Pastore G, Santantonio T, Milella M, Monno L, Mariano N, Moschetta R, Pollice L
Institute of Infectious Diseases, University of Bari, Italy.
J Hepatol. 1992 Mar;14(2-3):221-5. doi: 10.1016/0168-8278(92)90161-h.
Eighteen heterosexual HBsAg carriers with anti-HBe- and HBV-DNA-positive chronic hepatitis B (CHB) were randomly assigned to receive human lymphoblastoid interferon (ly-IFN) at a dose of 5 MU/m2 i.m. three times a week for 6 months (ten cases) or no treatment (eight cases). All patients were followed for 24 months after IFN discontinuation and received a second liver biopsy. During the 6 months of treatment all patients had a progressive reduction of serum HBV-DNA levels, and at the end of therapy nine out of ten were HBV-DNA-negative and had normal ALT values. None of the untreated patients became persistently HBV-DNA-negative or showed significant variations of ALT levels. During the post-treatment follow-up, from 1 to 17 months after ly-IFN discontinuation, eight of the nine responders (89%) had recurrent or persistent reappearance of HBV-DNA in the serum and reactivation of the liver disease activity, with an ALT peak in four of them. On the post-trial liver biopsy seven of the eight relapsed patients showed persistence of HBcAg reactivity with no significant difference in the percentage of positive cells with respect to the pre-treatment liver specimen. Histological features improved in four treated patients, worsened in one untreated case and were unchanged in the remaining patients. These results indicate that ly-IFN shows a transient antiviral effect in the therapy of anti-HBe- and HBV-DNA-positive CHB. The 6-month treatment regimen employed in this study seems insufficient for eradicating the replicating virus from the liver cells in the majority of patients and consequently does not appear to prevent HBV reactivation after IFN discontinuation.
18名抗-HBe和HBV-DNA阳性的慢性乙型肝炎（CHB）异性恋HBsAg携带者被随机分配，10例接受剂量为5 MU/m²的人淋巴母细胞干扰素（ly-IFN），每周肌肉注射3次，共6个月；8例不接受治疗。所有患者在停用干扰素后随访24个月，并接受第二次肝活检。在6个月的治疗期间，所有患者血清HBV-DNA水平逐渐降低，治疗结束时，10例中有9例HBV-DNA阴性且ALT值正常。未治疗的患者中没有一例持续HBV-DNA阴性或ALT水平有显著变化。在治疗后的随访中，即停用ly-IFN后的1至17个月，9例有反应者中的8例（89%）血清中HBV-DNA复发或持续再现，肝病活动重新激活，其中4例ALT达到峰值。在试验后的肝活检中，8例复发患者中有7例显示HBcAg反应持续存在，阳性细胞百分比与治疗前肝标本相比无显著差异。4例接受治疗的患者组织学特征改善，1例未治疗患者组织学特征恶化，其余患者组织学特征未改变。这些结果表明，ly-IFN在抗-HBe和HBV-DNA阳性CHB的治疗中显示出短暂的抗病毒作用。本研究采用的6个月治疗方案似乎不足以从大多数患者的肝细胞中清除复制病毒，因此似乎无法预防停用干扰素后HBV的重新激活。
