BPIG FOR PREVENTION OF OTITIS MEDIA IN INFANTS

2570例婴幼儿中耳炎发病情况的近期研究 研究显示，三分之一的儿科医生就诊是因为任何类型的疾病 导致了中耳疾病的诊断。 结论是“任何旨在降低急性OM发生率的干预措施 加速中耳积液的消退将大大减少 为儿童提供护理服务的成本。 儿童表现出慢性OM与较低的分数有关 言语和语言发展的测试。这种联系是最强烈的 在前6个月有持续性中耳积液的儿童 生活。 我们对婴儿期OM发生的研究为 早期发现极高风险的婴儿 反复中耳感染和持续性中耳积液。 制定用于这些婴儿的预防措施是一个长期的过程 我们研究的目的。 细菌多糖免疫球蛋白(BPIG)是一种特殊的免疫 马萨诸塞州正在开发的球蛋白(丙种球蛋白) 公共卫生生物实验室和美国红十字会预防 由最常引起的细菌种类引起的感染 奥姆。 本研究为BPIG预防急性OM的对照试验 在年幼的儿童中。出生第一年的高危儿童 获得父母同意后，将在以下位置给予BPIG或安慰剂注射 进入研究和一个月后。在为期4个月的学习期间 我们将进行鼓室穿刺术(从中耳收集液体) 确定引起急性OM发作的细菌。研究还将 以确定BPIG治疗对这些患者的免疫学效应 孩子们。寻求的主要结果将是临床上检测到一种 有效且在统计上显著减少由以下原因引起的OM攻击 球蛋白捐献者已经免疫的细菌。 这项研究是预防复发性OM的一种独特方法。 基于免疫球蛋白的公认安全性，免疫球蛋白通常是 用于预防感染，BPIG可能比 广泛接受的治疗这种疾病的药物和手术的使用。这项研究 还将提供有关以下角色的新的重要信息 OM中的豁免权。

A recent study of the occurrence of otitis media (OM) in 2570 infants showed that one-third of visits to pediatricians "for illness of any kind resulted in the diagnosis of disease of the middle ear." The authors concluded that "any intervention to decrease the incidence of acute OM or to hasten the resolution of middle-ear effusions would substantially reduce the costs of providing care to children." Later studies of the same children demonstrated an association of chronic OM with lower scores in tests of speech and language development. This association was strongest in children who had persistent middle ear effusion in the first 6 months of life. Our studies of the occurrence of OM in infancy have provided criteria for early detection of infants who are at extraordinarily high risk for recurrent middle-ear infection and persistent middle ear effusion. Development of preventive measures for use in these infants is a long-range objective of our research. Bacterial Polysaccharide Immune Globulin (BPIG) is a special immune globulin (gamma-globulin) which is being developed by the Massachusetts Public Health Biologic Laboratories and American Red Cross for prevention of infections caused by the bacterial species which most frequently cause OM. This study is to be a controlled trial of BPIG for prevention of acute OM in young children. High-risk children in the first year of life for whom parental consent is obtained will be given BPIG or placebo injections at entry into the study and one month later. During the 4-month study period we will perform tympanocentesis (collection of fluid from the middle ear) to define the bacteria which cause episodes of acute OM. Studies will also be performed to establish the immunologic effects of BPIG therapy in these children. The major result to be sought will be detection of a clinically useful and statistically significant reduction in attacks of OM caused by bacteria against which the globulin donors have been immunized. This study represents a unique approach to prevention of recurrent OM. Based on the established safety of immune globulins which are in general use for preventing infections, BPIG may have significant advantages over the widely accepted use of drugs and surgery for this disease. The study will also provide novel and important information about the role of immunity in OM.