摘要
目的评价恩替卡韦抗病毒治疗慢性乙型肝炎(CHB)48周的疗效和安全性。方法193例CHB患者随机分为治疗组和对照组,治疗组(118例)予恩替卡韦0.5mg,1次/d口服,对照组(75例)予以干扰素α-2b 500MU,1次/d肌注,1月后隔日1次。结果治疗组治疗4周和8周时HBV DNA水平较治疗前显著下降;治疗12周,HBV DNA阴转率为57.6%,显著优于对照组,表现出较高的抗病毒早期应答率;治疗24周和48周时,HBV DNA阴转率为81.3%和92.3%,与对照组比较差异显著;48周时HBeAg阴转率为28.8%,肝功能复常率为98.3%,且无耐药病例出现,提示有较良好的持续应答反应。治疗过程中未发生与观察药物相关的严重不良反应。结论恩替卡韦能快速、强效地抑制乙肝病毒复制,安全性和耐受性良好。
Objective To evaluate the 48 weeks therapeutic effects and safety of anti-virus therapy of entecavir in patients with chronic hepatitis B(CHB). Methods One hundred and ninty-eight CHB cases were divided into the treated group(118) and the control group(75) randomly.Patients were given entecarvir(0.5mg po qd)in the treated group,while the others were given interferon α-2b(500MU im qd,after lmonth im qod)in the control group. Results In the treated group,the levels of serum HBV DNA was obviously decreased than that before treatment at the 4th and 8th week;at the 12th week ,the ratio of negative transformation of HBV DNA was 57.6% ,which was superior to the control group,there was higher ratio of early response of anti-virus therapy;at the 24th and 48th week,the ratios of negative transformation of HBV DNA were 81.3%and 92.3%,there were significent difference between these two groups;at the 48th week the ratio of negative transformation of HBeAg was separately 28.8% and the ratio of recovery of liver function was 98.3% ,and there was no drug-resistant case,it demonstrated favourable reaction of sustained response. There was no serious adverse event related with entecavir. Conclusion Entecavir can inhibit the replication of hepatitis B virus and have good safety and tolerance.
出处
《中国现代医生》
2009年第21期64-65,88,共3页
China Modern Doctor