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重组促红细胞生成素在预防慢性肺病中作用的随机对照双盲研究

Randomised controlled double blind study of role of recombinant erythropoietin in the prevention of chronic lung disease.

作者信息

Griffiths G, Lall R, Chatfield S, Short A, Mackay P, Williamson P, Brown J, Levene M I

机构信息

Department of Paediatrics, Leeds General Infirmary.

出版信息

Arch Dis Child Fetal Neonatal Ed. 1997 May;76(3):F190-2. doi: 10.1136/fn.76.3.f190.

Abstract

AIM

To evaluate the role of recombinant human erythropoietin (R-HuEpo) in reducing iron infusion, which may exacerbate free radical damage, leading to chronic lung disease.

METHODS

A multicentre, randomised, placebo controlled, double blind study was carried out in four neonatal intensive care units in Yorkshire. Infants were randomly allocated and received either R-HuEpo (480 U/kg/wk) or placebo by twice weekly subcutaneous injection. The primary outcome measure was the number of days on respiratory support and a secondary outcome the number of blood transfusions required.

RESULTS

Forty two very low birthweight (VLBW) infants were randomly allocated. There was little difference in the need for respiratory support one month after randomisation, but subsequently there was a trend towards a reduction in the proportion requiring respiratory support in the R-HuEpo group (difference at three months -0.50, 95% confidence interval -1.00, 0.17). During stay in hospital, the median number of blood transfusions was lower for infants in the R-HuEpo group (difference in medians -2, 95% CI -4, 0). The study was stopped early because of failure to recruit babies at the expected rate.

CONCLUSIONS

R-HuEpo seems to reduce the number of days in oxygen for ill VLBW infants. These data could be used to construct a larger multicentre study to evaluate this effect further.

摘要

目的

评估重组人促红细胞生成素(R-HuEpo)在减少铁输注方面的作用,铁输注可能会加剧自由基损伤,进而导致慢性肺病。

方法

在约克郡的四个新生儿重症监护病房开展了一项多中心、随机、安慰剂对照、双盲研究。婴儿被随机分组,通过每周两次皮下注射接受R-HuEpo(480 U/kg/周)或安慰剂。主要结局指标是呼吸支持天数,次要结局指标是所需输血次数。

结果

42名极低出生体重(VLBW)婴儿被随机分组。随机分组后1个月,两组在呼吸支持需求方面差异不大,但随后R-HuEpo组中需要呼吸支持的比例有下降趋势(3个月时差异为-0.50,95%置信区间为-1.00,0.17)。住院期间,R-HuEpo组婴儿的输血中位数较低(中位数差异为-2,95%CI为-4,0)。由于未能按预期速度招募婴儿,该研究提前终止。

结论

R-HuEpo似乎能减少患病VLBW婴儿的吸氧天数。这些数据可用于开展更大规模的多中心研究以进一步评估这种效果。

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