Simoes E A, Groothuis J R, Tristram D A, Allessi K, Lehr M V, Siber G R, Welliver R C
Department of Pediatrics, Divisions of Infectious Diseases and Neonatology, the University of Colorado School of Medicine and Children's Hospital, Denver 80218, USA.
J Pediatr. 1996 Aug;129(2):214-9. doi: 10.1016/s0022-3476(96)70245-7.
Acute otitis media (AOM) has been associated with respiratory syncytial virus (RSV) infection; AOM develops in up to one third of children with RSV illness. A masked multicenter trial used an immune globulin enriched with RSV-neutralizing antibodies (RSVIG) to prevent RSV infection of the lower respiratory tract in 249 children with either bronchopulmonary dysplasia, congenital heart disease, or prematurity. To determine whether monthly RSVIG therapy might decrease the incidence of AOM, we retrospectively analyzed the records of 109 children in two of the centers. RSVIG was administered during RSV season of a high dose of 750 mg/kg monthly or a low dose of 150 mg/kg monthly; control children received no RSVIG. Children were examined for AOM by masked observers using pneumatic otoscopy. No difference in sex, race, underlying diagnosis, number of persons in the home, exposure to smoking, or atopy was found between groups studied. In recipients of high doses of RSVIG, significantly less AOM developed per season than in control children (mean episodes, 0.15 vs 0.78; p = 0.003), and fewer episodes of RSV-related AOM occurred (0 vs 5; p = 0.047). Low doses of RSVIG did not have a clinically significant impact. High doses of RSVIG appeared to have a significant impact on preventing AOM (both RSV- and non-RSV-related AOM) in these-high risk populations. This finding may have important implications in the development of improved preventive modalities for AOM.
急性中耳炎（AOM）与呼吸道合胞病毒（RSV）感染有关；在感染RSV疾病的儿童中，多达三分之一会患上AOM。一项双盲多中心试验使用了富含RSV中和抗体的免疫球蛋白（RSVIG），以预防249名患有支气管肺发育不良、先天性心脏病或早产的儿童发生下呼吸道RSV感染。为了确定每月使用RSVIG治疗是否会降低AOM的发病率，我们回顾性分析了其中两个中心109名儿童的记录。在RSV流行季节，RSVIG的给药剂量为每月高剂量750mg/kg或低剂量150mg/kg；对照儿童未接受RSVIG治疗。由双盲观察者使用鼓气耳镜检查儿童是否患有AOM。在研究的各组之间，未发现性别、种族、基础诊断、家庭人口数量、接触吸烟或特应性方面存在差异。在接受高剂量RSVIG的儿童中，每个季节发生的AOM明显少于对照儿童（平均发作次数，0.15比0.78；p=0.003），且与RSV相关的AOM发作次数更少（0比5；p=0.047）。低剂量的RSVIG没有产生临床显著影响。高剂量的RSVIG似乎对预防这些高危人群的AOM（包括与RSV相关和与非RSV相关的AOM）有显著影响。这一发现可能对开发改进的AOM预防方法具有重要意义。
