加强光疗与换血对新生儿重症高胆红素血症的疗效及神经结局

Treatment effects and neurological outcome between intensive phototherapy and exchange transfusion in newborn infants with severe hyperbilirubinemia

摘要:

目的 比较加强光疗（IPT）与换血（ET）对新生儿重症高胆红素血症的疗效及神经结局的差异。 方法 分析符合ET标准的260例高胆红素血症新生儿的临床资料，根据治疗方式的不同分为IPT组（n＝111）和ET组（n＝149）。按临床试验的意向性（ITT）原则进行分析。比较两组患儿入院后的血清总胆红素（TSB）水平、关键治疗时间、治疗18 h和48 h后TSB下降程度、光疗时间、住院时间、医疗费用以及神经结局的差异。 结果 两组新生儿的胎龄、出生体重、性别、娩出方式及喂养方式等差异均无统计学意义（P＞0.05）；IPT组入院日龄 ≤ 72 h者以及血型不合溶血病的比例少于ET组（P < 0.05）；入院后两组间TSB水平相当（P＞0.05），但ET组患者TSB峰值与ET阈值的差值高于IPT组（P < 0.05）；IPT组关键治疗时间（入院至TSB降至ET阈值以下50 μmol/L所需时间）较ET组（入院至ET结束所用时间）更短（P < 0.05），而关键治疗时间内，ET组TSB下降速度较IPT组更为显著（P < 0.05）；入院治疗18 h，ET组TSB下降程度较IPT组更为明显（P < 0.05），治疗48 h后，两组患儿TSB的下降程度相当（P＞0.05）；ET组的住院时间更长，医疗费用更高（P < 0.05）；两组患儿间急性胆红素脑病和核黄疸的发生率差异无统计学意义（P＞0.05）。 结论 IPT未增加神经系统不良结局的发生，但基于本研究选择偏倚的存在，尚不能提供IPT可完全取代ET的临床证据。

Abstract:

Objective To compare the treatment effects and neurological outcome between intensive phototherapy （IPT） and exchange transfusion （ET） in newborn infants with severe hyperbilirubinaemia. Methods The clinical data of 260 neonates with hyperbilirubinemia conforming to ET criteria were analyzed. The infants were divided into IPT group （n＝111） and ET group （n＝149）. The analyses were based on the intention-to-treat （ITT） principle.The level of total serum bilirubin （TSB） after admission，the duration of critical treatment，the decreasing levels of TSB at 18-hour and 48-hour after hospitalization，duration of phototherapy，hospitalization days and costs，neurological outcomes were compared between two groups. Results There were no significant differences in gestational age，birth weight，gender，mode of delivery and feeding method between the two groups （P＞0.05）. The proportion of patients with hospital age ≤ 72 h and blood incompatibility hemolytic disease in IPT group was lower than that in ET group （P < 0.05）. No significant difference in the highest TSB level between two groups （P＞0.05），while the ET group had higher degree of TSB above the ET threshold than the IPT group （P < 0.05）. The infants in the IPT group had shorter duration of critical treatment （from admission to TSB level below to 50 μmol/L of the ET threshold） than those in the ET group infants （from admission to the end of ET） （P < 0.05）. However，compared with the IPT group，the ET group had faster descent rate of TSB during the period of critical treatment （P < 0.05）. After 18-hour of hospitalization，the decreasing level of TSB in the ET group was more obvious than that in the IPT group （P < 0.05）. There were no significant differences at 48-hour after admission between two groups （P＞0.05）. Compared with the ET group，the IPT group had shorter duration of hospitalization and lower hospitalization costs （P < 0.05）. No differences were observed in the incidences of acute bilirubin encephalopathy and kernicterus between the two groups （P＞0.05）. Conclusion IPT did not increase the incidence of neurological adverse outcomes.?However，due to the selection bias，this study couldn’t provide clinical evidence that IPT can completely replace ET.