替诺福韦联合干扰素α1b治疗慢性乙型肝炎的临床观察

Clinical Observation of Tenofovir Combined with Interferon α1b for Chronic Hepatitis B

目的:观察替诺福韦联合干扰素α1b治疗慢性乙型肝炎(以下简称"乙肝")的临床疗效与安全性。方法:96例慢性乙肝患者依据随机数字表法分为对照组、A观察组与B观察组,各32例。对照组患者给予恩替卡韦口服,每次0.5 mg,qd;A观察组患者给予替诺福韦口服,每次1片,qd;B观察组患者在A观察组基础上肌内注射干扰素α1b,每次50μg,每周3次。3组疗程均为48周。比较3组患者的临床疗效、治疗前后血清肝功能指标、乙肝病毒脱氧核糖核酸(HBV-DNA)阴转率及不良反应发生情况。结果:B观察组患者的总有效率(84.38%)明显高于A观察组(62.60%)和对照组(37.50%),A观察组明显高于对照组,差异均有统计学意义(P<0.05)。与治疗前比较,3组患者治疗后的血清天冬氨酸转氨酶、丙氨酸转氨酶、总胆红素水平均明显下降,且B观察组患者的各项指标均明显低于A观察组和对照组,差异均有统计学意义(P<0.05),而A观察组和对照组之间比较,差异均无统计学意义(P>0.05)。B观察组患者治疗12周和24周的HBV-DNA阴转率均明显高于同期A观察组和对照组,差异均有统计学意义(P<0.05),而A观察组和对照组之间比较,差异均无统计学意义(P>0.05)。3组患者均未见明显不良反应发生。结论:替诺福韦联合干扰素α1b治疗慢性乙肝的临床疗效显著,明显优于单用恩替卡韦和替诺福韦。

OBJECTIVE：To observe clinical efficacy and safety of individual antiviral therapy of tenofovir combined with interferon α 1b for chronic hepatitis B（CHB）. METHODS：96 CHB patients were randomly divided into control group,observation group A and observation group B,with 32 cases in each group. Control group was given entecavir orally,0.5 mg,qd;observation group A was given tenofovir orally,1 piece,qd;observation group B was additionally given interferon α 1b,50 μ g,3 times a week,on the basis of observation group A. The treatment course lasted for 48 weeks in 3 groups. Clinical efficacy of 3 groups was compared,and the changes of serum liver function indexes,HBV-DNA negative conversion rate and the occurrence of ADR were compared before and after treatment. RESULTS：The total effective rate of observation group B（84.38%）was significantly higher than that of observation group A（62.60%）and control group（37.50%）,and that of observation group A was significantly higher than control group,with statistical significance（P〈0.05）. Compared with before treatment,the serum levels of AST,ALT and TBIL were significantly decreased after treatment in 3 groups;the observation group B were significantly lower than those of observation group A and control group,with statistical significance（P〈0.05）;there was no statistical significance between observation group A and control group（P〉0.05）. The negative rate of HBV-DNA in observation group B were significantly higher than those in control group and observation group A after 12 and 24 weeks of treatment,with statistical significance（P〈0.05）;there was no statistical significance between observation group A and control group（P〉0.05）. No obvious ADR was found in 3 groups. CONCLUSIONS：Tenofovir combined with interferon α 1b shows significant clinical efficacy for CHB,and is significantly better than that of entecavir and tenofovir alone.