茵栀黄口服液辅助治疗妊娠肝内胆汁淤积症的Meta分析

Meta-analysis of Yinzhihuang oral liquid in treatment of intrahepatic cholestasis of pregnancy

系统评价茵栀黄口服液辅助治疗妊娠肝内胆汁淤积症(intrahepatic cholestasis of pregnancy,ICP)的有效性和安全性。计算机检索截止2016年6月,在Medline,Pubmed,Cochrane Library,中国期刊全文数据库(CNKI),中国生物医学文献数据库(CBM),万方和维普数据库中,检索茵栀黄口服液辅助治疗ICP的临床随机对照试验,对符合纳入标准的文献进行质量评价,使用Rev Man 5.3软件对数据进行Meta分析。最终纳入7篇随机对照研究,总计711例患者。Meta分析结果显示,与对照组相比,茵栀黄口服液能明显改善患者瘙痒症状[MD=-0.68,95%CI(-0.95,-041),P<0.000 01];降低血生化指标:总胆汁酸(TBA)[MD=-7.23,95%CI(-10.88,-3.58),P=0.000 1]、总胆红素(TB)[MD=-1.90,95%CI(-3.09,-0.70),P=0.002]、谷丙转氨酶(ALT)[MD=-39.08,95%CI(-56.46,-21.70),P<0.000 1]、甘胆酸(CG)[MD=-0.71,95%CI(-0.89,-0.52),P<0.000 01];在改善妊娠结局方面,能明显增加新生儿出生体重[MD=430.03,95%CI(219.28,640.78),P<0.000 1];但在剖宫产率[OR=0.93,95%CI(0.36,2.36),P=0.87]、早产率[OR=0.63,95%CI(0.28,1.42),P=0.26]、新生儿窒息率[OR=0.50,95%CI(0.18,1.43),P=0.20]方面差异无统计学意义。目前有限的证据表明茵栀黄口服液辅助治疗ICP具有一定的疗效性且优于对照组,不良反应轻微,但需要更多设计严谨、大样本、高质量的临床随机对照研究进一步证实。

To systematically review the clinical efficacy and safety of Yinzhihuang oral liquid in the treatment of intrahepatic cholestasis of pregnancy（ ICP）. Literatures published by June 2016 were searched in databases,such as Medline,Pubmed,Cochrane Library,China National Knowledge Infrastructure（ CNKI）,Chinese Scientific Journals Full-text Database（ VIP）,Chinese biomedical literature database（ CBM）,and Wanfang Database. Randomized controlled trials（ RCT） of Yinzhihuang oral liquid were collected according to the inclusion criteria,and the methodological quality of selected literatures was evaluated. The Meta-analysis was conducted by using Rev Man 5. 3 software. A total of 7 RCTs involving 711 patients were included. The results of Meta-analysis showed that,compared with control group,Yinzhihuang oral liquid significantly alleviated pruritus symptoms[MD =-0. 68,95% CI（-0. 95,-041）,P 〈 0. 000 01],reduced blood biochemical indexes including TBA[MD =-7. 23,95% CI（-10. 88,-3. 58）,P = 0. 000 1],TB[MD =-1. 90,95% CI（-3. 09,-0. 70）,P = 0. 002],ALT[MD =-39. 08,95% CI（-56. 46,-21. 70）,P 〈 0. 000 1],and CG [MD =-0. 71,95% CI（-0. 89,-0. 52）,P 〈 0. 000 01]. In the respect of pregnancy outcome,Yinzhihuang oral liquid can distinctly improve birth weight [MD = 430. 03,95% CI（ 219. 28,640. 78）,P 〈 0. 000 1]. However,there was no significant difference in cesarean section rate [OR = 0. 93,95% CI（ 0. 36,2. 36）,P = 0. 87 ],preterm birth rates [OR = 0. 63,95% CI（ 0. 28,1. 42）,P = 0. 26],and neonatal asphyxia rate [OR = 0. 50,95% CI（ 0. 18,1. 43）,P = 0. 20]. Yinzhihuang oral liquid showed better efficiency and slighter adverse reaction. However,more rigorously designed,double-blind,randomized controlled trials with large sample size and high quality are required to provide further evidences.