Brady M T, Sears S D, Pacini D L, Samorodin R, DePamphilis J, Oakes M, Soo W, Clements M L
Department of Pediatrics, Ohio State University, Columbus.
Antimicrob Agents Chemother. 1990 Sep;34(9):1633-6. doi: 10.1128/AAC.34.9.1633.
A placebo-controlled, double-blind study to evaluate the safety and prophylactic efficacy of a low dose (100 mg) of rimantadine hydrochloride against naturally occurring influenza in adults was conducted at two sites. After the onset of the influenza season, volunteers (ages, 18 to 55 years) were assigned randomly to receive rimantadine or placebo daily. Subjects were monitored for adverse effects and evidence of influenza virus infection weekly for six weeks. Only 10 (8.7%) of 114 rimantadine recipients and 5 (4.4%) of 114 placebo control recipients reported one or more mild to moderate adverse symptoms, most of which were related to the gastrointestinal or central nervous system. Compared with placebo, low-dose rimantadine was highly effective in the prevention of influenza A virus infection (20 of 110 versus 7 of 112 participants; P less than 0.01) and influenza illness (7 of 110 versus 1 of 112 participants; P = 0.04). Influenza A/Leningrad/87-like (H3N2) virus was recovered from the nasopharynxes of only five placebo recipients. These findings indicate that low-dose rimantadine is well tolerated and highly effective for the prevention of influenza A illness in healthy adults.
在两个地点开展了一项安慰剂对照、双盲研究，以评估低剂量（100毫克）盐酸金刚乙胺对成人自然发生流感的安全性和预防效果。流感季节开始后，志愿者（年龄18至55岁）被随机分配，每天接受金刚乙胺或安慰剂治疗。对受试者进行为期六周的每周监测，观察不良反应和流感病毒感染迹象。114名接受金刚乙胺治疗的受试者中，只有10名（8.7%）报告了一种或多种轻至中度不良症状，114名接受安慰剂对照的受试者中有5名（4.4%）报告了此类症状，其中大多数与胃肠道或中枢神经系统有关。与安慰剂相比，低剂量金刚乙胺在预防甲型流感病毒感染（110名参与者中的20名 vs 112名参与者中的7名；P<0.01）和流感疾病（110名参与者中的7名 vs 112名参与者中的1名；P=0.04）方面非常有效。仅从5名接受安慰剂治疗的受试者的鼻咽中分离出甲型/列宁格勒/87样（H3N2）病毒。这些结果表明，低剂量金刚乙胺耐受性良好，对预防健康成人的甲型流感疾病非常有效。
