Abstract:

Objective

To evaluate the efficacy and safety of Yinzhihuang oral solution for the treatment of hyperbilirubinemia in neonatal infants.

Methods

The neonatal patients with hyperbilirubinemia，with gestational age≥32 weeks and birth weight≥1 500 g，were collected in the neonatal ward of children diagnosis and treatment center of Xuzhou central hospital，Nanjing university of traditional Chinese medicine from September 2015 to July 2016.Infants were randomly divided into two groups：light therapy group（phototherapy group，n=67）and phototherapy with Yinzhihuang oral solution group （combined group，n=69）.Phototherapy group was given only light therapy.Combined group was given light therapy and Yinzhihuang oral solution 2 mL/（kg·time），once every 12 hours，for 5 days.Peritoneal bilirubin （TCB）levels were monitored on the left margin of the sternum every 12 hours.The levels of TCB were recorded at 0 h of light therapy，60 h after light therapy and 120 h after light therapy in two groups.The incidence of rash and the incidence of diarrhea were also recorded.The decrease rate of TCB was calculated.The t-test was used to compare TCB levels at 60 h，the decrease rates of TCB at 60 h，TCB levels at 120 h and the decrease rates of TCB at 120 h between two groups.Theχ² test was used to compare the incident rates of rash and diarrhea between two groups.The repeated measurement of variance analysis was used to compare levels of TCB at 0 h of light therapy，60 h after light therapy and 120 h after light therapy between two groups.

Results

There were significant differences in TCBlevels at 0 h of light therapy，60 h after light therapy and 120 h after light therapy between two groups.（F=168.255，P＜0.05）.TCB levels were（167.6±23.9）μmol/L and （160.7 ±18.8）μmol/L at 120 h after light therapy for phototherapy group and combined group （t=2.027，P＜0.05）.The decrease rates of TCB at 60 h were（12.9±19.5）%and （19.3±14.6）%in phototherapy group and combined group，and there was significant difference between two groups（t=-2.155，P＜0.05）.The incident rates of rash at 120 h were 9.0% （6/67）and 10.1% （7/69）respectively in the phototherapy group and the combined group.The incident rates of diarrhea were 11.9% （8/67）and 21.7% 15/69）in the two groups.There were no significant differences in incident rates of rash and diarrhea between the two groups（χ² =0.056 and 2.323，P＞0.05）.

Conclusion

Yinzhihuang oral solution shows certain curative effect for neonatal hyperbilirubinemia as an adjuvant therapy，because of its slow and weak effect.

Key words: Drugs，Chinese herba, Hyperbilirubinemia，neonatal, Infant，premature