Objective: To investigate the clinical effect and safety of entecavir capsules in the treatment of treatment-naïve HBeAg-positive patients with chronic hepatitis B (CHB). Methods: A total of 158 HBeAg-positive CHB patients were given oral entecavir capsules at a dose of 0.5 mg/time once a day for 144 weeks. Clinical outcome and safety were evaluated at baseline and at 24, 48, 72, 96, 120, and 144 weeks of treatment respectively. The Fisher's exact test was used for the analysis of categorical data. Results: After 144 weeks of treatment, 90.91% of all patients achieved virologic response (< 69 IU/ml), the normalization rate of alanine aminotransferase was 88.18%, the clearance rate of HBeAg was 33.33%, and the seroconversion rate of HBeAg was 24.07%. Of all patients, 2 dropped out due to adverse events and 5 experienced serious adverse reactions. Conclusion: Entecavir capsules can inhibit viral replication and have good safety in treatment-naïve HBeAg-positive CHB patients.
目的： 评价恩替卡韦胶囊治疗HBeAg阳性慢性乙型肝炎初治患者的有效性、安全性。 方法： 158例HBeAg阳性的慢性乙型肝炎患者接受口服恩替卡韦胶囊抗病毒治疗，1次/d，每次0.5 mg，共144周。于基线、24周、48周、72周、96周、120周和144周均监测患者疗效及安全性。计数资料采用Fisher精确概率检验。 结果： 经过144周治疗，病毒学应答率(HBV DNA<69 IU/ml)为90.91%，丙氨酸氨基转移酶复常率为88.18%，HBeAg转阴率为33.33%，HBeAg血清转换率为24.07%；因不良事件退出2例，发生严重不良反应5例。 结论： 恩替卡韦胶囊治疗HBeAg阳性慢性乙型肝炎初治患者具有强效抑制病毒复制的作用及良好的安全性。.
Keywords: Efficacy; Entecavir capsule; Safety.