恩替卡韦分散片治疗慢性乙型肝炎临床观察

目的 评价恩替卡韦分散片治疗慢性乙型肝炎的抗病毒疗效及安全性.方法 选慢性乙型肝炎患者88例,完全随机分为研究组(45例)和对照组(43例),分别应用恩替卡韦分散片和恩替卡韦片,均为10 mg/次,1次/d,连续口服48周.结果 治疗12周时,研究组和对照组的ALT复常率分别为68.9％(31/45)和62.8％(27/43)；治疗24周时,分别为88.9％(40/45)和86.0％(37/43)；治疗48周时分别为95.5％(42/44)和93.0％(40/43),组间差异均无统计学意义(均P＞0.05).治疗12、24和48周时,研究组血清HBeAg阴转率、HBeAg/HBeAb血清转换率与对照组的差异均无统计学意义(均P＞0.05).治疗24周时,研究组血清HBV DNA完全应答率略低于对照组,治疗48周时,研究组血清HBV DNA完全应答率略高于对照组,差异均无统计学意义(P＞0.05).治疗24、48周时,研究组与对照组血清HBV DNA水平下降≥2 lg拷贝/ml的比例均逐渐下降,组间差异无统计学意义(P＞0.05).研究组和对照组均未发生任何严重不良事件.结论 恩替卡韦分散片在治疗慢性乙型肝炎方面具有明显的抗病毒作用,疗效与恩替卡韦片相当,是一种安全有效的抗乙型肝炎病毒药物.

Clinical observation of entecavir dispersible tablets treating chronic hepatitis B

Objective To evaluate the efficacy and safety of entecavir dispersible tablet for the treatment of chronic hepatitis B （CHB）. Methods Totally 88 CHB patients were randomly divided into a test group （n = 45 ） and a control group（n =43）. During the 48 weeks, the patients in the test group were administered with 10 mg of entecavir dispersible tablet and one tablet of dummy entecavir. The test group was treated with entecavir dispersible tablets （ 10 mg per day） and the control group was treated with entecavir tablets （ 10 mg per day）. All the patients were treated for 48 weeks. Results The rates of alanine aminotransferase normalization in the test group and the control group were 68.9% （31 cases） and 62.8% （27 cases） at week 12, 88.9% （40 cases） and 86.0% （ 37 cases ） at week 24, 95.5 % （42 cases ） and 93.0% （40 cases） at week 48, respectively ; all the differences were not significant between the two groups. Serum HBeAg/HBeAb conversion rate of the test group and the control group was not significant between the two groups. The rates of serum HBV DNA suppression （ 〈 1 ×10^3 U/ml） in the test group and in the control group were 68.9% （3I cases）and 69.8% （30 cases） at week 24; they were 84. 1% （37 cases） and 79.1% （ 34 cases ） at week 48, respectively ; the differences were not significant between the two groups. Compared with the baseline levels （≥2 lg copies/ml） in serum HBV DNA levels in the test group and in the control group were 97.8% （44 cases） and 100. 0% （43 cases） at week 24; they were 95.5% （42 cases） and 95.3% （41 cases） at week 48. The differences were not significant between the two groups. No patients in the two groups had any severe adverse events. Conclusions Entecavir dispersible tablet has a significant efficacy on CHB patients. It is an effective and safe agent for the treatment of CHB patients.