两种剂量重组干扰素-α2a治疗慢性丙型肝炎随机对照研究

Two doses of recombinant interferon alpha 2 a in treating chronic hepatitis C: a randomized comparative study

目的比较两种剂量的重组干扰素－α２ａ（ｒＩＦＮ－α２ａ）对慢性丙型肝炎的疗效。方法６８例经血清学和肝组织学证实的慢性丙型肝炎病人，随机分成两组，其中６３例完成全疗程，５例中途退出。Ａ组３０例，用ｒＩＦＮ－α２ａ注射，６００万单位每周３次，１２周，继之为３００万单位每周３次，１２周。Ｂ组３３例，ＩＦＮ－α２ａ３００万单位每周３次，共２４周。结果治疗结束时，Ａ组的ＡＬＴ复常率为６０．０％，丙型肝炎病毒（ＨＣＶ）ＲＮＡ的阴转率为５３．３％。Ｂ组的ＡＬＴ复常率和ＨＣＶＲＮＡ阴转率分别为７２．７％和６１．３％。停药６个月后，Ａ组的ＡＬＴ复常率和ＨＣＶＲＮＡ阴转率分别为５６．７％和６３．３％；Ｂ组分别为６９．７％和５４．８％。６例病人在治疗过程中出现干扰素中和抗体，４例显效，２例无效。ｒＩＦＮ－α２ａ的不良反应与文献报告相同，但绝大多数病人能耐受。本组中，１例因疗程中病情加重，１例白细胞明显降低，１例持续发热而中止治疗。结论两种剂量的疗效差异无显著性（Ｐ＞０．０５）。ＨＣＶ基因型和疗效关系不大，肝组织学病变较轻者疗效较好。

Objective To compare the efficacy of a dose of 3MU of recombinant interferon alpha 2a (rIFN α2a) three times a week for 6 months with a starting dose of 6MU three times a week for 3 months and subsequent reduction to 3MU three times a week for another 3 months. Methods Sixty eight serologically and histologically proven chronic hepatitis C patients with elevated serum ALT were randomized into two groups. 63 patients completed the full course of treatment. 5 patients were withdrawn from the trial, 2 due to personal reasons and 3 due to aggravation of the disease or leucopenia during treatment. 30 patients received 6MU rIFN α2a three times a week for 3 months followed by 3MU three times a week for another 3 months (group A). 33 patients received 3MU rIFN α2a three times a week for 6 months (group B). The sex, age, serum bilirubin, ALT and AST levels were well matched in the two groups. Results At the end of 6th month the complete and partial response rates in group A were 60.0% and 16.7% respectively, the clearance of serum hepatitis C virus (HCV) RNA was 53 3%. In group B, the complete and partial response rates were 72.7% and 3 0%, and the clearance of HCV RNA was 61.3%. These patients were followed up 6 months after stopping treatment. In group A, the rates of complete normalization of ALT and clearance of serum HCV RNA were 56.7% and 63 3% respectively. In group B, the rates of normalization of ALT and clearance of HCV RNA were 69 7% and 54.8%. Six patients developed neutralization antibodies to rIFN α2a during treatment, four of them responded to the treatment. Adverse drug reactions (ADR) were common but most of them were tolerable. The incidence of ADR were similar in both groups. Conclusion The efficacy between the two dosage groups showed no statistical significance. The response rate of treatment were similar in patients with HCV genotype 1b and 2a.