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目的 :研究联合应用卡介苗素 (E -BCG)与拉米夫定 (3 -TC)治疗慢性乙型肝炎 (CHB)的疗效及其治疗机制。方法 :68例CHB患者随机分为治疗组 (n=37)与对照组 (n=31) ,治疗组给予E -BCG1.0mg,肌注 ,每周3次 ,连续6月 ,与3 -TC(100mg,每日1次 ,连续12个月)联合治疗 ;对照组单独用拉米夫定治疗 ,方法同上。治疗前、治疗2周、4周、8周、12周、16周、20周、26周、52周及停药后6个月分别检测HBV标志物、肝功能、肾功能及HBVDNA定量 ,并记录治疗期间临床和实验室检查发生的一切不良事件。结果 :疗程结束时 ,治疗组ALT复常率、HBeAg阴转率、HBeAg/HBeAb转换率与完全应答率分别为89.2 %、45.9 %、43.2 %与40.5 % ,高于对照组的67.7 %、22.6 %、16.1 %与16.1 % ,差异有显著性 (P<0.05)。疗程结束后6mo,治疗组HBeAg阴转率、HBeAg/HBeAb转换率分别为54.1 %与51.4 % ,明显高于对照组的19.4 %与12.9 % ,差异有非常显著性 (P<0.01)。复发率治疗组为25.0 % ,低于对照组的35.7 % ,差异有显著性 (P<0.05)。HBVDNA阴转率在两组间无显著性差异 (P>0.05)。结论 :采用3 -TC与E -BCG联合治疗CBH ,在提高ALT复常、促进HBeAg阴转与HBeAg/HBeAb转换、降低复发方面 ,较单用3 -TC更有效
Objective: To investigate the curative effect and therapeutic mechanism of combined use of BCG and lamivudine (3 -TC) on chronic hepatitis B (CHB). Methods: Sixty-eight CHB patients were randomly divided into treatment group (n = 37) and control group (n = 31). The treatment group was given E-BCG 1.0 mg intramuscularly, three times a week for 6 consecutive months. (100mg once daily for 12 months) combined treatment; control group was treated with lamivudine alone, the method above. HBV markers, liver function, renal function and HBVDNA were measured before treatment, 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 26 weeks, 52 weeks and 6 months after drug withdrawal Record all clinical and laboratory adverse events during treatment. Results: At the end of treatment, the ALT normalization rate, HBeAg negative conversion rate, HBeAg / HBeAb conversion rate and complete response rate of the treatment group were 89.2%, 45.9%, 43.2% and 40.5% respectively, higher than 67.7% of the control group and 22.6% %, 16.1% and 16.1%, respectively (P <0.05). After 6 months, the conversion rate of HBeAg and HBeAg / HBeAb in the treatment group were 54.1% and 51.4% respectively, which was significantly higher than that of the control group (19.4% and 12.9%, P <0.01). The recurrence rate was 25.0% in the treatment group, which was lower than 35.7% in the control group (P <0.05). HBVDNA negative rate in the two groups no significant difference (P> 0.05). Conclusion: The combination of 3 -TC and E-BCG in the treatment of CBH is more effective than 3 -TC alone in improving the normalization of ALT, promoting the conversion of HBeAg to HBeAg / HBeAb, and reducing the recurrence rate