Castilla A, Camps-Bansell J, Civeira M P, Prieto J
Department of Internal Medicine, University of Navarre, Pamplona, Spain.
Am J Gastroenterol. 1993 Feb;88(2):233-9.
Forty patients with chronic hepatitis C (CHC) were included in an open randomized controlled trial of lymphoblastoid alpha-interferon (L-IFN) versus no treatment. Twenty patients entered each group, and features of therapy and control cases were similar. L-IFN was given in low doses (1.5-4.5 megaunits) for 1 yr. In 16 of 20 patients treated with L-IFN (80%), but in only one of 20 nontreated cases (0.5%; p < 0.001), amino-transferase activities became normal. In four patients there was a reactivation of the disease during treatment after 4, 5, 6, and 8 months with normal aminotransferase levels. A posttherapy reactivation of hepatitis was observed in four additional cases after 1, 1, 1, and 3 months of follow-up. The other eight patients (40%) continued with normal aminotransferase levels for 1.52 +/- 0.74 (range, 1-2.1) yr after IFN doses were discontinued. In all treated patients except two nonresponders, but in only one of 20 nontreated cases (p < 0.001), Knodell's histological activity index decreased. Procollagen type III aminoterminal peptide levels did not change significantly in nontreated and nonresponder patients, diminished slightly in patients with a transient response, and normalized in cases with a long-standing response, suggesting that this serum test may be a reliable marker for monitoring response to IFN therapy in patients with CHC. Finally, L-IFN treatment induced significant increments in CD4/CD8 index, phytohemagglutinin-induced blastogenesis, and natural killer activity. This study shows that L-IFN diminish inflammatory and fibrogenic activity in most patients with CHC. In 40% of patients treated in this trial, a long-standing remission of the disease was observed.
40例慢性丙型肝炎（CHC）患者被纳入一项关于淋巴母细胞α干扰素（L-IFN）与不治疗的开放性随机对照试验。每组纳入20例患者，治疗组和对照组的特征相似。L-IFN以低剂量（1.5 - 4.5百万单位）给药1年。接受L-IFN治疗的20例患者中有16例（80%）转氨酶活性恢复正常，但未治疗的20例患者中只有1例（0.5%；p < 0.001）转氨酶活性恢复正常。4例患者在治疗期间，于4、5、6和8个月时转氨酶水平正常，但疾病复发。在随访1、1、1和3个月后，又有4例患者出现肝炎治疗后复发。另外8例患者（40%）在停用IFN剂量后，转氨酶水平持续正常1.52±0.74（范围1 - 2.1）年。除2例无反应者外，所有接受治疗的患者Knodell组织学活性指数均下降，但未治疗的20例患者中只有1例下降（p < 0.001）。未治疗和无反应患者的III型前胶原氨基末端肽水平无显著变化，短暂反应患者的该水平略有下降，长期反应患者的该水平恢复正常，这表明该血清检测可能是监测CHC患者对IFN治疗反应的可靠标志物。最后，L-IFN治疗使CD4/CD8指数、植物血凝素诱导的细胞增殖和自然杀伤活性显著增加。本研究表明，L-IFN可降低大多数CHC患者的炎症和纤维化活性。在本试验中接受治疗的患者中有40%观察到疾病长期缓解。
