硫酸锌治疗新生儿重症监护病房早产儿间接高胆红素血症的疗效：一项双盲、随机临床试验。
Efficacy of zinc sulfate on indirect hyperbilirubinemia in premature infants admitted to neonatal intensive care unit: a double-blind, randomized clinical trial.
机构信息
Department of Pediatrics, Faculty of Medicine, Birjand University of Medical Sciences, South Khorasan Province, Birjand, Iran.
Faculty of Medicine, Birjand University of Medical Sciences, Birjand, Iran.
出版信息
BMC Pediatr. 2020 Mar 19;20(1):130. doi: 10.1186/s12887-020-02025-9.
BACKGROUND
Hyperbilirubinemia is a common neonatal problem. Studies conducted on the effectiveness of zinc salts on serum indirect bilirubin levels in newborns have yielded different results, all calling for further research. This study aimed to determine the effect of oral zinc sulfate on indirect hyperbilirubinemia in preterm infants admitted to the neonatal intensive care unit.
METHODS
A randomized double-blind clinical trial was performed in the neonatal intensive care unit of Vali-e-Asr Hospital in Birjand, Iran. The study population comprised neonates aged between 31 and 36 gestational weeks, who required phototherapy in the neonatal intensive care unit. A total of 60 neonates were selected by census and allocated into an experimental group and a control group. In addition to phototherapy, the experimental group received 1 cc/Kg zinc sulfate syrup (containing 5 mg/5 cc zinc sulfate; Merck Company, Germany), and the control group received a placebo syrup (containing 1 cc/kg sucrose). Data were analyzed in SPSS-21 software using the independent t-test, repeated-measures ANOVA, Bonferroni post-hoc test, and Mann-Whitney test. P-values smaller than 0.05 were considered significant.
RESULTS
Bilirubin level changes in the experimental and control groups six hours after intervention were - 1.45 ± 3.23 and - 0.49 ± 0.37 (p = 0.024), respectively. The changes 24 and 48 h after intervention were-3.26 ± 2.78 and - 1.89 ± 1.20 (p = 0.017) in the experimental group and - 4.89 ± 2.76 and - 3.98 ± 2.32 (p = 0.23) in the control group, respectively. There was no significant difference in the phototherapy duration between the two groups (p = 0.24).
CONCLUSIONS
The results of this study showed that the use of zinc sulfate syrup in preterm infants with indirect hyperbilirubinemia significantly reduced bilirubin levels within 48 h of treatment.
TRIAL REGISTRATION
Trial registration: IRCT, IRCT2015120825439N1. Registered 21 February 2016, http://irct.ir/trial/21277.
背景
高胆红素血症是一种常见的新生儿问题。关于锌盐对新生儿血清间接胆红素水平影响的研究结果各异，均需要进一步研究。本研究旨在评估硫酸锌口服对新生儿重症监护病房早产儿间接性高胆红素血症的影响。
方法
本研究采用随机、双盲临床试验，在伊朗比尔詹德瓦利-阿萨医院的新生儿重症监护病房进行。研究对象为胎龄 31-36 周、需要在新生儿重症监护病房接受光疗的新生儿。采用普查法选择了 60 名新生儿，并将其分为实验组和对照组。除光疗外，实验组还接受 1 cc/Kg 硫酸锌糖浆（含 5mg/5cc 硫酸锌；默克公司，德国）治疗，对照组则接受安慰剂糖浆（含 1cc/kg 蔗糖）治疗。采用 SPSS-21 软件进行数据分析，采用独立 t 检验、重复测量方差分析、Bonferroni 事后检验和 Mann-Whitney 检验。P 值小于 0.05 为差异有统计学意义。
结果
干预后 6 小时，实验组和对照组胆红素水平分别下降 1.45±3.23 和 0.49±0.37（p=0.024）；干预后 24 和 48 小时，实验组胆红素水平分别下降 3.26±2.78 和-3.26±2.78，对照组分别下降 4.89±2.76 和-3.98±2.32（p=0.017）。两组患儿光疗持续时间无显著差异（p=0.24）。
结论
本研究结果表明，硫酸锌糖浆治疗早产儿间接性高胆红素血症可在治疗后 48 小时内显著降低胆红素水平。
试验注册
试验注册：IRCT，IRCT2015120825439N1。注册于 2016 年 2 月 21 日，http://irct.ir/trial/21277。
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