Groothuis J R, Simoes E A, Lehr M V, Kramer A A, Hemming V G, Rodriguez W J, Arrobio J, Welliver R C, Siber G R
Department of Pediatrics, University of Colorado School of Medicine, Denver, USA.
Antimicrob Agents Chemother. 1995 Mar;39(3):668-71. doi: 10.1128/AAC.39.3.668.
Respiratory syncytial virus (RSV) causes serious illness (lower respiratory illness) in preterm infants. RSV antibody-enriched immunoglobulin (RSVIG) that was lyophilized (LYO) protected against RSV lower respiratory illness. The Food and Drug Administration now requires an additional viral inactivation step (VI). We compared LYO, LYO-VI, and a more convenient liquid RSVIG (LIQ-VI) in 30 preterm infants (median age, 7 months; median weight, 5.4 kg). Infants were randomized to receive LYO (n = 10), LYO-VI (n = 10), or LIQ-VI (n = 10) in monthly infusions of 750 mg/kg of body weight per dose (December to March). Children were monitored closely for adverse reactions to RSVIG and for RSV illness.
呼吸道合胞病毒（RSV）可导致早产儿患严重疾病（下呼吸道疾病）。冻干的富含RSV抗体的免疫球蛋白（RSVIG）可预防RSV下呼吸道疾病。美国食品药品监督管理局现在要求增加一个病毒灭活步骤（VI）。我们在30名早产儿（中位年龄7个月；中位体重5.4千克）中比较了冻干型、冻干-病毒灭活型和更方便的液体RSVIG（液体-病毒灭活型）。婴儿被随机分为接受冻干型（n = 10）、冻干-病毒灭活型（n = 10）或液体-病毒灭活型（n = 10），每月输注，每剂750毫克/千克体重（12月至3月）。密切监测儿童对RSVIG的不良反应以及RSV疾病情况。
