核苷（酸）类似物治疗慢性乙型肝炎停药 48 周后的结局及复发的相关因素。

48-Week Outcome after Cessation of Nucleos(t)ide Analogue Treatment in Chronic Hepatitis B Patient and the Associated Factors with Relapse.

机构信息

Department of Infectious Diseases, Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong 510630, China.

Guangdong Key Laboratory of Liver Disease Research, Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong 510630, China.

出版信息

Can J Gastroenterol Hepatol. 2018 May 10;2018:1817680. doi: 10.1155/2018/1817680. eCollection 2018.

BACKGROUND AND AIMS

We aimed to ascertain the feasibility and safety of NA cessation, the status of patients after cessation, and the predictive factors for relapse and subsequent retreatment.

METHODS

A total of 92 patients were enrolled in this prospective study. Patients were monitored every month for the first 3 months after cessation and every 3 months thereafter.

RESULTS

Sixty-two patients finished 48 weeks of follow-up. None died or developed liver failure, cirrhosis, or HCC. The 62 patients could be divided into 4 categories according to the 48-week clinical development of relapse. Virologic relapses occurred in 39 (62.9%) patients, with 72.7% occurring in the first 24 weeks in origin HBeAg positive patients and 82.4% in the first 12 weeks in origin HBeAg negative patients. Age (OR = 1.06, 95% CI = 1.02-1.10; = 0.003), the HBsAg level (OR = 2.21, 95% CI = 1.47-3.32; < 0.001), and positive origin HBeAg status (OR = 0.32, 95% CI = 0.14-0.74; = 0.008) were predictive factors to virologic relapse. HBV DNA level (OR = 1.34, 95% CI = 1.13-1.58; < 0.001) was predictive factor to retreatment.

CONCLUSIONS

NA cessation is safe under supervision. Age, HBsAg level, and origin HBeAg status can be predictive factors for virologic relapse. The study was submitted to ClinicalTrials.gov Protocol Registration and Results System with the assigned NCT ID NCT02883647.

背景和目的

我们旨在确定 NA 停药的可行性和安全性、停药后患者的状况，以及复发和随后再次治疗的预测因素。

方法

这项前瞻性研究共纳入 92 例患者。在停药后前 3 个月每月监测患者，此后每 3 个月监测一次。

结果

62 例患者完成了 48 周的随访。无患者死亡或发生肝功能衰竭、肝硬化或 HCC。根据复发的 48 周临床进展，62 例患者可分为 4 类。39 例（62.9%）患者发生病毒学复发，在原始 HBeAg 阳性患者中，72.7%发生在最初 24 周，在原始 HBeAg 阴性患者中，82.4%发生在最初 12 周。年龄（OR = 1.06，95%CI = 1.02-1.10； = 0.003）、HBsAg 水平（OR = 2.21，95%CI = 1.47-3.32； < 0.001）和阳性原始 HBeAg 状态（OR = 0.32，95%CI = 0.14-0.74； = 0.008）是病毒学复发的预测因素。HBV DNA 水平（OR = 1.34，95%CI = 1.13-1.58； < 0.001）是再次治疗的预测因素。