目的评价长期服用熊去氧胆酸对原发性胆汁性肝硬化的疗效和安全性。方法对全世界熊去氧胆酸与安慰剂对照治疗原发性胆汁性肝硬化的随机对照试验进行系统评价。结果共纳入10个研究,1278例患者。熊去氧胆酸能改善患者的肝功能生化指标,但是不能改善患者的疲劳和瘙痒症状。Meta-分析治疗组与对照组病死率OR值为0.97(95%CI:0.61~1.53)、肝移植率OR值为0.87(95%CI:0.56-1.35)、死亡和/或肝移植OR值为0.96(95%CI:0.69~1.32)、肝病相关死亡率OR值为1.03(95%CI:0.75~1.41)、不良反应事件OR值为1.40(95%CI:0.72~2.71),差异无统计学意义(P〉0.05)。结论熊去氧胆酸虽然可以改善肝功能生化指标,但是不能改善症状,也无足够证据支持熊去氧胆酸延长原发性胆汁性肝硬化患者生存时间。
Objective To assess the long-term efficacy and safety of ursodeoxycholic acid (UDCA) treatment for primary biliary cirrhosis (PBC). Methods A systematic review of all randomized controlled trials (RCT) comparing UDCA with placebo was performed. Results Ten trials including 1 278 patients were assessed. UDCA could significantly improve liver biochemistry, but had no effect on pruritus and fatigue. Meta-analysis showed no significant difference in the incidence of death ( odds ratio 0.97,95% confidence interval 0.61 - 1.53 ), liver transplantation (0.87,0.56 - 1.35 ), death and/or liver transplantation (0.96,0.69 - 1.32), liver related death ( 1.03,0.75 - 1.41 ) and adverse event ( 1.40,0.72 - 2.71 ) between the UDCA and placebo groups. Conclusion The analysis of RCTs of UDCA versus placebo shows improvement of liver biochemistry, but not improvement of clinical symptoms and survival.