Yao G B, Ji Y Y, Xu D Z, Gao J, Wu X H, Zhang Q B, Hu D C
Jiang An Clinical Immunology Research Centre, Shanghai, China.
Hepatogastroenterology. 1999 Mar-Apr;46(26):1059-64.
BACKGROUND/AIMS: This study is the first randomized prospective clinical trial of interferon in hepatitis to be conducted according to the guidelines of Good Clinical Practice (GCP) in China. The object of this study is to compare the long-term efficacy of a dose of 3MU of recombinant IFN alpha 2a (rIFN-alpha 2a) three times a week (t.i.w.) for 6 months with a starting dose of 6MU for 3 months and subsequent reduction to 3 MU t.i.w for a further 3 months.
Sixty-eight serological and histologically proven chronic hepatitis C patients with elevated serum ALT were randomized into two groups. A total of 63 patients were studied with full course of treatment. Five patients were withdrawn from the trial, 2 due to personal reasons and 3 due to adverse drug reactions during treatment. Thirty patients received 6MU IFN-alpha 2a t.i.w. for 3 months followed by 3MU t.i.w. for another 3 months (group A). Thirty-three patients received 3MU IFN-alpha 2a t.i.w. for 6 months (group B).
The sex, age, baseline serum bilirubin, ALT and AST levels were matched in both groups. At the end of 6 months the complete and partial response rates in group A were 60.0% and 16.7%, respectively, and the clearance of serum HCV-RNA was 53.3%. In group B, the complete and partial response rates were 72.7% and 3.0%, respectively, and the clearance of HCV-RNA was 61.3%. These patients were followed up for 6, 12, and 18 months after stopping treatment. In group A, the rates of complete normalization of ALT and clearance of serum HCV-RNA at 24 months were 50.0% and 60.0%, respectively. In group B, the rates of normalization of ALT and clearance of HCV-RNA at 24 months were 54.4% and 41.9%, respectively. The efficacy between the two groups showed no statistically significant difference; the response rates of treatment were similar to the patients with HCV genotype 1b and 2a. Six patients (10.8% of the study population) developed neutralization antibodies to IFN-alpha 2a during treatment, 4 of them responded to the treatment. Adverse drug reactions (ADR) were common, but most of them were tolerable and the incidence of ADR was similar in both groups.
IFN-alpha 2a is effective in the treatment of Chinese patients with chronic hepatitis C. The sustained response rates and ADR among two dose schedule groups are similar.
背景/目的：本研究是中国首个按照药物临床试验质量管理规范（GCP）指南进行的干扰素治疗肝炎的随机前瞻性临床试验。本研究的目的是比较每周3次、每次3MU重组干扰素α2a（rIFN-α2a）、共治疗6个月的方案与起始剂量6MU、治疗3个月、随后减至每周3次、每次3MU再治疗3个月的方案的长期疗效。
68例血清学和组织学证实的血清谷丙转氨酶（ALT）升高的慢性丙型肝炎患者被随机分为两组。共有63例患者完成了全程治疗。5例患者退出试验，2例因个人原因，3例因治疗期间出现药物不良反应。30例患者接受每周3次、每次6MU干扰素α2a治疗3个月，随后每周3次、每次3MU再治疗3个月（A组）。33例患者接受每周3次、每次3MU干扰素α2a治疗6个月（B组）。
两组患者的性别、年龄、基线血清胆红素、ALT和谷草转氨酶（AST）水平相匹配。6个月结束时，A组的完全缓解率和部分缓解率分别为60.0%和16.7%，血清丙型肝炎病毒核糖核酸（HCV-RNA）清除率为53.3%。B组的完全缓解率和部分缓解率分别为72.7%和3.0%，HCV-RNA清除率为61.3%。这些患者在停药后分别随访了6、12和18个月。A组在24个月时ALT完全恢复正常率和血清HCV-RNA清除率分别为50.0%和60.0%。B组在24个月时ALT恢复正常率和HCV-RNA清除率分别为54.4%和41.9%。两组间疗效无统计学显著差异；治疗反应率与HCV基因1b型和2a型患者相似。6例患者（占研究人群的10.8%）在治疗期间产生了针对干扰素α2a的中和抗体，其中4例对治疗有反应。药物不良反应（ADR）很常见，但大多可以耐受，两组ADR发生率相似。
干扰素α2a对中国慢性丙型肝炎患者有效。两种剂量方案组的持续反应率和ADR相似。
