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目的:观察恩替卡韦分散片(雷易得,苏州东瑞制药有限公司)治疗HBeAg阳性慢性乙型肝炎的48周疗效和安全性。方法:将符合诊断标准的85例HBeAg阳性慢性乙型肝炎患者随机分为治疗组和对照组,治疗组(55例)口服恩替卡韦分散片,对照组(30例)口服恩替卡韦片(博路定,中美上海施贵宝制药有限公司)。治疗4、12、24、48周时观察患者HBV-DNA阴转率、ALT复常率、HBeAg阴转率。结果:治疗组和对照组在4、12、24、48周时HBV-DNA阴转率、ALT复常率、HBeAg阴转率差异均无统计学意义(P>0.05)。治疗过程中两组均未见明显不良反应。结论:恩替卡韦分散片在治疗慢性乙型肝炎方面疗效与博路定相当,有较强的抗乙肝病毒作用,是一种疗效好且安全性高的抗乙肝病毒药物。
Objective: To observe the efficacy and safety of entecavir dispersible tablets (Rayleigh, Suzhou Dongrui Pharmaceutical Co., Ltd.) for 48 weeks in the treatment of HBeAg-positive chronic hepatitis B patients. Methods: Eighty-five patients with HBeAg-positive chronic hepatitis B who met the diagnostic criteria were randomly divided into treatment group and control group. Entecavir dispersible tablets were given to the treatment group (n = 55), entecavir tablets (n = Sino-US Shanghai Squibb Pharmaceutical Co., Ltd.). At 4, 12, 24, and 48 weeks after treatment, HBV-DNA negative conversion rate, ALT normalization rate and HBeAg negative conversion rate were observed. Results: There was no significant difference between the treatment group and the control group in HBV DNA negative rate, normal ALT rate and HBeAg negative rate at 4, 12, 24 and 48 weeks (P> 0.05). No significant adverse reactions were seen in both groups during the course of treatment. Conclusion: Efficacy of entecavir dispersible tablets in the treatment of chronic hepatitis B and Bordetella clinically equivalent, a strong anti-hepatitis B virus effect, is a good effect and safe anti-hepatitis B virus drugs.