Wang H M, Zhou Y Z, Chang Y N, He Y, Peng X R, Hu P, Ren H, Xu H M
Department of Infection, Children's Hospital of Chongqing Medical University, National Clinical Research Center for Child Health and Disorders, Ministry of Education Key Laboratory of Child Development and Disorders, Chongqing Key Laboratory of Pediatrics, Chongqing 400014, China.
Department of Infectious Diseases, Institute for Viral Hepatitis, Key Laboratory of Molecular Biology for Infectious Diseases, Ministry of Education, Second Affiliated Hospital of Chongqing Medical University, Chongqing 400016, China.
Zhonghua Gan Zang Bing Za Zhi. 2022 Oct 20;30(10):1056-1062. doi: 10.3760/cma.j.cn501113-20210225-00094.
To compare the efficacy, safety, and influencing factors among children with hepatitis B virus e antigen (HBeAg)-positive chronic hepatitis B (CHB) who received short-term therapy with pegylated interferon alfa-2a (Peg-IFNα-2a) or continuous therapy with entecavir (ETV). Quantitative data were compared using analysis of variance to compare the differences between groups. Enumeration data were compared by test (or Fisher's exact test). Univariate and multivariate logistic regressions were used to analyze the influencing factors. Peg-IFNα-2a, ETV, and untreated group had HBsAg clearance rates of 46.2%, 5.3%, and 0 after 52 weeks of therapy, respectively. HBsAg clearance in the patients' group with Peg-IFNα-2a and ETV was all accompanied by anti-HBS positive conversion, and the difference was statistically significant (=13.616, =0.001). Peg-IFNα-2a group was followed-up for 104 weeks. Peg-IFNα-2a, ETV, and the untreated group had HBsAg clearance rates of 46.2%, 10.5%, and 0%, respectively, and the differences were statistically significant (=11.056, =0.004). Only one of the two children with HBsAg clearance in the ETV group had achieved anti-HBs antibodies, and the difference was statistically significant (=13.616, =0.001). Univariate and multivariate logistic regression analysis showed that HBsAg clearance was associated with age and antiviral therapy. During treatment, adverse events such as fever (=4, 30.8%), rash (=4, 30.8%), fatigue (=1, 7.7%), leukopenia (=7, 53.8%), arthritis (=1, 7.7%), and alopecia (=3, 23.1%) were observed in the Peg-IFNα-2a group, while none were observed in the ETV group. Peg-IFNα-2a antiviral therapy produced higher HBsAg clearance than ETV in five-year-old and younger children with HBeAg-positive CHB, while ETV had fewer adverse events and was safer than Peg-IFNα-2a.
比较接受聚乙二醇干扰素α-2a（Peg-IFNα-2a）短期治疗或恩替卡韦（ETV）持续治疗的乙肝病毒e抗原（HBeAg）阳性慢性乙型肝炎（CHB）儿童的疗效、安全性及影响因素。采用方差分析比较定量数据以比较组间差异。计数数据采用检验（或Fisher精确检验）进行比较。采用单因素和多因素逻辑回归分析影响因素。治疗52周后，Peg-IFNα-2a组、ETV组和未治疗组的HBsAg清除率分别为46.2%、5.3%和0。Peg-IFNα-2a组和ETV组患者的HBsAg清除均伴有抗-HBS血清学转换，差异有统计学意义（=13.616，=0.001）。Peg-IFNα-2a组随访104周。Peg-IFNα-2a组、ETV组和未治疗组的HBsAg清除率分别为46.2%、10.5%和0%，差异有统计学意义（=11.056，=0.004）。ETV组HBsAg清除的2例儿童中仅1例获得抗-HBs抗体，差异有统计学意义（=13.616，=0.001）。单因素和多因素逻辑回归分析显示，HBsAg清除与年龄及抗病毒治疗有关。治疗期间，Peg-IFNα-2a组观察到发热（=4，30.8%）、皮疹（=4，30.8%）、乏力（=1，7.7%）、白细胞减少（=7，53.8%）、关节炎（=1，7.7%）和脱发（=3，23.1%）等不良事件，而ETV组未观察到。对于HBeAg阳性CHB的5岁及以下儿童，Peg-IFNα-2a抗病毒治疗产生的HBsAg清除率高于ETV，而ETV不良事件较少，比Peg-IFNα-2a更安全。
