熊去氧胆酸对光疗新生儿间接高胆红素血症的影响：一项随机临床试验。
The effect of ursodeoxycholic acid on indirect hyperbilirubinemia in neonates treated with phototherapy: a randomized clinical trial.
机构信息
Student Research Committee, Arak University of Medical Sciences, Arak, Iran.
Department of Pediatrics, School of Medicine, Arak University of Medical Sciences, Arak, Iran.
出版信息
J Matern Fetal Neonatal Med. 2022 Nov;35(21):4075-4080. doi: 10.1080/14767058.2020.1846705. Epub 2020 Nov 22.
OBJECTIVES
Indirect hyperbilirubinemia during neonatal period is a common problem, and most preterm and more than half of the term neonates find this problem. Ursodeoxycholic acid (UDCA) protects the liver against oxidative stresses and prevents cellular apoptosis. In addition, it causes stimulation of bile flow, is well tolerated by the patient, and has limited side effects. Thus, the aim of this study was to investigate the effect of UDCA in treating neonates with unconjugated hyperbilirubinemia undergoing phototherapy.
METHODS
In this randomized clinical trial, 220 neonates with unconjugated hyperbilirubinemia who referred to Amir-Kabir Hospital, Arak, Iran in 2017-2018, were randomly assigned to phototherapy group (Control group) and phototherapy plus UDCA group (Intervention group) as 10 mg/kg/day. The level of total bilirubin was measured at the baseline, and after 12, and 24 h using spectrophotometric, and the duration of receiving phototherapy was also measured in both groups.
RESULTS
The mean age of included neonates in the control and intervention group was 5.3 and 4.9 days, respectively. The results revealed that after 12 h of treatment, the total bilirubin level in the control group had diminished by 2.70 mg/dL on average while, in the intervention group, the reduction was 3.7 md/dL ( = .001) and after 24 h of treatment, the total bilirubin level in the control group had diminished by 5.22 mg/dL on average and in the intervention group, the reduction was 6.54 md/dL ( = .001). It was also observed that there is no significant difference between groups in terms of the mean of the duration required for phototherapy ( = .63).
CONCLUSIONS
UDCA combined with phototherapy enhances TSB decrease, but this effect is not relevant from a clinical point of view because it does not decrease phototherapy and hospital stay duration. Thus, this study does not support the UDCA use in the clinical practice.
TRIAL REGISTRATION
IRCT, IRCT2017071515511N2. Registered 21 Aug 2017 - Retrospectively registered, https://en.irct.ir/trial/14763.
目的
新生儿期间接高胆红素血症是一个常见问题，大多数早产儿和一半以上的足月新生儿都会出现这种问题。熊去氧胆酸（UDCA）可保护肝脏免受氧化应激，防止细胞凋亡。此外，它还能刺激胆汁流动，患者耐受性良好，副作用有限。因此，本研究旨在探讨 UDCA 治疗接受光疗的未结合高胆红素血症新生儿的效果。
方法
在这项随机临床试验中，2017 年至 2018 年，伊朗阿拉克阿米尔卡比尔医院收治了 220 例未结合高胆红素血症新生儿，将其随机分为光疗组（对照组）和光疗加 UDCA 组（干预组），剂量为 10mg/kg/天。在基线、12 小时和 24 小时使用分光光度法测量总胆红素水平，并测量两组接受光疗的时间。
结果
对照组和干预组新生儿的平均年龄分别为 5.3 和 4.9 天。结果显示，治疗 12 小时后，对照组总胆红素水平平均下降 2.70mg/dL，而干预组下降 3.7md/dL（ = .001）；治疗 24 小时后，对照组总胆红素水平平均下降 5.22mg/dL，而干预组下降 6.54 md/dL（ = .001）。此外，还观察到两组光疗所需平均时间无显著差异（ = .63）。
结论
UDCA 联合光疗可增强 TSB 下降，但从临床角度来看，这种效果并不相关，因为它不会缩短光疗和住院时间。因此，本研究不支持 UDCA 在临床实践中的应用。
试验注册
IRCT，IRCT2017071515511N2。注册于 2017 年 8 月 21 日-回顾性注册，https://en.irct.ir/trial/14763.
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