Groothuis J R, Simoes E A, Levin M J, Hall C B, Long C E, Rodriguez W J, Arrobio J, Meissner H C, Fulton D R, Welliver R C
Department of Pediatrics, University of Colorado School of Medicine, Denver.
N Engl J Med. 1993 Nov 18;329(21):1524-30. doi: 10.1056/NEJM199311183292102.
Infants with cardiac disease or prematurity are at risk for severe illness caused by respiratory syncytial virus. Immune globulin with a high titer of antibodies against respiratory syncytial virus may offer infants and young children at risk protection from this serious, common respiratory illness.
We studied 249 infants and young children (mean age, eight months) who had bronchopulmonary dysplasia due to prematurity (n = 102), congenital heart disease (n = 87), or prematurity alone (n = 60). Respiratory syncytial virus immune globulin was given monthly to some of these children in either a high dose (750 mg per kilogram of body weight; n = 81) or low dose (150 mg per kilogram; n = 79); 89 controls received no immune globulin. Group assignments were random. Assessments of respiratory illness and management were conducted without knowledge of the children's group assignments.
There were 64 episodes of respiratory syncytial virus infection: 19 in the high-dose group, 16 in the low-dose group, and 29 in the control group. In the high-dose group there were fewer lower respiratory tract infections (7, vs. 20 in the control group; P = 0.01), fewer hospitalizations (6, vs. 18 in the control group; P = 0.02), fewer hospital days (43, vs. 128 in the control group; P = 0.02), fewer days in the intensive care unit (P = 0.05), and less use of ribavirin (P = 0.05). In the low-dose group there was a significant reduction only in the number of days in the intensive care unit (P = 0.03). Adverse events during the 580 infusions were generally mild and included fluid overload (in five children), oxygen desaturation (eight), and fever (six). Six children died: three in the high-dose group, three in the low-dose group, and none in the control group (P = 0.15), but no death was attributed to the use of immune globulin or to illness caused by respiratory syncytial virus.
Administration of high doses of respiratory syncytial virus immune globulin is a safe and effective means of preventing lower respiratory tract infection in infants and young children at high risk for this disease.
患有心脏病或早产的婴儿有因呼吸道合胞病毒而患重病的风险。具有高滴度抗呼吸道合胞病毒抗体的免疫球蛋白可能为有风险的婴幼儿提供针对这种严重常见呼吸道疾病的保护。
我们研究了249名婴幼儿（平均年龄8个月），他们因早产（n = 102）、先天性心脏病（n = 87）或单纯早产（n = 60）而患有支气管肺发育不良。这些儿童中的一些人每月接受呼吸道合胞病毒免疫球蛋白，剂量分为高剂量（每公斤体重750毫克；n = 81）或低剂量（每公斤150毫克；n = 79）；89名对照未接受免疫球蛋白。分组是随机的。在不知道儿童分组情况的前提下进行呼吸道疾病评估和管理。
发生了64次呼吸道合胞病毒感染：高剂量组19次，低剂量组16次，对照组29次。高剂量组下呼吸道感染较少（7次，对照组为20次；P = 0.01），住院次数较少（6次，对照组为18次；P = 0.02），住院天数较少（43天，对照组为128天；P = 0.02），重症监护病房天数较少（P = 0.05），利巴韦林使用较少（P = 0.05）。低剂量组仅在重症监护病房天数上有显著减少（P = 0.03）。580次输注期间的不良事件一般较轻，包括液体超负荷（5名儿童）、氧饱和度下降（8名）和发热（6名）。6名儿童死亡：高剂量组3名，低剂量组3名，对照组无死亡（P = 0.15），但没有死亡归因于免疫球蛋白的使用或呼吸道合胞病毒引起的疾病。
给予高剂量的呼吸道合胞病毒免疫球蛋白是预防高危婴幼儿下呼吸道感染的一种安全有效的方法。
