聚乙二醇干扰素仪α-2a联合阿德福韦酯治疗HBeAg阴性慢性乙型肝炎的临床研究  

Efficacy and safety of peginterferon alfa-2a （40 kd） plus adefovir for 96 weeks in HBeAg-negative chroni chepatitis B patients

作　　者：曹振环[1] 马丽娜[1] 柳雅立[1] 金怡[1] 鲁俊峰[1] 张永宏[1] 陈新月[1] 

机构地区：[1]首都医科大学附属北京佑安医院国际医疗部,北京100069

出　　处：《中华肝脏病杂志》2013年第7期498-501,共4页Chinese Journal of Hepatology

基　　金：基金项目：“十二五”国家科技重大专项（2013ZXl0002002-006,2012ZX10002003）;首都市民健康项目培育（Z111107067311049）;首都卫生发展科研专项项目（首发2011-2018-08）

摘　　要：目的探讨聚乙二醇干扰素（Peg—IFN）α—2a联合阿德福韦酯（ADV）治疗HBeAg阴性慢性乙型肝炎（CHB）96周的疗效及安全性。方法25例初治HBeAg阴性CHB患者接受Peg-IFNα-2a（135ug／周或180ug／周）联合ADV（10mg／d）治疗。96周治疗结束时，如获得HBsAg血清学转换则停药随访，否则停用Pe口IFNα—2a，继续ADV维持治疗。所有患者随访至120周。基线和治疗过程中每12周检测HBVDNA和HBsAg水平。计数资料采用x2检验或Fisher Sexacttest检验。结果Peg-IFNα－2a联合ADV治疗48周时，100％（25／25）的患者HBVDNA低于检测值（〈500拷贝／ml），且在治疗过程中始终保持不可检测水平;;治疗48周时HBsAg血清学转换率为12％（3／25），96周上升至28％（7／25）。随访至120周，HBsAg血清学转换率为32％（8／25）。延长治疗至96周未见新的不良反应发生，其安全性同48周。结论Peg-IFNα-2a联合ADV并延长疗程可显著提高HBeAg阴性CHB患者的抗病毒疗效，尤其可以提高HBsAg血清学转换率，是值得探索的优化治疗策略之一。To investigate the efficacy and safety of an extended course （96-week） of combination treatment with peginterferon alfa-2a （Peg-IFNtt-2a; 40 kd] plus adefovir （ADV） for treating chronic hepatitis B （CHB） in Chinese patients with negativity for hepatitis B e antigen （HBeAg）. Methods A total of 25 consecutive patients with HBeAg-negative CHB were administered Peg-IFNct-2a （135-180 pg/week） plus ADV （10 mg/day） for 96 weeks. All patients were followed-up for 24 weeks after treatment completion. Levels of hepatitis B virus （HBV） DNA and hepatitis B surface antigen （HbsAg） were measured by fluorescence quantitative polymerase chain reaction （FQ-PCR） and chemiluminescent microparticle immunoassay, respectively, at 12-week intervals throughout the treatment course and at the end-of-follow-up （week 120）. Patients underwent serological analysis at 3-6 month intervals during treatment and follow-up to evaluate occurrence of adverse events; serological parameters included blood count, markers of liver, kidney and thryoid function, and levels of autoantibodies and creatine kinase. Results For all patients, the 96-week course of Peg-IFNa-2a plus ADV reduced the level of HBV DNA below the detection threshold （〈 500 copies/ml by FQ-PCR）. The overall rate of HBsAg seroconversion was 12% （3/25） at week 48, 28% （7/25） at week 96, and 32% （8/25） at week 120. The occurrences of adverse events were similar at week 48 and week 96. Conclusion The extended-course Peg-IFNa-2a plus ADV combination therapy acheived a 100% virological response and better rates of HBsAg seroconversion than 48 weeks of therapy, without a decrease in safety.

关 键 词：肝炎 乙型 慢性 肝炎e抗原 乙型 干扰素Α-2A 阿德福韦酯 血清学转换 

分 类 号：R512.62[医药卫生—内科学]