聚乙二醇干扰素α-2a联合双环醇治疗高转氨酶水平慢性乙型肝炎疗效初探

目的 探讨慢性乙型肝炎患者接受聚乙二醇干扰素-2a(派罗欣)±核苷(酸)类似物(NUC)治疗前和治疗早期转氨酶明显升高者,联合双环醇(百赛诺)治疗的疗效.方法 收集HBeAg阳性/阴性慢性乙型肝炎患者,给予派罗欣180 μg,每周一次,皮下注射,疗程48周以上,治疗结束后随访26周.HBV DNA≥1×108拷贝/ml者联合NUC(阿德福韦或恩替卡韦).治疗前ALT＞ 500 U/L或派罗欣治疗第一针后ALT＞ 300 U/L者联用双环醇25 mg,每日3次,治疗1～2个月.治疗前2 × ULN＜ ALT ＜300 U/L或治疗后ALT＜ 300 U/L者单用抗病毒治疗.比较两组患者的治疗应答和不良反应状况.结果总计54例患者(HBeAg阳性44例,HBeAg阴性10例)完成治疗及随访,其中20例联用双环醇(联合治疗组),34例未联用双环醇(对照组).结果 显示双环醇联合治疗组于治疗后ALT水平逐周下降,4周后有90％( 18/20)患者ALT＜ 200 U/L,对照组为85.3％ (29/34例).随访26周时两组ALT复常率分别为80％(16/20)和85.3％ (29/34)；病毒学应答率相仿,联合治疗组较对照组HBsAg血清学转换率有明显增高(P =0.044),分别为30％ (6/20)和11.8％(4/34).结论 双环醇可明显缓解干扰素治疗诱导的转氨酶升高反应,确保干扰素治疗顺利进行,且不影响其抗病毒疗效.

Efficacy of combination therapy with peginterferon alfa-2a and bicyclol in chronic hepatitis B with high ALT levels

Objective To evaluate the effect of combination therapy with peginterferon alfa-2a （Pegasys） ＋ nucleos（t）ide analogues （NUC） and bicyclol in chronic hepatitis B with high ALT levels at baseline and during early treatment. Methods CHB patients were treated with PEG-IFNα-2a for a minimum of 48 weeks. All patients were followed up for 26 weeks post-treatment. Patients with HBV DNA/〉 1 × 108 copies/ml were combined with NUC （adefovir or entecavir） treatment. Patients with ALT 〉 500 U/L at baseline or ALT 〉 300 U/L after first injection of PEG-IFNct-2a received bicyclol treatment for 1-2 months （treatment group）. Patients with 2 x ULN 〈 ALT 〈 300 U/L and ALT 〈 300 U/L during treatment were enrolled into PEG-IFNα-2a ＋ NUC antiviral monotherapy （control group）. Responses defined as HBV DNA 〈 1 × 103 copies/ml, normal serum ALT, and HBeAg/HBsAg loss and seroconversion were analyzed at 26 weeks post-treatment. Results A total of 54 patients （44 HBeAg positive, 10 HBeAg negative）were divided into two groups according to combination of bicyclol ： treatment group （ n = 20） -those who received combinition therapy with PEG-IFNα-2a ＋ NUC and bicyclol, and control group （ n = 34）-those who were treated with PEG-IFNα-2a ＋ NUC antiviral monotherapy. During the first month of treatment, ALT levels declined gradually in treatment group. At 26 weeks post-treatment, the rates of ALT normalization and HBV DNA below the limit of 1 × 103 copies/ml were similar in both groups. Six patients in treatment group achieved HBsAg seroconversion at 26 weeks post-treatment, whereas so did 4 patients of control group（30% vs. 11.8% , P =0. 044）. Conclusion Bicyclol could significantly relief elevation of ALT induced by the IFN treatment.