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目的 进一步验证抗HBV治疗性疫苗治疗HBV携带者的临床疗效。方法 将确诊为HBV携带者的 6 0 0例患者随机分为两组 ,一组为抗HBV治疗性疫苗实验组 ,30 0例 ,用抗HBV治疗性疫苗治疗 ,每月 1次 ,皮下注射 ,同时服用维生素C 5 0 0mg/d,疗程为1 2个月 ;另一组为对照组 ,30 0例 ,用生理盐水 2ml,皮下注射 ,每月 1次 ,同时服用维生素C 5 0 0mg/d,1 2个月为 1疗程。两组在年龄、性别、病程、HBV标记物状况方面均有良好的可比性。治疗过程中第 1 2、2 4、4 8周复诊 1次。治疗前及每次复诊时检测血清HBsAg、HBeAg、HBVDNA、抗 HBe、抗 HBs及ALT。上述指标第 4 8周的检验结果作为评价疗效的依据。疗程期满停止治疗后 ,对实验组 2 0 8例与对照组 1 96例进行为期 1 2个月的随访。随访期内第 1 2个月做上述HBV标记物检测 ,以评价终止治疗 1 2个月内HBV标记物的改变。结果 抗HBV治疗性疫苗实验组的HBsAg、HBeAg、HBVDNA的阴转率及抗 HBe与抗 HBs的阳转率分别为 1 4 7%、32 0 %、37 3%、2 0 0 %和 7 1 % ;对照组分别为 2 0 %、6 0 %、6 7%、1 3%和 0 % ,两组相比差异有统计学意义 (P <0 0 5 )。实验组停止治疗后随访 1年 ,复发率为 5 9%。结论 抗HBV治疗性疫苗治疗对HBV携带者有一定的抗病毒疗效
Objective To further verify the clinical efficacy of anti-HBV therapeutic vaccine in the treatment of HBV carriers. Methods Six hundred patients diagnosed with HBV carriers were randomly divided into two groups. One group was treated with anti-HBV therapeutic vaccine, 300 cases were treated with anti-HBV therapeutic vaccine once a month, subcutaneously, At the same time taking vitamin C 500 mg / d, the course of treatment was 12 months; the other group as the control group, 30 cases with saline 2ml, subcutaneously once a month, taking vitamin C 500 mg / d , 1 2 months for a course of treatment. The two groups had good comparability in terms of age, sex, course of disease and HBV marker status. During treatment 1, 2, 4, 4, 8 weeks 8 weeks referral 1 times. Serum HBsAg, HBeAg, HBVDNA, anti-HBe, anti-HBs and ALT were detected before treatment and at each visit. The index of 48 weeks of the test results as a basis for evaluating the efficacy. After the course of treatment was stopped, 208 patients in the experimental group and 1 96 in the control group were followed up for 12 months. Follow-up period of the first 2 months to do the above HBV markers to assess the termination of treatment of HBV markers within 1 2 months of change. Results The negative conversion rates of HBsAg, HBeAg and HBVDNA and the positive conversion rates of anti-HBe and anti-HBs in experimental anti-HBV therapeutic vaccine group were 14.7%, 32.0%, 37.3%, 200% and 71 %, Respectively. The control group was 20%, 60%, 67%, 13% and 0%, respectively. There was significant difference between the two groups (P <0.05). The experimental group was followed up for 1 year after treatment, the recurrence rate was 59%. Conclusion Anti-HBV therapeutic vaccine has certain anti-virus effect on HBV carriers