中药辅助治疗乙型肝炎相关性肝衰竭随机对照试验的系统综述

作者	单位	E-mail
王若宇,周宇帆,费宇彤
孙克伟	湖南中医药大学第一附属医院肝病中心（长沙410007）	keweisun@yahoo.com.cn

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中文摘要:

目的评价中药辅助治疗乙型肝炎相关性肝衰竭的疗效、安全性。方法以“肝衰竭、hepatic failure、重型肝炎、乙型肝炎、中医、随机、对照”等为主题词或自由词对相关随机对照试验进行检索，检索 PubMed、Cochrane肝胆病组试验注册资料库、Cochrane图书馆对照试验注册库、中国知网、维普数据库、万方数字化期刊网、中国临床试验注册中心（ChiCTR）。鉴定的相关文章附录的参考文献作为补充检索。参照Cochrane系统评价的要求，对所有评价中药治疗或辅助治疗乙型肝炎相关性肝衰竭有效性和安全性的随机对照试验进行方法学质量评价、数据的提取和数据的分析。结果共计21项随机对照试验被纳入，涉及1 881例肝衰竭患者。纳入的研究方法学质量普遍偏低。5项报道了病死率的研究中3项显示试验组病死率低于对照组（RR 0.40，95%CI ［0.20， 0.79］，P=0.0002）。6项随机对照试验共计20项结局报道了并发症的控制情况，8项结局显示试验组对某些并发症的控制优于对照组。无研究报道复发率及生活质量评价的情况。次要指标方面，4项研究显示试验组在无效率降低以及总胆红素值（TBIL）下降、凝血酶原活动度（PTA）升高方面优于对照组，其他研究做描述性分析发现对于次要指标的报道，试验组总体优于对照组，但并非所有指标比较差异均有统计学意义。仅2项研究报道了不良反应情况，均显示无严重不良反应发生。结论根据现有证据，尚无法判断常规西医治疗基础上的中药治疗对于肝衰竭患者病死率、复发率的降低、并发症的减少以及生活质量的改善是否有益。

英文摘要:

Objective To evaluate the effectiveness and safety of Chinese herbs as an adjuvant treatment for hepatitis virus B （HBV） related hepatic failure. MethodsData were retrieved through the Cochrane Hepato Biliary Group Controlled Trials Register， The Cochrane Library， PubMed， CNKI， VIP， Wanfang Database， and ChiCTR by key words or free words such as hepatic failure， severe hepatitis， HBV， Chinese medicine， randomization， and control. Appendix references of related papers were taken as supplementary indices. According to requirement for Cochrane systematic evaluation， randomized clinical trials on assessing the effectiveness and safety of Chinese herbs as main or adjuvant treatment in treating HBV related hepatic failure were methodologically assessed， data extracted and analyzed. ResultsTotally 21 trials on Chinese herbal medicine therapy versus standard medical therapy （involving 1 881 patients） were included. Most trials had unclear risk bias. In 5 studies on the mortality， 3 trials showed that the mortality was lower in the test group than in the control group ［RR 0.40， 95%CI （0.20， 0.79）， P=0.0002］． In 6 randomized control trials， totally 20 papers reported the control of complications. Eight results showed Chinese herbal medicine therapy had better effect in controlling complications. The recurrence rate and assessment of the survival quality were reported. Considering secondary indicators， four trials showed Chinese herbal medicine therapy had better effect in lowering the ineffective rate， decreasing total bilirubin （TBIL）， and elevating prothrombin activity （PTA）. Other prescriptive analyses found that the overall effect on secondary indicators was better in the test group than in the control group， but not all the indicators were statistically different. Adverse reactions were only reported in two papers， showing no severe adverse reaction. ConclusionAccording to present evidence， till now， we could not judge whether Chinese herbs， as an adjuvant treatment， could do any favor for lowering the incidence and recurrence of hepatic failure patients， and improving their survival qualities.

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