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基线HBsAg水平对聚乙二醇干扰素α-2b治疗慢性乙型肝炎效果的预测价值
Value of baseline HBsAg quantification in predicting the clinical effect of pegylated interferon α-2b in treatment of chronic hepatitis B
文章发布日期:2020年07月09日  来源:  作者:陈曦,赵文静,孙岩,等  点击次数:763次  下载次数:52次

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【摘要】:目的 评估基线HBsAg定量值对聚乙二醇干扰素α-2b(PEG-IFNα-2b)治疗低水平HBsAg慢性乙型肝炎(CHB)患者HBsAg清除的预测价值。方法 选取2016年3月-2018年9月于吉林省肝胆病医院接受核苷酸类似物治疗达到HBV DNA<20 IU/ml、ALT水平正常、0.05 IU/ml<HBsAg定量<1500 IU/ml,序贯PEG-IFNα-2b治疗的HBeAg阴性CHB患者51例。收集基线及治疗12、24、36、48周时血清HBsAg定量、抗-HBs定量、HBV DNA定量、ALT检测结果。治疗48周时,出现HBsAg清除为应答组(19例),HBsAg未清除为非应答组(32例)。非正态分布的计量资料两组间比较采用Mann-Whitney U检验。采用受试者工作曲线(ROC曲线)分析基线HBsAg定量对治疗48周HBsAg清除的预测价值。结果 PEG-INFα-2b治疗48周时HBsAg清除19例(37.25%),其中基线HBsAg定量≤10 IU/ml者7例、10 IU/ml<HBsAg定量≤100 IU/ml者9例、100 IU/ml<HBsAg定量≤500 IU/ml、500 IU/ml<HBsAg定量≤1000 IU/ml及1000 IU/ml<HBsAg定量≤1500 IU/ml各1例;HBsAg血清学转换8例(15.69%),其中10 IU/L<抗-HBs≤100 IU/L 4例,100 IU/L<抗-HBs≤500 IU/L 3例,抗-HBs>500 IU/L 1例。应答组基线HBsAg定量明显低于非应答组[16.38(2.25~61.62) IU/ml vs 363.73(110.14~927.72) IU/ml],差异有统计学意义(Z=-4.442,P<0.001)。治疗12、24周两组血清ALT水平均升高,应答组与非应答组比较差异有统计学意义[82.00(55.00~123.00) U/L vs 49.00(34.00~65.00) U/L、78.00(46.00~88.00)U/L vs 48.08(29.79~71.75)U/L,Z值分别为-2.286、-2.617,P值均<0.05]。PEG-INFα-2b治疗12、24周时,应答组HBsAg水平下降幅度明显高于非应答组[91.77(49.62~99.28)% vs 44.03(15.75~68.90)%,99.00(98.00~100.00)% vs 77.94(37.02~89.60)%,Z值分别为-3.312、-5.100,P值均<0.05]。停药随访24周19例HBsAg清除者均维持应答,HBsAg血清学转换7例。ROC曲线分析结果显示,基线HBsAg水平可预测治疗48周HBsAg的清除率,其最佳预测值为86.36 IU/ml,ROC曲线下面积为0.875(95%可信区间:0.764~0.986),敏感度和特异度分别为84.4%和84.2%。阳性预测值和阴性预测值分别为84.21%和84.37%。结论 核苷酸类似物经治的HBsAg低水平(≤100 IU/ml)的CHB患者,序贯PEG-INFα-2b治疗能够明显提高HBsAg清除和血清学转换,特别是治疗早期HBsAg降幅明显、ALT水平明显升高者,有助于治疗48周HBsAg的清除。基线HBsAg定量<86.36 IU/ml可预测48周HBsAg的清除。
【Abstract】:Objective To investigate the value of baseline HBsAg quantification in predicting HBsAg clearance in pegylated interferon α-2b (PEG-INFα-2b)-treated chronic hepatitis B (CHB) patients with a low level of HBsAg. Methods A retrospective analysis was performed for 51 HBeAg-negative CHB patients who achieved HBV DNA <20 IU/ml after nucleos(t)ide analogue (NA) treatment, had a normal level of alanine aminotransferase (ALT) and an HBsAg quantification of >0.05 IU/ml and <1500 IU/ml, and received sequential PEG-INFα-2b treatment in Hepatobiliary Hospital of Jilin from March 2016 to September 2018. The clinical data of serum HBsAg quantification, anti-HBs quantification, HBV DNA quantification, and ALT level were collected at baseline and at weeks 12, 24, 36, and 48 of treatment. At week 48 of treatment, 19 patients with HBsAg clearance were enrolled as response group, and 32 patients without HBsAg clearance were enrolled as non-response group. The Mann-Whitney U test was used for comparison of non-normally distributed continuous data between two groups, and the receiver operating characteristic (ROC) curve was used to analyze the value of baseline HBsAg quantification in predicting HBsAg clearance at week 48 of treatment. Results At week 48 of treatment, 19 patients (37.25%) achieved HBsAg clearance, among whom 7 (7/19, 36.84%) had a baseline HBsAg quantitation of ≤10 IU/ml, 9 (9/19, 47.37%) had a baseline HBsAg quantitation of >10 IU/ml and ≤100 IU/ ml, 1 had a baseline HBsAg quantitation of >100 IU/ml and ≤500 IU/ml, 1 had a baseline HBsAg quantitation of >500 IU/ml and ≤1000 IU/ml, and 1 had a baseline HBsAg quantitation of >1000 IU/ml and ≤1500 IU/ml; 8 patients (15.69%) achieved HBsAg seroconversion, among whom 4 had an anti-HBs level of >10 IU/L and ≤100 IU/L, 3 had an anti-HBs level of >100 IU/L and ≤500 IU/L, and 1 had 500 IU/L. The response group had a significantly lower baseline HBsAg quantitation than the non-response group [16.38 (2.25-61.62) IU/ml vs 363.73 (110.14-927.72) IU/ml, Z=-4.442, P<0.001]. At weeks 12 and 24 of treatment, both groups had an increase in serum ALT level, and there was a significant difference between the response group and the non-response group [week 12: 82.00 (55.00-123.00) U/L vs 49.00 (34.00-65.00) U/L, Z=-2.286, P=0.005; week 24: 78.00 (46.00-88.00) U/L vs 48.08 (29.79-71.75) U/L, Z=-2.617, P=0.009]. At weeks 12 and 24 of treatment, the response group had a significantly greater reduction in HBsAg than the non-response group [week 12: 91.77% (49.62%-99.28%) vs 44.03% (15.75%-68.90%), Z=-3.312, P=0.001; week 24: 99.00% (98.00%-100.00%) vs 77.94% (37.02%-89.60%), Z=-5.100, P<0.001]. The patients were followed up for 24 weeks after drug withdrawal, and the results showed that all 19 patients with HBsAg clearance achieved sustained response and 7 patients achieved HBsAg seroconversion. The ROC curve analysis showed that baseline HBsAg quantification predicted HBsAg clearance rate at week 48 of treatment, with an optimal predictive value of 86.36 IU/ml, an area under the ROC curve of 0.875 (95% confidence interval: 0.764-0.986), a sensitivity of 84.4%, and a specificity of 84.2%. The positive predictive value and negative predictive value were 84.21% and 84.37%, respectively. Conclusion In CHB patients with a low level of HBsAg (≤100 IU/ml) treated by NAs, sequential PEG-INFα-2b treatment can significantly improve HBsAg clearance and seroconversion and help with HBsAg clearance at week 48 of treatment especially in those with a significant reduction in HBsAg and a significant increase in ALT in the early stage of treatment. Baseline HBsAg quantification <86.36 IU/ml can predict HBsAg clearance at week 48 of treatment.
【关键字】:乙型肝炎,慢性; 乙型肝炎表面抗原; 聚乙烯二醇类; 干扰素类
【Key words】:hepatitis B,chronic; hepatitis B surface antigens; polyethylene glycols; interferons
【引证本文】:CHEN X, ZHAO WJ, SUN Y, et al. Value of baseline HBsAg quantification in predicting the clinical effect of pegylated interferon α-2b in treatment of chronic hepatitis B[J]. J Clin Hepatol, 2020, 36(8): 1723-1726. (in Chinese)
陈曦, 赵文静, 孙岩, 等. 基线HBsAg水平对聚乙二醇干扰素α-2b治疗慢性乙型肝炎效果的预测价值[J]. 临床肝胆病杂志, 2020, 36(8): 1723-1726.

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