布拉氏酵母菌联合熊去氧胆酸治疗新生儿高胆红素血症患儿的临床研究

Clinical trial of Sacoharomyces boulardi with ursodeoxycholic acid in the treatment of neonatal hyperbilirubinemia

目的探讨分析应用布拉氏酵母菌联合熊去氧胆酸治疗新生儿高胆红素血症患儿对血清γ-谷氨酸转肽酶(γ-GT)、胰岛素样生长因子-1(IGF-1)、视黄醇结合蛋白(RBP)水平的影响。方法将新生儿高胆红素血症患儿按队列法分为对照组和试验组,对照组给予熊去氧胆酸片,每次5 mg·kg^(-1),每日2次,取片研成粉末,温水冲服;试验组在对照组治疗的基础上增加布拉氏酵母菌治疗,每次1袋,每24 h口服1次。比较2组患儿的临床疗效、退黄情况,比较治疗前后的血清总胆红素(TBIL)、间接胆红素(IBIL)、转铁蛋白(TRF)水平及血清γ-GT、IGF-1、RBP水平,并评价安全性。结果对照组和试验组分别纳入148和152例。治疗后,试验组和对照组的的总有效率分别为94.08%(143例/152例)和81.76%(121例/148例);再次光疗率分别为8.55%(13例/152例)和20.95%(31例/148例),在统计学上差异均有统计学意义(均P<0.05)。试验组和对照组的光疗持续时间分别为(20.17±5.32)和(26.39±7.69)h,退黄时间分别为(3.97±0.60)和(5.59±0.83)d,住院时间分别为(7.17±0.66)和(9.16±0.90)d;治疗后,试验组和对照组的TBIL分别为(133.26±15.69)和(179.15±17.65)μmol·L^(-1),IBIL分别为(141.88±18.19)和(198.65±19.26)μmol·L^(-1),γ-GT分别为(38.19±3.75)和(50.87±4.25)U·L^(-1),RBP分别为(20.42±3.21)和(25.50±3.43)mg·L^(-1),IGF-1分别为(20.43±3.06)和(26.51±3.38)ng·L^(-1),TRF分别为(1.98±0.27)和(1.65±0.20)g·L^(-1)。试验组的上述指标与对照组比较,在统计学上差异均有统计学意义(均P<0.05)。试验组和对照组的药物不良反应主要有腹泻、恶心呕吐、皮疹。试验组和对照组的药物不良反应总发生率分别为8.52%(13例/152例)和9.46%(14例/148例),在统计学上差异无统计学意义(P>0.05)。结论新生儿高胆红素血症患儿应用布拉氏酵母菌联合熊去氧胆酸治疗可有效改善血清γ-GT、IGF-1、RBP水平,临床疗效较好。

Objective To investigate the effects of Sacoharomyces boulardi combined with ursodeoxycholic acid on serum levels of gamma-glutamate transpeptidase(γ-GT),insulin like growth factor-1(IGF-1)and retinol binding protein(RBP)in neonates with hyperbilirubinemia.Methods Neonatal hyperbilirubinemia children were divided into control group and treatment group by cohort method.The control group was given ursodeoxycholic acid,5 mg·kg-'each time,twice a day,and took the tablet powder in warm water;the treatment group was additionally treated with Sacoharomyces boulardi on the basis of the control group,1 bag each time,orally once every 24 h.The clinical efficacy,yellows regression,serum total bilirubin(TBIL),indirect bilirubin(IBIL),transferrin(TRF)levels and serum-GT,IGF^(-1)and RBP levels before and after treatment were compared between the two groups.And evaluated the safety.Results 152 cases in treatment group and 148 cases in control group were enrolled.After treatment,the clinical efficacy of the treatment group and control group was 94.08%(143 cases/152 cases)and 81.76%(121 cases/148 cases);the re-phototherapy rate was 8.55%(13 cases/152 cases)and 20.95%(31 cases/148 cases),the difference was statistically significant(all P<0.05).The duration of phototherapy in the treatment group and control group were(20.17±5.32)and(26.39±7.69)h;the decolorization time were(3.97±0.60)and(5.59±0.83)d;the hospital stay were(7.17±0.66)and(9.16±0.90)d;the TBIL were(133.26±15.69)and(179.15±17.65)μmol·L^(-1);the IBIL were(141.88±18.19)and(198.65±19.26)μmol·L^(-1);the-GT were(38.19±3.75)and(50.87±4.25)U.L-l;the RBP were(20.42±3.21)and(25.50±3.43)mg·L^(-1);the IGF^(-1)were(20.43±3.06)and(26.51±3.38)ng·L^(-1);the TRF were(1.98±0.27)and(1.65±0.20)g·L^(-1),the difference was statistically significant(all P<0.05).The adverse drug reactions of treatment group and control group were diarrhea,nausea and vomiting,rash.The total incidence of adverse reactions in treatment group and control group was 8.52%(13 cases/152 cases)and 9.46%(14 cases/148 cases),there was no significant difference in the incidence of adverse reactions between the two groups(P>0.05).Conclusion The treatment of neonatal hyperbilirubinemia with yeast burra combined with ursodeoxychonic acid can effectively improve the levels of serum-GT,IGF-1 and RBP,and the clinical efficacy is good.