To Evaluate Yinzhihuang Oral Solution In Treating Neonatal Hyperbilirubinemia By Transcutaneous Bilirubin Meter

Objective:To evaluate the accuracy about the correlation of transcutaneous bilirubin(TcB)for total serum bilirubin(TSB)before and after phototherapy,at different sites:sternum(covered and uncovered),forehead and scapula.And to evaluate the efficacy and safety of Yinzhihuang oral solution for the treatment of neonatal hyperbilirubinemia,especially for preterm infants by TcB.Methods:Neonates who underwent blood test for TSB were enrolled from September 2015 to July 2016 in our hospital.1.TcB measurements were done by the transcutaneous bilirubinometer(JH20-1C)within 30 minutes after blood sampling for TSB after enrolled(364 cases,437 data).After phototherapy,TcB were measured at covered sternum,forehead,scapula within 30 minutes after blood sampling for TSB at the first hour(193 data)and 12-24 hours(175 data).2.Neonates(gestation age>32 weeks,and birth weight>1500g)with hyperbilirubinemia were divided randomly into two groups:phototherapy group(67 cases,treatead only with phototherapy),and combine group(69 cases,treated with phototherapy and Yinzhihuang oral liquid,2ml/kg,q 12 h,and persisited for 5 days.The transcutaneous bilirubin(TcB)was measured at the left marginal sternum coverd by opaque material per 12 hours.The demographic data of infants in each group were recorded.TcB before treatment,after treatment for 60 h and 120 h were checked.The total time of phototherapy,the rate of re-phototherapy and the adverse events were recorded during treatment as well.IBM SPSS 20.0 software was used for data analysis.Data were compared by Pearson correlation analysis,chi-square test,ANOVA of repeated measurement data,student's t test and Bland-Altman analysis.Results:1.Before phototherapy,correlations between TSB and TcB were similar for all TcB measurement sites(P<0.05),especially taken from sternum.After phototherapy both at the first hour and 12-24 hours,difference between TSB and TcB taken from covered sternum was similar(-1.2±2.3 mg/dl?-0.5±1.6 mg/dl).When TSB>15 mg/dl before phototherapy,difference between TSB and TcB taken from sternum was 1.5±1.6 mg/dl.When TSB<15 mg/dl,difference was-1.9±1.9 mg/dl.They were significantly different(P=0.000).And difference between TSB and TcB taken from sternum was not affected by sexuality,gestation age,birth wight,measured time and repeated measurement.When TcB taken from covered or uncovered sternum was less than TSB threshold for phototherapy 3.3 mg/dl and 4.2 mg/dl,or for stopping phototherapy 2.6 mg/dl and 3.2 mg/dl,it has false negative rate of 2.5%and 1%.2.TcB after treatment for 60 h between two groups was not significantly different(P>0.05).TcB after treatment for 120 h in combine group was lower than that in phototherapy group(9.4±1.1 mg/dl vs.9.8±1.4 mg/dl,P=0.045).The reduction rate of TcB in combine group was higher than that in phototherapy group.The total time of phototherapy(70.1± 13.0 h vs.72.0±13.4 h),the rate of re-phototherapy(31.9%vs.34.3%),the incidence of rushes(10.1%vs.9.0%)were not significantly different(P>0.05).The incidence of diarrhea in combine group was higher than that in phototherapy group(21.7%vs.11.9%),but there were no statistically significant difference(P=0.127).The number of bowel movement and the reduction value of TcB were significant linear positive correlation during 120 h(r=0.75,P=0.000).For combine group,the reduction rate of TcB after treatment for 60h and 120h in preterm infants subgroup(41 cases)were significantly lower than that in term infants subgroup(28 cases)(14.0±13.1%vs.26.9±13.4%,P=0.000;24.3±12.7%vs.35.4±11.7%,P=0.000).The total time of phototherapy(72.3±14.8 h vs.66.9±8.9 h),the rate of re-phototherapy(34.1%vs.28.6%),the incidence of rushes(9.8%vs.10.7%)and diarrhea(24.4%vs.17.9%)were not significantly different(P>0.05).Conclusions:1.Both uncovered sternum before phototherapy and covered sternum after phototherapy have better correlation with TSB,and can calculate TSB in assessment and management of neonatal jaundice.2.Yinzhihuang oral solution had certain curative effect for neonatal hyperbilirubinemia as an adjuvant therapy,but it took on action slowly and this effect was weak.The main adverse reaction was slightly increased number of bowel movement.The number of bowel movement and the effect were positive correlation.Yinzhihuang oral liquids had efficacy and safety treatment in preterm neonatal hyperbilirubinemia as an adjuvant therapy,but the efficacy was slightly lower than that in term infants.