中药联合核苷和核苷酸类药物治疗慢性乙型肝炎的系统评价  

Meta-analysis of the clinical efficacy of combination therapy with traditional Chinese medicine and nucleoside analogue antiviral drugs for chronic hepatitis B

作　　者：任爽[1] 张华[1] 胡鑫才 刘平[1,3] 

机构地区：[1]上海中医药大学附属曙光医院肝病研究所,上海201203 [2]江西中医学院附属医院,南昌330006 [3]上海中医药大学上海高校中医内科学E研究院,上海201203

出　　处：《临床肝胆病杂志》2013年第4期264-269,275,共7页Journal of Clinical Hepatology

摘　　要：目的系统评价中药联合核苷和核苷酸类药物治疗慢性乙型肝炎的疗效。方法检索中国期刊全文数据库、万方中国学位论文全文数据库、维普期刊全文数据库、中国生物医学文献数据库、MEDLINE、Embase、BIOSIS等数据库,纳入国内外公开发表的以中药联合核苷和核苷酸类药物为试验组,核苷和核苷酸类药物为对照组的治疗慢性乙型肝炎的随机对照试验(RCT);采用Jadad评分来评估各个研究的质量;研究数据的统计学分析使用Cochrane协作网提供的Revman5.0软件完成,采用固定或随机效应模型汇总研究结果。结果最终纳入14个随机对照试验,1篇研究方法学Jadad评分为3分,1篇为2分,其余为1分,共1386例慢性乙型肝炎患者,其中试验组703例,对照组683例。对于14篇的Meta分析显示:在治疗6个月和12个月时肝功能复常率(ALT、AST)和病毒学指标(HBeAg阴转率、HBeAg血清转换率、HBV DNA阴转率),联合干预组均优于对照组,两组比较差异有统计学意义;对于YMDD变异发生率,在6个月时两组差异无统计学意义,而继续治疗至12个月,联合干预组优于对照组。结论本系统评价结果表明,6个月以上的中药联合核苷和核苷酸类药物干预能明显改善慢性乙型肝炎患者肝功能(ALT、AST)以及HBeAg阴转率、HBeAg血清转换率、HBV DNA阴转率、YMDD变异发生率,优于核苷和核苷酸类药物单用。由于系统评价纳入的RCT和患者数量有限,且存在选择性偏倚和发表偏倚,期待有高质量的随机双盲对照实验提供有效证据。Objective To investigate whether the collected randomized controlled trials （RCTs） published to date have shown that supple- mental application of traditional Chinese medicine （TCM） improves the outcome of chronic hepatitis B （CHB） patients treated with nucleo- side analogue antiviral drugs. Methods Literature collections on the Chinese Biomedical Literature Database, the Chinese Academic Jour- nal Full -text Database, the Chinese Scientific Journals Database, PubMed, and Embase were searched from inception to July 2012 to iden- tify publications of RCTs comparing the therapeutic efficacy of TCM combined with nucleoside analogues lamivudine （ LDM ） , adefovir （ ADV）, entecavir （ETV） ） to treat CHB. Inclusion criteria included： patients with CHB for more than six months, serum HbsAg - positivi- ty, 2 x upper normal limit （ULN） ~〈 alanine aminotransferase （ALT） ~〈 10 x ULN, hepatitis B virus （HBV） DNA - positivity, and no pre- vious antiviral therapy for six months prior to study; a control group receiving a single nucleoside analogue; study treatment time of at least three months. The methodological quality of included RCTs was assessed using the Jadad scale. The meta - analysis was carried out with RevMan 5.0 software. Heterogeneity was examined by Chi - squared test. Pooled data was analyzed by the fixed effects model or random effects model, according to presence of heterogeneity. Publication bias was assessed by funnel plot asymmetry. Results A total of 14 RCTs were included in the analysis and comprised 1386 CHB patients with 703 in the trial groups and 683 in the control groups. Only one study had moderate -high methodological quality （Jadad score： 3 ）, and the remaining studies had low methodological quality （Jadad score： 2, n = 1 ; 1, n = 12）. The outcome measures included ： ALT normalization rate, aspartate aminotransferase （AST） normalization rate, hepatitis B e antigen （HbeAg） -negativity rate, HBeAg seroconversion rate, HBV DNA -negativi

关 键 词：肝炎 乙型 慢性 抗病毒药 核苷类 核苷酸类 

分 类 号：R512.62[医药卫生—内科学]