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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研究 被引量:2

A randomized controlled study on the efficacy and safety of Yinzhihuang oral liquid for the treatment of hyperbilirubinemia in preterm infants
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摘要 目的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。方法选取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2ml/(kg?次),每日2次,连服5d。每12h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、5minApgar评分≤7分、生后24h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<30g/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120h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)。结果两组患儿在性别、胎龄、出生体质量、5minApgar评分≤7分、生后24h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<30g/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)。与光疗组比较,联合组光疗第120小时TcB显著降低,差异有统计学意义[(160.7±15.4)μmol/Lvs.(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120h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)。结论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。 Objective To evaluate the efficacy and safety of Yinzhihuang oral liquid for the treatment of hyperbilirubinemia in preterm infants.Yinzhihuang oral liquid is a herbal extract with the main components of Herba Artemisiae Scopariae,Scutellaria,Lonicera Japonica and Gardenia jasminoides. Methods The preterm infants Neonates with hyperbilirubinemia were enrolled from September 2016 to February 2018 in the Affiliated Xuzhou Hospital of Southeast University.All 136 cases were divided randomly into two groups:phototherapy group (67 cases,treatead only with phototherapy),and combine group (69 cases,treated with phototherapy and Yinzhihuang oral liquid,2 ml/kg,q12 h,and persisited for 5 days).The transcutaneous bilirubin (TcB) was measured at the marginal sternum coverd by opaque material per 12 hours.The demographic data of infants in each group were compared by student′s t test and chi-square test.TcB before treatment,after treatment for 60 h and 120 h,the reduction rate of TcB for 60 h and 120 h were compared by ANOVA of repeated measurement data.The number of bowel movement and the reduction value of TcB in combine group were compared by Pearson correlation analysis.Results The demographic data of infants in each group was not significantly different (P > 0.05).TcB after treatment for 60 h between two groups was not significantly different (P > 0.05).TcB after treatment for 120 h in combine group was lower than that in phototherapy group [(160.7±15.4)μmol/L vs.(167.6±18.8)μmol/L,P=0.016].The reduction rate of TcB for 60 h and 120 h between two groups was not significantly different (P > 0.05). The incidence of diarrhea and rushes were not significantly different (P > 0.05).Serious diarrhea was not found in phototherapy group,but 2 cases were found in combine group.Serious rushes were not found in both groups.The number of bowel movement and the reduction value of TcB were significant linear positive correlation during 120 h (r=0.709,P < 0.001).Conclusion Yinzhihuang oral liquid had certain curative effect for hyperbilirubinemia in preterm infants as an adjuvant therapy,but it took on action slowly and this effect was weak.Compared with phototherapy group,the incidence of adverse reaction such as diarrhea and rushes were not significantly different.
作者 赵丹丹 黄迪 高翔羽 杨波 任漪 李敏 张静 Zhao Dandan;Huang Di;Gao Xiangyu;Yang Bo;Ren Yi;Li Min;Zhang Jing(Department of Neonatology,The Affiliated Xuzhou Hospital of Southeast University,Xuzhou 221009,China)
出处 《中华临床医师杂志(电子版)》 CAS 2019年第1期1-6,共6页 Chinese Journal of Clinicians(Electronic Edition)
基金 江苏省妇幼健康重点学科专项资金(1-2-2017.2.4)
关键词 茵栀黄 高胆红素血症 婴儿 早产 Yinzhihuang hyperbilirubinemia infant,preterm
作者简介 通信作者:高翔羽,Email:g.xy@163.com.
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