摘要
目的评价聚乙二醇干扰素α-2a（Peg—IFNα-2a）治疗HBeAg阳性慢性乙型肝炎（CHB）疗程对疗效的影响，探讨影响疗效的相关因素。方法收集2006年9月至2009年10月进行Peg—IFNα-2a（180μg每周1次）治疗的HBeAg阳性CHB病例，将其分为常规治疗组（疗程48周）和延长治疗组（疗程72周）。疗程结束后均随访24周。每3个月评估病毒学及生物化学应答直至疗程结束后24周。应用X^2检验比较两组治疗结束时应答率，利用t检验、logistic回归探讨影响应答的因素。结果完成本研究的患者86例，其中常规治疗组53例，延长治疗组33例，比较两组的人口学特征、性别、年龄、基线ALT水平、基线HBVDNA载量及基线HBeAg半定量（S／CO），P值均〉0．05，差异无统计学意义。治疗结束后，常规治疗组与延长治疗组比较：HBVDNA阴转率分别为41．5％、60．6％；HBeAg血清学转换率分别为32．1％、42．4％；HBsAg清除率分别为9．4%、18．2％；P值均〉0．05，差异均无统计学意义。治疗结束后随访24周，常规治疗组与延长治疗组比较：HBVDNA阴转率分别为62．3％、97．0%，x2=13．273；HBeAg血清学转换率分别为39．6％、57．6%，x2=6．765；HBsAg清除率分别为15．1％、36．4％，X2=5．155；复发率分别为58．5％、33．3％，x2=6．713；P值均〈0．05，差异均有统计学意义。根据logistic回归分析显示HBeAg清除与疗程（OR=3．702，95％CI为1．225～11．188）和性别（女性，OR=3．005，95％CI为1．038～8．595）呈正相关，与基线HBeAg水平（OR=0．999，95％CI为0．998～1．000）和年龄（OR=0．902，95％CI为0．839～0．970）无关。结论延长Peg-IFNα-2a治疗疗程可使HBeAg阳性CHB患者获得较高的HBVDNA阴转率、HBeAg血清学转换率、HBsAg清除率及更低的复发率，HBeAg清除与疗程及患者性别呈正相关。
Objective Hepatitis B e antigen （HBeAg） seroconversion and/or hepatitis B surface antigen （HBsAg） clearance are considered as good prognostic indicators of treatment outcome in HBeAg- positive chronic hepatitis B （CHB） patients. While a sustained virological response （SVR） can be achieved by a finite 48-week course of pegylated-interferon alfa-2a （Peg-lFNa-2a）, it has been suggested that longerterm treatment can improve the rate of SVR. Therefore, the aim of this study was to compare the effects of prolonged and routine Peg-IFNa-2a therapy in patients with HBeAg-positive CHB. Methods Eightysix consecutive patients diagnosed with HBeAg-positive CHB at our hospital between September 2006 and October 2009 were enrolled in the study. The patients were randomly assigned to receive Peg-IFNa-2a （180 ug once weekly） for either 48 weeks （routine therapy group, n = 53） or 72 weeks （prolonged therapy group, n = 33）. Serum samples were collected from each patient every three months until the end of the 24-week follow-up, and standard viral and biochemical tests were carried out. Relapse was defined as HBV DNA concentrations 〉 105 copies/mL or an HBeAg-positive test at the end of the 24-week follow-up. Chi-squared test and the t-test were used to determine the significance of intergroup differences. Logistic regression analysis was employed to determine the correlation of outcome parameters to treatment duration, expressed as odds ratio （OR） with 95% confidence interval （CI）. Results The two treatment groups were similar at baseline （pre-treatment） in demographic data, sex ratio, age, alanine aminotransferase （ALT） level, HBV DNA load, and semi-quantitative level of HBeAg （s/co） （all, P〉 0.05）. At the end of the 24-week follow-up, there were significant differences between the 48-week treatment group and the 72-week treatment group in patients with HBV DNA negativity （62.3% vs. 97.0%, 22= 13.273, P= 0.000）, HBeAg seroconversion （39.6% vs. 57.6%,2,2= 6.765,P = 0.009）, HBsAg clearance （15.1% vs. 36.4%,22= 5.155,P= 0.023）, and relapse （58.5% vs. 33.3%,22 = 6.713, P = 0.010）. Logistic regression analysis indicated that therapy duration was correlated to HBeAg clearance （OR = 3.702, 95% CI： 1.225-11.188） and male sex （OR = 3.005, 95% CI： 1.038-8.696） but not to HBeAg level at baseline （OR = 0.999, 95% CI： 0.998-1.000） or age （OR = 0.902, 95% CI： 0.839-0.970）. Conclusion In this single-center cohort study, superior therapeutic benefit was achieved by extending the Peg-IFNa-2a therapy out to 72 weeks for patients with HBeAg-positive CHB. The prolonged duration therapy produced a higher HBsAg loss ratio, HBeAg seroconversion ratio, HBV DNA negativity ratio, and a lower relapse ratio. Furthermore, HBeAg clearance was positively correlated with duration and male sex.
出处
《中华肝脏病杂志》
CAS
CSCD
北大核心
2012年第10期737-741,共5页
Chinese Journal of Hepatology
基金
基金项目：福建省科技重大专项（2004YZ01-3）
关键词
干扰素Α-2A
肝炎
乙型
慢性
肝炎E抗原
疗效
Interferon alfa-2a
Hepatitis B, chronic
Hepatitis B e antigens
Treatment outcome
