Groothuis J R, Simoes E A, Hemming V G
Department of Pediatrics, University of Colorado School of Medicine, Denver, USA.
Pediatrics. 1995 Apr;95(4):463-7.
To evaluate the safety and efficacy of respiratory syncytial virus immune globulin (RSVIG) in the prevention of severe respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI) in infants born prematurely with or without bronchopulmonary dysplasia (BPD).
Data from a prospective, blinded, randomized, multicenter trial during three consecutive RSV seasons involving 249 children. This analysis comprises 162 preterm children, of whom 102 had BPD. The 87 children with congenital heart disease (CHD) were excluded from this analysis. Children were randomized to receive monthly infusions of RSVIG 750 mg/kg (high dose), RSVIG 150 mg/kg (low dose), or no RSVIG: Results from the preterm infants with and without BPD who received RSVIG 750 mg/kg are contrasted with control infants who did not receive RSVIG:
As compared with controls, high-dose RSVIG administration significantly reduced the incidences of RSV LRTI (P = .01) and moderate-to-severe LRTI (P = .006). RSV-associated hospitalization also was decreased (P = .06) as well as were total RSV-associated days in the intensive care unit (P = .05). Significantly fewer preterm infants developed severe RSV LRTI in the RSVIG group compared with controls (4/58 [7%] vs 14/58 [24%], respectively; P = .01). Adverse reactions occurred in 5% of RSVIG infusions. These were generally mild and included reversible fluid overload, transient fever, and decreases in oxygen saturation. There was one death unrelated to either RSV or RSVIG administration.
Prophylaxis with RSVIG is safe and is currently the only effective means to prevent severe RSV LRTI in high-risk preterm infants.
评估呼吸道合胞病毒免疫球蛋白（RSVIG）预防有或无支气管肺发育不良（BPD）的早产婴儿发生严重呼吸道合胞病毒（RSV）下呼吸道感染（LRTI）的安全性和有效性。
来自一项前瞻性、盲法、随机、多中心试验的数据，该试验连续三个RSV流行季节纳入了249名儿童。本分析包括162名早产儿，其中102名患有BPD。87名患有先天性心脏病（CHD）的儿童被排除在本分析之外。将儿童随机分为每月接受750mg/kg RSVIG（高剂量）、150mg/kg RSVIG（低剂量）输注或不接受RSVIG：将接受750mg/kg RSVIG的有或无BPD的早产儿的结果与未接受RSVIG的对照婴儿的结果进行对比。
与对照组相比，高剂量RSVIG给药显著降低了RSV LRTI的发生率（P = 0.01）和中重度LRTI的发生率（P = 0.006）。RSV相关住院率也有所降低（P = 0.06），重症监护病房中RSV相关的总天数也有所减少（P = 0.05）。与对照组相比，RSVIG组发生严重RSV LRTI的早产儿明显更少（分别为4/58 [7%]对14/58 [24%]；P = 0.01）。5%的RSVIG输注出现不良反应。这些反应通常较轻，包括可逆性液体超负荷、短暂发热和氧饱和度下降。有1例死亡与RSV或RSVIG给药无关。
RSVIG预防是安全的，并且是目前预防高危早产婴儿发生严重RSV LRTI的唯一有效手段。
