对干扰素治疗无反应的慢性丙型肝炎患者使用高剂量α干扰素联合或不联合利巴韦林治疗：一项前瞻性随机试验的最终结果。奥地利肝炎研究小组

Treatment of patients with chronic hepatitis C not responding to interferon with high-dose interferon alpha with or without ribavirin: final results of a prospective randomized trial. Austrian Hepatitis Study Group.

作者信息

Ferenci P, Stauber R, Steindl-Munda P, Gschwantler M, Fickert P, Datz C, Müller C, Hackl F, Rainer W, Watkins-Riedel T, Lin W, Krejs G J, Gangl A

机构信息

Department of Internal Medicine IV, University of Vienna, Austria.

出版信息

Eur J Gastroenterol Hepatol. 2001 Jun;13(6):699-705. doi: 10.1097/00042737-200106000-00014.

DOI:10.1097/00042737-200106000-00014

PMID:11434597

Abstract

OBJECTIVE

To investigate the efficacy of high-dose interferon alpha (IFN-alpha) with or without ribavirin in interferon (IFN) non-responders.

STUDY DESIGN

304 chronic hepatitis C patients received 5 MU IFN-alpha2b (IntronA, Schering-Plough, Kenilworth, NJ, USA) three times a week for 3 months. Non-responders were randomized either to continue with IFN (IFN 5 MU/TIW followed by 10 MU/TIW, each for 3 months) alone (group A: n = 76, m: f = 54: 22, age 45.7 +/- 12 years, 16% cirrhosis, alanine aminotransferase [ALT] 66 +/- 35 U/l) or in combination with ribavirin (approximately 14 mg/kg/day) (group B: n = 81, m: f = 57: 24, age 48.2 +/- 12 years, 17% cirrhosis, ALT 71 +/- 40 U/l). At the end of treatment, patients were followed for 6 months.

MAIN OUTCOME MEASURES

Virological response at end of treatment and 6 months thereafter.

SETTING

University hospitals and tertiary referral centres.

RESULTS

At the end of treatment, eight (10.8%) and 25 (31.3%, P= 0.0066) patients were HCV-RNA negative, and 51 and 39 were HCV-RNA positive, in groups A and B, respectively. There were 17 drop-outs in each group. Six months after treatment, only one patient in group A (1.3%) and seven patients (8.6%, P= 0.06) in group B had normal ALT and undetectable serum HCV-RNA.

CONCLUSIONS

A combination of high-dose IFN with ribavirin induces a short-lasting complete response in about one-third of IFN-non-responders.

摘要

目的

研究大剂量α干扰素（IFN-α）联合或不联合利巴韦林治疗对干扰素（IFN）无应答者的疗效。

研究设计

304例慢性丙型肝炎患者接受5MU IFN-α2b（美国新泽西州肯尼尔沃思先灵葆雅公司的IntronA），每周3次，共3个月。无应答者被随机分为两组，一组继续单独使用IFN（IFN 5MU/周，随后10MU/周，各治疗3个月）（A组：n = 76，男:女 = 54:22，年龄45.7±12岁，16%为肝硬化，丙氨酸转氨酶[ALT] 66±35U/L），另一组联合利巴韦林（约14mg/kg/天）（B组：n = 81，男:女 = 57:24，年龄48.2±12岁，17%为肝硬化，ALT 71±40U/L）。治疗结束后，对患者随访6个月。

主要观察指标

治疗结束时及之后6个月的病毒学应答。

研究地点

大学医院和三级转诊中心。

结果

治疗结束时，A组和B组分别有8例（10.8%）和25例（31.3%，P = 0.0066）患者HCV-RNA阴性，51例和39例患者HCV-RNA阳性。每组各有17例退出研究。治疗6个月后，A组仅1例患者（1.3%），B组7例患者（8.6%，P = 0.06）ALT正常且血清HCV-RNA检测不到。