红素低（分别为p = 0.0004和0.0077）。反应者移植与开始治疗之间的间隔往往较长（经秩逻辑回归分析，p = 0.10）。副作用导致2例患者提前停止治疗，6例患者减少剂量。（摘要截短于250字）
