两种检测HBV RNA方法在核苷(酸)类似物经治和初治慢性乙型肝炎患者中的相关性和一致性评价

摘要/Abstract

摘要： 目的: 比较RACE法和Sansure法检测核苷(酸)类似物经治和初治慢性乙型肝炎患者HBV RNA定量值的相关性和一致性。方法: 纳入南方医科大学南方医院门诊随访的慢性乙型肝炎患者并收集患者血清学、病毒学和生化数据。采集患者血清分别用RACE法和Sansure法检测HBV RNA水平,分析两者检测值的相关性和一致性。结果: 共入组101例慢性乙型肝炎患者,其中接受核苷(酸)类似物治疗62例,未曾接受核苷(酸)类似物治疗39例。治疗和未治疗组的HBsAg和HBV DNA水平存在显著差异,HBV RNA水平差异有统计学意义。两种方法相比,RACE法比Sansure法检测到的阳性患者更多(60/101和56/101),平均检测值更高(3.16和2.53 lg 拷贝/mL)。HBV DNA水平与HBV RNA水平在治疗组没有相关性(RACE法R²= 0.440 6,Sansure法R²= 0.508 1),在未治疗组显著相关(RACE法R²= 0.844 8,Sansure法R²= 0.866 7)。RACE法和Sansure法HBV RNA检测值显著相关(R²= 0.874 0);此外,两种HBV RNA检测方法Bland-Altman分析显示,95%一致性界限的范围较窄(在治疗组为-1.789～0.22 lg 拷贝/mL,在未治疗组为-2.25～0.53 lg 拷贝/mL);以RACE法为基准,Sansure法的偏差在治疗组为-0.78 lg 拷贝/mL,在未治疗组为-0.86 lg 拷贝/mL。两种方法线性回归后方程:Y(Sansure法)=0.918 9X(RACE法)-0.3754。结论: 两种HBV RNA检测方法的相关性显著,一致性较好,可用线性回归方程互算;两种HBV RNA检测方法均可有效弥补血清HBV DNA检测对指导慢性乙型肝炎临床诊治方面的不足。

关键词: 肝炎病毒,乙型, HBV RNA, RACE法, Sansure法, 相关性, 一致性

Abstract: Objective To compare Race method and Sansure method in HBV RNA quantification in naive and treated patients with chronic hepatitis B (CHB). Methods Clinical datas were collected from patients who were followed up in the outpatient department of Nanfang Hospital. RACE method and Sansure method were used to detect patients' serum HBV RNA levels. The correlation and consistency of the two assays were analyzed. Results A total of 101 patients were enrolled, including 62 patients who received nucleoside/nucleotide analogues (NAs) treatment and 39 patients who did not receive any NAs treatment (i.e., na?ve patients). There were significant differences in HBsAg and HBV DNA levels between the treated and untreated groups. There were statistically differences in serum HBV RNA levels in the two groups. Detectable serum HBV RNA was seen in more patients in RACE group than in Sansure group, as well as higher mean levels of serum HBV RNA (3.16 lg copies/mL vs 2.53 lg copies/mL). There was no significant correlation between HBV DNA levels and HBV RNA levels in the treatment group (RACE R²= 0.4406, Sansure R²= 0.5081); while in the untreated group, there has significant correlation between the two methods (Race R²= 0.8448, Sansure R²= 0.8667). RACE and Sansure were significantly correlated in detectable HBV RNA levels (R²= 0.93498740, P<0.001). In addition, Bland-Altman analysis showed that the 95% of agreement of the two HBV RNA detection methods was relatively narrow (-1.789~0.22 lg copies /mL in the treatment group,and -2.25~0.53 lg copies /mL in the untreated group). If RACE method was used as the baseline, the deviation of Sansure method was -0.78 lg 拷贝/mL in the treatment group and -0.86 lg 拷贝/mL in the untreated group. Linear regression equation: Y (Sansure) =0.918 9X (RACE)-0.3754. Conclusion The correlation between the two methods is significant and can be calculated by linear regression equation; Both the two HBV RNA detection methods can effectively make up for the deficiency of serum HBV DNA detection in guiding the clinical diagnosis and treatment of CHB.

Key words: Hepatitis B virus, HBV RNA, RACE method, Sansure method, Correlation, Consistency

王雪刚, 张新枝, 杨澍, 甘苏琴, 刘诗, 郝坤艳, 周彬, 于乐成. 两种检测HBV RNA方法在核苷(酸)类似物经治和初治慢性乙型肝炎患者中的相关性和一致性评价[J]. 肝脏, 2020, 25(7): 736-742.

WANG Xue-gang, ZHANG Xin-zhi, YANG Shu, GAN Su-qin, LIU Shi, HAO Kun-yan, ZHOU Bin, YU Yue-cheng. The correlation and consistency of two methods for HBV RNA detection in chronic hepatitis B patients with or without nucleoside/nucleotide analogues treatment[J]. Chinese Hepatolgy, 2020, 25(7): 736-742.

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