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[摘要]
目的 系统评价茵栀黄口服制剂联用双歧杆菌活菌制剂治疗新生儿黄疸的有效性和安全性。方法 检索2000年1月-2018年12月PubMed、Embase、中国学术期刊全文数据库(CNKI)、中国生物医学文献数据库(CBM)、维普中文期刊全文数据库(VIP)和万方数据库发表的有关茵栀黄口服制剂联用双歧杆菌活菌制剂治疗新生儿黄疸的随机对照试验(RCT),应用RevMan 5.3软件进行Meta-分析。结果 共纳入14项RCTs,观察组和对照组分别为1 042例和972例。Meta-分析结果显示:观察组的痊愈率大于对照组[RR=0.68,95% CI (0.62,0.76),P<0.01]、黄疸消退时间小于对照组[MD=1.97,95% CI (1.77,2.17),P<0.01]、日均胆红素下降值大于对照组[MD=10.64,95% CI (9.07,12.20),P<0.01],亚组分析结果一致。在安全性方面,观察组不良反应(ADR)发生率小于对照组[RR=1.96,95% CI (1.23,3.13),P<0.01];亚组分析显示观察组ADR发生率小于空白对照组[RR=2.51,95% CI (1.12,5.66),P=0.03],但与茵栀黄口服制剂组[RR=1.98,95% CI (0.90,4.33),P>0.05]和双歧杆菌活菌制剂组[RR=1.45,95% CI (0.62,3.39),P>0.05]无统计学差异。结论 茵栀黄口服制剂联用双歧杆菌活菌制剂可以提高新生儿黄疸的疗效,同时可以有效减少新生儿黄疸的持续时间,加快黄疸的消退。
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[Abstract]
Objective To systematically review the efficacy and safety of Yinzhihuang Oral Preparation combined with Bifidobacteria Preparation in the treatment of neonatal jaundice. Methods RevMan 5.3 software was used to perform a Metaanalysis of randomized controlled trials (RCT) on the Yinzhihuang Oral Preparation combined with Bifidobacteria Preparation in the treatment of neonatal jaundice published from Jan. 2000 to Dec. 2018 in PubMed, Embase, CNKI, CBM,VIP and Wanfang database. Results A total of 14 RCTs were selected, with 1 042 cases in the intervention group and 972 cases in the control group. Metaanalysis showed that the cure rate of the intervention group was greater than that of the control group[RR=0.68, 95%CI(0.62, 0.76), P<0.01], jaundice regression time was shorter than that of the control group[MD=1.97, 95%CI (1.77, 2.17), P<0.01] and daily average bilirubin decline was higher than that of the control group[MD=10.64, 95%CI (9.07, 12.20), P<0.01], and subgroup analysis results were consistent. In terms of safety, the rate of ADR in the intervention group was lower than that in the control group[RR=1.96, 95%CI (1.23, 3.13), P<0.01], but subgroup analysis showed that, the rate of ADR in the intervention group was lower than that in the blank control group[RR=2.51, 95%CI (1.12, 5.66), P=0.03]. There had no statistical difference in Yinzhihuang Oral Preparation group[RR=1.98, 95%CI (0.90, 4.33), P>0.05] and Bifidobacteria Preparation group[RR=1.45, 95%CI (0.62, 3.39), P>0.05]. Conclusion Yinzhihuang Oral Preparation combined with Bifidobacteria Preparation can improve the efficacy of neonatal jaundice, and can effectively reduce the duration of neonatal jaundice and accelerate the regression of jaundice.
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