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。
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-IFNa-2a （180 gg once a week, PEG-IFN group）, 51 patients with conventional IFNa （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 （X^2=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-IFNa-2a and conventional IFNa for 48 weeks can achieve a higher HBeAg seroconversion rate than ETV, but the latter produces a higher HBV DNA undetectable rate. For PEG-IFNa-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.
出处
《南方医科大学学报》
CAS
CSCD
北大核心
2013年第6期878-881,共4页
Journal of Southern Medical University
基金
国家自然科学基金(30771899)
广东省药学会科学研究基金(2012GRS04)~~
