摘要
目的探讨聚乙二醇干扰素（Peg-IFN）α-2a治疗HBeAg阳性慢性乙型肝炎24周应答不佳患者序贯替比夫定及恩替卡韦104周疗效及安全性。方法130例经24周Peg-IFN。α-2a治疗，HBVDNA≥5．01gIU／ml，同时HBsAg定量较基线下降〈1．0lgIU／ml的HBeAg阳性慢性乙型肝炎患者，随机进入替比夫定组和恩替卡韦组，脱落5例。观察104周的HBeAg阴转率和血清学转换率、HBVDNA阴转率、安全性、耐药率。据资料不同分别采用t检验，x2检验或多因素Cox回归分析进行统计学分析。结果治疗104周，替比夫定组HBVDNA阴转率与恩替卡韦组相比差异无统计学意义垆=0．363）；HBeAg阴转率和HBeAg血清转换率替比夫定组均显著高于恩替卡韦组（61．29％与23．81％，51．61％与19．05％，P值均〈0．01）。男性、替比夫定治疗是HBeAg血清转换的基线预测因素。多因素Cox回归分析（ForwardLR，a=0．05）显示男性（HR=4．917）、替比夫定治疗12周HBsAg下降〉0．5lgIU／ml（FIR=3．514）、替比夫定治疗12周HBeAg下降〉1lgCOI（HR=8．651）与替比夫定治疗104周时是否出现HBeAg血清学转换相关。结论序贯替比夫定在HBeAg阴转率及血清转换率优于思替卡韦，可以作为Peg—IFN治疗HBeAg阳性慢性乙型肝炎24周应答不佳患者的优化治疗方案。12周HBeAg较基线下降〉1lgCOI可作为104周HBeAg血清学转换预测因素。
Objective To investigate the efficacy and safety of 104-week sequential therapy with telbivudine or entecavir in I-IBeAg-positive chronic hepatitis B （CHB） patients with suboptimal responses to 24- week pegylated interferon-α-2a （PEG-IFN-α-2a） therapy. Methods A total of 130 HBeAg-positive CHB patients with HBV DNA 〉/5.0 lg IU/ml and a reduction in HBsAg quantitation 〈 1 lg IU/ml compared with baseline who received PEG-1FN-α-2a therapy for 24 weeks were enrolled and randomly divided into telbivudine group and entecavir group, and 5 of them were lost. HBeAg clearance rate and seroconversion rate, HBV DNA clearance rate, safety, and drug resistance rate at week 104 were observed. The t-test, chi-square test, or multivariate Cox regression analysis were used for statistical analysis of different types of data. Results At week 104 of treatment, HBV DNA clearance rate showed no significant difference between the telbivudine group and entecavir group （P = 0.363）,and the telbivudine group had significantly higher HBeAg clearance rate and HBeAg seroconversion rate than the entecavir group （HBeAg clearance rate： 61.29% vs 23.81%, P 〈 0.01; HBeAg seroconversion rate： 51.61% vs 19.05%, P 〈 0.01）. Male sex and telbivudine therapy were baseline predictors of HBeAg multivariate Cox regression analysis （Forward LR, a = 0.05） showed that the presence or absence of HBeAg at week 104 was significantly associated with male sex （HR = 4.917）, a reduction in HBsAg 〉 0.5 lg IU/ml at week 12 of treatment compared baseline （HR = 3.514）, and a reduction in HBeAg 〉 1 lg COl at week 12 of treatment compared baseline （HR = 8.651）. Conclusion In HBeAg-positive CHB patients with suboptimal responses to 24-week PEG-IFNa-2a therapy, the sequential therapy with telbivudine helps achieve better HBeAg clearance rate and seroconversion rate compared with the sequential therapy with entecavir and can be used as a therapeutic regimen for such patients. A reduction in HBeAg 〉 1 lg COl at week 12 of treatment compared baseline can be used as a predictive factor for HBeAg seroconversion at week 104.
出处
《中华肝脏病杂志》
CAS
CSCD
北大核心
2016年第4期241-245,共5页
Chinese Journal of Hepatology
关键词
肝炎
乙型
慢性
干扰素
应答不佳
替比夫定
Hepatitis B, chronic
Interferon
Telbivudine
Suboptimal responses
