南方医科大学学报

南方医科大学学报 ›› 2013, Vol. 33 ›› Issue (06): 878-.

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干扰素α和恩替卡韦治疗HBeAg阳性慢性乙型肝炎疗效的预测因素

谢志伟，周福元，周元平   

  • 出版日期:2013-06-20 发布日期:2013-06-20

Analysis of the factors for predicting the outcomes of interferon-α and entecavir treatments for chronic hepatitis B with positive HBeAg

  • Online:2013-06-20 Published:2013-06-20

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摘要： 目的探讨干扰素α和恩替卡韦（ETV）治疗e抗原（HBeAg）阳性慢性乙型肝炎（CHB）的48周临床疗效及其预测因素。方
法采用回顾性研究方法。共入组HBeAg阳性CHB患者129例，其中聚乙二醇化干扰素α-2a（PEG-IFNα-2a）组27例；普通干扰
素α（IFNα）组51 例；ETV组51 例。记录基线、12 周、24 周及48 周HBeAg定量、HBV DNA定量及丙氨酸氨基转移酶（ALT）水
平。采用t检验、Wilcoxon秩和检验、F检验、Kruskal-Wallis H检验、χ2检验及受试者工作特征曲线（ROC）进行统计学分析。结
果治疗48 周时，PEG-IFNα-2a 组、IFNα组和ETV组HBV DNA检测不到率分别为55.6%、72.5%和84.3%，差异有统计学意义
（P<0.05）；PEG-IFNα-2a组、IFNα组和ETV组治疗48周时HBeAg血清转换率分别为33.3%、43.1%和11.8%，差异有统计学意义
（P<0.05），但PEG-IFNα-2a组与IFNα组患者HBeAg血清学转换率无统计学差异（P>0.05）。PEG-IFNα-2a组和ETV组在治疗
48周时是否出现HBeAg血清学转换与基线时的年龄、性别、HBeAg、HBV DNA定量和ALT水平无关；IFNα组在治疗48周时是
否出现HBeAg血清学转换与基线HBeAg水平相关（P=0.048），与基线时的年龄、性别、HBV DNA定量和ALT水平无关。依据
基线时的年龄、HBeAg、HBV DNA定量及ALT水平，12周和24周HBeAg、HBV DNA定量、ALT水平及HBeAg较基线的下降
率、24周HBeAg较12周的下降率获得的ROC曲线，在PEG-IFNα-2a治疗组，24周HBeAg较基线的下降大于97.81%（曲线下面
积（AUC）=0.827，P=0.006），其48周时HBeAg血清学转换敏感性和特异性分别为0.778和0.889，阳性预测值和阴性预测值分别
为0.778和0.889；若24周HBeAg较12周下降大于42.75%（AUC=0.790，P=0.016），其48周时HBeAg血清学转换敏感性和特异
性分别为0.889 和0.722，阳性预测值和阴性预测值分别为0.615 和0.929。结论治疗HBeAg 阳性慢性乙型肝炎48 周，
PEG-IFNα-2a和IFNα较ETV有更高的HBeAg血清学转换率，ETV较PEG-IFNα-2a和IFNα有更高的HBV DNA转阴率。24周
HBeAg较基线下降大于97.81%可作为PEG-IFNα-2a组患者48周HBeAg血清学转换的最佳预测因素。

Abstract: Objective To analyze the predictive factors of the therapeutic effects of interferons (IFNs) and entecavir (ETV)
treatments for 48 weeks in patients with chronic hepatitis B (CHB) positive for HBeAg. Methods This retrospective analysis
compared the treatment efficacy of IFNs and ETV in 129 CHB patients positive for HBeAg. Twenty-seven of the patients were
treated with PEG-IFNα-2a (180 μg once a week, PEG-IFN group), 51 patients with conventional IFNα (5 MIU three times a
week, IFN group), and 51 with ETV (0.5 mg once daily, ETV group) for 48 weeks. Results After completion of the treatment
cycles, the patients in ETV group showed a significantly higher HBV DNA undetectable rate and a significantly lower HBeAg
seroconversion rate than those in PEG-IFN and IFN groups (P<0.05); HBeAg seroconversion rates were similar between
PEG-IFN group and IFN group (χ2=0.709, P=0.400). In PEG-IFN and ETV groups, HBeAg seroconversion rates were not
associated with age, gender, baseline HBeAg, baseline HBV DNA and baseline ALT. In IFN group, HBeAg seroconversion
rates were associated with baseline HBeAg (P=0.048) but not with age, gender, baseline HBV DNA and baseline ALT. In
PEG-IFNα-2a group, ROC analysis showed that the sensitivity and specificity of HBeAg seroconversion at 48 weeks were 0.778
and 0.889, respectively, when the decline rate of HBeAg between baseline and week 24 exceeded 97.81% , with the
corresponding positive and negative predictive values (PPV and NPV) of 0.778 and 0.889, respectively; the sensitivity and
specificity of HBeAg seroconversion at 48 weeks were 0.889 and 0.722, respectively, when the decline rate of HBeAg between
week 12 and week 24 was over 42.75%, with the corresponding PPV and NPV of 0.615 and 0.929, respectively. Conclusions
Treatments with PEG-IFNα-2a and conventional IFNα for 48 weeks can achieve a higher HBeAg seroconversion rate than ETV, but the latter produces a higher HBV DNA
undetectable rate. For PEG-IFNα-2a treatment, the decline rate of HBeAg between baseline and week 24 over 97.81% is the best predicting factor for HBeAg seroconversion at
week 48 in CHB patients positive for HBeAg.