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一项关于对早产儿静脉注射免疫球蛋白安全性的随机、双盲、安慰剂对照研究。

A randomized, double-blind, placebo-controlled investigation of the safety of intravenous immune globulin administration to preterm neonates.

作者信息

Christensen R D, Hardman T, Thornton J, Hill H R

机构信息

Department of Pediatrics, University of Utah School of Medicine, Salt Lake City 84132.

出版信息

J Perinatol. 1989 Jun;9(2):126-30.

PMID:2738720
Abstract

Intravenous immune globulin (750 mg/kg), or an equivalent volume of a placebo, was administered during the first week of life, in a randomized trial, to 20 preterm neonates weighing 710 to 1800 g. A variety of laboratory and clinical values were measured serially and analyzed for possible untoward effects. Serum IgG levels were also determined serially. No differences in heart rate, respiratory rate, urine output, blood glucose, serum osmolality, BUN, SGPT, pH, blood gasses, serum electrolytes, total or direct bilirubin, blood leukocyte concentration, absolute neutrophil count, or blood platelet concentration were observed between the intravenous immune globulin (IVIG) and placebo recipients before or following IVIG administration. The red blood cell concentration of IVIG recipients diminished transiently and only slightly (P less than .05). Serum IgG levels increased from 503 +/- 162 mg/dL (X +/- SD) to 1492 +/- 201 mg/dL 15 minutes after the IVIG administration (P less than .001). After 8 days, serum IgG levels were still elevated, at 675 +/- 297 mg/dL. All patients randomized to receive the placebo experienced a diminution in serum IgG over this 8-day period (P less than .01). All 20 patients survived and none in either group had a documented nosocomial infection. This study suggests that IVIG can safely be administered to preterm neonates, resulting in serum IgG levels comparable to those of term infants.

摘要

在一项随机试验中,对20名体重710至1800克的早产新生儿在出生后第一周静脉注射免疫球蛋白(750毫克/千克)或等量的安慰剂。连续测量了各种实验室和临床指标,并分析了可能的不良反应。还连续测定了血清IgG水平。在静脉注射免疫球蛋白(IVIG)前后,IVIG组和安慰剂组在心率、呼吸频率、尿量、血糖、血清渗透压、血尿素氮、谷丙转氨酶、pH值、血气、血清电解质、总胆红素或直接胆红素、血白细胞浓度、绝对中性粒细胞计数或血小板浓度方面均未观察到差异。IVIG组的红细胞浓度短暂且轻微下降(P<0.05)。静脉注射IVIG后15分钟,血清IgG水平从503±162毫克/分升(X±标准差)升至1492±201毫克/分升(P<0.001)。8天后,血清IgG水平仍升高,为675±297毫克/分升。所有随机接受安慰剂的患者在这8天内血清IgG均下降(P<0.01)。所有20例患者均存活,两组均无医院感染记录。这项研究表明,IVIG可安全地用于早产新生儿,使血清IgG水平与足月儿相当。

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引用本文的文献

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Intravenous Immune Globulin Uses in the Fetus and Neonate: A Review.静脉注射免疫球蛋白在胎儿和新生儿中的应用:综述
Antibodies (Basel). 2020 Nov 4;9(4):60. doi: 10.3390/antib9040060.
2
Intravenous immunoglobulin for preventing infection in preterm and/or low birth weight infants.静脉注射免疫球蛋白预防早产和/或低出生体重儿感染
Cochrane Database Syst Rev. 2020 Jan 29;1(1):CD000361. doi: 10.1002/14651858.CD000361.pub4.
3
Administration of intravenous immunoglobulins for prophylaxis or treatment of infection in preterm infants: meta-analyses.
静脉注射免疫球蛋白用于预防或治疗早产儿感染的荟萃分析。
Arch Dis Child Fetal Neonatal Ed. 1995 May;72(3):F151-5. doi: 10.1136/fn.72.3.f151.