Andreone P, Cursaro C, Gramenzi A, Zavagliz C, Rezakovic I, Altomare E, Severini R, Franzone J S, Albano O, Ideo G, Bernardi M, Gasbarrini G
Patologia Medica 1, Università di Bologna, Italy.
Hepatology. 1996 Oct;24(4):774-7. doi: 10.1002/hep.510240404.
It has recently been shown that thymosin-alpha1(T-alpha1), a synthetic polypeptide of thymic origin, is able to promote disease remission and inhibition of hepatitis B virus (HBV) replication in patients affected by hepatitis B e antigen (HBeAg)-positive chronic active hepatitis. We evaluated the efficacy and safety of T-alpha1 treatment in patients with hepatitis B e antibody (anti-HBe) and HBV-DNA-positive chronic hepatitis. Thirty-three patients were randomly assigned to receive either T-alpha1 900 microg/m2 body surface area twice weekly (17 patients) or 5 MU of interferon alfa (IFN-alpha) three times weekly (16 patients) for 6 months. At baseline, both groups were comparable concerning age, sex, liver histology, and alanine transaminase (ALT) levels. At the end of treatment, complete response (defined as ALT normalization and HBV-DNA loss) occurred in 5 of 17 (29.4%) in the T-alpha1 group and in 7 of 16 (43.8%) in the IFN-alpha group (P = not significant). After a follow-up period of 6 months, a complete response was observed in 7 of 17 (41.2%) in the T-alpha1 group and in 4 of 16 (25%) in the IFN-alpha group (P = n.s.). Compared with the results observed in a group of 15 patients never treated with IFN-alpha and followed for 12 months, the rate of complete response was significantly higher in the IFN-alpha group at the end of therapy (1 of 15 vs. 7 of 16, respectively; P < .05) and in the T-alpha1 group at the end of follow-up (1 of 15 vs. 7 of 17, respectively; P < .05). Unlike IFN-alpha, T-alpha1 was well tolerated by all patients. The only side effect, reported by some, was local discomfort at injection sites. The results of this trial suggest that T-alpha1 is able to reduce HBV replication in patients affected by anti-HBe-positive chronic hepatitis. Furthermore, compared with IFN-alpha, T-alpha1 is better tolerated and seems to induce a gradual and more sustained ALT normalization and HBV-DNA loss. In conclusion, T-alpha1 appears to be a safe and effective alternative treatment for anti-HBe-positive chronic hepatitis. The benefit of this agent in producing long-term inhibition of HBV replication must be confirmed by future trials.
最近研究表明，胸腺素α1（T-α1），一种胸腺来源的合成多肽，能够促进乙肝e抗原（HBeAg）阳性慢性活动性肝炎患者的疾病缓解并抑制乙肝病毒（HBV）复制。我们评估了T-α1治疗乙肝e抗体（抗-HBe）和HBV-DNA阳性慢性肝炎患者的疗效和安全性。33例患者被随机分为两组，一组17例，每周两次接受体表面积900μg/m2的T-α1治疗；另一组16例，每周三次接受5MU的α干扰素（IFN-α）治疗，疗程均为6个月。基线时，两组在年龄、性别、肝脏组织学及丙氨酸转氨酶（ALT）水平方面具有可比性。治疗结束时，T-α1组17例中有5例（29.4%）出现完全应答（定义为ALT正常化及HBV-DNA转阴），IFN-α组16例中有7例（43.8%）出现完全应答（P=无显著差异）。随访6个月后，T-α1组17例中有7例（41.2%）出现完全应答，IFN-α组16例中有4例（25%）出现完全应答（P=无显著差异）。与一组15例未接受IFN-α治疗且随访12个月的患者结果相比，治疗结束时IFN-α组的完全应答率显著更高（分别为15例中的1例与16例中的7例；P<0.05），随访结束时T-α1组的完全应答率也显著更高（分别为15例中的1例与17例中的7例；P<0.05）。与IFN-α不同，所有患者对T-α1耐受性良好。一些患者报告的唯一副作用是注射部位局部不适。该试验结果表明，T-α1能够降低抗-HBe阳性慢性肝炎患者的HBV复制。此外，与IFN-α相比，T-α1耐受性更好，似乎能使ALT逐渐且更持久地正常化以及使HBV-DNA转阴。总之，T-α1似乎是抗-HBe阳性慢性肝炎一种安全有效的替代治疗方法。该药物在长期抑制HBV复制方面的益处必须通过未来试验加以证实。
