中药联合熊去氧胆酸胶囊治疗原发性胆汁性肝硬化疗效系统评价*

目的 系统评价中药联合熊去氧胆酸胶囊治疗原发性胆汁性肝硬化的有效性及安全性。方法 采用Cochrane 系统评价方法，计算机系统检索中国知识资源总库（CNKI）、万方学术期刊全文数据库、维普期刊全文（VIP）数据库、MEDLINE、PUBMED，检索2009年11月～2014年11月正式发表的文献。根据纳入和排除标准选择文献，按照相关质量评价标准进行评价，提取相关性研究指标，应用Revman5.3软件对数据进行Meta分析。结果 共纳入10项中西医结合治疗原发性胆汁性肝硬化的随机对照试验（RCT），Jadad量表评分均为1～3分；纳入研究中提及治疗疗效的共有8个RCT文献，包括368例PBC患者，其中中药联合熊去氧胆酸（UDCA）治疗组187例，单用UDCA治疗的对照组181例。Meta分析显示中药联合UDCA治疗的有效率明显高于单用UDCA组，差异有统计学意义OR=3.83，95%CI （2.09，7.02），P<0.0001]；联合组患者血清ALP、GGT、TBIL、ALT、AST、TBA水平下降较对照组更明显。结论 中药联合熊去氧胆酸胶囊治疗原发性胆汁性肝硬化的疗效显著优于单用熊去氧胆酸胶囊治疗，但该类研究的论文质量不高，可信度较低。

Systemic review of Chinese herbal medicine combined with ursodeoxycholic acid in treatment of patients with primary biliary cirrhosis

Objectives To evaluate the effectiveness and safety of Chinese herbal medicine combined with ursodeoxycholic acid （UDCA） in treatment of patients with primary biliary cirrhosis （PBC）. Methods The randomized controlled trials（RCT） articles on combination of herbal medicine and UDCA in treatment of patients with PBC were retrieved from China national knowledge infrastructure （CNKI），Wanfang academic journal database，Vip journal database（VIP），Medline and Pubmed from November 2009 to November 2014 by Cochrane systemic review method and materials were analyzed by Revman5.3 software. Results We obtained 10 randomized controlled trials and their Jadad scores were one to three. Eight out of the ten RCT giving efficacy included 368 patients with PBC，with 187 with combination treatment and 181 with UDCA alone. Meta analysis showed that the effectiveness rate in combination group was statistically significant different as compared to that in UDCA alone OR=3.83，95%CI （2.09，7.02），P<0.0001]；the serum ALP，GGT，TBIL，ALT，AST，TBA levels in combination group decreased more obviously than in control. Conclusion Chinese herbal medicine combined with UDCA in treatment of patients with PBC is promising，but the studies needs more evidences to prove it.