Bresci G, Parisi G, Banti S, Capzia A
Unità Operative di Gastroenterologia, Pisa, Italy.
J Viral Hepat. 1995;2(3):155-8. doi: 10.1111/j.1365-2893.1995.tb00022.x.
Non-responders to 6-months treatment with recombinant interferon (rIFN)-alpha, 3 MU thrice weekly (primary non-responders) were treated for 6 further months with the same therapy or with a double dose of rIFN-alpha or with a different type of IFN (L-IFN). 112 primary non-responders were randomly enrolled into four groups of 28 patients each over a period of 4 years and were followed up for 6 months: group A continued the same dose of rIFN-alpha, group B was treated with the same rIFN-alpha but received a double dose (6 MU thrice weekly), group C received L-IFN, 3 MU thrice weekly, and group D stopped IFN therapy and did not receive any treatment. Patients were examined at monthly intervals and response was defined as a complete normalization of alanine amino transferase (ALT). The four groups were homogeneous as to age, sex, duration of the disease, probable source of infection, histological diagnosis. ALT and gamma glutamyl transferase (gamma GT) levels. No patient discontinued therapy for side-effects. Further treatment with rIFN-alpha 3 MU thrice weekly (group A) induced normalization of ALT levels in four patients (14%); treatment with double-dosed rIFN-alpha (group B) induced normalization of liver enzymes in six cases (21%); a different type of interferon (L-IFN) (group C) achieved normalization of serum ALT in five patients (18%). None of 28 primary non-responders who did not receive any treatment (group D) showed normalization of ALT levels. None of the patients was anti-HCV negative at the end of the study and no statistically significant difference was noted between responders and non-responders to the second course of IFN therapy as to age, sex, duration of the disease. ALT and gamma GT levels at the end of the trial. Overall at the end of the study the primary non-responders with normal levels of ALT were 15/112 (13%), with a therapeutic advantage of 7%. No statistically significant difference in the response rate was found among patients who continued IFN therapy, but prolongation of rIFN-alpha treatment at double dosage seems to be the best therapeutic regimen.
对重组干扰素（rIFN）-α进行为期6个月、每周3次、每次3MU治疗无反应的患者（原发性无反应者），再接受相同治疗、双倍剂量rIFN-α或不同类型干扰素（L-IFN）治疗6个月。在4年时间里，112名原发性无反应者被随机分为4组，每组28例，并随访6个月：A组继续使用相同剂量的rIFN-α；B组使用相同的rIFN-α但接受双倍剂量（每周3次，每次6MU）；C组接受L-IFN，每周3次，每次3MU；D组停止干扰素治疗且不接受任何治疗。每月对患者进行检查，反应定义为丙氨酸氨基转移酶（ALT）完全恢复正常。四组在年龄、性别、疾病持续时间、可能的感染源、组织学诊断、ALT和γ-谷氨酰转移酶（γGT）水平方面具有同质性。没有患者因副作用而停止治疗。每周3次、每次3MU的rIFN-α进一步治疗（A组）使4例患者（14%）的ALT水平恢复正常；双倍剂量rIFN-α治疗（B组）使6例患者（21%）的肝酶恢复正常；不同类型的干扰素（L-IFN）（C组）使5例患者（18%）的血清ALT恢复正常。28例未接受任何治疗的原发性无反应者（D组）中没有一例ALT水平恢复正常。在研究结束时，没有患者抗-HCV呈阴性，在年龄、性别、疾病持续时间方面，对第二轮干扰素治疗有反应者和无反应者之间在ALT和γGT水平上没有发现统计学上的显著差异。总体而言，在研究结束时，ALT水平正常的原发性无反应者为15/112（13%），治疗有效率为7%。在继续接受干扰素治疗的患者中，反应率没有发现统计学上的显著差异，但双倍剂量延长rIFN-α治疗似乎是最佳治疗方案。
