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目的评价熊去氧胆酸对妊娠期肝内胆汁淤积症患者妊娠结局的影响。方法检索Pubmed、Medline、中国期刊文献数据库、维普中文科技期刊全文数据库、万方数据库及中国生物医学文献数据库,纳入熊去氧胆酸治疗妊娠期肝内胆汁淤积症的随机对照临床试验(RCTs)研究文献并评价其质量,用Stata 12.0统计软件进行分析。结果共纳入12个随机对照试验,包括664例妊娠期肝内胆汁淤积症患者。Meta分析结果显示:1熊去氧胆酸组在降低早产率[RR=0.49,95%CI=0.28~0.84,P=0.01]和胎儿窘迫发生率[RR=0.45,95%CI=0.20~0.99,P=0.04]方面优于S-腺苷基蛋氨酸组,在剖宫产率、羊水粪染率、5 min Apgar评分<7发生率人数及入住新生儿重症监护室发生率方面无显著性差异;2熊去氧胆酸组在降低早产率[RR=0.50,95%CI=0.34~0.73,P=0.000 1]、胎儿窘迫发生率[RR=0.52,95%CI=0.29~0.94,P=0.02]、5 min Apgar评分<7发生率人数[RR=0.26,95%CI=0.10~0.69,P=0.006]以及入住新生儿重症监护室发生率方面[RR=0.39,95%CI=0.17~0.88,P=0.02]优于安慰剂组,而在降低剖宫产率、羊水粪染率方面无显著性差异;(3)熊去氧胆酸组在降低早产率方面优于消胆胺组[RR=0.50,95%CI=0.27~0.94,P=0.03];(4)熊去氧胆酸组与地塞米松组相比,各项指标均无显著性差异。结论熊去氧胆酸对改善妊娠期肝内胆汁淤积症患者妊娠结局有一定的效果。
Objective To evaluate the effect of ursodeoxycholic acid on pregnancy outcome in patients with intrahepatic cholestasis of pregnancy. Methods Randomized controlled trials (RCTs) of Pubmed, Medline, Chinese Periodical Literature Database, VW Chinese Science and Technology Journals Full Text Database, Wanfang Database and China Biomedical Literature Database were included in this study. The literature was reviewed and evaluated for quality, using Stata 12.0 statistical software for analysis. Results A total of 12 randomized controlled trials were included, including 664 patients with intrahepatic cholestasis of pregnancy. Meta-analysis showed that: 1 Ursodeoxycholic acid group in reducing preterm birth rate [RR = 0.49,95% CI = 0.28-0.84, P = 0.01] and fetal distress incidence [RR = 0.45,95% CI = 0.20 ~ 0.99 , P = 0.04] was superior to S-adenosylmethionine group. There was no significant difference in cesarean section rate, meconium-stained amniotic fluid, 5-minute Apgar score <7 and incidence of neonatal intensive care unit ; 2 Ursodeoxycholic acid group in reducing preterm birth rate [RR = 0.50,95% CI = 0.34-0.73, P = 0.0001], fetal distress incidence [RR = 0.52,95% CI = 0.29 ~ 0.94, P = 0.02]. The incidence of Apgar score <7 at 5 min [RR = 0.26, 95% CI = 0.10-0.69, P = 0.006] and incidence of neonatal intensive care unit admission [RR = 0.39,95% CI = 0.88, P = 0.02] was superior to placebo group, but there was no significant difference in reducing cesarean section rate and meconium-stained amniotic fluid rate. (3) Ursodeoxycholic acid group was superior to cholestyramine group in reducing preterm labor rate [RR = 0.50, 95% CI = 0.27-0.94, P = 0.03]; (4) Compared with dexamethasone group, there was no significant difference in each index between the ursodeoxycholic acid group and the dexamethasone group. Conclusion Ursodeoxycholic acid has some effect on improving pregnancy outcome in patients with intrahepatic cholestasis of pregnancy.