目的评价熊去氧胆酸(UDCA)与s一腺苷蛋氨酸(SAMe)联合及单独使用改善妊娠肝内胆汁淤积症(ICP)妊娠结局的疗效和安全性。方法计算机检索MEDLINE、EMBASE、Cochaneubrary、CBM、CNKI和万方数据库,检索日期为建库始至2011年12月,根据C0chrane手册评价纳入研究的偏倚风险。结果共纳入10项随机对照试验的727例研究对象,偏倚风险低。Meta分析显示:UDCA与SAMe联合使用,较单用UDCA能降低剖官产率(OR=0.45,95%CI:0.24~0.86)、早产率(OR=0.36,95%CI:0.20~0.63)和新生儿窒息率(OR=0.27,95%CI:0.13~0.56),差异均有统计学意义(P〈0.05),但不能改善羊水粪染率(OR=0.38,95%CI:0.14~1.01)和新生儿出生体质量(MD=397.36,95%CI:-96.17~890.89);联合使用较单用SAMe能降低早产率(OR=0.39,95%CI:0.21~0.73)、新生儿窒息率(OR=0.23,95%CI:0.07~0.75)和羊水粪染率(OR=0.41,95%CI:0.20~0.85),差异均有统计学意义(P〈0.05),但不能改善剖宫产率(OR=0.62,95%CI:0.27~1.44)和新生儿出生体质量(MD=445.95,95%a:-143.51~1035.42);单用UDCA与单用SAMe在改善剖宫产率(OR=0.91,95%CI:0.47~1.78)、早产率(OR=0.82,95%CI:0.49~1.38)、新生儿窒息率(OR=0.90,95%CI:0.38~2.12)、羊水粪染率(OR=1.14,95%CI:0.61~2.13)和新生儿出生体质量(MD=-62.86,95%CI:-157.81~32.09)方面,差异无统计学意义。6项研究报道无不良反应产生。本系统评价纳入研究未使用随机分配方案的隐藏和盲法。结论UDCA与SAMe联合使用较单用UDCA或SAMe能更好改善ICP妊娠结局,且较为安全,但仍需高质量、大样本、严格设计和实施的多中心随机对照研究提供证据。
Objective To conduct a systematic review and meta-analysis of randomized controlled trials (RCTs) that have assessed the effect and safety of ursodeoxycholic acid (UDCA), S-adenosylmethionine (SAMe) and UDCA-SAMe combination therapies for intrahepatic cholestasis of pregnancy (ICP). Methods Using searching protocols and assessment methods recommended by the Cochrane Collaboration to reduce bias in systematic reviews, the databases of Medline, EMBASE, Cochrane Central Register of Controlled Trials (CCRT), China National Knowledge Infrastructure (CNKI), Chinese BioMedical Literature (CBM) and Wanfang China Online Journals were searched to identify relevant RCTs published from database inception to December 2011. Results Ten RCTs (of 727 pregnant women) were included in the study and represented a low risk for bias. Compared to the patients who received UDCA monotherapy, those who received UDCA-SAMe combination therapy had significantly lower rates of Cesarean section (odds ratio (OR) = 0.45, 95% confidence interval (CI: 0.24-0.86), preterm birth (OR = 0.36, 95% CI: 0.20-0.63), and fetal asphyxia (OR = 0.27, 95% CI: 0.13-0.56) (all, P 〈 0.05); however, the UDCA-SAMe therapy did not provide better rates of amniotic fluid pollution (OR = 0.38, 95% CI: 0.14-1.01) or better new born weight (mean difference (MD) = 397.36, 95% CI: -96.17-890.89). Compared to the patients who received SAMe monotherapy, those who received UDCA-SAMe combination therapy had significantly lower rates of preterm birth (OR = 0.39, 95% CI: 0.21-0.73), fetal asphyxia (OR = 0.23, 95% CI: 0.07-0.75), and amniotic fluid pollution (OR = 0.41, 95% CI: 0.20-0.85) (all, P 〈 0.05); however, the UDCA-SAMe therapy did not provide better rates of Cesarean section (OR = 0.62, 95% CI: 0.27-1.44) or better new born weight (MD = 445.95, 95% CI:-143.51-1035.42). Comparison of the two monotherapies (UCDA vs. SAMe) showed no statistical differences