Craxì A, Di Marco V, Lo Iacono O, Almasio P, Bruno R, Cammà C, Volpes R, Pagliaro L
Instituto di Medicina Generale e Pneumologia, University of Palermo, Italy.
J Hepatol. 1996 May;24(5):539-46. doi: 10.1016/s0168-8278(96)80138-3.
To compare the long-term effects of brief and prolonged therapy with alpha-n1 interferon for transfusion-associated chronic hepatitis C.
One hundred and sixteen subjects (male/female 48/68, mean age 46.9 years) were studied. Sixty patients were randomised to brief treatment (group 1: interferon 5 Mu/msq. t.i.w. for 2 months, then 3 Mu/msq. t.i.w. for 4 months), and 56 to prolonged treatment (group 2: interferon 5 Mu/msq. t.i.w. for 2 months, then 3 Mu/msq. t.i.w. for 10 months). All were followed for 12 months after stopping interferon.
The early response rate was 47.4% (Group 1 [45%], Group 2[50%]. No "breakthrough" reactivations were observed. The early response rate was 19% in patients with and 63% in patients without cirrhosis. Twenty-three (19.8%) subjects stopped therapy. Among 54 evaluable early responders, 21 had a sustained response. The rate of sustained response was comparable in group 1 (18.3%) and group 2 (18.2%). All sustained response subjects and some non-responders were HCV-RNA negative at the end of follow-up. Histological improvement was seen only after sustained response. Cirrhosis developed in 20% of non-responders. Overall, interferon induced a long-lasting remission of chronic hepatitis C in about one of every five patients.
In a population predominantly infected by hepatitis C virus type 1, 12 months of therapy with high doses of interferon does not confer any additional benefit on the early response or sustained response rates as compared to a 6-month course.
比较短期和长期使用α-n1干扰素治疗输血相关慢性丙型肝炎的长期疗效。
对116名受试者（男48名/女68名，平均年龄46.9岁）进行研究。60名患者被随机分配至短期治疗组（第1组：干扰素5Mu/m²，每周3次，持续2个月，然后3Mu/m²，每周3次，持续4个月），56名患者被分配至长期治疗组（第2组：干扰素5Mu/m²，每周3次，持续2个月，然后3Mu/m²，每周3次，持续10个月）。所有患者在停用干扰素后均随访12个月。
早期应答率为47.4%（第1组[45%]，第2组[50%]）。未观察到“突破”再激活情况。有肝硬化患者的早期应答率为19%，无肝硬化患者的早期应答率为63%。23名（19.8%）受试者停止治疗。在54名可评估的早期应答者中，21名获得持续应答。第1组（18.3%）和第2组（18.2%）的持续应答率相当。所有获得持续应答的受试者以及部分无应答者在随访结束时HCV-RNA均为阴性。仅在获得持续应答后可见组织学改善。20%的无应答者发展为肝硬化。总体而言，干扰素使约五分之一的慢性丙型肝炎患者获得持久缓解。
在主要感染1型丙型肝炎病毒的人群中，与6个月疗程相比，12个月的高剂量干扰素治疗在早期应答率或持续应答率方面未带来任何额外益处。
