首页|高敏PCR在HBV极低病毒载量的慢性乙型肝炎患者中检测的临床意义

高敏PCR在HBV极低病毒载量的慢性乙型肝炎患者中检测的临床意义

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  • 国家科技期刊平台
  • NETL
  • NSTL
  • 万方数据
目的 探讨使用高敏PCR在HBV极低病毒载量(HBV DNA 10～99 IU/mL)人群检测中的意义.方法 选取2019年9月—2022年2月在广州医科大学附属第五医院接受核苷(酸)类似物(NAs)治疗≥48周且经普敏HBV DNA检测(检测下限100 IU/mL)结果为低于检测下限的慢性乙型肝炎(CHB)患者,进一步行高敏HBV DNA检测(检测下限10 IU/mL),根据结果分为极低病毒载量(VLVL,HBV DNA 10～99 IU/mL)组和完全病毒学应答(CVR,HBV DNA<10 IU/mL或未检测到)组.比较两组患者的一般特征、血清病毒学指标、生化学指标、无创肝纤维化指标,评价相关血清病毒学指标对高敏HBV DNA高于检测下限的预测价值,并探讨未实现CVR的影响因素.符合正态分布的计量资料两组间比较采用成组t检验;非正态分布的计量资料两组间比较采用Mann-Whitney U检验.计数资料两组间比较采用χ2检验或Fisher精确检验.采用受试者工作特征曲线(ROC曲线)评价相关血清病毒学指标对高敏HBV DNA高于检测下限的预测价值.采用二元Logistic回归分析探讨未实现CVR的影响因素.结果 共纳入106例CHB患者,其中VLVL组24例、CVR组82例.VLVL组年龄小于CVR组(P=0.004),VLVL组qHBsAg水平(P=0.002)、HBeAg阳性率(P=0.002)、pgRNA阳性率(P=0.010)及ALT水平(P=0.017)高于CVR组.qHBsAg水平预测CHB患者采用高敏HBV DNA检查结果高于检测下限(>10 IU/mL)的ROC曲线下面积为0.717(P=0.002),最佳cut-off值为1214.5 IU/mL,敏感度为95.5%,特异度为53.9%.HBeAg阳性(OR=3.654,95%CI:1.162～11.489,P=0.027)和qHBsAg(OR=2.985,95%CI:1.058～8.422,P=0.039)是未实现CVR的独立影响因素.结论 CHB患者经普敏检测HBV DNA低于<100 IU/mL,但经高敏PCR检测实际仍存在VLVL.VLVL患者炎症损伤水平、pgRNA阳性率以及HBeAg阳性率均显著高于CVR者.HBeAg阳性和高qHBsAg水平是CHB患者未实现CVR的独立影响因素.临床医师不应忽视CHB患者中VLVL人群,需及时行高敏HBV DNA检测.
Significance of high-sensitivity polymerase chain reaction in detecting hepatitis B virus in chronic hepatitis B patients with a very low viral load
Objective To investigate the significance of high-sensitive polymerase chain reaction(PCR)in detecting hepatitis B virus(HBV)among the population with a very low viral load(HBV DNA 10—99 IU/mL).Methods This study was conducted among the chronic hepatitis B(CHB)patients who were treated with nucleos(t)ide analogues for≥48 weeks in The Fifth Affiliated Hospital of Guangzhou Medical University from September 2019 to February 2022 and had an HBV DNA load below the lower limit of ordinary-sensitivity detection(100 IU/mL).Then high-sensitivity HBV DNA detection was performed for all patients,and according to these results,the patients were divided into very low viral load group(VLVL group with an HBV DNA load of 10—99 IU/mL)and complete virologic response group(CVR group with an HBV DNA load of<10 IU/mL or without HBV DNA detected).The two groups were compared in terms of general characteristics,serum virological indicators,biochemical parameters,and noninvasive fibrosis markers;the value of related serum virological indicators in predicting the results of high-sensitivity HBV DNA above the lower limit of detection were assessed;the influencing factors for failure to achieve CVR were analyzed.The independent-samples t test was used for comparison of normally distributed continuous data between two groups,and the Mann-Whitney U test was used for comparison of non-normally distributed continuous data between two groups;the chi-square test or the Fisher's exact test was used for comparison of categorical data between two groups.The receiver operating characteristic(ROC)curve was used to investigate the value of related serum virological indicators in predicting the results of high-sensitivity HBV DNA above the lower limit of detection,and a binary logistic regression analysis was used to investigate the influencing factors for failure to achieve CVR.Results A total of 106 CHB patients were enrolled,with 24 in the VLVL group and 82 in the CVR group.Compared with the CVR group,the VLVL group had a significantly younger age(P=0.004)and significantly higher quantitative hepatitis B surface antigen(qHBsAg)level(P=0.002),HBeAg positive rate(P=0.002),pgRNA positive rate(P=0.010),and alanine aminotransferase level(P=0.017).The qHBsAg level had an area under the ROC curve of 0.717(P=0.002)in predicting the results of high-sensitivity HBV DNA above the lower limit of detection(>10 IU/mL),with an optimal cut-off value of 1214.5 IU/mL,a sensitivity of 95.5%,and a specificity of 53.9%.Positive HBeAg(odds ratio[OR]=3.654,95%confidence interval[CI]:1.162—11.489,P= 0.027)and qHBsAg(OR=2.985,95%CI:1.058—8.422,P=0.039)were independent influencing factors for failure to achieve CVR.Conclusion Some CHB patients have an HBV DNA load of<100 IU/mL by ordinary-sensitivity detection,but with the presence of VLVL determined by high-sensitivity PCR.The VLVL group had significantly higher level of inflammatory damage and positive rates of pgRNA and HBeAg.Positive HBeAg and high qHBsAg level are independent influencing factors for failure to achieve CVR.Clinicians should not ignore the presence of VLVL in CHB patients,and high-sensitivity HBV DNA detection should be performed in a timely manner.

Hepatitis B,ChronicPolymerase Chain ReactionVery Low Viral Load

邱功钦、谢丹、陈姿任、欧阳石

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广州医科大学附属第五医院感染性疾病科,广州 510000

广州医科大学附属第五医院广东高校生物靶向诊治与康复重点实验室,广州 510000

乙型肝炎,慢性 聚合酶链反应 极低病毒载量

国家自然科学基金广东高校生物靶向诊治与康复重点实验室广州市医学重点学科项目(2021-2023年)本科生创新能力提升计划广州医科大学科研能力提升项目2022年广州医科大学学科建设项目2023年市校(院)企联合资助项目2023年北京肝胆相照公益基金会资助项目2023年北京肝胆相照公益基金会资助项目

818038842021KSYS0092022JXA00302-410-2302092XM02-410-22060132023A03J0421iGanF-1082023-RGG023

2024

10.12449/JCH240308

临床肝胆病杂志
吉林大学

临床肝胆病杂志

CSTPCD北大核心
影响因子：1.428
ISSN：1001-5256
年,卷(期)：2024.40(3)
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