期刊文献+

茵栀黄口服液治疗足月新生儿高间接胆红素血症的多中心随机对照研究 被引量:71

A multicenter randomized controlled study on the efficacy and safety of Yinzhihuang oral solution for the treatment of neonatal indirect hyperbilirubinemia in term newborn infants
原文传递
导出
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72h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626μmol/L。其中血清总胆红素水平在342μmol/L~427μmol/L((20mg/dl~25mg/dl)的重度高胆红素血症186例,占15.8%;〉427μmol/L(25mg/dl)的极重度高胆红素血症30例,占2.5%。3组间治疗72h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(x^2=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。 Objective A large-scale prospective multicenter randomized controlled trial was conducted to evaluate the efficacy and safety of Yinzhihuang oral solution for the treatment of neonatal indirect hyperbilimbinemia 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 626μmol/L. The severe hyperbilirnbinemia ( total bilirnbin 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 bilirnbin levels, reduce the phototherapy requirement.
出处 《中华儿科杂志》 CAS CSCD 北大核心 2011年第9期663-668,共6页 Chinese Journal of Pediatrics
关键词 高胆红素血症 新生儿 婴儿 新生 中草药 Hyperbilirnbinemia, neonatal Infant, newborn Drugs, Chinese herbal
  • 相关文献

参考文献12

二级参考文献24

  • 1殷杰,理查德.温伯格,刘家伟,周汉昭,张宝林,夏运成,王继贵,梁燕玲,许树梧,冯清泉.茵栀黄对动物高间接胆红素血症的胆红素排泄作用[J].中西医结合杂志,1989,9(5):289-291. 被引量:21
  • 2凌一揆 颜正华.中药学[M].上海:上海科学技术出版社,1992.136.
  • 3TheGroupofNeonatology ChinesePediatricSociety ChineseMedicalAssociation(中华医学会儿科学分会新生儿学组).Recommended intervention program of neonatal jaundice[J].中华儿科杂志,2001,39(3):184-187.
  • 4American Academy of Pediatrics Subcommittee on Hyper-bilirubinemia.Management of hyperbilirubinemia in the new-born infant 35 or more weeks of gestation.Pediatrics,2004,114(1):297-316.
  • 5Bhutani VK,Johnson L,Sivieri EM.Predictive ability of a predisarge hour-specific serum bilirubin for subsequent significant hyperbilirubinemia in healthy term and near-term newborns.Pediatrics,1999,103(1):6-14.
  • 6Bhutani VK,Maisels MJ,Stark AR,et al.Management of jaundice and prevention of severe neonatal hyperbilirubinemia in infants >or=35 weeks gestation.Neonatology,2008,94(1):63-67.
  • 7DongXY(董小玥) ChenYL YuZB etal.Comparison of three methods of measuring bilirubin and its clinical use[J].中国医师进修杂志,2009,32(33):63-66.
  • 8Karina G,Markus R,Boris R,et al.Bilirubin measurement for neonates:comparison of 9 frequently used methods.Pediatrics,2006,117(4):1174-1183.
  • 9Eggert LD,Wiedmeier SE,Wilson J,et al.The effect of instituting a prehospital-discharge newborn bilirubin screening program in an 18-hospital health system.Pediatrics,2006,117(5):855-862.
  • 10Varvarigou A,Fouzas S,Skylogianni E,et al.Transcutaneous bilirubin nomogram for prediction of significant neonatal hyperbilirubinemia.Pediatrics,2009,124(4):1052-1059.

共引文献83

同被引文献587

引证文献71

二级引证文献564

相关作者

内容加载中请稍等...

相关机构

内容加载中请稍等...

相关主题

内容加载中请稍等...

浏览历史

内容加载中请稍等...
;
使用帮助 返回顶部