目的

评价茵栀黄口服液对新生儿高胆红素血症的疗效及安全性。

方法

收集2015 年9 月至2016 年7 月南京中医药大学附属徐州中心医院儿童诊疗中心新生儿科收治的胎龄≥32 周且出生体质量≥1 500 g的高胆红素血症患儿194 例。 按照随机数字表法随机分为单纯光疗组（光疗组）67 例和光疗联合茵栀黄组（联合组）69 例。 光疗组仅给予光疗治疗；联合组给予光疗治疗和茵栀黄口服液2 mL/（kg·次），每12 小时1 次，连续服用5 d。 每12 小时监测1 次胸骨左缘贴片遮盖下的经皮胆红素（TCB）水平，记录2 组患儿开始光疗时TCB水平、第60 小时TCB水平和第120 小时TCB水平，皮疹发生率及腹泻发生率，并计算TCB下降率。 采用SPSS20.0 行t检验比较2 组患儿第60 小时TCB水平、第60 小时TCB水平下降率、第12 小时TCB水平和第120 小时TCB水平下降率差异；采用χ² 检验比较2 组患儿皮疹发生率和腹泻发生率差异；采用重复测量方差分析比较2 组患儿开始光疗TCB水平、第60 小时TCB水平和第120 小时TCB水平差异。

结果

2 组重复测量开始光疗TCB水平、第60 小时TCB水平和第120 小时TCB水平的方差分析显示，2 组3 个时间点TCB水平比较，差异有统计学意义（F=168.255，P＜0.05）。 光疗组和联合组第120 小时TCB水平分别为（167.6 ±23.9）μmol/L和（160.7 ±18.8）μmol/L，2 组比较差异有统计学意义（t=2.027，P＜0.05）。 光疗组和联合组在第60 小时TCB水平下降率分别为（12.9 ±19.5）%和（19.3 ±14.6）%，2 组比较差异有统计学意义（t=-2.155，P＜0.05）。 光疗组和联合组在入组120 小时内皮疹发生率分别为9.0%（6/67）和10.1%（7/69），腹泻发生率分别为11.9%（8/67）和21.7%（15/69），2 组皮疹发生率和腹泻发生率比较，差异均无统计学意义（χ² 值分别为0.056 和2.323，P均＞0.05）。

结论

茵栀黄口服液在辅助光疗治疗新生儿高胆红素血症方面具有一定疗效，但起效较慢，作用较弱，仅能作为一种辅助疗法。

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.