Objective: 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). Methods: Quantitative data were compared using analysis of variance to compare the differences between groups. Enumeration data were compared by χ2 test (or Fisher's exact test). Univariate and multivariate logistic regressions were used to analyze the influencing factors. Results: 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 (χ2=13.616, P=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 (χ2=11.056, P=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 (χ2=13.616, P=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 (n=4, 30.8%), rash (n=4, 30.8%), fatigue (n=1, 7.7%), leukopenia (n=7, 53.8%), arthritis (n=1, 7.7%), and alopecia (n=3, 23.1%) were observed in the Peg-IFNα-2a group, while none were observed in the ETV group. Conclusion: 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.
目的： 对比接受有限疗程聚乙二醇干扰素α-2a（Peg-IFNα-2a）或接受恩替卡韦（ETV）持续治疗的乙型肝炎病毒e抗原（HBeAg）阳性慢性乙型肝炎（CHB）儿童的疗效和安全性，分析疗效的影响因素。 方法： 回顾性分析2014年2月至2019年3月符合入组标准HBeAg阳性CHB患儿资料，比较Peg-IFNα-2a组、ETV组和未治疗组患儿的HBsAg清除率等。计量资料采用方差分析比较组间差异；计数资料采用χ2检验（或Fisher确切概率法）进行比较；采用单因素及多因素logistic回归方法分析影响因素。 结果： 治疗52周时，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，差异有统计学意义（χ2=13.616，P=0.001），且Peg-IFNα-2a组和ETV组中发生HBsAg清除者均伴有抗-HBs转阳；随访共104周时，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（χ2=11.056，P=0.004），其中Peg-IFNα-2a组发生HBsAg清除者均伴有抗-HBs转阳，ETV组2例发生HBsAg清除的患儿中仅有1例同时伴有抗-HBs转阳，差异有统计学意义（χ2=13.616，P=0.001）。单因素及多因素logistic回归分析结果显示，HBsAg清除与年龄、抗病毒治疗药物相关。治疗期间，Peg-IFNα-2a组出现发热（n=4，30.8%）、皮疹（n=4，30.8%）、乏力（n=1，7.7%）、白细胞减少症（n=7，53.8%）、关节炎（n=1，7.7%）和脱发（n=3，23.1%）等不良反应，而ETV组未观察到上述不良事件。 结论： 5岁及以下HBeAg阳性CHB儿童采用Peg-IFNα-2a进行抗病毒治疗可比采用ETV达到更高的HBsAg清除率，而ETV相较Peg-IFNα-2a的不良反应较少，更为安全。.