评价茵栀黄口服液辅佐治疗早产儿高胆红素血症的效果及安全性。

选取2016年9月至2018年2月东南大学附属徐州医院新生儿科收治的早产儿高胆红素血症患儿纳入研究。按照随机数字法将最终入选的136例患儿随机分为两组：单纯光疗组（光疗组，67例），仅给予光疗治疗；光疗联合茵栀黄组（联合组，69例），给予光疗及茵栀黄口服液2 ml/kg，每日2次，连服5 d。每12小时检测1次胸骨旁贴片遮盖下的经皮胆红素（TcB）。采用四格表资料的χ²检验比较光疗组和联合组男性比例、5 min Apgar评分≤7分、生后24 h内发现黄疸、入组前纯母乳喂养、同族免疫性溶血病、体温不稳定、显著萎靡、头颅血肿、血白蛋白<30 g/L、腹泻和皮疹等情况。采用两组独立样本均数t检验比较两组胎龄、出生体质量、开始光疗时龄等资料。采用重复测量数据的方差分析比较光疗组和联合组光疗第0小时、第60小时和第120小时的TcB以及光疗第60小时和第120小时的TcB下降率。对联合组光疗120 h内大便总次数与光疗第120小时TcB下降值的相关性采用积矩相关性分析（Pearson相关系数）。

两组患儿在性别、胎龄、出生体质量、5 min Apgar评分≤7分、生后24 h内发现黄疸、开始光疗时龄、入组前纯母乳喂养、同族免疫性溶血病、体温不稳定、显著萎靡、头颅血肿、血白蛋白<30 g/L等方面差异均无统计学意义（P均>0.05）。联合组光疗第60小时TcB与光疗组比较，差异无统计学意义（P>0.05）。联合组光疗第120小时TcB与光疗组比较显著降低，差异有统计学意义［（160.7±15.4）μmol/L vs（167.6±18.8）μmol/L，P=0.016］。两组光疗第60小时、第120小时TcB下降率比较，差异无统计学意义（P均>0.05）。两组腹泻、皮疹发生率差异无统计学意义（P均>0.05）。光疗组未发生严重腹泻，联合组发生2例严重腹泻；两组均未发生严重皮疹。联合组光疗120 h内大便总次数与光疗第120小时TcB下降值呈显著线性正相关关系（r=0.709，P<0.001）。

茵栀黄口服液在辅佐光疗治疗早产儿高胆红素血症方面有一定效果，但起效较慢；腹泻和皮疹等不良反应发生率与单纯光疗比较无明显差别。

To evaluate the efficacy and safety of Yinzhihuang oral liquid for the treatment of hyperbilirubinemia in preterm infants.

One hundred and thirty-six preterm infants with hyperbilirubinemia were enrolled from September 2016 to February 2018 at the Affiliated Xuzhou Hospital of Southeast University, and they were divided randomly into either a phototherapy group (67 cases, treated only with phototherapy) or a combination treatment group (69 cases, treated with phototherapy and Yinzhihuang oral liquid (2 mL/kg, q12h, for 5 days). Transcutaneous bilirubin (TcB) was measured at the marginal sternum covered by opaque material per 12 hours. The demographic data of infants in each group were compared by the Student′s t-test and chi-square test. TcB at 0 h , 60 h and 120 h after treatment and the reduction rates of TcB at 60 h and 120 h were compared by ANOVA of repeated measurement data. The correlation between the number of bowel movements and the reduction value of TcB during 120 h in the combination treatment group was analyzed by Pearson correlation analysis.

The demographic data of infants in each group were not significantly different (P>0.05). TcB at 60 h after treatment was not significantly different between the two groups (P>0.05). TcB at 120 h in the combination treatment group was significantly lower than that in the phototherapy group (160.7±15.4 μmol/L vs 167.6±18.8 μmol/L, P=0.016). The reduction rates of TcB at 60 h and 120 h were not significantly different between the two groups (P>0.05). The incidence of diarrhea and rashes were not significantly different between the two groups (P>0.05). Serious diarrhea was not found in the phototherapy group, but two cases were found in the combination treatment group. Serious rashes were not found in either group. The number of bowel movements and the reduction value of TcB had a significant positive linear correlation during 120 h (r=0.709, P<0.001).

Yinzhihuang oral liquid as an adjuvant therapy has an appreciated curative effect for hyperbilirubinemia in preterm infants, but it functions slowly and has a weak effect. Compared with the phototherapy group, the incidence of adverse reaction such as diarrhea and rashes is not significantly different in the combination treatment group.