摘要
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 explore the efficacy, safety, compliance and correlation factors of domestic adefovir dipivoxil （ AD） and interferonα-2b （ IFNα-2b） in the treatment of hepatitis Be antigen （ HBeAg）-positive chronic hepatitis B （ CHB） for 48 weeks.Methods A total of 68 patients who were screened from hepatitis B prevention and treatment comprehensive demonstration zones in Shandong Province were enrolled in this prospective open cohort study, randomly receiving antiviral treatment with IFNα-2b （33 cases） and ADV （35 cases）.The biochemical, virological, serological response, toxicity and compliance were observed and correlation factors analysis was investigated after 48 weeks. Results At the 48th week, normalization rates of ALT in IFNα-2b and ADV groups were 24.2% and 85.7% （ ITT analysis）, 57.1%and 88.2%（PP analysis）;HBV DNA undetectable rates were 24.2%and 88.6%（ITT analysis）,＆nbsp;57.1%and 91.2%（PP analysis）; normalization rate of ALT and HBV DNA undetectable rates in ADV group were higher than those in IFNα-2b group （P0.05）.The toxicity of IFNα-2b group was common.The drop-out rates of IFNα-2b and ADV were 18.2%and 2.9%（P=0.044）.Univariate analysis found that HBV DNA undetection in the two groups was associated with baseline AST and no factors were related to HBeAg loss. Multi-factor analysis showed that ADV and baseline AST level were predictive factors for HBV DNA undetection, and the independent predictive factor of HBeAg loss was ADV.Conclusion Both domestic ADV and IFNα-2b can treat chronic hepatitis B （ CHB） patients effectively, while the efficacy, safety and compliance of domestic ADV is inferior to IFNα-2b.
出处
《山东大学学报（医学版）》
CAS
北大核心
2014年第6期72-77,共6页
Journal of Shandong University:Health Sciences
基金
艾滋病和病毒性肝炎等重大传染病防治"十一五"和"十二五"国家科技重大专项(2009ZX10002-028
2013ZX10004902)
