高灵敏度real-time PCR在低病毒载量病毒性肝病中的临床应用价值

摘要
图/表
参考文献(26)
相关文章 (1)

全文: PDF (448 KB) HTML (1 KB)
输出: BibTeX | EndNote (RIS)

摘要目的评估高灵敏度实时荧光定量聚合酶链反应（real-time PCR）在病毒性肝病病毒核酸定量检测中的临床应用价值，为该方法的普及应用提供依据。方法收集2016年1月～2018年12月于湖北省中医院（以下简称“我院”）就诊的病毒性肝病患者895例，同期选取我院100名健康体检者作为对照组。分别应用常规方法和高灵敏度real-time PCR方法检测血清病毒核酸载量，比较两种方法检测结果的差异。对其中低病毒载量患者的生物化学指标、免疫学指标、凝血国际标准化比值（INR）和肝纤维化FIB-4指数的变化趋势、特点及其与病毒核酸载量的相关性进行统计分析。结果受检人群中低病毒载量患者呈高比例分布。高灵敏度real-time PCR方法检测HBV DNA的阳性率远高于常规方法（P ＜ 0.05），而对于HCV RNA，两种方法检测结果的一致性较好。低病毒载量患者的多项生物化学指标波动并不明显，且多项生物化学指标与病毒核酸载量无相关性（P ＞ 0.05）。大部分低病毒载量乙肝患者表现为HBeAg阴性的低水平复制状态。免疫学诊断指标与病毒核酸载量间存在不同程度的不一致和弱关联度。低病毒载量患者的凝血INR和肝纤维化FIB-4指数均高于对照组，差异有统计学意义（P ＜ 0.05），但其与病毒核酸载量无相关性（P ＞ 0.05）。结论高灵敏度real-time PCR方法对病毒核酸载量的检测具有不可比拟的优势，结合其他的诊断指标，其可在低拷贝病毒性肝病的病程管理中发挥不可替代的重要作用。

	服务

	把本文推荐给朋友
	加入我的书架
	加入引用管理器
	E-mail Alert
	RSS
	作者相关文章
	陈鹏1 孙玉良1 邓星1 肖明中2

关键词 ：高灵敏度, 实时荧光定量聚合酶链反应, 病毒性肝病, 病毒核酸定量, 低病毒载量

Abstract：Objective To evaluate the clinical application value of high-sensitivity real-time polymerase chain reaction (real-time PCR) in the quantitative detection of viral nucleic acid in viral hepatitis, and to provide the basis for the widespread application of this method. Methods A total of 895 patients with viral hepatitis were enrolled from January 2016 to December 2018 in Hubei Provincial Hospital of Traditional Chinese Medicine (hereinafter referred to as “our hospital”), and meanwhile another 100 normal people in our hospital were recruited as control group. Serum viral loads were detected by routine and high sensitive real-time PCR, then the difference of results between the two methods was compared. The trends and characteristics of biochemical indices，immunological markers, international standardized ratio of coagulation (INR), index of liver fibrosis FIB-4 and their correlation with viral load were analyzed statistically in viral hepatitis patients with low viral load. Results The proportion of patients with low viral load was high among the population surveyed. The positive rate of HBV DNA detected by real-time PCR with high sensitivity was much higher than that by routine method（P ＜ 0.05），but for HCV RNA, the two methods showed good consistency. The fluctuation of several biochemical indices was not obvious in low viral load patients, and multiple biochemical indexes were not correlated with viral nucleic acid load (P ＞ 0.05). Most hepatitis B patients with low viral load showed a status of low level HBeAg-negative replication. There were different degrees of inconsistency and weak correlation between immunological diagnostic markers and viral load results. INR of coagulation and FIB-4 index of liver fibrosis in patients with low viral load were higher than those in the control group, and the difference was statistically significant (P ＜ 0.05), but there was no correlation between them and viral nucleic acid load (P ＞ 0.05). Conclusion High sensitivity real-time PCR has incomparable advantages in the detection of viral nucleic acid，combined with other diagnostic markers，it can play an irreplaceable role in the course management of low viral load hepatitis.

Key words： High sensitivity Real-time polymerase chain reaction Viral hepatitis Viral nucleic acid quantification Low viral load

基金资助:国家中医临床研究基地业务建设科研专项基金资助项目（JDZX2012055）。

作者简介: 陈鹏（1981.2-），男，硕士，主要从事临床感染性疾病的病原分子生物学检验与研究。

引用本文:

陈鹏1 孙玉良1 邓星1 肖明中2. 高灵敏度real-time PCR在低病毒载量病毒性肝病中的临床应用价值[J]. 中国医药导报, 2020, 17(19): 151-155.
CHEN Peng1 SUN Yuliang1 DENG Xing1 XIAO Mingzhong2. Clinical application value of high-sensitivity real-time PCR in low load viral hepatitis. 中国医药导报, 2020, 17(19): 151-155.

链接本文:

http://www.yiyaodaobao.com.cn/CN/ 或 http://www.yiyaodaobao.com.cn/CN/Y2020/V17/I19/151

[1] Sun YT，Zhang YX，Tang H，et al. Clinical characteristics and current management of hepatitis B and C in China [J]. World J Gastroenterol，2014，20（37）：13582-13590.
[2] Qin Q，Smith MK，Wang L，et al. Hepatitis C virus infection in China：an emerging public health issue [J]. J Viral Hepat，2015，22（3）：238-244.
[3] Strassl R，Rutter K，St?覿ttermayer AF，et al. Real-time PCR assays for the quantification of HCV RNA：concordance，discrepancies and implications for response guided therapy [J]. PLoS One，2015，10（8）：e0135963.
[4] 周惠娟，谢青.精准医学时代中国丙型肝炎诊疗一体化的病毒学应答指导治疗策略[J].临床肝胆病杂志，2016， 32（7）：1262-1265.
[5] Cai SH，Lv FF，Zhang YH，et al. Dynamic comparison between Daan real-time PCR and Cobas TaqMan for quantification of HBV DNA levels in patients with CHB [J]. BMC Infect Dis，2014，14：85.
[6] Villar LM，Cruz HM，Barbosa JR，et al. Update on hepatitis B and C virus diagnosis [J]. World J Virol，2015，4（4）：323-342.
[7] 中华医学会肝病学分会，中华医学会感染病学分会.慢性乙型肝炎防治指南(2015更新版)[J].中华肝脏病杂志，2015，23（12）：888-905.
[8] 中华医学会肝病学分会，中华医学会感染病学分会.丙型肝炎防治指南(2015更新版)[J].中华肝脏病杂志，2015， 23（12）：906-923.
[9] Singh MP，Galhotra S，Saigal K，et al. Quantitative nucleic acid amplification methods and their implications in clinical virology [J]. Int J Appl Basic Med Res，2017，7（1）：3-9.
[10] 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.
[11] European Association for Study of Liver. EASL Clinical Practice Guidelines：management of hepatitis C virus infection [J]. J Hepatol，2014，60（2）：392-420.
[12] European Association for Study of Liver. EASL Recommendations on treatment of hepatitis C 2015 [J]. J Hepatol，2015，63（1）：199-236.
[13] Terrault NA，Bzowej NH，Chang KM，et al. AASLD guidelines for treatment of chronic hepatitis B [J]. J Hepatol，2016，63（1），261-283.
[14] European Association for the Study of the Liver. EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection [J]. J Hepatol，2017，67（2），370-398.
[15] World Gastroenterology Organisation. World Gastroenterology Organisation global guidelines：diagnosis，management，and prevention of hepatitis C（2017 update）[EB/OL]. World Gastroenterology Organisation，2017.
[16] 刘立，刘春云，王霖，等.低水平HBsAg患者肝组织HBsAg、HBcAg表达与血清HBsAg水平、HBV DNA载量的相关性[J].实用医学杂志，2017，33（21）：3639-3642.
[17] Tripodi G，Larsson SB，Norkrans G，et al. Smaller reduction of hepatitis B virus DNA in liver tissue than in serum in patients losing HBeAg [J]. J Med Virol，2017， 89（11）：1937-1943.
[18] Wang H，Fang M，Gu X，et al. The intracellular HBV DNAs as novel and sensitive biomarkers for the clinical diagnosis of occult HBV infection in HBeAg negative hepatocellular carcinoma in China [J]. PLoS One，2014，9（9）：e107162.
[19] Arora S，Doda V，Kirtania T. Sensitivity of individual donor nucleic acid testing（NAT） for the detection of hepatitis B infection by studying diluted NAT yield samples [J]. Blood Transfus，2015，13（2）：227-232.
[20] Khadem-Ansari MH，Omrani MD，Rasmi Y，et al. Diagnostic validity of the chemiluminescent method compared to polymerase chain reaction for hepatitis B virus detection in the routine clinical diagnostic laboratory [J]. Adv Biomed Res，2014，3：116.
[21] Laperche S，Nübling CM，Stramer SL，et al. Sensitivity of hepatitis C virus core antigen and antibody combination assays in a global panel of window period samples [J]. Transfusion，2015，55（10）：2489-2498.
[22] Liu C，Chang L，Ji H，et al. Prevalence of HBV DNA among 20 million seronegative blood donations in China from 2010 to 2015 [J]. Sci Rep，2016，11（6）：1-7.
[23] Cheng J，Dai Y，Yan L，et al. Clinical characteristics and correlation analysis of subjects with chronic hepatitis B virus （HBV） infection and sustained low levels of hepatitis B surface antigen（HBsAg）[J]. Med Sci Monit，2018， 24：1826-1835.
[24] Jiang JN，Huang ZL，He LX，et al. Residual amount of HBV DNA in serum is related to relapse in chronic hepatitis B patients after cessation of nucleos（t）ide analogs [J]. J Clin Gastroenterol，2015，49（4）：323-328.
[25] Liu YP，Yao CY. Rapid and quantitative detection of hepatitis B virus [J]. World J Gastroenterol，2015，21（42）：11954-11963.
[26] 康晓征，赵勇，蒋善珍，等.FIB-4指数联合天冬氨酸氨基转移酶与血小板比值对HBV患者治疗后病情转归的预测价值[J].实用医学杂志，2018，34（11）：1782-1786.