Hayden F G, Sperber S J, Belshe R B, Clover R D, Hay A J, Pyke S
University of Virginia, Charlottesville 22908.
Antimicrob Agents Chemother. 1991 Sep;35(9):1741-7. doi: 10.1128/AAC.35.9.1741.
The therapeutic activity of rimantadine and its relationship to the shedding of drug-resistant influenza A virus were assessed in two randomized, double-blind, placebo-controlled trials involving patients with laboratory-documented influenza A virus (H3N2 subtype) illness of 2 days' duration or less. In a family-based study, rimantadine treatment for 10 days (24 children and adults) was associated with significant decreases in the number of days to a 50% reduction in symptoms (mean difference, 2.5 days), days of fever (1.6 days), and days of restricted activity (1.5 days) compared with the results obtained with placebo-treated patients (32 children and adults). Drug-resistant virus was recovered from eight (33%) of the rimantadine recipients on day 5. No differences in patient demographics or illness severity at the time of enrollment in the study were apparent between those who shed resistant virus and those who did not. Illness resolution tended to be slower in those who shed resistant virus compared with that in those who did not. In a study of adults treated for 5 days (six treated with rimantadine, six treated with placebo), resistant virus was recovered in three rimantadine recipients by day 3 of treatment. The results indicate that drug-resistant influenza A virus (H3N2) can be recovered from rimantadine-treated children and adults as early as 2 days after starting treatment, but that rimantadine retains a net therapeutic benefit compared with that of placebo.
在两项随机、双盲、安慰剂对照试验中,对金刚乙胺的治疗活性及其与耐药甲型流感病毒排出的关系进行了评估,试验涉及实验室确诊为甲型流感病毒(H3N2亚型)且病程不超过2天的患者。在一项基于家庭的研究中,与接受安慰剂治疗的患者(32名儿童和成人)相比,金刚乙胺治疗10天(24名儿童和成人)使症状减轻50%的天数(平均差异为2.5天)、发热天数(1.6天)和活动受限天数(1.5天)显著减少。在第5天,从8名(33%)接受金刚乙胺治疗的患者中分离出耐药病毒。在研究入组时,排出耐药病毒的患者与未排出耐药病毒的患者在人口统计学特征或疾病严重程度方面没有明显差异。与未排出耐药病毒的患者相比,排出耐药病毒的患者病情缓解往往较慢。在一项对成人进行5天治疗的研究中(6名接受金刚乙胺治疗,6名接受安慰剂治疗),在治疗第3天,3名接受金刚乙胺治疗的患者中分离出耐药病毒。结果表明,在开始治疗后2天,就可以从接受金刚乙胺治疗的儿童和成人中分离出耐药甲型流感病毒(H3N2),但与安慰剂相比,金刚乙胺仍具有净治疗益处。