红细胞持续输注3小时和4小时改善贫血早产儿脑组织氧合的非随机对照试验

目的：探讨红细胞持续输注（本文简称输血）3 h和4 h对贫血早产儿脑、肠、肾组织氧合的影响。方法：以在复旦大学附属儿科医院（我院）新生儿科住院、胎龄<37周、符合早产儿输血指征的早产儿为研究对象，以我院新生儿科二和三病区分别为输血3 h和4 h组，设定输血3 h和4 h后可接受的CrSO2变化差值为4%；主要结局指标：输血后12~24 h时间段的脑组织氧饱和度（CrSO2 )；次要结局指标：输血前2 h、输血过程中和之后2、~4、~6、~12 h时间段的脑组织氧饱和度（CrSO2 )，输血前2 h、输血过程中和之后2、~4、~6、~12和~24 h时间段肠组织氧饱和度（SrSO2）和肾组织氧饱和度（RrSO2），输血前2 h、输血过程中和之后2 h每搏输出量（SV）、心输出量（CO）、心率（HR）、经皮动脉氧饱和度（TcSaO2）和平均动脉血压（MABP）。采用非劣效检验分析两组患儿组织氧饱和度、心功能指标和基本生命体征参数输血前后差值的差异性。结果：①符合本文纳入、排除和剔除标准的患儿共52例。输血3 h和4 h组分别为21和31例，输血时矫正胎龄分别为（38.6±4.3）和（36.4±3.1）周（P=0.033）。②输血3 h组输血前后CrSO2、SrSO2和RrSO2分别为（0.573±0.025） vs （0.600±0.017）、（0.530±0.038） vs （0.561±0.032）、（0.564±0.035） vs （0.595±0.037），输血4 h组输血前后CrSO2、SrSO2和RrSO2分别为（0.573±0.045） vs （0.596±0.033）、（0.543±0.052） vs （0.552±0.052）、（0.533±0.063） vs （0.576±0.050）；两组患儿组内比较，输血前后CrSO2、SrSO2和RrSO2差异均有统计学意义（P均<0.05）；组间比较，CrSO2、SrSO2和RrSO2输血前后差值差异均无统计学意义，非劣效检验成立。③两组患儿组内比较，输血前后HR和MABP差异均有统计学意义（P均<0.05）。结论对于输血时矫正胎龄大于38周的早产儿组织氧合影响输血3 h不劣于常规的输血4 h。

Improvement of cerebral tissue oxygenation in anemic preterm infants by transfusing red blood cells for 3 hours and 4 hours: A non-randomized controlled trial

Objective:To investigate the effects of red cell transfusions for 3 h and 4 h on tissue (cerebral, splanchnic, renal) oxygenations in anemic preterm infants.Methods:In this study, premature infants with gestational age<37 weeks who were admitted to the Department of Neonatology, Children's Hospital of Fudan University (our hospital) and met the indication for transfusion of premature infants were recruited. Anemic preterm infants were categorized into 3 h blood transfusion group and 4 h blood transfusion group based on two neonatal wards. It was acceptable when the CrSO2 difference between 3 h blood transfusion group and 4 h blood transfusion group was below 4%. Primary outcome measures were cerebral tissue oxygen saturation (CrSO2) in the period of 12-24 h after blood transfusion. The secondary outcome measures were CrSO2in 2 h before blood transfusion, blood transfusion and 2, -6 and -12 h after blood transfusion; splanchnic tissue oxygen saturation (SrSO2) and renal tissue oxygen saturation (RrSO2) in 2 h before blood transfusion, blood transfusion and 2, -6, -12 and -24 h after blood transfusion; stroke volume (SV), cardiac output (CO), heart rate (HR), transcutaneous arterial oxygen saturation (TcSaO2) and mean arterial blood pressure (MABP) in 2 h before blood transfusion, blood transfusion and 2 h after blood transfusion. The changes of tissue oxygen saturations, cardiac function indexes and basic vital signs parameters in both groups before and after blood transfusions were analyzed by the method of non-inferiority test. Results:① A total of 52 infants were included. There were 21 cases in 3 h blood transfusion group and 31 cases in 4 h blood transfusion group. There was significant difference in correct gestational age at blood transfusion between 3 h and 4 h blood transfusion groups, (38.6±4.3) vs. (36.4±3.1) weeks. ② CrSO2, SrSO2 and RrSO2 before and after transfusion were respectively (0.573±0.025) vs (0.600±0.017), (0.530±0.038) vs (0.561±0.032), (0.564±0.035) vs (0.595±0.037) in 3 h blood transfusion group and (0.573±0.045) vs (0.596±0.033), (0.543±0.052) vs (0.552±0.052), (0.533±0.063) vs (0.576±0.050) in 4 h blood transfusion group. In both groups, compared in each group before and after blood transfusion, there were significant differences in CrSO2, SrSO2 and RrSO2(P<0.05), but there was no significant difference in CrSO2, SrSO2 and RrSO2 before and after blood transfusion between two groups, and non-inferiority tests were established. ③ In both groups, there were significant differences in HR and MABP before and after blood transfusion (P<0.05). Conclusion:The effects of blood transfusions for 3 h on tissue oxygenations in anemic preterm infants with correct gestational age>38 weeks were not inferior to that of conventional blood transfusions for 4 h.