聚乙二醇干扰素-α-2a治疗血清低水平HBsAg阳性的慢性乙型肝炎患者临床结局预测研究*

doi:10.3969/j.issn.1672-5069.2018.04.020

摘要/Abstract

摘要： 目的分析聚乙二醇干扰素-α-2a (Peg-IFNα-2a)治疗低水平HBsAg阳性的慢性乙型肝炎（CHB）患者的临床结局及其血清HBsAg水平对疗效的预测价值。方法 2014年4月~2016年4月我院就诊的低水平HBsAg 阳性的CHB患者80例,采用随机数字表法将其分成两组,每组40例。患者入组前经核苷（酸）类似物（NAs）治疗获得病毒学应答。给予对照组恩替卡韦治疗,观察组接受恩替卡韦和Peg-IFNα-2a联合治疗48 w。采用受试者工作特征曲线（ROC）下面积（AUC）评估基线HBsAg水平预测HBsAg清除的效能。结果在治疗48 w末,观察组血清HBsAg和HBV DNA水平分别为（1.5±0.3） lg U/ml和（0.1±0.1） lg U/ml,显著低于对照组的（2.0±0.2）lg U/ml和（1.3±0.3） lg U/ml（P<0.05）,观察组HBsAg清除率和HBV DNA转阴率分别为32.5%和92.5%,显著高于对照组的6.3%和55.0%（P<0.05）;基线HBsAg水平是HBsAg清除的独立相关因素（OR:0.337,95%CI:0.026~0.652, P<0.05）;经ROC曲线分析,以基线HBsAg水平等于2.0 lg U/mL为截断点,基线HBsAg水平预测治疗48 w血清HBsAg清除的AUC为0.77,敏感度为0.85,特异度为0.68,阳性预测值为67.2%,阴性预测值为85.3%,正确性为72.5%。结论应用peg-IFN-α-2a治疗已经NAs治疗获得低水平HBsAg阳性的CHB患者可进一步提高临床疗效,且基线HBsAg水平能预测治疗结束时血清HBsAg清除情况。

关键词: 慢性乙型肝炎, 聚乙二醇干扰素-α, -2a, 低水平HBsAg, HBsAg清除, 治疗

Abstract: Objective To investigate the prediction of response in patients with low serum HBsAg level chronic hepatitis B （CHB） receiving peginterferon-α-2a （Peg-IFNα-2a） after nucleos（t）ide analogues （NAs） treatment. Methods 80 patients with CHB with low HBsAg level admitted to our hospital between April 2014 and April 2016, and they were randomly divided into the observation group and the control group with 40 cases in each by the randomized number table. All patients had been given NAs for a long time and had gained virologic response before enrollment. Patients in the control group was given entecavir,and those in the observation group was additionally given peg-IFNα-2a besides entecavir for 48 weeks. The multivariate analysis was performed, and the baseline serum HBsAg level was estimated for the virologic response at the end of treatment by the area under the curve（AUC） of receiver operating characteristic（ROC）. Results At the end of 48 weeks of treatment,serum HBsAg level and HBV DNA load were （1.5±0.3） lg U/ml and （0.1±0.1） lg U/ml,respectively,in the observation group,significantly lower than （2.0±0.2） lg U/ml and（1.3±0.3） lg U/ml in the control（P<0.05）,and serum HBsAg clearance rate and HBV DNA negative rate were 32.5% and 92.5%,respectively,in the observation group,significantly higher than 6.3% and 55.0% in the control （P<0.05）;the baseline serum HBsAg level was an independent factor for HBsAg clearance （OR: 0.337,95% CI: 0.026-0.652,P<0.05）;According to AUC analysis,the sensitivity,specificity,positive predictive value, negative predictive value and the accuracy rate were 0.85,0.68,67.2% and 85.3% and 72.5% when baseline HBsAg level being 2.0 lg U/ml as the cut-off value. Conclusions The peg-IFN-α-2a treatment can improve the clinical efficacy in CHB patients with low serum HBsAg level after NAs therapy,and the baseline HBsAg level has some predictive values for end of treatment response.

Key words: Chronic hepatitis B, Peginterferon-α-2a;, Serum HBsAg levels, HBsAg clearance, Therapy

史罗明, 周根法, 孙冬林. 聚乙二醇干扰素-α-2a治疗血清低水平HBsAg阳性的慢性乙型肝炎患者临床结局预测研究^*[J]. 实用肝脏病杂志, 2018, 21(4): 565-568.

Shi Luoming, Zhou Gengfa, Sun Donglin. Prediction of response in patients with low serum HBsAg level chronic hepatitis B receiving peginterferon-α-2a after nucleos(t)ide analogues treatment[J]. JOURNAL OF PRACTICAL HEPATOLOGY, 2018, 21(4): 565-568.

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聚乙二醇干扰素-α-2a治疗血清低水平HBsAg阳性的慢性乙型肝炎患者临床结局预测研究^*

Prediction of response in patients with low serum HBsAg level chronic hepatitis B receiving peginterferon-α-2a after nucleos(t)ide analogues treatment

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