核苷类药物联合或序贯聚乙二醇干扰素α-2a治疗的安全性

Safety study of peginterferon alpha-2a combined treatment or sequential therapy with nucleoside analogues

目的对比研究长期接受核苷(酸)药物治疗的慢性乙肝患者联合或序贯聚乙二醇干扰素α-2a治疗的安全性方面的差异。方法回顾性研究长期接受核苷(酸)药物治疗的慢性乙肝患者共181例。其中93例患者是联合聚乙二醇干扰素α-2a治疗(联合治疗组),88例患者是停用核苷(酸)药物并接受聚乙二醇干扰素α-2a治疗(序贯治疗组)。统计干扰素治疗0、12、24和48周时血清HBV DNA、血常规、肝功能、甲状腺功能及发热等症状和指标,记录结果并利用SPSS 16.0软件进行分析。结果在接受聚乙二醇干扰素α-2a治疗12、24和48周时,联合治疗组患者和序贯治疗组患者在骨髓抑制、流感样综合征发生率、甲状腺功能异常、血糖升高、抗核抗体升高和其他少见不良反应发生率方面均差异无统计学意义(P>0.05);序贯治疗组患者比联合治疗组患者在治疗结束时具有更高的肝功能异常率和HBV DNA升高率,差异有统计学意义(P<0.05)。结论对长期接受核苷(酸)药物的慢性乙型肝炎患者,聚乙二醇干扰素α-2a联合核苷(酸)药物治疗和序贯于核苷(酸)药物治疗其安全性无差异。

Objective To investigate the safety of peginterferon alpha-2 a combined treatment or sequential therapy with nucleoside analogues(NAs). Methods A total of 181 CHB patients with NAs treatment were enrolled into this retrospective study. Ninty-three patients were treated with PEG IFNα-2 a combined with NAs(combined treatment group) and 88 patients received the monotherapy of PEG IFNα-2 a(sequential treatment group). The two groups were compared in side effects symptoms and testing indexes, including ALT,HBV DNA levels, platelet count, neutrophil count, white blood cell count and flu syndrome etc, at 0, 12, 24 and 48 week.Statistical analysis was performed with the SPSS 16.0. Results At Week 0, levels of aminotransferases and HBV DNA were not statistically significant different between the two groups(P>0.05). At Week 12, 24 and 48, there was no significant difference in the incidence of myelosuppression, influenza-like syndrome, thyroid dysfunction, elevated blood glucose, elevated antinuclear antibodies and other rare side effects between the two groups(P>0.05). At the end of treatment, patients in the combined treatment group had higher rates of abnormal liver function and HBV DNA elevation(P<0.05).Conclusion PEG-IFN-alpha combination or sequential treatment with nucleoside(acid) drugs in long-term treatment of chronic hepatitis B patients are not statistically different in safety.