Chayama K, Tsubota A, Kobayashi M, Hashimoto M, Miyano Y, Koike H, Kobayashi M, Koida I, Arase Y, Saitoh S, Murashima N, Ikeda K, Kumada H
Department of Gastroenterology, Toranomon Hospital, Okinaka Memorial Institute for Medical Research, Tokyo, Japan.
Hepatology. 1996 May;23(5):953-7. doi: 10.1053/jhep.1996.v23.pm0008621174.
Interferon treatment reduces the serum level of hepatitis C virus (HCV) and improves inflammatory activity, but relapse is frequently observed. In an attempt to develop a new therapeutic strategy that may reduce relapse and cure the disease, we evaluated the effect of corticosteroid priming on lymphoblastoid interferon alfa in an open randomized clinical trial. The level of HCV RNA increased significantly during corticosteroid priming (from 5.60 [median] to 21.0 x 10(5) Eq/mL; P = .0004) but decreased to the pretreatment level 4 weeks after cessation of corticosteroid (7.0 x 10(5) Eq/mL; P = .07). Sustained normalization of alanine transaminase (ALT) level and virus clearance, confirmed by negative results for HCV RNA using reverse-transcription nested polymerase chain reaction (PCR), were observed over a period of 6 months in 8 of 19 (42.1%) corticosteroid-primed patients, compared with 6 of 19 patients (31.6%) treated with interferon only. A "rebound" of ALT after the withdrawal of corticosteroid was observed in only 2 of 19 patients primed with corticosteroid, but both showed sustained responses. Multivariate analysis for factors predictive of the sustained response indicated that HCV titers measured immediately before interferon therapy and HCV genotype were statistically significant (P = .006 and P = .025, respectively). Our results indicated that corticosteroid priming has a marginal benefit over treatment with interferon alone and that large-scale clinical trials are necessary to determine whether interferon with corticosteroid priming is more effective than interferon alone.
干扰素治疗可降低丙型肝炎病毒（HCV）的血清水平并改善炎症活动，但复发情况经常出现。为了开发一种可能减少复发并治愈该疾病的新治疗策略，我们在一项开放性随机临床试验中评估了皮质类固醇预处理对淋巴母细胞干扰素α的影响。在皮质类固醇预处理期间，HCV RNA水平显著升高（从中位数5.60升至21.0×10⁵Eq/mL；P = 0.0004），但在皮质类固醇停用4周后降至预处理水平（7.0×10⁵Eq/mL；P = 0.07）。在19例接受皮质类固醇预处理的患者中，有8例（42.1%）在6个月期间观察到丙氨酸转氨酶（ALT）水平持续正常化且病毒清除，这通过逆转录巢式聚合酶链反应（PCR）检测HCV RNA呈阴性结果得以证实，而仅接受干扰素治疗的19例患者中有6例（31.6%）出现这种情况。在19例接受皮质类固醇预处理的患者中，仅2例在停用皮质类固醇后出现ALT“反弹”，但两者均显示持续应答。对预测持续应答的因素进行多变量分析表明，干扰素治疗前即刻测得的HCV滴度和HCV基因型具有统计学意义（分别为P = 0.006和P = 0.025）。我们的结果表明，皮质类固醇预处理比单独使用干扰素治疗有一定益处，并且需要进行大规模临床试验来确定皮质类固醇预处理的干扰素是否比单独使用干扰素更有效。
