中文摘要：

目的观察恩替卡韦分散片治疗慢性乙型肝炎患者的疗效和安全性。方法未经过抗病毒治疗的慢性乙型肝炎患者194例进行回顾性分析，予以恩替卡韦分散片0．5mg，口服每日1次，分别检测治疗0、4、12、24、48、72周时患者血清的乙型肝炎病毒脱氧核糖核酸（HBV-DNA）水平、表面抗原（HBsAg）与e抗原（HBeAg）状态和肝功能情况，同时观察治疗过程中药物的安全性。结果恩替卡韦分散片治疗至72周时HBV-DNA水平平均下降幅度达到3．60 log10，HBV-DNA未检出率达到96．37％，谷丙转氨酶（ALT）复常率达到97．93％；HBeAg和HBsAg血清学转换率为7．81％和3．13％；治疗前基线ALT水平〉5ULN组HBV-DNA阴转率和HBeAg转阴率明显高于ALT2～5ULN组和ALT02ULN组，差异有统计学意义（P＜0．01），HBeAg转换率与ALT＜2ULN组比较差异有统计学意义（P＜0．01）；HBV-DNA＜10^7 copies／ml组在HBV—DNA阴转率、HBeAg转阴率及转换率方面均高于HBV-DNA＞10^7～10^8 copies／ml组和HBV-DNA〉10^8 copies／ml组，差异有统计学意义（P＜0．05），HBeAg转阴率与HBV—DNA〉10^8 copies／ml组，差异有统计学意义（P＜0．01）。结论恩替卡韦分散片治疗慢性乙型肝炎患者在抑制病毒复制、提高HBeAg血清转换率方面均有疗效，且安全有效。

英文摘要：

OBJECTIVE To observe the efficacy and safety of entecavir in treatment of the patients with chronic hepatitis B. METHODS Totally 194 patients with chronic hepatitis B who did not receive the antiviral therapy in the Zhejiang University of Traditional Chinese Medicine Affiliated the sixth Hospital of Hangzhou were retrospectively reviewed, then the subjects were given 0.5 mg of entecavir dispersible tablet, oral administration, once per day; the serum HBV-DNA level, HBsAg and HBeAg content, and liver function were determined at week 0, 4, 12, 24, 48 and 72 of treatment, and the safety of use of drugs was observed. RESULTS At week 72 of the treatment with entecavir dispersible tablet, the HBV-DNA level deceased by 3.60 log10, 96.37% were detected negative for HBV-DNA, the recovery rate of alanine aminotransferase （ALT） reached 97. 93%; the seroconversion rates of HBeAg and HBsAg were 7. 81% and 3.13%, respectively. The negative rates of the HBV-DNA and HBeAg were significantly higher in the baseline ALT level more than 5 ULN group than in the baseline ALT level varying from 2 to 5 ULN group and the baseline ALT level less than 2 ULN group, and there was significant difference（P〈0. 01） ; as compared with the baseline ALT level less than 2 ULN group, the difference in the conversion rate of HBeAg was significant （P〈0.01）. The negative rate of HBV-DNA, the negative rate of HBeAg, and the conversion rate were higher in the HBV-DNA less than 10 copies/ml group than in the HBV-DNA more than 107-10s copies/ml group and the HBV-DNA more than 108 copies/ml group, and there was significant difference （P〈0.05）; as compared with the HBV-DNA more than 10s copies/ml group, the difference in the negative rate of HBeAg was significant （P〈0.01）. CONCLUSION Entecavir dispersible tablet can achieve significant efficacy in inhibiting viral replication and raising the seroconversion rate of HBeAg, and it is safe and effective.