Arase Y, Chayama K, Tsubota A, Murashima N, Suzuki Y, Koida I, Kobayashi M, Saitoh S, Ikeda K, Kumada H, Kobayashi M, Suzuki H
Department of Gatroenterology, Toranomon Hospital, Tokyo, Japan.
J Gastroenterol. 1996 Aug;31(4):559-64. doi: 10.1007/BF02355057.
Intermittent interferon (IFN) therapy appears to be effective for patients with e-antigen-negative chronic hepatitis B who exhibit abnormal fluctuations of alanine aminotransferase (ALT) levels and histological evidence of disease progression. To determine the optimal dose of IFN in such patients, we studied the effects of natural IFN-beta in a prospective, randomized, double-blind, controlled trial in 36 patients with e-antigen-negative chronic hepatitis B who repeatedly demonstrated abnormal fluctuations in ALT levels. Thirty-six patients were randomly assigned to three groups, receiving doses of: 0.3 MIU IFN (group 1; n = 12), 1 MIU (group 2; n = 12), or 3 MIU (group 3; n = 12), administered twice per week for 24 weeks. Patients were regarded as responders if ALT levels remained within the normal range and HBV-DNA tested negative for 6 months after the initiation of the therapy. According to this criterion, treatment was effective in 16.7% of the patients (2/12) in group 1, 33.3% (4/12) in group 2, and 75% (9/12) in group 3, the efficacy rate in group 3 being significantly higher than that in the other two groups. However, in 12 of the 15 responders, (80%) ALT levels were frequently elevated again within 3 years of the termination of IFN therapy. Although IFN was effective in controlling the manifestations of hepatitis in terms of e-antigen-negative patients who exhibited abnormal fluctuations in ALT, it appears that continuous treatment with intermittent high-dose IFN is necessary to maintain ALT levels within the normal range.
对于e抗原阴性的慢性乙型肝炎患者，若其丙氨酸氨基转移酶（ALT）水平出现异常波动且有疾病进展的组织学证据，间歇性干扰素（IFN）治疗似乎有效。为确定此类患者的最佳IFN剂量，我们在一项前瞻性、随机、双盲、对照试验中，对36例ALT水平反复出现异常波动的e抗原阴性慢性乙型肝炎患者，研究了天然β-干扰素的疗效。36例患者被随机分为三组，分别接受以下剂量治疗：0.3MIU IFN（第1组；n = 12）、1MIU（第2组；n = 12）或3MIU（第3组；n = 12），每周给药两次，共24周。如果治疗开始后6个月ALT水平保持在正常范围内且HBV - DNA检测为阴性，则患者被视为治疗有效。根据该标准，第1组患者的治疗有效率为16.7%（2/12），第2组为33.3%（4/12），第3组为75%（9/12），第3组的有效率显著高于其他两组。然而，在15例治疗有效的患者中，有12例（80%）在IFN治疗结束后3年内ALT水平再次频繁升高。尽管对于ALT水平出现异常波动的e抗原阴性患者，IFN在控制肝炎表现方面有效，但似乎需要间歇性高剂量IFN持续治疗，才能使ALT水平维持在正常范围内。
