Clinical efficacy of traditional Chinese medicine/herbal decoction combined with ursodeoxycholic acid for primary biliary cirrhosis:a meta-analysis
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摘要:
目的系统评价中药汤剂/中成药治疗原发性胆汁性肝硬化(PBC)的有效性,以期为临床用药提供参考。方法计算机检索Cochrane Library、Pub Med、中国期刊全文数据库(CNKI)、中文科技期刊全文数据库(VIP)、中国生物医学文献数据库(CBM)、万方医药期刊全文及学位论文数据库,截止日期2014年7月31日。收集公开发表的关于中药汤剂/中成药联合熊去氧胆酸(UDCA)与单用UDCA治疗PBC的随机对照试验(RCT),对纳入的文献进行资料提取和质量评价,采用Rev Man5.0软件进行Meta分析。结果共纳入12篇RCT文献,共计681例患者,其中试验组346例,对照组335例。Meta分析结果显示:在治疗6个月时,总体有效率、症状改善率、肝功能(ALT、ALP、GGT、TBil)、肝纤维化四项等指标,试验组优于对照组,两组比较差异有统计学意义(P值均<0.05);对于免疫学指标(免疫球蛋白a、免疫球蛋白g、抗线粒体抗体、抗线粒体抗体m2亚型),两组比较差异无统计学意义(p值均>0.05)。结论中药汤剂/中成药联合UDCA干预在治疗6个月时能明显改善PBC患者的肝...
Abstract:Objective To systematically evaluate the efficacy of traditional Chinese medicine / herbal decoction combined with ursodeoxycholic acid(UDCA) in the treatment of primary biliary cirrhosis(PBC),and to provide a reference for clinical medication.Methods Literature published before July 31,2014 was searched in databases as follows:Cochrane Library,Pub Med,China National Knowledge Infrastructure(CNKI),Chinese Scientific Journals Full-text Database(VIP),Chinese Biomedical Literature Database(CBM),and Wanfang Data.The randomized controlled trials(RCTs) comparing the efficacy of traditional Chinese medicine / herbal decoction combined with UDCA versus UDCA alone in PBC patients were included in the analysis.The methodological quality of included trials was assessed and the data were extracted,followed by meta-analysis using Rev Man 5.0 software.Results A total of 12 RCTs were included,involving 681 patients with 346 in the test group and 335 in the control group.The results of meta-analysis showed that,after 6 months of treatment,the overall response rate,improvement rate,and biochemical indices of liver function(ALT,ALP,GGT,and TBil) and hepatic fibrosis in the test group were significantly improved compared with those in the control group(all P < 0.05).There were no significant differences between the two groups in the immunological indices such as Ig A,Ig G,anti-mitochondrial antibody(AMA),and AMA M2 subtype(all P > 0.05).Conclusion Traditional Chinese medicine / herbal decoction combined with UDCA markedly improves the indices of hepatocellular necrosis and cholestasis,degree of hepatic fibrosis,and clinical symptoms in PBC patients after 6 months of treatment,but leads to no significant improvement in immunological indices.Due to the limited number of included RCTs and patients through systematic evaluation,and the presence of selection bias and publication bias,more double-blind randomized controlled trials with large sample size,multicenter involvement,and high quality are required to provide convincing evidence.
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