Meta-analysis of randomized controlled trials of integrative medicine therapy for treatment of cholestatic liver disease
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摘要: [目的]评价中西医结合治疗肝内胆汁淤积性肝病（ICLD）的有效性。[方法]以"中医"、"中药"、"中成药"、"中西医结合"、"胆汁淤积"和"淤胆型肝炎"为检索词，检索CNKI、万方数据库知识平台、PubMed、VIP、CBM。纳入标准：纳入比较中药联合西医综合治疗ICLD与西医综合治疗的随机对照试验。采用Cochrane协作网提供的软件RevMan5.1进行资料分析。结局的效应指标为相对危险度或均数差，均以效应值和95%置信区间表示。[结果]共纳入22项随机对照试验，涉及1 579例ICLD患者，文献质量普遍偏低。口服中药、中药制剂及中药联合西医综合治疗均显著优于单纯西医治疗；中西医结合治疗降低TBIL、DBIL、ALP、γ-GT、ALT、AST疗效显著优于西医组，单纯口服中药在降低ALP方面显著优于西医组。[结论]中西医结合治疗ICLD具有促进肝功能恢复和提高有效率的作用。但是由于中文发表的临床试验质量较低，中西医结合治疗ICLD的优越性尚缺乏有力的证据。Abstract: [Objective] To evaluate the efficacy of integrative Chinese and western medicine therapy for cholestatic liver disease.[Methods] Literature was searched from China National Knowledge Infrastructure Database, Wanfang Database, PubMed and Chinese Scientific Periodical Full Text Database.The time limitation ran from 2001 to December 31, 2012.The methodological quality of literature was assessed by risk of bias table from Cochrane Collaboration and the data were analyzed by RevMan 5.1 software.The efficacy measure was relative risk(RR) or mean difference with a 95% confidence interval(CI).[Results] A total of 22 RCTs involving 1 579 patients with intrahepatic cholestasis liver disease was included.Quality of all included trials was low.In improving total effective rate, the oral Chinese medicine, Chinese medicine preparations and combined Chinese medicine and western medicine were superior to western medicine alone.In laboratory parameters, the integrative medicine group was better than western control group in reducing the total bilirubin, direct bilirubin, alkaline phosphatase alanine, γ-glutamyl transpeptadase, aminotransferase enzyme and aspartate aminotransferase.The oral Chinese medicine alone was better than western medicine alone in reducing the alkaline phosphatase alanine.[Conclusion] Integrate Chinese and western medicine can promote the recovery of liver function and improve the efficacy.However, because of a lower quality of clinical trials published in Chinese journals, the evidence is insufficient to prove the superiority of integrative therapy.
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