Rodriguez W J, Gruber W C, Welliver R C, Groothuis J R, Simoes E A, Meissner H C, Hemming V G, Hall C B, Lepow M L, Rosas A J, Robertsen C, Kramer A A
Children's Hospital National Medical Center, Washington, DC 20010, USA.
Pediatrics. 1997 Mar;99(3):454-61. doi: 10.1542/peds.99.3.454.
To evaluate the efficacy of high-titer intravenous respiratory syncytial virus immune globulin (RSVIG) in the treatment of children at high risk for severe RSV infection who were hospitalized with proven RSV.
Infants and young children younger than 2 years with bronchopulmonary dysplasia, chronic lung disease, congenital heart disease, or prematurity (<32 weeks' gestational age), hospitalized with a history of lower respiratory tract infection (LRI) of less than 4 days, were enrolled in this study. Patients were randomized in a blinded fashion to receive either 1500 mg/kg RSVIG or placebo in equal volumes. They were evaluated daily for safety and respiratory scores and for RSV nasal shedding.
One hundred seven high-risk children were randomized--54 in the RSVIG group and 53 in the placebo group. Of these children, 51 in each group were considered evaluable. Children with pulmonary disease, congenital heart disease, or prematurity were equally distributed between the two treatment groups. However, two important differences were found in baseline variables between the two groups: there were more patients in the placebo group who had histories of previous LRI and there was a trend toward more severe disease at study entry in the RSVIG group. This was manifested by a higher entry respiratory score in the RSVIG group than in the placebo group (3.4 +/- 0.2 vs 3.1 +/- .01). A higher proportion of children in the RSVIG group (47%) than in the placebo group (28%) required intensive care at entry and mechanical ventilation at study entry (31% RSVIG-treated vs 18% placebo-treated patients). No significant difference was found between groups in the mean unadjusted duration of hospitalization (RSVIG group, 9.10 +/- 1.18 days; control group, 8.17 +/- 1.08 days). When the mean was adjusted for entry respiratory score, likewise, no difference was observed between each group (8.41 +/- 0.97 vs 8.89 +/- .99 days). The lack of efficacy observed in the study primary endpoint was observed in all diagnostic groups. No differences between the RSVIG and placebo groups were observed in the following secondary endpoints: duration of intensive care unit stay, duration of intensive care unit stay for RSV, mechanical ventilation, or supplemental oxygen. No significant differences in adverse events were reported in the RSVIG group (16 children) when compared with the control group (10 children).
RSVIG treatment was safe but not efficacious in the treatment of children with bronchopulmonary dysplasia, congenital heart disease, or premature gestation who were hospitalized with RSV LRI.
评估高滴度静脉注射呼吸道合胞病毒免疫球蛋白（RSVIG）对确诊感染呼吸道合胞病毒（RSV）并住院治疗的严重RSV感染高危儿童的治疗效果。
招募年龄小于2岁、患有支气管肺发育不良、慢性肺病、先天性心脏病或早产（胎龄<32周）、有小于4天的下呼吸道感染（LRI）病史且住院的婴幼儿。患者以盲法随机分组，分别接受1500mg/kg RSVIG或等体积的安慰剂。每天对他们进行安全性、呼吸评分及RSV鼻腔排毒情况评估。
107名高危儿童被随机分组，RSVIG组54名，安慰剂组53名。每组中51名儿童被视为可评估对象。患有肺病、先天性心脏病或早产的儿童在两个治疗组中分布均衡。然而，两组在基线变量上存在两个重要差异：安慰剂组中有更多患者有既往LRI病史，且RSVIG组在研究入组时疾病有更严重的趋势。这表现为RSVIG组入组时的呼吸评分高于安慰剂组（3.4±0.2对3.1±0.01）。RSVIG组中需要入组时重症监护和研究入组时机械通气的儿童比例高于安慰剂组（分别为47%对28%以及31%接受RSVIG治疗的患者对18%接受安慰剂治疗的患者）。两组间未调整住院时间的均值无显著差异（RSVIG组，9.10±1.18天；对照组，8.17±1.08天）。同样，当对入组呼吸评分进行均值调整后，两组间也未观察到差异（8.41±0.97对8.89±0.99天）。在所有诊断组中均未观察到研究主要终点的疗效差异。在以下次要终点方面，RSVIG组与安慰剂组之间未观察到差异：重症监护病房住院时间、因RSV在重症监护病房的住院时间、机械通气或补充氧气情况。与对照组（10名儿童）相比，RSVIG组（16名儿童）报告的不良事件无显著差异。
RSVIG治疗对确诊RSV LRI并住院治疗的支气管肺发育不良、先天性心脏病或早产儿童安全但无效。
