Moscarella S, Buzzelli G, Romanelli R G, Monti M, Giannini C, Careccia G, Marrocchi E M, Zignego A L
Istituto di Medicina Interna, Universita' di Firenze, Florence, Italy.
Liver. 1998 Oct;18(5):366-9. doi: 10.1111/j.1600-0676.1998.tb00819.x.
AIMS/BACKGROUND: This randomized study was performed to compare the efficacy of interferon-alpha (IFN-alpha) + thymosin alpha 1 (Talpha1) treatment to that of IFN-alpha alone in light of biochemical and virological response of naive patients with chronic hepatitis C.
Seventeen patients were treated with IFN alpha-2b (3 million units MU three times a week) + Talpha1 (1 mg twice weekly); the other 17 patients received only IFN alpha-2b at the same dose. All patients were treated for 6 months and followed up for 12 months. Biochemical (ALT values) and virological (HCV-RNA) responses to treatment were determined.
Combination therapy showed significantly higher efficacy than monotherapy in achieving biochemical and virologic end-of-treatment response (p<0.05). At 12 month follow-up, the sustained biochemical response was slightly greater in patients treated with combination therapy than in those treated with monotherapy. No significant difference in response by HCV-1b subtype was observed between the two treatment groups; however, HCV-2c subtype showed a trend to responding better to IFN-alpha+Talpha1 than to IFN-alpha alone.
These data suggest that the immune modulator Talpha1 may be additive or synergistic with IFN-alpha in normalizing end-treatment biochemical and virological responses in patients with chronic hepatitis C. Higher doses and/or more prolonged courses may improve the sustained response rates to this treatment.
目的/背景：本随机研究旨在根据初治慢性丙型肝炎患者的生化和病毒学反应，比较干扰素-α（IFN-α）联合胸腺肽α1（Tα1）与单用IFN-α的疗效。
17例患者接受IFNα-2b（300万单位，每周3次）联合Tα1（1mg，每周2次）治疗；另外17例患者仅接受相同剂量的IFNα-2b治疗。所有患者均接受6个月治疗，并随访12个月。测定治疗的生化（ALT值）和病毒学（HCV-RNA）反应。
联合治疗在实现治疗结束时的生化和病毒学反应方面显示出比单一疗法显著更高的疗效（p<0.05）。在12个月的随访中，联合治疗组患者的持续生化反应略高于单一治疗组。两个治疗组之间在HCV-1b亚型的反应上未观察到显著差异；然而，HCV-2c亚型显示出对IFN-α+Tα1的反应优于单用IFN-α的趋势。
这些数据表明，免疫调节剂Tα1在使慢性丙型肝炎患者治疗结束时的生化和病毒学反应正常化方面可能与IFN-α具有相加或协同作用。更高的剂量和/或更长的疗程可能会提高这种治疗的持续反应率。
