Marcellin P, Pouteau M, Martinot-Peignoux M, Degos F, Duchatelle V, Boyer N, Lemonnier C, Degott C, Erlinger S, Benhamou J P
Service d'Hépatologie, INSERM Unité 24, Clichy, France.
Gastroenterology. 1995 Jul;109(1):156-65. doi: 10.1016/0016-5085(95)90281-3.
BACKGROUND & AIMS: In patients with chronic hepatitis C treated with interferon alfa, sustained normalization of alanine aminotransferase was observed in about 20%, and no predictive factor of response could be clearly identified. The aims of this study were to assess the efficacy of an escalating dose of interferon and to determine the predictive factors of response.
Seventy-five patients were randomly assigned to two groups. Twenty-five patients received a dosage of 3 million units of recombinant interferon alfa-2b three times weekly for 24 weeks, and 50 patients received a dose that was increased to 5 million units at 8 weeks in nonresponders and to 10 million units 8 weeks later in persistent nonresponders. Multivariate analysis was performed to determine the features associated with response.
A sustained response was observed in 17% of the patients with constant dosage and in 19% of patients with an escalating dosage. Low pretreatment serum hepatitis C virus RNA levels and hepatitis C virus genotype were found to be independent predictive factors of sustained response.
In patients with chronic hepatitis C, an escalating dosage of interferon did not improve the overall rate of response. Low pretreatment serum hepatitis C virus RNA levels and genotype other than 1b were the only predictive factors of sustained response.
在接受α干扰素治疗的慢性丙型肝炎患者中,约20%的患者丙氨酸转氨酶持续正常,且未明确发现反应的预测因素。本研究的目的是评估递增剂量干扰素的疗效并确定反应的预测因素。
75例患者被随机分为两组。25例患者每周3次接受300万单位重组α干扰素-2b治疗,共24周;50例患者在无反应者中于第8周将剂量增至500万单位,持续无反应者在8周后将剂量增至1000万单位。进行多变量分析以确定与反应相关的特征。
固定剂量组17%的患者和递增剂量组19%的患者出现持续反应。治疗前血清丙型肝炎病毒RNA水平低和丙型肝炎病毒基因型被发现是持续反应的独立预测因素。
在慢性丙型肝炎患者中,递增剂量的干扰素并未提高总体反应率。治疗前血清丙型肝炎病毒RNA水平低和非1b型基因型是持续反应的唯一预测因素。