中等剂量熊去氧胆酸治疗原发性胆汁性肝硬化的系统评价  

Mid-dosage ursodeoxycholic acid treatment for primary biliary cirrhosis:a systematic review

作　　者：施健[1] 刘苏[1] 陈伟忠[1] 曾欣[1] 陈岳祥[1] 杨秀疆[1] 谢渭芬[1] 

机构地区：[1]第二军医大学长征医院消化内科,上海200003

出　　处：《中华消化杂志》2005年第6期355-358,共4页Chinese Journal of Digestion

摘　　要：目的评价长期应用中等剂量熊去氧胆酸治疗原发性胆汁性肝硬化的疗效及安全性。方法对全世界关于中等剂量(13～15mg·kg-1·g-1)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7项随机对照试验,累计1038例患者。熊去氧胆酸能显著改善患者的肝功能生化检测指标,但不能改善疲劳和瘙痒等症状。病程Ⅰ至Ⅱ期的患者治疗2年后肝脏组织学显著好于对照组(P=0.03),但分析所有患者时差异无统计学意义(P=0.08)。荟萃分析显示治疗组与对照组间死亡率(OR0.99,95%可信区间0.62～1.58)、肝病相关死亡率(1.05,0.53～2.05)、肝移植率(0.87,0.53～1.41)、死亡和(或)肝移植率(0.92,0.64～1.31)和肝功能失代偿率(0.94,0.60～1.49)差异无统计学意义。结论熊去氧胆酸能有效改善肝功能,但不能改善症状,也无足够证据支持熊去氧胆酸能延长患者的生存期。早期患者及早并长期应用熊去氧胆酸可能延缓肝脏组织学进展。Objective To assess the long-term efficacy and safety of mid-dosage (13～15 mg·kg-1·g-1) 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 Seven trials including 1038 patients were assessed. UDCA could significantly improve liver biochemistry, but had no effect on pruritus and fatigue. In the patients with initial stage Ⅰ-Ⅱ, there was a significant decrease in the histologic progression after treatment with UDCA for 2 years compared with the placcebo group(P=0.03), but there was no significant difference between the two groups when considering overall patients with initial stage Ⅰ-Ⅳ (P=0.08). Meta-analysis showed no significant difference in the incidence of death (odds ratio 0.99, 95% confidence interval 0.62-1.58), liver related death (1.05, 0.53-2.05), liver trans-plantation (0.87, 0.53-1.41), death and/or liver transplantation (0.92, 0.64-1.31) and liver decompensation (0.94, 0.60-1.49) between the UDCA and placebo groups. Conclusions The analysis of RCTs of UDCA versus placebo shows improvement of liver biochemistry, but not improvement of clinical symptoms and survival. UDCA may slow down liver histologic progression in the early-stage patients with PBC.

关 键 词：熊去氧胆酸 治疗 原发性胆汁性肝硬化 评价 

分 类 号：R575.2[医药卫生—消化系统]