摘要目的 比较拉米夫定联合胸腺素α1与单独应用拉米夫定治疗慢性乙型肝炎(CHB)患者的临床疗效及安全性.方法 采用多中心、完全随机、对照的方法,按1:1比例将68例入选的CHB患者随机分为实验组和对照组,实验组服用拉米夫定12个月,同时注射胸腺素α1 6个月;对照组单独服用拉米夫定12个月.在治疗第3、6、12和18个月时(停药6个月随访)观察2组患者血清HBV DNA转阴率、HBeAg转阴率、HBeAg血清学转换率、ALT复常率以及胸腺素α1的安全性.结果 治疗12个月时,实验组HBV DNA转阴率、HBeAg转阴率和ALT复常率与对照组比较差异有统计学意(χ2值分别为31.17、7.17和5.92,P值均＜0.05);停药6个月随访,实验组的HBV DNA转阴率和HBeAg转阴率与对照组比较差异有统计学意义(χ2值分别为4.53和7.17,P值均＜0.05);在停药6个月的随访过程中,实验组有2例患者检测不出HBV DNA.治疗中及之后随访观察期间未出现严重不良反应.结论 拉米夫定联合胸腺索α1治疗CHB患者的疗效优于单用拉米夫定,且安全性良好.

abstractsObjective To evaluate the efficacy and safety of lamivudine combined with thymosin α1 therapy for patients with chronic hepatitis B.Methods Sixty-eight eligible patients with chronic hepatitis B were enrolled in this multi-center randomized controlled rlinical trial.Patients were randomized into the trial group and the control group(n=34 for each).Patients in trial group received thymosin α1 for 6 months and lamivudine for 12 menths:patients in control group received lamivudine for 12 months only.The rates of serum HBV DNA clearance.HBeAg loss,HBeAg seroconversion,ALT normalization and the safety of thymosin α1 were observed at 3rd.6th,12th and 18th month during and after the treatment.Results At 12th month of the treatment,there were significant differences in the rates of serum HBV DNA clearance,HBeAg loss and ALT normalization between two groups(χ2=31.17,7.17 and 5.92,P＜0.05);at 6th month after the treatment.there were significant differences in the rates of sernm HBV DNA clearance and HBeAg loss between two groups(χ2=4.53 and 7.17,P＜0.05).HBV DNA was not detected in 2 patients during 6-month follow-up study and no sever side effect was observed throughout the study.Conclusion The conlbination of lamivudine and thymosin α1 is safe and has better effect than the monotherapy of lamivudine in patients with chronic hepatitis B.