聚乙二醇干扰素α-2b治疗慢性乙型肝炎患者血清HBsAg清除率的效果分析

Effect of pegylated interferonα-2b on serum HBsAg clearance rate in treatment of patients with chronic hepatitis B

目的真实世界中评价聚乙二醇干扰素α-2b(PEG-IFNα-2b)在治疗慢性乙型肝炎(CHB)中清除HBsAg的效果。方法回顾性纳入2017年6月—2021年1月就诊于河南省人民医院感染科的411例CHB患者,所有患者均应用PEG-IFNα-2b治疗。收集患者性别、年龄、抗病毒治疗方案、基线HBsAg水平、治疗后HBsAg水平,观察分析24、48及96周HBsAg清除率。在不同HBsAg基线水平(<500 IU/mL、500~1500 IU/mL、1501~5000 IU/mL)及不同既往治疗情况和治疗方案后应用PEG-IFNα-2b,比较各随访节点的HBsAg清除率。计量资料两组间比较采用成组t检验,计数资料组间比较采用χ^(2)检验和趋势性χ^(2)检验。结果完成24周治疗患者HBsAg清除率9.9%(26/263)。完成48周治疗患者HBsAg清除率19.7%(25/127)。完成96周治疗患者HBsAg清除率41.7%(30/72)。不同基线HBsAg水平患者治疗24、48及96周时HBsAg清除率比较差异均有统计学意义(χ^(2)值分别为52.265、32.764、30.918,P值均<0.01),随着治疗时间延长,HBsAg清除率逐渐升高,并且这种趋势有统计学意义(趋势χ^(2)值分别为44.517、29.147、22.260,P值均<0.01)。随访24、48及96周时,HBsAg 500~1500 IU/mL组和1501~5000 IU/mL组的HBsAg清除率较HBsAg<500 IU/mL组均明显下降(P值均<0.001)。在治疗24、48及96周时,治疗情况(初治或经治)及治疗方案(单用或联合)患者相比较,仅初治与经治组在男女比例上存在差异(χ^(2)=5.029,P=0.025);初治或经治组间、单用或联合治疗组间HBsAg清除率比较差异均无统计学意义(P值均>0.05)。结论PEG-IFNα-2b在治疗CHB中对清除HBsAg有良好的效果,并且基线HBsAg水平越低,HBsAg清除率越高,随着治疗时间的延长,HBsAg清除率呈上升趋势。基线HBsAg 500 IU/mL可作为优势人群的分界点。

Objective To investigate the effect of pegylated interferonα-2b(PEG-IFNα-2b)on HBsAg clearance in the treatment of chronic hepatitis B(CHB)in a real-world setting.Methods A retrospective analysis was performed for 411 CHB patients who attended Department of Infectious Diseases,Henan Provincial People’s Hospital,from June 2017 to January 2021,and all these patients were treated with PEG-IFNα-2b.Related clinical data were collected,including sex,age,antiviral treatment regimen,baseline HBsAg level,and post-treatment HBsAg level,and HBsAg clearance rate was observed at 24,48,and 96 weeks.HBsAg clearance rate at different time points of follow-up was compared between the patients with different baseline HBsAg levels(<500 IU/mL,500-1500 IU/mL,and 1501-5000 IU/mL)or with the use of PEG-IFNα-2b after different previous treatment conditions and regimens.The independent-samples t test was used for comparison of continuous data between two groups,and the chi-square test and the trend chi-square test were used for comparison of categorical data between groups.Results The HBsAg clearance rate was 9.9%(26/263)in the patients who completed 24 weeks of treatment,19.7%(25/127)in the patients who completed 48 weeks of treatment,and 41.7%(30/72)in the patients who completed 96 weeks of treatment.There was a significant difference in HBsAg clearance rate between the patients with different baseline HBsAg levels at 24,48,and 96 weeks of treatment(χ^(2)=52.265,32.764,and 30.918,all P<0.01),and HBsAg clearance rate gradually increased over the time of treatment(χ^(2) trend=44.517,29.147,and 22.260,all P<0.01).Compared with the HBsAg<500 IU/mL group,the 500-1500 IU/mL group and the 1501-5000 IU/mL group had a significant reduction in HBsAg clearance rate at 24,48,and 96 weeks of follow-up(all P<0.001).As for the comparison of the patients with different treatment conditions(previously untreated or treatment-experienced)and treatment regimens(monotherapy or combined therapy)at 24,48,and 96 weeks of treatment,there was a significant difference in fame/female ration between the previously untreated group and the treatment-experienced group(χ^(2)=5.029,P=0.025),and there was no significant difference in HBsAg clearance rate between the previously untreated group and the treatment-experienced group and between the monotherapy group and the combined therapy group(all P>0.05).Conclusion PEG-IFNα-2b has a marked effect on HBsAg clearance in the treatment of CHB,and patients with a lower baseline HBsAg level tend to have a higher HBsAg clearance rate.HBsAg clearance rate tends to increase over the time of treatment.A baseline HBsAg level of 500 IU/mL can be used as the cut-off point to identify the dominant population.