Kotto-Kome Anne C, Garcia Maria G, Calhoun Darlene A, Christensen Robert D
Division of Neonatology, Department of Pediatrics, University of South Florida College of Medicine and All Children's Hospital, St. Petersburg, FL 33772, USA.
J Perinatol. 2004 Jan;24(1):24-9. doi: 10.1038/sj.jp.7211018.
Erythrocyte transfusions to neonates can be categorized as "early" if given during the first 3 weeks of life and "late" if given thereafter. We used a meta-analysis to determine whether recombinant erythropoietin (rEpo) administration to very-low-birth-weight (VLBW, <1500 g) neonates, beginning in the first week of life, reduces either "early" or "late" transfusions.
Studies that used a randomized, placebo-controlled, double-masked design were deemed acceptable. We identified 12 acceptable, relevant, clinical trials. Additional data not provided in the publications were obtained from two of the authors.
The acceptable studies involved an aggregate of 561 rEpo and 529 placebo recipients. If rEpo was begun in the first week of life, the summary odds ratio (OR) for receiving any transfusion ("early" or "late") was 0.52, 95% confidence interval (CI): 0.34 to 0.79 (p=0.001). The OR for receiving an "early" transfusion was 0.54 (95% CI: 0.25 to 1.15; p=0.055), and the OR for receiving a "late" transfusion was 0.56 (95% CI: 0.37 to 0.83; p=0.036). Heterogeneity among studies was too great to estimate the effect of rEpo on the number of transfusions received or the volume of blood transfused (p<0.001 for the Q-test statistic). Subgroup analysis suggested that when rEpo is begun in the first week of life, neonates 1000 to 1500 g and >29 weeks are more likely to completely avoid transfusion than are extremely low-birth-weight (ELBW, <1000 g) neonates. No dose-response relationship was apparent between rEpo dose or iron dose and transfusion. No difference was apparent depending on whether the rEpo was given subcutaneously vs intravenously.
If rEpo is begun in the first week of life, a moderate reduction can be expected (p=0.001) in the proportion of VLBW neonates transfused. Reduction is less significant in "early" transfusion (p=0.055) than in "late" transfusion (p=0.036). Such treatment is not likely to eliminate transfusions among ELBW neonates completely.
新生儿红细胞输血若在出生后3周内进行可归类为“早期”输血,之后进行则为“晚期”输血。我们采用荟萃分析来确定对出生体重极低(VLBW,<1500 g)的新生儿在出生后第一周开始使用重组促红细胞生成素(rEpo)是否能减少“早期”或“晚期”输血。
采用随机、安慰剂对照、双盲设计的研究被认为是可接受的。我们确定了12项可接受的、相关的临床试验。从两位作者处获得了出版物中未提供的其他数据。
可接受的研究共纳入了561名接受rEpo治疗的新生儿和529名接受安慰剂治疗的新生儿。如果在出生后第一周开始使用rEpo,接受任何输血(“早期”或“晚期”)的汇总比值比(OR)为0.52,95%置信区间(CI):0.34至0.79(p = 0.001)。接受“早期”输血的OR为0.54(95%CI:0.25至1.15;p = 0.055),接受“晚期”输血的OR为0.56(95%CI:0.37至0.83;p = 0.036)。各研究之间的异质性过大,无法估计rEpo对接受输血次数或输血量的影响(Q检验统计量p<0.001)。亚组分析表明,在出生后第一周开始使用rEpo时,体重1000至1500 g且胎龄>29周的新生儿比极低出生体重(ELBW,<1000 g)的新生儿更有可能完全避免输血。rEpo剂量或铁剂剂量与输血之间未发现明显的剂量反应关系。rEpo皮下注射与静脉注射之间未发现明显差异。
如果在出生后第一周开始使用rEpo,预计VLBW新生儿输血比例会有适度降低(p = 0.001)。“早期”输血的降低幅度(p = 0.055)小于“晚期”输血(p = 0.036)。这种治疗不太可能完全消除ELBW新生儿的输血情况。