Monto A S, Albrecht J K, Schwartz S A
Department of Epidemiology, University of Michigan, Ann Arbor 48109.
Antimicrob Agents Chemother. 1988 Jan;32(1):47-50. doi: 10.1128/AAC.32.1.47.
Recombinant alpha-2b interferon was evaluated in two controlled trials, each lasting for 2 months or more, with different dose levels and schedules of administration. The first study was conducted during a period of transmission of type A (H1N1) and type B influenza. At 2.5 x 10(6) IU per day, no effect on influenza infection could be detected, but there appeared to be an effect on rhinovirus isolation. During the subsequent autumn 1.7 x 10(6) IU per day was found to have only a minimal effect on rhinovirus infection (efficacy from 22 to 27%). Under similar circumstances the preceding year, but with a daily dose of 3.0 x 10(6) IU, efficacy had been 76%. Since there was no evidence of change in rhinovirus strains circulating or their interferon susceptibility, this represented a dose-response relationship. It was possible to evaluate side effects in the 1,200 individuals involved. A lower dose was associated with lower frequency of symptoms of blood-tinged mucus. Persons using a placebo spray had a higher frequency of this side effect than an observed control. Using the spray 5 days a week was no less likely to produce symptoms than everyday use. Once-daily use was less likely to produce side effects than twice-daily use. There was no indication of sensitization when interferon was used for two separate periods of 4 weeks.
在两项对照试验中对重组α-2b干扰素进行了评估，每项试验持续2个月或更长时间，采用了不同的剂量水平和给药方案。第一项研究是在甲型（H1N1）和乙型流感传播期间进行的。每天2.5×10⁶国际单位时，未检测到对流感感染有影响，但似乎对鼻病毒分离有影响。在随后的秋季，发现每天1.7×10⁶国际单位对鼻病毒感染仅有极小的影响（疗效为22%至27%）。前一年在类似情况下，每日剂量为3.0×10⁶国际单位时，疗效为76%。由于没有证据表明循环中的鼻病毒株发生变化或其对干扰素的敏感性改变，这代表了一种剂量反应关系。有可能对涉及的1200人进行副作用评估。较低剂量与血性黏液症状的发生率较低相关。使用安慰剂喷雾剂的人出现这种副作用的频率高于观察到的对照组。每周使用喷雾剂5天产生症状的可能性与每天使用无异。每日一次使用产生副作用的可能性低于每日两次使用。当干扰素在两个单独的4周期间使用时，没有致敏迹象。
