替比夫定治疗慢性乙型肝炎疗效的系统评价  

Efficacy of telbivudine for chronic hepatitis B:a systematic review

作　　者：杨声坪[1,2] 李婧媛[1,3] 张鹏 袁金秋[1,2] 刘雅莉[1] 

机构地区：[1]兰州大学循证医学中心兰州大学基础医学院,甘肃省兰州市730000 [2]兰州大学第一临床医学院,甘肃省兰州市730000 [3]平凉市人民医院,甘肃省平凉市744000

出　　处：《世界华人消化杂志》2011年第26期2777-2785,共9页World Chinese Journal of Digestology

摘　　要：目的:系统评价替比夫定(LDT)治疗慢性乙型肝炎(CHB)的治疗效果.方法:应用Cochrane系统评价方法计算机检索Cochrane Library(2009年第3期)、PubMed(1966-2009.9)、EMBASE(1974-2009.9)、中国生物医学数据库(CBM,1978-2009.9)、中国期刊全文数据库(CNKI,1979-2009.9)和维普数据库(VIP,1989-2009.9),同时在临床试验注册网站及Google搜索引擎进行检索,并追查纳入研究参考文献,收集以LDT治疗CHB的所有随机对照试验(RCT)和交叉试验.根据Cochrane协作网推荐的"风险评估工具"进行风险偏倚评估,用RevMan5.0软件进行统计学分析.结果:最终纳入10个RCTs,共4037例患者.7篇LDT对比拉米夫定(LAM)的研究结果显示,对于HBeAg阳性患者,LDT组较LAM组更有效提高血清HBVDNA检测不到率(RR=1.50,95%CI:1.38-1.64)、ALT复常率(RR=1.10,95%CI:1.05-1.16)、HBeAg转阴率(RR=1.23,95%CI:1.08-1.40)和HBeAg血清转换率(RR=1.17,95%CI:1.01-1.35);对于HBeAg阴性患者,LDT组较LAM组更有效提高血清HBVDNA检测不到率(RR=1.29,95%CI:1.12-1.40),两组ALT复常率差异无统计学意义(RR=1.08,95%CI:0.96-1.21).2篇LDT对比阿德福韦酯以及1篇LDT对比治疗方案不详的常规内科治疗的研究结果均显示LDT组效果优于对照组.结论:LDT相比其他药物治疗CHB对病毒学应答、血清学应答、生化学应答等方面指标有效,但对于不同疗程的总体效果还需要更为大量的高质量文献提供科学的证据.AIM： To evaluate the efficacy of telbivudine in the treatment of chronic hepatitis B. METHODS： Based on the principles and methods for Cochrane systematic reviews, we searched the Cochrane Library, PubMed, EM- BASE, Chinese Bio-medicine Database, China Journal Full-text Database, VIP database, as well as websites of clinical trial registries and search engine Google. Randomized controlled trials （RCTs） or cross-over trials of telbivudine for chronic hepatitis B were included. We assessed the quality of the included trials according to the Cochrane Handbook for Systematic Reviews of Interventions Version. The Cochrane Collaboration＇s software RevMan 5.0 was used for meta- analysis. RESULTS： Ten RCTs totaling 4 037 patients were included. Compared to HBeAg-positive patients treated with lamivudine, those treated with telbivudine had significantly higher rates of serum HBV DNA undetectable by PCR （RR = 1.50, 95%CI： 1.38, 1.64）, ALT normalization （RR = 1.10, 95%CI： 1.05, 1.16）, HBeAg loss （RR = 1.23, 95%CI： 1.08-1.40）, and HBeAg seroconversion （RR -- 1.17, 95%CI： 1.01-1.35）. HBeAg-negative patients treated with lamivudine had a lower rate of serum HBV DNA undetectable by PCR （RR = 1.29, 95%Ch 1.12-1.40） than those treated with telbivudine. CONCLUSION： Current evidence demonstrates that treatment with telbivudine can improve virological response, serological response and biochemical response in patients with chronic hepatitis B compared to lamivudine therapy.

关 键 词：替比夫定 慢性乙型肝炎 系统评价 

分 类 号：R4[医药卫生—临床医学]