拉米夫定单药治疗慢性HBV感染患者的临床研究

目的：研究合理选择拉米夫定的临床策略。方法：入选2002年9月-2006年8月期间108例慢性HBV感染患者,根据HBeAg情况分为HBeAg（＋）组和HBeAg（-）组。两组患者均给予拉米夫定,100mg/d,口服,长期治疗,随访终点至2009年9月。结果：108例患者随访37~84月,平均（58±13.6）月,两组患者的病毒学突破率与HBVDNA阴转速度有关,阴转速度越快,以后发生耐药的机会越低;2周内HBVDNA阴转患者,发生病毒学突破率为0%,临床耐药率为0%,HBeAg血清转换率为62.5%;3～4周内阴转患者,在随访期发生病毒学突破率分为8.3%和11.1%,临床耐药率为0%,HBeAg血清转换率为50%;5~8周、9~12周、13~24周发生阴转患者,随访期间发生病毒学突破率分别为44%~52.6%、75%~80%和100%。结论：2周、4周的病毒学应答能更精确地预测慢性HBV感染患者应用拉米夫定抗病毒治疗的远期疗效和耐药,对临床早期筛查拉米夫定治疗慢性HBV感染患者具有重要的指导意义。

Clinical research of treating patients with chronic HBV infection by only using lamivudine

Objective:To study clinical strategies of optimal treatment with lamivudine for patients with chronic HBV infection.Methods: Form Sep 2002 to Aug 2006,108 cases of chronic HBV infection were divided into HBeAg positive group and HBeAg negative group in which all patients were given lamivudine 100mg/d,p.o for long-term treatment and following-up endpoint was in Sep 2009.Results: 108 patients were observed with following-up 37~84 months,averaged(58 ± 13.6) months.In both HBeAg positive group and HBeAg negative group,the incidences of virological breakthrough were related to the decline speed of HBVDNA levels in which the more fastly speed of HBVDNA declined,the lower rate of resistance was.The level of HBVDNA changed negatively at 2 weeks,the rate of virology breakthrough was 0%,the rate of HBeAg serum conversion was 62.5%;HBVDNA level changed negatively at 3~4 weeks,the rate of virological breakthrough was from 0% to 11%,the rate of HBeAg serum conversion was 50%.At 5~8 weeks,9~12weeks and 13~24weeks,the rates of virological breakthrough in the patient of levels of HBVDNA changed negatively were 44%~52.6%,75%~80% and 100%.Conclusion: Virological response at 2-week or 4-week can predict more accurately the occurrence of drug resistance and the risk of long-term effect,which is a great significance to help us select appropriate patients with lamivudine therapy.