[恩替卡韦治疗后终点不理想的慢性乙型肝炎患者序贯聚乙二醇干扰素α-2a治疗实现HBeAg血清学转换]
[HBeAg seroconversion achieved by sequential peginterferon alfa-2a therapy in chronic hepatitis B patients with unsatisfactory end point following entecavir treatment].
作者信息
Chen Xue-fu, Chen Xiao-ping, Ma Xiao-jun, Chen Wen-li, Luo Xiao-dan, Liao Jin-yao
机构信息
Guangdong General Hospital, Guangdong Academy of Medical Sciences, Guangzhou 510080, China.
出版信息
Zhonghua Gan Zang Bing Za Zhi. 2013 Jul;21(7):502-5. doi: 10.3760/cma.j.issn.1007-3418.2013.07.007.
OBJECTIVE
To investigate the efficacy and safety of peginterferon alfa-2a (Peg-IFNa-2a) therapy for treating chronic hepatitis B (CHB) in patients who failed to achieve a satisfactory end point with entecavir (ETV) treatment.
METHODS
Fifty-seven CHB patients with positivity for hepatitis B e antigen (HBeAg) who had completed a standard ETV monotherapy course, of at least 96 weeks, and who had achieved a virological response (defined as HBV DNA less than 500 copies/ml) but without HBeAg seroconversion (defined as 0.227 PEI U/ml less than HBeAg less than or equal to 50 PEI U/ml) were enrolled in the study. The patients were randomly assigned to receive a 48-week treatment with Peg -IFNa-2a (experimental group, n = 27) or continued ETV therapy (control group, n = 30). Serum samples were collected from all patients for assessment of biochemical, virological and serological responses to treatment. Inter-group differences were statistically evaluated by t-test or Chi-squared test.
RESULTS
The baseline levels of alanine aminotransferase, hepatitis B surface antigen (HBsAg), and HBeAg were similar between the patients comprising the experimental and controls groups. At treatment week 48, the experimental group showed significantly higher rates of HBeAg clearance (Peg-IFNa-2a: 40.7% vs. ETV: 16.7%, x2 = 4.079, P less than 0.05) and seroconversion (37.0% vs. 13.3%, x2 = 5.110, P less than 0.05). The experimental group also showed higher rates of HBsAg clearance (7.4% vs. 0%) and HBV DNA relapse (11.1% vs. 0%), but the differences did not reach statistical significance (x2 = 2.307 and 3.519, both P more than 0.05). However, the level of HBsAg was significantly lower in the experimental group (2866.0+2580.4 vs. 4335.8+2650.0 IU/ml, t = 5.11, P less than 0.05).
CONCLUSION
HBeAg-positive CHB patients with unsatisfactory response to initial ETV monotherapy achieved HBeAg seroconversion and clearance following sequential Peg-IFN a-2a treatment.
目的
探讨聚乙二醇干扰素α-2a（Peg-IFNa-2a）治疗对恩替卡韦（ETV）治疗未达到满意终点的慢性乙型肝炎（CHB）患者的疗效和安全性。
方法
57例乙型肝炎e抗原（HBeAg）阳性的CHB患者完成了至少96周的标准ETV单药治疗疗程，达到病毒学应答（定义为HBV DNA低于500拷贝/ml）但未发生HBeAg血清学转换（定义为0.227 PEI U/ml＜HBeAg≤50 PEI U/ml），纳入本研究。患者被随机分配接受Peg-IFNa-2a治疗48周（试验组，n = 27）或继续ETV治疗（对照组，n = 30）。收集所有患者的血清样本，评估治疗的生化、病毒学和血清学应答。组间差异采用t检验或卡方检验进行统计学评估。
结果
试验组和对照组患者的基线丙氨酸氨基转移酶、乙型肝炎表面抗原（HBsAg）和HBeAg水平相似。在治疗第48周时，试验组的HBeAg清除率（Peg-IFNa-2a：40.7% vs. ETV：16.7%，x2 = 4.079，P＜0.05）和血清学转换率（37.0% vs. 13.3%，x2 = 5.110，P＜0.05）显著更高。试验组的HBsAg清除率（7.4% vs. 0%）和HBV DNA复发率（11.1% vs. 0%）也更高，但差异未达到统计学意义（x2 = 2.307和3.519，P均＞0.05）。然而，试验组的HBsAg水平显著更低（2866.0+2580.4 vs. 4335.8+2650.0 IU/ml，t = 5.11，P＜0.05）。
结论
对初始ETV单药治疗应答不佳的HBeAg阳性CHB患者，序贯Peg-IFNα-2a治疗后实现了HBeAg血清学转换和清除。
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