Treatment of chronic hepatitis B (HBeAg-HBV DNA-positive) with lymphoblastoid alpha interferon with or without corticosteroids: short- and long-term follow-up.

C Zavaglia, R Bottelli, G Bellati, L Asti, L Mondazzi, G Iamoni, A Zanetti, E Tanzi, E Fesce, F Gelosa, G Maggi, G Ideo
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Abstract

Efficacy and safety of therapy with lymphoblastoid interferon-alpha alone or combined with deflazacort has been investigated in 38 HBsAg-HBeAg+ patients with biopsy-proven chronic hepatitis. Group I received 5 MU/m2 interferon thrice a week for 26 weeks; group II took interferon for 26 weeks simultaneously with a 6-week course of deflazacort. Follow-up was 18-72 months (median 42). After 12 months, responses were achieved in 3 (18%) out of 17 patients on interferon alone vs 5 (26%, p > 0.05) out of 19 on combined therapy. Blind histological assessment revealed no improvement in either group or in patients who responded to therapy within the first year of follow-up ("early responders"). "Delayed" responses were observed in 4 (29%) patients who took interferon alone vs 5 (36%, p > 0.05) who took the combined therapy. Serum HBV DNA levels decreased significantly during treatment and remained low up to 24 and 36 months of follow-up in both groups. One early responder developed hepatocellular carcinoma, another had exacerbation of liver disease in long-term follow-up. No non-responders developed liver failure or hepatocellular carcinoma. These results indicate that lymphoblastoid interferon-alpha inhibits HBV replication and corticosteroids have no synergistic effect in treatment of HBsAg-HBeAg+ chronic hepatitis.

淋巴母细胞α干扰素联合或不联合皮质类固醇治疗慢性乙型肝炎(HBeAg-HBV dna阳性):短期和长期随访
在38例经活检证实的HBsAg-HBeAg阳性慢性肝炎患者中,研究了淋巴母细胞样干扰素- α单用或联合地拉法柯治疗的有效性和安全性。1组患者给予干扰素5 MU/m2,每周3次,连用26周;II组患者服用干扰素26周,同时服用地拉法柯特6周疗程。随访18-72个月,中位42个月。12个月后,单独使用干扰素治疗的17例患者中有3例(18%)获得缓解,而联合治疗的19例患者中有5例(26%,p > 0.05)获得缓解。盲法组织学评估显示,两组患者或在随访一年内对治疗有反应的患者(“早期反应者”)均无改善。单独使用干扰素的患者中有4例(29%)出现延迟反应,而联合使用干扰素的患者中有5例(36%,p > 0.05)出现延迟反应。两组患者的血清HBV DNA水平在治疗期间显著下降,并在随访24个月和36个月时保持较低水平。一名早期应答者发展为肝细胞癌,另一名在长期随访中出现肝病恶化。无应答者未发生肝功能衰竭或肝细胞癌。这些结果表明,淋巴母细胞样干扰素- α抑制HBV复制,而皮质类固醇在治疗HBsAg-HBeAg+型慢性肝炎中没有协同作用。
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