免疫耐受期慢性乙型肝炎儿童抗病毒治疗临床随访
DOI: 10.3969/j.issn.1001-5256.2021.07.016
Clinical follow-up of children with immune-tolerant chronic hepatitis B receiving antiviral therapy
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摘要:
目的 评估免疫耐受期慢性乙型肝炎儿童抗病毒治疗的长期临床获益。 方法 对前期随机对照临床试验纳入的46例治疗组免疫耐受期慢性乙型肝炎儿童进行长期随访,在临床试验开始后的第108、120、132、144、168、192周分别对患者进行临床评估。 结果 46例患者均完成随访。随访结束(第192周)与临床试验完成时(临床试验开始后第96周)相比较,血清HBV DNA阴转增加3例,血清HBeAg阴转增加7例,HBeAg抗体转换增加6例,血清HBsAg阴转例数无变化,HBsAg抗体转换例数增加3例,总计分别为37例(80.4%)、22例(47.8%)、21例(45.7%)、10例(21.7%)、10例(21.7%)。9例(19.6%)未达到HBV DNA阴转,停药后均出现病毒学突破。 结论 免疫耐受期慢性乙型肝炎儿童抗病毒治疗需要更大样本量的研究深入论证。 Abstract:Objective To investigate the long-term clinical benefits of antiviral therapy in children with immune-tolerant chronic hepatitis B. Methods Long-term follow-up was performed for 46 children with immune-tolerant chronic hepatitis B who were enrolled in the treatment group of the previous randomized controlled trial, and clinical evaluation was performed at weeks 108, 120, 132, 144, 168, and 192 after the trial started. Results All 46 patients completed the follow-up. From week 96 (after the clinical trial started) to week 192 (when the follow-up ended), another 3 patients achieved serum HBV DNA clearance, another 7 patients achieved serum HBeAg clearance, another 6 patients achieved HBeAg seroconversion, and another 3 patients achieved HBsAg seroconversion, while there was no change in the number of patients who achieved serum HBsAg clearance, with a total number of 37 (80.4%), 22 (47.8%), 21 (45.7%), 10(21.7%), and 10(21.7%), respectively. Among these patients, 9(19.6%) did not achieve HBV DNA clearance and they all had virologic breakthrough after drug withdrawal. Conclusion Further large-sample clinical trials are needed to investigate antiviral therapy for children with immune-tolerant chronic hepatitis B. -
Key words:
- Hepatitis B, Chronic /
- Immune Tolerance /
- Child
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表 1 各随访时间点主要指标阴转情况
指标 96周 108周 120周 132周 144周 168周 192周 HBV DNA阴转(例) 34 34 37 36 37 37 37 HBeAg阴转(例) 15 15 17 18 19 21 22 HBeAg抗体转换(例) 15 16 16 17 19 20 21 HBsAg阴转(例) 10 10 10 10 10 10 10 HBsAg抗体转换(例) 7 7 8 10 10 10 10 -
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