LAM联合ADV治疗慢性乙型肝炎的疗效及安全性分析

Efficacy and safety of Lamivudine combined with Adefovir Dipivoxil therapy in treatment of patients with chronic hepatitis B

目的探讨拉米夫定(LAM)联合阿德福韦酯(ADV)治疗慢性乙型肝炎的疗效和安全性。方法选取慢性乙型肝炎患者76例,随机分为观察组和对照组各38例。对照组采用LAM 0.1 g/d口服治疗,观察组在对照组的基础上,加用ADV 10 mg/d口服,共治疗48周。对比两组患者治疗24周及48周时的HBV-DNA定量检测结果、HBeAg转阴率、HBeAg血清转换率、谷丙转氨酶复常率以及不良反应发生情况。结果治疗24周时,观察组的乙肝病毒载量为(5.18±1.14)log10copies/mL,对照组为(5.87±1.13)log10copies/mL,均显著低于治疗前(均P<0.05);治疗48周时,观察组的乙肝病毒载量为(3.32±0.73)log10copies/mL,对照组为(4.64±0.81)log10copies/mL,均显著低于治疗24周时(均P<0.05)。治疗48周时,观察组HBV-DNA<500copies/mL和HBV-DNA<1 000 copies/mL的转阴率均为81.58%,均显著高于对照组(47.37%和50.00%)(均P<0.05)。两组患者治疗24周时以及治疗48周时的HBeAg转阴率以及HBeAg血清学转换率对比,差异均没有显著性(均P>0.05)。治疗48周时,观察组谷丙转氨酶复常率为89.47%,显著高于对照组(P<0.05)。观察组治疗过程中有1例患者发生乙肝病毒耐药,对照组治疗过程中有4例患者发生乙肝病毒耐药。两组患者在治疗过程中均没有发生严重的不良反应。结论相对于单纯应用拉米夫定,拉米夫定联合阿德福韦酯能够更有效抑制乙肝病毒的复制,减少肝细胞损伤,稳定患者的病情,且安全性良好,值得在临床上进一步推广应用。

[Objective] To investigate the efficacy and safety of Lamivudine （LAM） combined with Adefovir Dip- ivoxil （ADV） in the treatment of chronic hepatitis B （CHB）. [ Methods ] Seventy-six patients with CHB were selected and randomly divided into observation group and control group with each group 38 cases. Subjects in the control group were treated with LAM, 0.1 g/d oral. Subjects in the observation group were treated with LAM 0.1 g/d, com- bined with ADV 10 mg/d orally. The two groups were given 48 weeks of treatment. HBV-DNA quantitative detection results, HBeAg negative rate, HBeAg sero-conversion rate and ALT normalization rate in the treatment of 24 weeks and 48 weeks of the two groups were compared and the incidence of adverse reactions were recorded. [ Results ] Af- ter 24 weeks＂ treatment, the hepatitis B viral load of the observation group was （5.18±1.14） logl0eopies/mL, and the control group （5.87±1.13） logl0copies/mL, which were significantly lower than that before the therapy （P 〈0.05）. Af- ter 48 weeks of treatment, the hepatitis B viral load of the observation group was （3.32±0.73） logl0copies/ml, and the control group （4.64±0.81） logl0copies/mL, which were significantly lower than the treatment of 24 weeks （P 〈0.05）. By 48 weeks, in the observation group, the negative rate of HBV-DNA〈500 copies/mL and HBV-DNA〈I 000 copies/mL all were 81.58%, which were significantly higher than that of the control group （47.37% and 50%） （all P 〈0.05）. The differences of HBeAg negative rate and HBeAg sero-conversion rate of the two groups were not statisti- cally significant by 24 and 48 weeks （P 〉0.05）. By 48 weeks of treatment, ALT normalization rate of the observation group was 89.47%, which was significantly higher than that of the control group （P 〈0.05）. 1 case in the observation group and 4 cases in the control group occurred hepatitis B virus resistant. Two groups of patients were no serious adverse reactions. [ Conclusions] Compared with LAM, the combination of LAM and ADV can more effectively in- hibit hepatitis B virus replication, reduce liver cell damage, stabilize the condition of the patients, which is save and worthy of further application in clinical.