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首页> 外文期刊>Clinical drug investigation >Randomised trial of two different daily doses of interferon-< alpha > versus classical therapy in treatment-naive patients with chronic hepatitis C
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Randomised trial of two different daily doses of interferon-< alpha > versus classical therapy in treatment-naive patients with chronic hepatitis C

机译：初治的慢性丙型肝炎患者中两种不同日剂量干扰素-α与经典疗法的随机对照试验

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Objective: To evaluate the efficacy and tolerability of two different daily doses of interferon-< alpha > (lymphoblastoid-IFN< alpha >-N1, WellferonR) [IFN< alpha >] for 2 months, followed by the same dose on alternate days for up to 1 year, versus administration on alternate days for 1 year. Patients and methods: A non-blind, randomised study of outpatients with chronic hepatitis C at five centres in Sicily, Italy. Ninety-seven consecutive treatment-naive patients [72 patients with hepatitis C virus (HCV) genotype 1b infection] with histological chronic hepatitis C were included in the study and randomised to receive IFN< alpha > subcutaneously: 5 million international units (MIU) daily for 2 months, followed by the same dose on alternate days for up to 1 year (n = 33, group A); 3 MIU for 2 months, followed by the same dose on alternate days for up to 1 year (32, group B); 5 MIU on alternate days for 12 months (32, group C). Adverse effects were monitored through interviews and by clinical and biochemical check-ups at 1-month intervals. Results: There were no significant differences between the three groups with regard to age, gender, HCV genotype distribution, or severity of histological findings. Seven patients dropped out of the study because of severe adverse effects: three from group A, two from group B, and three from group C. Approximately 30% of the 97 patients, equally distributed between the three groups, had a 'flu-like syndrome of mild-to-moderate intensity. Dosage reduction of IFN< alpha > from 5 MIU to 3 MIU daily was necessary in two patients in group A during the first month of treatment. Overall, 88 patients completed treatment as scheduled. After the induction phase, HCV was eradicated from the bloodstream in 27 patients (81.8%) from group A versus 15 (46.9%) from group B (p < 0.001) and 15 (46.9%) from group C (p < 0.001). The switch to maintenance dosages caused some infection breakthroughs, with the result that at the end of treatment 16 patients in group A, 12 in group B and 14 in group C had undetectable serum levels of HCV-RNA. After treatment discontinuation, however, five patients in group A, four in group B and six in group C became HCV-RNA positive. Thus, at the end of follow-up, 11 patients in group A, eight in group B and eight in group C had a sustained virological response. Conclusion: The present study shows that induction therapy with 5 MIU of IFN< alpha > administered daily for 2 months is well tolerated and that the percentage of patients with viral eradication at the end of this phase is higher than the percentage obtained with traditional therapy. Unfortunately, this good initial response decreases as treatment continues with conventional therapy, thus nullifying the benefits of the induction phase.
机译：目的：评价两种不同日剂量干扰素-α（淋巴母细胞-IFN <α> -N1，WellferonR）[IFN <α>]的疗效和耐受性，持续2个月，然后隔天重复相同剂量最多1年，而隔天管理1年。患者和方法：在意大利西西里岛的五个中心对患有慢性丙型肝炎的门诊患者进行的非盲目随机研究。该研究纳入了97例连续未接受治疗的初治患者[72例具有慢性乙型肝炎病毒（HCV）基因型1b感染的患者]，并随机分配至皮下接受IFN ：每天500万国际单位（MIU）持续2个月，然后每隔几天服用相同剂量的药物，最长1年（n = 33，A组）; 3个MIU，持续2个月，随后每隔几天服用相同剂量的药物最多1年（32，B组）;每隔5天进行一次MIU，持续12个月（32组，C组）。通过访谈以及每隔1个月进行一次临床和生化检查来监测不良反应。结果：在年龄，性别，HCV基因型分布或组织学检查结果的严重性方面，三组之间无显着差异。由于严重的不良反应，有7名患者退出了研究：A组中的3名，B组中的2名，C组中的3名。97名患者中大约30％（平均分布在三组之间）呈“流感样”中度至中等强度的综合征。在治疗的第一个月中，A组中的两名患者有必要将IFNα剂量从每天5 MIU降低到3 MIU。总体上，有88位患者按计划完成了治疗。诱导期后，A组的27例患者（81.8％）的HCV被清除，而B组的15例（46.9％）（P <0.001）和C组的15例（46.9％）（p <0.001）被消除。转向维持剂量引起了一些感染突破，其结果是，在治疗结束时，A组16名患者，B组12名患者和C组14名患者的血清HCV-RNA水平未检出。但是，停药后，A组5例，B组4例和C组6例变为HCV-RNA阳性。因此，在随访结束时，A组11例，B组8例和C组8例具有持续的病毒学应答。结论：本研究表明，每天给予5 MIU IFN <α>的诱导治疗持续2个月，耐受性良好，并且在该阶段结束时具有病毒根除的患者百分比高于传统疗法。不幸的是，这种良好的初始反应随着常规疗法的继续治疗而降低，从而使诱导期的益处无效。

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