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早期静脉注射免疫球蛋白(两剂量方案)治疗严重 Rh 溶血病新生儿——一项前瞻性随机对照试验。

Early intravenous immunoglobin (two-dose regimen) in the management of severe Rh hemolytic disease of newborn--a prospective randomized controlled trial.

机构信息

Department of Pediatric Hematology, Faculty of Medicine, Ain Shams University Cairo, Morbah, 1153, Egypt.

出版信息

Eur J Pediatr. 2011 Apr;170(4):461-7. doi: 10.1007/s00431-010-1310-8. Epub 2010 Oct 6.

Abstract

Phototherapy is the standard treatment in moderately severe hemolytic disease of newborn (HDN), whereas exchange transfusion (ET) is the second line in progressive cases. Intravenous immunoglobin (IVIG) has been suggested to decrease the need for ET. We aimed at assessing the efficacy of early two-dose regimens of IVIG to avoid unnecessary ET in severe Rh HDN. The study included 90 full-term neonates with Rh incompatibility unmodified by antenatal treatment and not eligible for early ET and which were randomly assigned into one of three groups: group (I), treated by conventional method; groups IIa and IIb received IVIG once at 12 h postnatal age if PT was indicated, in a dose of 0.5 and 1 g/kg, respectively. Analysis revealed 11 neonates (22%) in the conventional group and 2 (5%) in the intervention group who administered low-dose IVIG at 12 h, while none in group IIb required exchange transfusion (p = 0.03). Mean bilirubin levels were significantly lower during the first 96 h in the intervention group compared to the conventional group (p < 0.0001). Shorter duration of phototherapy (52.8 ± 12.39 h) and hospital stay (3.25 ± 0.71 days) in the IVIG group compared to conventional group (84 ± 12.12 h and 4.72 ± 0.78 days, p < 0.0001, respectively) were observed. We conclude that IVIG administration at 12 h was effective in the treatment of severe Rh HDN; the low-dose IVIG (0.5 g/kg) was as effective as high dose (1 g/kg) in reducing the duration of phototherapy and hospital stay, but less effective in avoiding exchange transfusion.

摘要

光照疗法是治疗中重度新生儿溶血病(HDN)的标准治疗方法,而换血疗法(ET)则是在病情进展时的二线治疗方法。有研究表明,静脉注射免疫球蛋白(IVIG)可减少 ET 的需求。本研究旨在评估早期两剂 IVIG 方案的疗效,以避免重度 Rh 新生儿溶血病(HDN)中不必要的 ET。本研究纳入了 90 例足月新生儿,这些新生儿因 Rh 不相容而患有未经产前治疗且不适合早期 ET 的严重 HDN,他们被随机分为三组:I 组采用常规方法治疗;如果 PT 提示需要治疗,IIa 组和 IIb 组分别在生后 12 小时内单次给予 0.5 和 1 g/kg 的 IVIG。结果显示,常规组中有 11 例(22%)新生儿和干预组中有 2 例(5%)新生儿在 12 小时时接受了低剂量 IVIG,而 IIb 组中没有新生儿需要换血(p = 0.03)。与常规组相比,干预组在最初 96 小时内的胆红素水平显著降低(p < 0.0001)。与常规组相比,IVIG 组的光疗时间(52.8 ± 12.39 h)和住院时间(3.25 ± 0.71 天)更短(p < 0.0001)。我们得出结论,在治疗严重 Rh HDN 时,12 小时时给予 IVIG 是有效的;与高剂量(1 g/kg)相比,低剂量(0.5 g/kg)IVIG 在减少光疗和住院时间方面同样有效,但在避免换血方面效果较差。

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