摘要目的 通过大样本的前瞻性多中心随机对照试验，评价茵栀黄口服液对足月新生儿高间接胆红素血症的治疗效果及安全性。方法 2010年3月至9月期间16家医院收治的胆红素水平达到美国儿科学会指南的时龄-胆红素水平曲线第40百分位的足月儿，随机分为单纯光疗组(409例)、苯巴比妥联合光疗组（373例）和茵栀黄口服液联合光疗组（395例）。入组后立即开始药物治疗，并持续5d,一旦胆红素水平达到光疗水平则加用光疗。分别记录各组患儿的一般资料，比较治疗前、治疗72 h和治疗完成后的血清胆红素水平及胆红素水平的下降率，以及不同干预对光疗率的影响。比较各组不良反应的发生率。结果 符合人选标准患儿共计1177例，男性707例(60.1％),汉族1119例(95.1％)。治疗前血清总胆红素平均为(282.0±70.9)μmol/L，最高为626 μmol/L。其中血清总胆红素水平在342 μmol/L～427μmol/L((20 mg/dl～25 mg/dl)的重度高胆红素血症186例，占15.8％；＞427 μmol/L(25 mg/dl)的极重度高胆红素血症30例，占2.5％。3组间治疗72 h的胆红素水平下降率差异没有统计学意义（F=2.89，P=0.056）。治疗完成后茵栀黄口服液组的胆红素水平下降率明显超过其他2组（F=5.55，P=0.004）。茵栀黄口服液组未接受光疗的比例显著高于苯巴比妥组和单纯光疗组(x2=47.38,P=0.000)。30例极重度高胆红素血症患儿，经过光疗或光疗联合药物治疗，虽未经换血，但均未出现神经系统症状。茵栀黄口服液联合光疗组有25.1％的患儿每天大便次数超过5次，该比例显著高于其他两组；皮疹的发生率高于苯巴比妥组，但是和单纯光疗组并没有显著差异。结论因黄疸入院的足月儿约18％是重度或极重度高胆红素血症。茵栀黄口服液联合光疗对于足月儿高间接胆红素血症具有较好的疗效，尽早服用茵栀黄口服液可以抑制胆红素水平进一步上升，使部分患儿避免光疗。应用茵栀黄口服液除大便次数增加和皮疹以外，未观察到其他严重不良反应。

abstractsObjective Alarge-scale prospective multicenter randomized controlled tial was conducted to evaluate the efficacy and safety of Yinzhihuang oral solution for the treatment of neonatal indirect hyperbilirubinemia in term newborn infants. Yinzhihuang oral solution is a herbal extract with the main components of Herba Artemisiae Scopariae, Scutellaria, Lonicera Japonica and Gardenia jasminoides. Methods A total of 16 hospitals participated in this study. From March to September 2010, the term infants whose bilirubin level ≥ 40 th percentile for age in hours were enrolled, except for those who received exchange transfusion or had signs of bilirubin encephalopathy. All the 1177 cases were divided randomly into three groups: phototherapy group (409 cases ), phenobarbital combined with phototherapy group (373 cases) and Yinzhihuang oral liquid combined with phototherapy group (395 cases). Phenobarbital and Yinzhihuang oral liquid was started once the infants participated the study, and persisted for 5 days. Phototherapy was added as soon as the bilirubin level reached the lowest threshold ( the threshold for infants at higher risk). The demographic data of infants in each group were recorded, the serum bilirubin level before treatment, after treatment for 72 hours and after the treatment completion were checked. The reduction rate of serum bilirubin and the phototherapy rate in different groups were compared. The adverse events were assessed as well. Results Of the total of 1177 cases, 707 (60. 1％ ) were male, 1119 cases (95. 1％ ) were of Han ethnicity. The average total bilirubin level before treatment was ( 282. 0 ± 70. 9) μmol/L and the highest level was 626 μmol/L The severe hyperbilirubinemia (total bilirubin level at 342 μmoL/L to 427 μmol/L) accounted for 15.8％ (186 cases), and the extremely severe hyperbilirubinemia (total bilirubin ＞427 μmol / L) accounted for 2. 5％ (30 cases). After treatment for 72 hours, the reduction of bilirubin was not significantly different among three groups ( F =2. 89, P =0. 056). After completion of treatment, the reduction rate of bilirubin in Yinzhihuang group was higher than that of the other two groups (F =5.55, P =0. 004). The rate of infants who did not receive phototherapy in Yinzhihuang group was higher than that in phenobarbital group (x2 =47. 38, P=0. 000). In Yinzhihuang group, more infants had bowel movements more than five times a day. The incidence of rashes was higher than that in phenobarbital group (P =0. 019), but no significant difference was found as compared with that in phototherapy group (P =0. 339). Conclusions About 18％ of the term infants who were admitted for jaundice had severe or extremely severe hyperbilirubinemia. Yinzhihuang oral solution combined with phototherapy is effective in bilirubin reduction. Early treatment with Yinzhihuang oral solution may inhibit further increase in bilirubin levels, reduce the phototherapy requirement.