免疫耐受期慢性乙型肝炎儿童抗病毒治疗临床随访

赵攀; 董漪; 刘佳琦; 高雪; 武艺伟; 朱世殊; 王丽旻; 魏振满

doi:10.3969/j.issn.1001-5256.2021.07.016

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

赵攀^a, ,,
董漪^b,
刘佳琦^a,
高雪^c,
武艺伟^a,
朱世殊^d, ,,
王丽旻^b,
魏振满^a

a.
解放军总医院第五医学中心感染病医学部，北京 100039
b.
解放军总医院第五医学中心肝病医学部，北京 100039
c.
解放军总医院第五医学中心病理科，北京 100039
d.
解放军总医院第五医学中心健康医学科，北京 100039

基金项目:

北京市科学技术委员会首都临床特色应用研究 (Z181100001718035);

国家自然科学基金 (81501652);

北京市自然科学基金 (7202193)

利益冲突声明：本研究不存在研究者、伦理委员会成员、受试者监护人以及与公开研究成果有关的利益冲突。

作者贡献声明：赵攀负责课题设计，数据核对，资料分析，撰写论文；朱世殊负责收集病例数据；董漪、刘佳琦、高雪、武艺伟、王丽旻、魏振满参与数据整理及资料分析。

详细信息

通信作者:
赵攀，doczhaopan@126.com

朱世殊，302zss@sina.cn

中图分类号: R512.62
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出版历程
- 收稿日期: 2021-01-28
- 录用日期: 2021-02-23
- 出版日期: 2021-07-20

Clinical follow-up of children with immune-tolerant chronic hepatitis B receiving antiviral therapy

Pan ZHAO^{a
, ,},
Yi DONG^b,
Jiaqi LIU^a,
Xue GAO^c,
Yiwei WU^a,
Shishu ZHU^{d
, ,},
Limin WANG^b,
Zhenman WEI^a

a.
Department of Infectious Diseases, The Fifth Medical Center of Chinese PLA General Hospital, Beijing 100039, China
b.
Department of Hepatology, The Fifth Medical Center of Chinese PLA General Hospital, Beijing 100039, China
c.
Department of Pathology, The Fifth Medical Center of Chinese PLA General Hospital, Beijing 100039, China
d.
Department of Health Examination, The Fifth Medical Center of Chinese PLA General Hospital, Beijing 100039, China

Research funding:

Beijing Municipal Science and Technology Commission （Z181100001718035）

National Natural Science Foundation of China （81501652）

Municipal Natural Science Foundation of Beijing of China （7202193）

摘要

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。
- 乙型肝炎, 慢性 /
- 免疫耐受 /
- 儿童
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.
- Hepatitis B, Chronic /
- Immune Tolerance /
- Child

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图 1 研究流程图

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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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参考文献(10)

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