| Objective:(1)To analyze the factors related prognosis of hearing loss in moderate and severe bilirubin encephalopathy of newborn;(2)To explore the efficacy and safety of adipose stem cell paracrine factor(ASCF)in the treatment of neonatal moderate and severe bilirubin encephalopathy hearing impairment.Methods:This prospective study was a double-blind randomized case-control study.Infants with moderate or severe bilirubin encephalopathy admitted in the full term department of Human Children's Hospital between August 1,2014 and Apr 30,2016,were included in the study.All infants were randomly divided into two groups:observation group and control group.During hospitalization,the conventional treatment of Two groups was the same,whereas the observation group increased ASCF sheath injection on the basis of conventional treatment,operating in 12h,36h and 72h after admission,Respectively(0.2ml/branch/time,1U.).Follow-up of all cases was being performed on a regular basis,respectively,in 1 month,3 months,6 months and 12months after discharge.According to the WHO hearing impairment classification standard,compare two groups hearing outcome,in 6months and 12 months.Then collected data,analysis the general information,the value of serum total bilirubin(TSB),clinical manifestation,BIND scores and the influence of treatment on prognosis of bilirubin encephalopathy hearing damage.Results:(1)A total of 45 newborn infants constituted the study population in statistics,included observation group(23 cases)and control group(22 cases),with 24 male and 21 female.The mean gestational age was 38.8±1.2 weeks,the mean birth weight was 3217±422g,the average hospitalized days were 6.9±2.7 days,the mean value of TSB was 655.3±111.96umol/L.Sex,age of hospitalized days,gestational age,birth weight,etiology,the maximum value of TSB and BIND scores were not found statistically significant in two groups(P>0.05).Follow-up to12 months,4 patients'hearing were normal(8.9%),9 cases(20%)were mild hearing impairment,7 cases(15.6%)were moderately severe hearing disorder,15 cases(33.3%)were severe hearing impairment,10cases(22.2%)were extremely severe hearing disabilities.(2)The average peak of TSB in severe and above hearing impairment group was higher than moderate-severe and below hearing impairment group,693.3±121.9umol/l?607.9±77.5umol/l separately,there was statistically significant(F=7.407,P=0.009).The average peak of BIND scores in severe and above hearing impairment group were 6.8±1.4,higher than moderate-severe and below hearing impairment group(5.9±1.3),the differences were statistically significant(F=4.290,P=0.044).(3)The rate of severe and above hearing impairment of he patients with central respiratory failure was 68.8%,it was higher than the rate of cases without central respiratory failure(23.1%),there was statistically significant(?~2=7.810,P=0.008).(4)Follow-up to 3 months,the incidence of severe and above earing impairment has no statistical significance between observation group and control group;However,follow-up to 6 months,the incidence of severe and above hearing impairment in observation group were 39.1%,it was lower than the control group with 72.7%,there was statistically significant(?~2=5.140,P=0.023).we also found that the hearing outcomes of two groups in 6 months and 12 months are basically identical.(5)The relationship between different affecting factors and the outcome of hearing impairment in the observation group and control group:1)Among the infants without central respiratory failure,the rate of severe and above hearing impairment in observation group was lower than it it of the control group,with 0%and 60%respectively,the difference was statistically significant(?~2=6.240,P=0.035).2)When BIND score?7scores(the patients with severe bilirubin encephalopathy),the rate of severe and above hearing disorder in observation group was45.5%,lower than control group(90.0%),it showed statistically significant(?~2=4.677,P=0.043).3)Among the newborns accepted blood exchange transfusion twice,the rate of severe and above hearing damage in observation group was 33.3%,lower than the control group(100%),there existed statistically significant(?~2=6.741,P=0.021).(6)During treatment and follow-up to 12 months,all cases in observation group were not found any adverse reactions associated with ASCF sheath injection.Conclusion:(1)The maximum value of TSB,central respiratory failure and BIND score is associated with prognosis of moderate-severe bilirubin encephalopathy hearing impairment;(2)The treatment of ASCF sheath injection in neonatal severe bilirubin encephalopathy hearing impairment has certain curative effect;(3)There is no adverse reactions occurred in the treatment of ASCF sheath injection in hearing impairment of moderate and severe bilirubin encephalopathy. |
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