恩替卡韦治疗拉米夫定耐药性慢性乙型肝炎的临床研究

Clinical Study of Entecavir in Treatment of Lamivudine-resistant Chronic Hepatitis B

目的观察恩替卡韦治疗拉米夫定耐药性慢性乙型肝炎(chronic hepatitis B,CHB)的临床效果。方法选择2010年2月—2012年3月我院收治的200例拉米夫定耐药性CHB作为研究对象,均口服恩替卡韦1.0 mg/d,治疗4年。观察临床疗效、乙型肝炎病毒基因(HBV-DNA)转阴率、病毒学反弹率、乙型肝炎病毒e抗原(HBeAg)和乙型肝炎病毒表面抗原(HBs Ag)血清学转换率及不良反应发生情况。结果本研究治疗第24周时总有效率达88.0%,治疗第48、96、144和200周时总有效率趋于平稳,直至治疗结束。本组治疗第8周HBV-DNA转阴率为9.0%,后逐渐上升,于96周时上升至46.0%,200周时达60.0%;治疗第8周时10例出现病毒学反弹,至治疗结束时共56例出现病毒学反弹;治疗第8周时2例出现HBeAg血清学转换,至200周时共64例出现HBeAg血清学转换;治疗第144周时14例出现HBs Ag血清学转换,至200周时共24例出现HBs Ag血清学转换。本组出现不良反应46例(23.0%),其中恶心18例,乏力14例,心动过速10例,尿白细胞阳性4例,予对症治疗后症状缓解。结论恩替卡韦治疗拉米夫定耐药性CHB临床效果显著,安全性较高。

Objective To observe clinical effects of Entecavir in treatment of Lamivudine-resistant chronic hepatitis B（ CHB）. Methods A total of 200 patients with Lamivudine-resistant CHB admitted during February 2010 and March 2012 were treated with 1. 0 mg/d Entecavir orally for 4 years. Clinical efficacy,negative rate of hepatitis B virus-deoxyribonucleic acid（ HBV-DNA）,rebound rate of virology,seroconversion rates of hepatitis B virus e antigen（ HBeAg） and hepatitis B virus S antigen（ HBs Ag） and incidence rate of adverse reactions were observed. Results The total effective rate was 88. 0%in the 24 thweeks of treatment,and the total effective rates were stable in the 48 th,96th,144 thand 200thweeks of treatments until the end of treatment. HBV-DNA negative rate was 9. 0% in the 8thweek of treatment,and then the rate was gradually increased to 46. 0% in the 96 thweeks of treatment,and the rate was 60. 0% in the 200 thweeks of treatment. In the 8thweek of treatment,10 patients had virology rebound,and 56 patients had virology rebound at the end of treatment. In the 8thweek of treatment,2 patients had HBeAg seroconversion,and 64 patients had HBeAg seroconversion in the 200 thweeks of treatment.In the 144 thweeks of treatment,14 patients had HBs Ag seroconversion,and 24 patients had HBs Ag seroconversion in the200 thweeks of treatment. Adverse reactions were found in 46 patients（ 23. 0%）,who included 18 patients with nausea,14 patients with fatigue,10 patients with tachycardia and 4 patients with positive white blood cell in urine,and symptoms were relieved after symptomatic treatment. Conclusion Entecavir in treatment of Lamivudine-resistant chronic hepatitis B can achieve good effect and safety.