论文部分内容阅读
目的研究国产干扰素α-2b(IFNα-2b)和阿德福韦酯(ADV)治疗HBeAg阳性慢性乙型肝炎(慢乙肝)48周的疗效、安全性、依从性和相关因素。方法将山东省乙型肝炎防治综合示范区筛查出的符合抗病毒治疗的68例HBeAg阳性慢乙肝患者建立前瞻性开放研究队列,随机给予IFNα-2b(33例)、ADV(35例)抗病毒治疗,观察治疗48周两组患者生化学、病毒学及血清学应答情况,以及不良反应和依从性并进行相关因素分析。结果治疗48周时,IFNα-2b组和ADV组ALT复常率分别为24.2%、85.7%(ITT分析)和57.1%、88.2%(PP分析);HBV DNA阴转率分别为24.2%、88.6%(ITT分析)和57.1%、91.2%(PP分析),ADV组ALT复常率、HBV DNA阴转率均高于IFNα-2b组(P<0.05)。两组HBeAg消失率分别为12.1%、31.4%(ITT分析)和28.6%、32.4%(PP分析),HBeAg血清转换率分别为6.1%、2.9%(ITT分析)和14.3%、2.9%(PP分析),差异均无统计学意义(P>0.05)。IFNα-2b组不良反应较多见。两组失访率分别为18.2%、2.9%(P=0.044)。单因素分析发现两组HBV DNA阴转均与基线AST有关,未发现HBeAg阴转相关因素;多因素分析显示ADV和基线AST为HBV DNA阴转预测因素,HBeAg阴转的独立预测因素为ADV。结论国产ADV和IFNα-2b均能有效治疗慢乙肝,并且国产ADV在疗效、安全性和依从性方面均优于IFNα-2b。
Objective To investigate the efficacy, safety, compliance and related factors of domestic interferon α-2b (IFNα-2b) and adefovir dipivoxil (ADV) for 48 weeks in HBeAg-positive chronic hepatitis B patients. Methods A prospective open cohort of 68 HBeAg-positive chronic hepatitis B patients who were screened out from the Hepatitis B Prevention and Treatment Comprehensive Demonstration Zone in Shandong Province were enrolled. IFNα-2b (33 cases), ADV (35 cases) Viral treatment, observation of biochemical, virological and serological response, as well as adverse reactions and compliance of the two groups of patients for 48 weeks of treatment and analysis of related factors. Results After 48 weeks of treatment, the rates of ALT abnormalities in IFNα-2b group and ADV group were 24.2%, 85.7% (ITT analysis) and 57.1%, 88.2% (PP analysis), respectively; HBV DNA negative conversion rates were 24.2%, 88.6 % (ITT analysis) and 57.1%, 91.2% (PP analysis). The ALT normalization rate and HBV DNA negative rate in ADV group were higher than those in IFNα-2b group (P <0.05). HBeAg seroconversion rates were 12.1%, 31.4% (ITT analysis) and 28.6%, 32.4% (PP analysis), HBeAg seroconversion rates were 6.1%, 2.9% (ITT analysis) and 14.3%, 2.9% Analysis), the difference was not statistically significant (P> 0.05). Adverse reactions to IFNα-2b were more common. The two groups lost rate was 18.2%, 2.9% (P = 0.044). Univariate analysis showed that the two groups of HBV DNA were negatively correlated with the baseline AST, and no correlation was found between the factors of negative conversion of HBeAg. Multivariate analysis showed that ADV and baseline AST were the predictors of HBV DNA negative conversion, and the independent predictors of HBeAg negative conversion were ADV. Conclusion Both domestic ADV and IFNα-2b can effectively treat chronic hepatitis B, and domestic ADV are superior to IFNα-2b in efficacy, safety and compliance.