α干扰素对慢性乙型肝炎e抗原阴性患者的疗效及影响因素

Efficacy of interferon-alpha therapy for HBeAg-negative chronic hepatitis B and its influencing factors

目的 了解α干扰素(1FN - α)对慢性乙型肝炎e抗原(HBeAg)阴性患者的疗效及影响因素。 方法 65例HBeAg阴性经肝穿刺活检证实的慢性乙型肝炎(CHB)患者,给予r1FN α 1b治疗,每次5 MU,每周3次。治疗结束后随访至少12个月。以188例HBeAg阳性CHB患者作对照。 结果 HBeAg阴性组治疗未时联合应答(CR)率为58.5％(38/65),与对照组差异无显著性;随访12个月时CR率为75.4％(49/65),高于对照组(X2=4.796,P<0.05)。治疗后12个月内复发率为15,8％(6/38),与对照组差异无显著性。终点疗程中位数为6个月,与对照组差异无显著性。多变量(?)分类Logistic回归分析结果显示,性别、年龄、肝组织炎症活动度、肝组织纤维化程度、丙氨酸氨基转移酶、天冬氨酸氨基转移酶 HBV DNA水平、抗-HBe诸因素中仅肝组织炎症活动度为疗效影响因素。 结论 1FN α对HBeAg阴性CHB患者近期疗效和持续效就与HBcAg阳性都相仿;肝组织炎症活动度高者疗效较佳。

Objective To investigate the efficacy of interferon-alpha (IFN-alpha) therapy for HBeAg-negative chronic hepatitis B. Methods Sixty-five Chinese HBeAg-negative chronic hepatitis B patients were treated with 5 MU recombinant rlFN-alpha lb subcutaneously thrice weekly for 5-24 months, followed by 12 months of treatment-free follow-up; one hundred and eighty-eight Chinese HBeAg-positive patients served as controls. For each patient, serum alanine transaminase (ALT) was measured biochemically and serum HBV DNA level was detected with fluorescent quantitative PCR, HBeAg with enzymoimmunoassay every l-3 months during therapy and during the follow-up period. HBeAg loss (only for HBeAg-positive cases), HBV DNA undetectable, and ALT normalization: the three together were considered a combined response. Results Rates of combined response were similar in HBeAg-negative patients (58.5%, 38/65) or HBeAg-positive ones at the end of treatment (weighted chi square test, x2 = 1.878, P > 0.05), but were higher at the end of the follow-up period in the HBeAg-negative cases (75.4%, 49/65) (weighted chi square test, x- = 4.796, P < 0.05). Furthermore, relapse rates at the end of the follow-up period, were also similar in HBeAg-negative patients (15.8%, 6/38) or HBeAg positive ( x2 = 0.205, P > 0.05). Combined response was achieved at a median of 6.0 months (2-16 months) of treatment course in HBeAg-negative patients while at a median of 6.0 months (1-22 months) in HBeAg-positive cases (Z = -0.186, P > 0.05, by the Wilcoxon rank sum test). The only factor predictive of combined response, by binary logistic regression analysis, was inflammatory activity in the liver biopsy. Gender, age, baseline ALT level, baseline HBV DNA level, and anti-HBe were not predictive factors. Conclusion Interferon-alpha therapy induces a similar primary and sustained response in HBeAg-negative and in HBeAg-positive chronic hepatitis B patients.