Yan Jing-Jing, Xia Xiao-Ping, Bu Na
Obstetrics and Gynecology Hospital Affiliated to School of Medicine, Zhejiang University, Hangzhou 310006, China.
Zhongguo Zhong Yao Za Zhi. 2016 Dec;41(23):4428-4435. doi: 10.4268/cjcmm20162322.
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 RevMan 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.
系统评价茵栀黄口服液治疗妊娠期肝内胆汁淤积症(ICP)的临床疗效及安全性。检索截至2016年6月发表在Medline、Pubmed、Cochrane图书馆、中国知网(CNKI)、维普中文科技期刊全文数据库(VIP)、中国生物医学文献数据库(CBM)和万方数据库等数据库中的文献。根据纳入标准收集茵栀黄口服液的随机对照试验(RCT),并对所选文献的方法学质量进行评价。采用RevMan 5.3软件进行Meta分析。共纳入7项RCT,涉及711例患者。Meta分析结果显示,与对照组相比,茵栀黄口服液能显著缓解瘙痒症状[MD = -0.68,95%CI(-0.95,-0.41),P < 0.000 01],降低包括总胆汁酸(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]和甘胆酸(CG)[MD = -0.71,95%CI(-0.89,-0.52),P < 0.000 01]在内的血液生化指标。在妊娠结局方面,茵栀黄口服液能显著提高出生体重[MD = 430.03,95%CI(219.28,640.78),P < 0.000 1]。然而,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]和新生儿窒息率[OR = 0.50,95%CI(0.18,1.43),P = 0.20]差异均无统计学意义。茵栀黄口服液疗效较好,不良反应较轻。然而,需要更多设计严谨、大样本、高质量的双盲随机对照试验来提供进一步的证据。