Crawford S A, Clover R D, Abell T D, Ramsey C N, Glezen P, Couch R B
Department of Family Medicine, College of Medicine, University of Oklahoma, Oklahoma City.
Pediatr Infect Dis J. 1988 Jun;7(6):379-83. doi: 10.1097/00006454-198806000-00002.
In a randomized, double-blind placebo-controlled clinical trial, we evaluated the prophylactic effectiveness of rimantadine in children (ages 1 to 18 years) against infection with influenza A (H3N2) and associated illness and the prevention of transmission of infection to adult members of the child's family. One hundred ten volunteers from 29 families completed this study during a naturally occurring outbreak of influenza A (H3N2). Influenza infections, defined as a positive viral throat culture or a 4-fold increase in antibody titer, occurred in 31.0% of children in the placebo group and 7.4% in the rimantadine group (P = 0.026). Clinical illness with laboratory evidence of influenza infection occurred in 24.1% of children in the placebo group and none in the rimantadine group (P = 0.007). Rimantadine was well-tolerated by the children, with no significant difference in reported adverse effects between the placebo and rimantadine groups. A combined analysis by families of these data and those of our similarly designed 1984 study, revealed that families in whom the children were given rimantadine had a significantly lower rate of influenza A infection and influenza-like illness compared with the families in whom the children were given placebo (68.8% vs. 18.8%, P less than 0.001) and (56.3% vs. 12.5%, P less than 0.001), respectively. We conclude that rimantadine prophylaxis of children appears to be an effective method to prevent influenza A (either H1N1 or H3N2) infection and illness in children.
在一项随机、双盲、安慰剂对照的临床试验中，我们评估了金刚乙胺对1至18岁儿童预防甲型（H3N2）流感感染及相关疾病的效果，以及预防儿童将感染传播给其家庭成年成员的作用。在甲型（H3N2）流感自然爆发期间，来自29个家庭的110名志愿者完成了这项研究。流感感染定义为病毒咽喉培养阳性或抗体滴度升高4倍，安慰剂组中31.0%的儿童发生感染，金刚乙胺组为7.4%（P = 0.026）。有流感感染实验室证据的临床疾病在安慰剂组24.1%的儿童中出现，金刚乙胺组无儿童出现（P = 0.007）。儿童对金刚乙胺耐受性良好，安慰剂组和金刚乙胺组报告的不良反应无显著差异。对这些数据与我们1984年类似设计研究的数据进行的家庭综合分析显示，与给予儿童安慰剂的家庭相比，给予儿童金刚乙胺的家庭甲型流感感染率和流感样疾病发生率显著较低（分别为68.8%对18.8%，P<0.001）和（56.3%对12.5%，P<0.001）。我们得出结论，对儿童进行金刚乙胺预防似乎是预防儿童甲型（H1N1或H3N2）流感感染和疾病的有效方法。
