Clinical trial of Sacoharomyces boulardii with ursodeoxycholic acid in the treatment of neonatal hyperbilirubinemia
Objective To investigate the effects of Sacoharomyces boulardii 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-1 each time,twice a day,and took the tablet powder in warm water;the treatment group was additionally treated with Sacoharomyces boulardii 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 γ-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 γ-GT were(38.19±3.75)and(50.87±4.25)U·L-1;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 γ-GT,IGF-1 and RBP,and the clinical efficacy is good.
Saccharomyces boulardiiursodeoxycholic acidhyperbilirubinemianewborngamma-glutamate transpeptidaseinsulin like growth factor-1retinol-binding protein
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