Senturk Hakan, Ersoz Galip, Ozaras Resat, Kaymakoglu Sabahattin, Bozkaya Hakan, Akdogan Meral, Mert Ali, Bozdayi Mithat, Tabak Fehmi, Yenice Necati, Ozbay Gulsen
Department of Internal Medicine, Cerrahpasa Medical Faculty, Istanbul University, Istanbul, Turkey.
Dig Dis Sci. 2003 Jun;48(6):1124-9. doi: 10.1023/a:1023725014751.
We aimed to compare the efficacy of interferon-alpha2b (IFN) induction treatment in combination with ribavirin to IFN induction alone in chronic hepatitis C. In total, 125 patients (66 male, 59 female, mean age: 48 +/- 9, range: 21-70) were enrolled and randomized into two arms: In the first, patients received 5 MU/day of IFN for 4 weeks followed by 3 MU/day for the next 4 weeks. Treatment was continued with 3 MU three times a week IFN for an additional 40 weeks. Ribavirin was administered 1000-1200 mg/day according to the body weight for the entire 48-week period. In the second arm, patients received placebo in addition to IFN. Fifty-nine patients were placed in the ribavirin arm and 66 in placebo arm. All patients were genotype 1. At week 48, 24/66 (36%) from the placebo and 31/59 (52%) from the ribavirin group responded (P > 0.05). However, during the 24-week untreated follow-up period, 13/24 (54%) from the placebo, and 8/31 (26%) from the ribavirin group relapsed (P = 0.002.), resulting in a sustained virologic response (SVR) rate of 17% in the placebo and 39% in the ribavirin group (P = 0.005.) In conclusion, IFN induction treatment in combination with ribavirin is superior to IFN induction treatment alone in genotype 1 patients, and the SVR rate of 39% is encouraging.
我们旨在比较α-干扰素2b（IFN）诱导治疗联合利巴韦林与单纯IFN诱导治疗对慢性丙型肝炎的疗效。总共纳入了125例患者（66例男性，59例女性，平均年龄：48±9岁，范围：21 - 70岁），并随机分为两组：第一组患者先接受4周每天5MU的IFN治疗，随后4周每天3MU。之后继续每周3次、每次3MU的IFN治疗40周。在整个48周期间，根据体重每天给予利巴韦林1000 - 1200mg。第二组患者除接受IFN治疗外还接受安慰剂治疗。59例患者被分入利巴韦林组，66例被分入安慰剂组。所有患者均为基因1型。在第48周时，安慰剂组66例中有24例（36%）、利巴韦林组59例中有31例（52%）出现应答（P>0.05）。然而，在24周的未治疗随访期内，安慰剂组24例中有13例（54%）、利巴韦林组31例中有8例（26%）复发（P = 0.002），导致安慰剂组的持续病毒学应答（SVR）率为17%，利巴韦林组为39%（P = 0.005）。总之，对于基因1型患者，IFN诱导治疗联合利巴韦林优于单纯IFN诱导治疗，39%的SVR率令人鼓舞。
