Andreone P, Gramenzi A, Cursaro C, Felline F, Loggi E, D'Errico A, Spinosa M, Lorenzini S, Biselli M, Bernardi M
Semeiotica Medica, Dipartimento di Medicina Interna, Cardioangiologia ed Epatologia, Università di Bologna Istituto Oncologico, Italy.
J Viral Hepat. 2004 Jan;11(1):69-73. doi: 10.1046/j.1365-2893.2003.00470.x.
In this pilot study, we evaluated the efficacy of interferon-alpha (IFN) plus Thymosin-alpha 1 (TA1) to that of IFN alone in naive patients with chronic hepatitis C. Twenty-two patients were randomized to receive interferon-alpha 2b (3 million units three times a week) plus thymosin-alpha l (900 microg/m2 body surface area) and 19 received interferon-alpha 2b alone at the same dose. Patients were treated for 6 months and followed up for another 6 months. Biochemical (alanine aminotransferase values) and virological (hepatitis C virus-RNA) responses to treatment were determined. Combination treatment showed significantly higher efficacy than monotherapy in achieving virological end-of-treatment response (P = 0.03). At 6-month follow up, the sustained biochemical and virological response was not different between the two groups. Our results indicate that the immune modulator TA1 may enhance the end-of-treatment response in naive patients with chronic hepatitis C. Higher doses and/ore more prolonged courses as well as the association with new interferon formulation such as pegylated interferons could improve the sustained response rates to this treatment.
在这项初步研究中，我们评估了α干扰素（IFN）联合胸腺肽α1（TA1）与单独使用IFN对初治慢性丙型肝炎患者的疗效。22例患者被随机分配接受α干扰素2b（300万单位，每周3次）加胸腺肽α1（900μg/m²体表面积），19例患者接受相同剂量的单独α干扰素2b治疗。患者接受6个月治疗，并随访6个月。测定治疗的生化（丙氨酸转氨酶值）和病毒学（丙型肝炎病毒RNA）反应。联合治疗在实现治疗结束时病毒学反应方面显示出比单一疗法显著更高的疗效（P = 0.03）。在6个月随访时，两组之间的持续生化和病毒学反应无差异。我们的结果表明，免疫调节剂TA1可能增强初治慢性丙型肝炎患者的治疗结束时反应。更高剂量和/或更长疗程以及与新的干扰素制剂如聚乙二醇化干扰素联合使用可能提高该治疗的持续反应率。
