抗HBV治疗性疫苗治疗HBV携带者的临床实验研究  

Clinical study on using anti-HBV therapeutic vaccine in the treatment of chronic HBV carriers

作　　者：李旭红[1] 潘兴南[1] 李树清[1] 杨红[1] 王崇国[1] 姚宁 苏盛 

机构地区：[1]解放军第180医院 [2]希波医学技术公司

出　　处：《解放军医学杂志》2004年第6期549-550,共2页Medical Journal of Chinese People's Liberation Army

摘　　要：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%。Objective To evaluate prove the clinical efficacy of anti HBV therapeutic vaccine in the treatment of chronic HBV carriers. Methods 600 patients diagnosed as chronic HBV carrier based on the criteria formulated by the National Conference of Viral Hepatitis in 1997 were enrolled for the study. The patients were randomly assigned into 2 groups. In the first group, 300 patients were given anti HBV therapeutic vaccine subcutaneously once a month, tagether with vitamin C 500mg p o. once a day for 12 months. Patients in the second group received normal saline 2 ml/month by subcutaneous injection and vitamin C 500mg/day p o. for 12months. There were no significant deferences in the age, sex, duration of the illness and the positive rate of serum HBV markers between the 2 groups. At the week 12, 24 and 48 after treatment, the patients were reexamined in the hospital. Serum HBsAg, HBeAg, HBV DNA, anti HBe, anti HBs and ALT were assayed before the treatment and at week 12, 24 and 48 during the course of the therapy. The efficacy of the treatment was evaluated on basis of the results of the assessment of parameters described above at week 48. After completion of the treatment, 208 patients in the treatment group and 196 cases in the control group were followed up for 12 months, and serum HBV markers were checked at the 12th month. The changes in HBV markers during the follow up study were analysed to evaluate the sustained effect after the therapy was ceased. Results The seronegative rates of serum HBsAg, HBeAg and HBV DNA in the treatment group were 14 7%, 32 0% and 37 3%, respectively, and they were significantly higher compared with the control group ( P <0 05). The seroconverstion of serum HBeAg to anti HBe and HBsAg to anti HBs in the treatment group were also significantly higher than that in the control group (20 0% and 7 1% compared to 1 3% and 0%); ( P <0 05). The relapse rate in the treatment group after completion of the treatment of 12 morths was 5 9%. Conclusion Anti HBV therapeutic

关 键 词：肝炎疫苗 乙型 免疫治疗 主动 肝炎 乙型 慢性 

分 类 号：R512.62[医药卫生—内科学]