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目的开展HBeAg阴性慢性乙型肝炎(chronic hepatitis B,CHB)的抗病毒优化治疗,以提高HBsAg清除率。方法采用前瞻性队列研究,纳入220例HBeAg阴性CHB患者;以不同治疗方案分组:核苷或核苷类似物(nucleoside analogues,NA)组(56例),简称NA组;聚乙二醇干扰素(pegylated interferons,Peg-IFN)组(53例),简称Peg-IFN组;Peg-IFN+NA联合治疗组(111例),简称联合组。疗程96周,随访至120周以评估疗效。结果 120周时HBV DNA不可检测率:联合组达到100%(107/107),明显优于Peg-IFN组68.6%(35/51),P<0.001;也高于NA组的92.9%(52/56),差异无统计学意义(P>0.05)。120周时HBsAg清除率:联合组28.9%(31/107),明显优于Peg-IFN组7.8%(4/51)及NA组1.8%(1/56),P均<0.001。不良反应:联合组及Peg-IFN组发热、头痛、粒细胞减少等不良反应发生率明显高于NA组(P均<0.05),联合组与Peg-IFN组的不良反应发生率类似(P均>0.05)。结论 96周长疗程Peg-IFNα-2a联合NA治疗HBeAg阴性CHB,可获得较高的HBsAg清除率和HBV DNA不可检测率,疗效明显优于Peg-IFN单药及NA单药的治疗方法。
Objective To carry out antiviral optimization of HBeAg-negative chronic hepatitis B (CHB) in order to improve the HBsAg clearance rate. Methods A prospective cohort study was conducted in 220 HBeAg-negative patients with CHB. The patients were divided into two groups according to different treatment regimens: nucleoside analogues (NA) group (n = 56), NA group; pegylated interferon Pegylated interferon (Peg-IFN) group (53 cases), Peg-IFN group for short; Peg-IFN + NA combined treatment group (111 cases) Course of 96 weeks, followed up to 120 weeks to assess the efficacy. Results At 120 weeks, the undetectable rate of HBV DNA was 100% (107/107) in the combination group, which was significantly higher than that in the Peg-IFN group (68.6%, 35/51, P <0.001), and also higher than that in the NA group (92.9%, 52 / 56), the difference was not statistically significant (P> 0.05). HBsAg clearance rate at week 120: 28.9% (31/107) in the combined group was significantly better than 7.8% (4/51) in the Peg-IFN group and 1.8% (1/56) in the NA group (P <0.001). Adverse reactions: fever, headache, neutropenia and other adverse reactions in the combination group and Peg-IFN group were significantly higher than NA group (all P <0.05), the incidence of adverse reactions in the combination group and Peg-IFN group were similar (P > 0.05). Conclusions Peg-IFNα-2a combined with NA treatment of HBeAg-negative CHB in 96-week treatment can achieve higher HBsAg clearance rate and HBV DNA undetectable rate, and the therapeutic effect is better than that of Peg-IFN single drug and NA single drug.