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核苷和核苷酸类药物治疗慢性乙型肝炎停药标准的探讨
Criteria for withdrawal of nucleos(t)ide analogues and their clinical significance in treatment of chronic hepatitis B
文章发布日期:2016年06月08日  来源:  作者:陈合民,邵国辉  点击次数:1748次  下载次数:324次

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【摘要】:目的探讨核苷和核苷酸类药物(NAs)治疗慢性乙型肝炎(CHB)停药后病毒学复发与停药时HBsAg定量、HBV DNA载量的关系。方法收集2010年1月-2014年6月于济宁市传染病医院门诊经NAs治疗达到《慢性乙型肝炎防治指南(2010年版)》制订的停药标准计划停药的CHB患者205例。停药前检测HBsAg定量、HBV DNA载量,其中HBV DNA<103 IU/ml的采用Roche COBAS TaqMan 480Ⅱ PCR进一步检测高灵敏度HBV DNA载量。停药后随访1年,HBV DNA载量>103 IU/ml定义为病毒学复发。计数资料组间比较采用χ2检验和Fisher精确检验。结果停药1年所有CHB患者的总病毒学复发率为65.9%(135/205)。20%(41/205)患者HBV DNA>103 IU/ml。HBsAg定量≤100 IU/ml患者的复发率为23.9%(11/46),>100 IU/ml患者的复发率为78.0%(124/159),两组比较差异有统计学意义(χ2=46.4,P<0.000 1)。高灵敏度HBV DNA载量<20 IU/ml患者的复发率为56.4%(62/110),≥20 IU/ml患者的复发率为76.8%(73/95),两组比较差异有统计学意义(χ2=9.5,P=0.002)。同时符合HBsAg定量≤100 IU/ml、高灵敏度HBV DNA定量<20 IU/ml的患者复发率为14.3%(5/35),余下患者复发率为76.5%(130/170),两组比较差异有统计学意义(χ2=49.9,P<0.000 1)。结论达到我国《慢性乙型肝炎防治指南(2010年版)》制订的停药标准停止抗病毒治疗后,CHB的复发与停药时HBsAg定量、HBV DNA载量有一定关系,参考HBsAg定量和(或)高灵敏度HBV DNA载量作为抗病毒治疗的停药指标,如HBsAg定量≤100 IU/ml、高灵敏度HBV DNA载量<20 IU/ml可达到最大的安全停药。
【Abstract】:ObjectiveTo investigate the association of virologic relapse after withdrawal of nucleos(t)ide analogues (NAs) with HBsAg quantitation and HBV DNA load at withdrawal in patients with chronic hepatitis B (CHB). MethodsA total of 205 CHB patients who were treated with NAs in the outpatient service of Jining Infectious Diseases Hospital from January 2010 to June 2014, met the criteria for drug withdrawal in Guidelines for Prevention and Treatment of Chronic Hepatitis B (version 2010), and planned to stop the drugs were enrolled. HBsAg and HBV DNA load were measured before drug withdrawal, and COBAS TaqMan 480 Ⅱ PCR was performed for patients with HBV DNA<103 IU/ml to measure highly sensitive HBV DNA load. The patients were followed up for 1 year after drug withdrawal and HBV DNA >103 IU/ml was defined as virologic relapse. The chi-square test and Fisher′s exact test were used for comparison of categorical data between groups. ResultsAt 1 year after drug withdrawal, the overall virologic relapse rate in all CHB patients was 65.9%(135/205), and 20%(41/205) had HBV DNA>103 IU/ml. In the patients with HBsAg quantitation ≤100 IU/ml or >100 IU/ml, the virologic relapse rate was 23.9%(11/46) and 78.0%(124/159), respectively, with a significant difference between the two groups (χ2=46.4, P<0000 1). In the patients with highly sensitive HBV DNA load <20 IU/ml or ≥20 IU/ml, the virologic relapse rate was 56.4%(62/110) and 76.8%(73/95), respectively, with a significant difference between the two groups (χ2=9.5, P=0.002). The patients with HBsAg quantitation ≤100 IU/ml and highly sensitive HBV DNA load <20 IU/ml had a relapse rate of 14.3%(5/35), and the other patients had a relapse rate of 765%(130/170); the relapse rate showed a significant difference between the two groups (χ2=49.9, P<0.000 1). ConclusionAfter the patients meet the criteria for drug withdrawal in Guidelines for Prevention and Treatment of Chronic Hepatitis B (version 2010) and stop the antiviral therapy, the relapse of CHB is associated with HBsAg quantitation and HBV DNA load at withdrawal. With reference to HBsAg quantitation and/or highly sensitive HBV DNA load as the criteria for withdrawal of antiviral therapy, such as HBsAg quantitation ≤100 IU/ml and highly sensitive HBV DNA load <20 IU/ml, patients can achieve the safest drug withdrawal.
【关键字】:肝炎, 乙型, 慢性; 核苷类; 核苷酸类; 复发
【Key words】:hepatitis B, chronic; nucleosides; nucleotides; recurrence
【引证本文】:陈合民, 邵国辉. 核苷和核苷酸类药物治疗慢性乙型肝炎停药标准的探讨[J]. 临床肝胆病杂志, 2016, 32(7): 1283-1286.

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