阿德福韦酯治疗慢性乙型肝炎的疗效观察

Therapeutic Efficacy of Adefovir Dipivoxil in Patients with Chronic Hepatitis B

目的:探讨阿德福韦酯(ADV)治疗慢性乙型肝炎(乙肝)的疗效及其影响因素。方法:选择门诊慢性乙肝患者68例,随机分为治疗组(35例)和对照组(33例)。2组均给予常规保肝治疗,治疗组在此基础上加用ADV治疗。2组均治疗观察48周,定期检测患者ALT、HBV DNA、HBeAg变化及不良反应;另根据治疗48周后HBV DNA转阴情况将治疗组分为HBV-DNA转阴组(A组,11例)和HBV-DNA未转阴组(B组,24例),分析影响ADV治疗疗效的相关因素。结果:(1)治疗48周时,治疗组ALT复常率、HBV DNA转阴率和HBeAg转阴率分别为74.2%,31.4%和33.3%;而对照组分别为9.1%、0和0;2组比较差异均有统计学意义(P<0.01)。(2)A、B组在给予ADV治疗前ALT水平分别为(180.25±97.00)U/L和(112.78±46.87)U/L,A组高于B组(t=2.800,P<0.01),HBV DNA水平分别为(4.91±1.13)log10拷贝/mL和(6.26±1.16)log10拷贝/mL,A组低于B组(t=3.221,P<0.01)。Logistic回归分析示治疗前HBV DNA和ALT水平与ADV抗病毒后HBV-DNA转阴相关(OR=15.487,P=0.025;OR=0.952,P=0.023)。(3)治疗中未发现严重不良反应。结论:(1)ADV治疗慢性乙型肝炎安全有效。(2)抗病毒治疗前,患者的ALT水平为ADV治疗疗效的保护因素,HBV DNA水平是其危险因素。

Objective： To investigate the efficacy of adefovir dipivoxil （ADV） in patients with chronic hepatitis B and the correlation factors associated with the therapeutic efficacy.Methods： Sixty-eight outpatients with chronic hepatitis B from Tianjin Infectious Disease Hospital were included in the study.The patients were divided into treatment group （n = 35） and the control group （n = 33） randomly.The patients in treatment group were added ADV treatment on the basis of conventional therapy;patients in control group were using conventional therapy only.The study observation of the two groups was completed in 48 weeks.The values of alanine transarninase （ALT）,hepatitis B virus （HBV） DNA,HBV e antigen（HBeAg）,and ADV adverse reactions were detected regularly.After 48 weeks of treatment,the patients in treatment group were further divided into 2 subgroups,HBV-DNA negative conversion group （group A,n = 11） and HBV-DNA positive group （group B,n = 24）.The ADV therapy-related factors were analyzed.Results： （1）After 48 weeks of treatment,the ALT normalization rate,HBV DNA negative conversion and HBeAg seroconversion were 74.2%,31.4% and 33.3% in the treatment group,and 25%,0 and 0 in control group.There were significantly different between two groups （P 0.01）.（2） The level of ALT was significantly higher in A group （180.25 ± 97.00 U/L） than that of B group （112.78 ± 46.87 U/L） before ADV treatment （t = 2.800,P 0.01）.The level of HBV DNA was significantly lower in A group（4.91 ± 1.13） copies/mL compared with that of B group （6.26 ± 1.16） log10 copies/mL （t = 3.221,P 0.01）.Logistic regression analysis showed a significant association between pre-treatment HBV DNA level and ALT level with HBV-DNA negative conversion rate （OR = 15.487,P = 0.025;OR = 0.952,P = 0.023）.（3） No serious adverse reactions were observed during the treatment.Conclusion： （1） Adefovir dipivoxil is an effective antiviral drug for chronic hepatitis B.（2） Before anti-virus treatment,the ALT level is a protective factor,but HBV DNA level is a risk factor in patients with ADV therapy.