替比夫定治疗慢性乙型肝炎早期病毒学应答临床研究

Clinical Study on Early Virological Response of LDT in the Treatment of CHB EVR

目的:探讨替比夫定对慢性乙型肝炎(CHB)治疗的早期病毒学应答。方法:将慢性乙型肝炎患者53例,HBeAg阳性(HBVDNA<9log10copies/mL)患者30例设为A组,HBeAg阴性(HBVDNA<7log10copies/mL)患者23例设为B组,两组都给予替比夫定600mg口服抗病毒治疗,每日1次。分别在治疗前、治疗后3个月、6个月时检查肝功能(ALT)、HBVDNA、乙肝两对半检测。以治疗前测得数值作为基线,观察患者在3个月、6个月时ALT复常率、HBVDNA检测不到率、HBeAg血清学转换率(HBeAg阳性患者),并对其临床疗效及临床有效率进行比较分析,从而预测其2年时的治疗应答和耐药发生。结果:A组:在治疗3个月时,HBVDNA检测不到率为46.7%,HBeAg血清学转换率为20.0%,ALT复常率为66.7%;在治疗6个月时,HBVDNA检测不到率为80.0%,HBeAg血清学转换率为26.7%,ALT复常率为76.7%。B组:在治疗3个月时,HBVDNA检测不到率为52.2%,ALT复常率为69.6%;在治疗6个月时,HBVDNA检测不到率为82.6%,ALT复常率为78.3%。两组间在治疗3个月、6个月时比较HBVDNA检测不到率、ALT复常率无显著性差异(P>0.05)。而A组在治疗3个月、6个月时HBVDNA检测不到率、ALT复常率、HBeAg血清学转换率与基线水平(治疗前)比较有显著性差异(P<0.01);B组在治疗3个月、6个月时HBVDNA检测不到率、ALT复常率与基线水平(治疗前)比较有显著性差异(P<0.05)。结论:替比夫定治疗CHB,在治疗24周时即取得了较高的HBVDNA检测不到率、ALT复常率及较好HBeAg血清学转换率(HBeAg阳性患者),且安全性良好。

Objective To study the early stage of virological response of LDT in the Treatment of CHB EVR.Methods 53 patients were divided into two groups,30 cases with HBeAg positive （HBV DNA 9 log10copies/mL） as Group A and 23 cases with HBeAg negative （HBV DNA 7 log10copies/mL） as Group B.All the patients were given LDT pills 600 mg once a day to antiviral therapy.On treatment3rd month and 6th month,checked up liver function （ALT）,HBV DNA and Second liver two half-and-half of each group.Taken the numerical value of the tests before treatment as a base line and observed ALT normalization rate,HBV DNA negative rate and serological conversion rate of HBeAg in patients with HBeAg positive,then compared and analysed the clinical effects and the effective rate between the two groups,then predicted the response to therapy and the resistance of LDT in two years.Results Group A： On treatment 3rd month,HBV DNA negative rate was 46.7%,serological conversion rate of HBeAg was 20.0%,ALT normalization rate was 66.7%,on treatment 6th month,HBV DNA negative rate was 80.0%,serological conversion rate of HBeAg was 26.7%,ALT normalization rate was 76.7%.Group B： On treatment 3rd month,HBV DNA negative rate was 52.2%%,ALT normalization rate was 69.6%,on treatment 6th month,HBV DNA negative rate was 82.6%,ALT normalization rate was 78.3%.On treatment 3rd and 6th month,there were no sinificant differences in HBV DNA negative rate and ALT normalization rate （P 0.05） between Group A and B.However,in Group A,on treatment 3rd and 6th month,there were sinificant differences in HBV DNA negative rate,serological conversion rate of HBeAg and ALT normalization rate （ P 0.01） compare to the baseline,so was Group B in HBV DNA negative rate and ALT normalization rate （P 0.05）.Conclusion In treatment of CHB with LDT on treatment 24th week,patients with HBeAg positive or negative all achived high ALT normalization rate,HBV DNA negative rate and serological conversion rate of HBeAg （in patients with HBeAg positive ）,and had a good safety during the treatment.The results showed that LDT has a early strong abillity of inhibiting the virus replication of HBV,a higher HBV DNA negative rate and better serological conversion rate of HBeAg （in patients with HbeAg positive）.And according to the former response to therapy on treatment 24th week,we are able to pridict the clinical effect and resistant rate of LDT in two years,therefore to increase the compliance of the patients and better achieve Double Standards and long-term treating target.