干扰素单药与联合核苷酸类似物治疗对慢乙肝初治患者临床治愈效果的比较

Comparison of the Clinical Curative Efficacy of Interferon Monotherapy and Combined with Nucleotide Analogues in the Treatment-Naive Patients with Chronic Hepatitis B

摘要: 目的：目前认为临床治愈是慢乙肝治疗追求的理想终点。本研究旨在观察干扰素单药或联合核苷酸类似物治疗慢性乙型肝炎患者的临床治愈率，从而为临床实践中的治疗选择提供更为科学的依据。方法：收集从2017年1月至2023年1月我院肝病科门诊已经确诊的CHB、并接受IFN单药或联合NAs (包括ETV、TDF)治疗的初治患者共107例，其中单药治疗44例，联合治疗63例，单药治疗组仅单独使用IFN抗病毒，而联合治疗组在IFN治疗的基础上加用NAs联合治疗，收集两组患者治疗前、治疗12周、24周及48周时乙肝五项定量、HBVDNA、肝功能、血常规等各项指标数据，比较两组之间HBsAg转阴率、HBeAg转阴率、HBeAg血清学转换率以及肝功能、血常规部分指标的波动情况。结果：1) 治疗48周后，其中联合治疗组有19例(30.2%)患者出现HBsAg转阴，单药治疗组中有6例患者(13.6%)出现HBsAg转阴，与单药治疗组相比，联合治疗组的HBsAg转阴率更高，两组之间具有统计学意义(P = 0.047)；2) 在治疗24周，联合治疗组HBeAg转阴率为78.3%，单药治疗组HBeAg转阴率为59.1%，联合治疗组的HBeAg转阴率更高，两组比较具有统计学意义(P = 0.034)。3) 治疗24周、48周时，联合治疗组HBeAg血清转换率分别为40%、33.3%，单药治疗组分别为0、2.3%，联合治疗组的HBeAg血清转换率更高，两组比较具有显著统计学意义(P < 0.001)。结论：相较于单用IFN治疗，IFN联合NAs治疗可提高慢乙肝初治患者HBsAg的转阴率、HBeAg血清转换率，但在HBeAg转阴率方面，两组无明显差异。

Abstract: Objective: At present, it is believed that clinical cure is the ideal end point for the treatment of chronic hepatitis B. The purpose of this study was to observe the clinical cure rate of interferon monotherapy or combined with nucleotide analogues in the treatment of patients with chronic hepatitis B, so as to provide a more scientific basis for treatment options in clinical practice. Methods: A total of 107 patients with CHB who were diagnosed in the outpatient department of liver disease in our hospital from January 2017 to January 2023 and received IFN monotherapy or combined with NAs (including ETV and TDF) were collected. Among them, 44 patients were treated with monotherapy and 63 patients were treated with combination therapy. The monotherapy group was only treated with IFN alone, while the combination therapy group was treated with NAs on the basis of IFN therapy. The data of five indicators of hepatitis B, HBV DNA, liver function and blood routine were collected before treatment, 12 weeks, 24 weeks and 48 weeks after treatment. The HBsAg negative conversion rate, HBeAg negative conversion rate, HBeAg serological conversion rate, liver function and blood routine were compared between the two groups. Results: 1) After 48 weeks of treatment, 19 patients (30.2%) in the combined treatment group had HBsAg negative conversion, and 6 patients (13.6%) in the single drug treatment group had HBsAg negative conversion. Compared with the single drug treatment group, the HBsAg negative conversion rate in the combined treatment group was higher, and there was statistical significance between the two groups (P = 0.047). 2) At 24 weeks of treatment, the HBeAg negative conversion rate of the combined treatment group was 78.3%, the HBeAg negative conversion rate of the single drug treatment group was 59.1%, and the HBeAg negative conversion rate of the combined treatment group was higher. The comparison between the two groups was statistically significant (P = 0.034). 3) At 24 and 48 weeks of treatment, the HBeAg seroconversion rates of the combined treatment group were 40% and 33.3%, respectively, and those of the single drug treatment group were 0% and 2.3%, respectively. The HBeAg seroconversion rate of the combined treatment group was higher, and the comparison between the two groups was statistically significant (P < 0.001). Conclusions: Compared with IFN treatment alone, IFN combined with NAs treatment can improve the negative conversion rate of HBsAg and HBeAg seroconversion rate in patients with chronic hepatitis B, but there was no significant difference in the negative conversion rate of HBeAg between the two groups.