Department of Family Medicine and Department of Pediatric Medicine and Neonatology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.
Department of Family medicine, Shiraz University of Medical Sciences, Shiraz, Iran.
J Paediatr Child Health. 2021 Aug;57(8):1175-1181. doi: 10.1111/jpc.15411. Epub 2021 Mar 8.
This study aimed to investigate the effect of adding ursodeoxycholic acid (UDCA) to phototherapy in neonates with glucose-6-phosphate dehydrogenase (G6PD) deficiency and hyperbilirubinaemia. G6PD deficiency is a common cause of severe hyperbilirubinaemia in neonates.
This study was a triple blind, clinical trial study of 40 neonates with G6PD deficiency and hyperbilirubinaemia who admitted for phototherapy in hospitals affiliated to the University of Medical Sciences. The treatment group (n = 20) received UDCA 10 mg/kg (2 cc/kg) daily divided into 2 doses every 12 h. The control group (n = 20) received the same volume of placebo syrup. The drug and placebo treatments were continued until the bilirubin level dropped below 171 μmol/L. Both the control and treatment group received continuous phototherapy. Independent sample t-test, survival analysis and logrank test were used to statistically analyse the results.
The mean total bilirubin level was 231.9 ± 18.8 μmol/L and 184.3 ± 18.6 μmol/L in the control and intervention group respectively, 24 h after drug administration and 209.7 ± 19.3 μmol/L and 157.4 ± 16.4 μmol/L, respectively, 48 h after intervention (P < 0.05). The median length of hospitalisation in the treatment group was approximately 1 day lower than the control group (logrank test P value: <0.001).
The study showed that the addition of UDCA to phototherapy accelerates the reduction of total bilirubin level in neonates with G6PD deficiency and can reduce the duration of hospitalisation.
本研究旨在探讨在葡萄糖-6-磷酸脱氢酶(G6PD)缺乏和高胆红素血症的新生儿中,添加熊去氧胆酸(UDCA)对光疗的影响。G6PD 缺乏是新生儿严重高胆红素血症的常见原因。
这是一项在医科大学附属医院接受光疗的 40 名 G6PD 缺乏和高胆红素血症新生儿中进行的三盲、临床试验研究。治疗组(n=20)接受 UDCA 10mg/kg(2cc/kg),每日 2 次,每 12 小时 1 次。对照组(n=20)接受相同体积的安慰剂糖浆。药物和安慰剂治疗持续到胆红素水平降至 171μmol/L 以下。对照组和治疗组均接受持续光疗。采用独立样本 t 检验、生存分析和对数秩检验对结果进行统计学分析。
药物治疗 24 小时后,对照组和干预组的总胆红素水平分别为 231.9±18.8μmol/L 和 184.3±18.6μmol/L,药物治疗 48 小时后,分别为 209.7±19.3μmol/L 和 157.4±16.4μmol/L(P<0.05)。治疗组的中位住院时间比对照组约低 1 天(对数秩检验 P 值:<0.001)。
本研究表明,在 G6PD 缺乏的新生儿中,添加 UDCA 可加速光疗降低总胆红素水平,并缩短住院时间。