干扰素α治疗儿童慢性乙型肝炎的疗效和安全性：来自中国

StephenW

Efficacy and safety of interferon alpha therapy in children with chronic hepatitis B: A long-term follow-up cohort study from China.
Hu Y1, Ye Y, Ye L, Wang X, Yu H.
Author information

1
    Department of Infectious Diseases, Children's Hospital of Fudan University, Shanghai, China.

Abstract

Interferon-alpha (IFN-α) is currently the preferred antiviral treatment for children with chronic hepatitis B (CHB) aged >1-year-old. However, the evidence regarding the exact efficacy and safety in the real world is not sufficient. This study aimed to investigate the efficacy of IFN-α therapy in children with CHB and to provide a theoretical basis for practically identifying ideal antiviral therapies for CHB children.Clinical manifestations, baseline characteristics, related laboratory tests, and adverse events were retrospectively analyzed in children with CHB who visited the Children's Hospital of Fudan University, were treated with IFN-α and were followed up from January 2003 to October 2018.A total of 18 immune-active patients without advanced fibrosis were enrolled, and their average age at the start of treatment was 4.45 ± 2.75 years old. IFN α-2b was administered subcutaneously by body surface area (BSA) category, based on 3 MU/m, for a median 48 weeks. Before treatment, the alanine aminotransferase (ALT) range was 81 to 409 U/L (median 158 U/L). The median hepatitis B virus (HBV)-DNA load was 9.89 × 10 IU/mL, and the HBV-DNA load varied from 3.10 × 10 to 4.56 × 10 IU/mL. The ALT levels of 17 children became normal at an average of 12 weeks during treatment, and those of 1 child became normal at 6 weeks after IFN-α withdrawal. Sixteen (88.9%, 16/18) children became HBV-DNA negative (<10 IU/mL) at an average of 24 weeks during treatment, while 1 became negative at 96 weeks after IFN-α withdrawal and 1 remained HBV-DNA positive. HBV e antigen (HBeAg) seroconversion occurred in 13 of 14 (92.9%, 13/14) HBeAg-positive patients at an average of 12 weeks during treatment. HBV s antigen (HBsAg) loss or seroconversion occurred in 4 (22.2%, 4/18) patients at an average of 21 weeks during treatment. Only mild flu-like symptoms and transient neutropenia appeared in some children at the early treatment stage. No severe abnormal results were observed in other laboratory parameters.The antiviral monotherapy of 48 weeks of IFN-α was well tolerated and good responded, which was associated with higher rates of HBeAg seroconversion and HBsAg clearance in the children in this study than in previously reported adults and pediatric patients.

PMID:
    31393369
DOI:
    10.1097/MD.0000000000016683

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StephenW

干扰素α治疗儿童慢性乙型肝炎的疗效和安全性：来自中国的长期随访队列研究。
胡Y 1，叶烨，叶莉，王,,余H.
作者信息

1
复旦大学附属儿童医院感染科，上海

抽象

干扰素-α（IFN-α）目前是年龄> 1岁的慢性乙型肝炎（CHB）儿童的首选抗病毒治疗药物。但是，关于现实世界中确切功效和安全性的证据还不够。本研究旨在探讨IFN-α治疗CHB患儿的疗效，为CHB患儿实际鉴别理想抗病毒治疗提供理论依据。对儿童的临床表现，基线特征，相关实验室检查和不良事件进行回顾性分析。参观复旦大学儿童医院的CHB患者接受IFN-α治疗，随访时间从2003年1月至2018年10月。共有18名无晚期纤维化的免疫活动患者入组，其平均年龄为治疗时间为4.45±2.75岁。 IFNα-2b通过体表面积（BSA）类别皮下给药，基于3MU / m，中位48周。在治疗前，丙氨酸氨基转移酶（ALT）范围为81至409 U / L（中位数158 U / L）。中位乙型肝炎病毒（HBV）-DNA载量为9.89×10IU / mL，HBV-DNA载量从3.10×10变为4.56×10IU / mL。治疗期间平均12周时，17名儿童的ALT水平恢复正常，1名儿童的ALT水平在IFN-α戒断后6周恢复正常。 16名（88.9％，16/18）儿童在治疗期间平均24周时变为HBV-DNA阴性（<10 IU / mL），而1例在IFN-α戒断后96周变为阴性，1例仍为HBV-DNA阳性。 HBV e抗原（治疗期间平均12周HBeAg阳性患者.4例（22.2％，4/18）患者发生HBV s抗原（HBsAg）丢失或血清转换治疗期间平均21周。仅轻度流感部分患儿在治疗初期出现类似症状和暂时性中性粒细胞减少症，其他实验室参数均未出现严重异常结果，48周IFN-α抗病毒单药治疗耐受良好，反应良好，与高剂量反应有关。本研究中儿童HBeAg血清转换率和HBsAg清除率高于先前报道的成人和儿科患者。

结论：
31393369
DOI：
10.1097 / MD.0000000000016683

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