乙肝疫苗治疗恢复期慢性乙型肝炎初步研究

发布时间：2018-07-11 09:27

本文选题：恢复期慢性乙型肝炎 + 乙肝疫苗　；参考：《重庆医科大学》2017年硕士论文

【摘要】：目的研究乙肝疫苗对恢复期慢性乙型肝炎的治疗效果、安全性和可行性。方法1.54例恢复期慢性乙型肝炎患者被随机分为治疗组和对照组:治疗组25例,采用乙肝疫苗治疗:20μg/次,每4周肌肉注射1次,24周为一疗程;对照组29例,无特殊治疗;两组肝功能异常患者给予常规保肝药物治疗。2.检测时点和指标:两组患者均于治疗前、治疗12周、治疗24周时分别检测血常规、肝肾功、肝纤谱、甲胎蛋白、乙肝病毒抗原抗体标志物、HBV DNA、腹部彩超等指标。3.结果分析采用SAS 9.2版统计学方法。结果1.基线特征比较:治疗组与对照组治疗前的年龄、性别均无统计学差异(P0.05)。2.肝功能比较:2.1在治疗前、治疗12周、治疗24周:治疗组ALT异常率分别为:8%,8%,8%;治疗组AST异常率分别为:8%,8%,8%;治疗组GGT异常率分别为:8%,8%,12%;对照组ALT异常率分别为:10.3%,3.4%,13.8%;对照组AST异常率分别为:13.8%,6.9%,10.3%;对照组GGT异常率分别为:24.1%,37.9%,27.6%。2.2不同时点组间比较,仅治疗12周时GGT治疗组均值低于对照组,P值0.05,有统计学差异;其他时点,治疗组与对照组ALT、AST以及GGT比较均无统计学差异,P值0.05。3.血清乙肝病毒抗原抗体标志物比较:3.1 HBs Ag、HBe Ag:治疗组与对照组各时点均为阴性。3.2 HBs Ab:组间比较,治疗前HBs Ab均值与阳性率治疗组分别为:125.9±210.86,88%;对照组分别为:28.29±87.48,79.31%;两组间比较均无显著差异,P值0.05。治疗12周、治疗24周治疗组HBs Ab均值与阳性率分别为:887.5±761.24及96%,1000±554.2及96%;对照组分别为:30.26±112.46及68.87%,28.6±106.99及65.52%,治疗组均较对照组显著升高,P值0.01。组内比较,治疗组HBs Ab在治疗12周、治疗24周分别与治疗前比较,均值与阳性率均显著升高,P值0.05。治疗12周与治疗24周比较,治疗组HBs Ab均值与阳性率均无显著性差异,P值0.05。对照组HBs Ab均值与阳性率各时点间均无显著性差异,P值0.05。3.3 HBe Ab、HBc Ab:各个时点组间或组内比较,HBe Ab、HBc Ab均值与阳性率均无显著性差异,P值0.05。4.血清HBV-DNA浓度比较:治疗组、对照组不同时间点HBV DNA始终维持在最低检测线之下,无病毒活动性复制。5.乙肝病毒相关性肝病发生率:各时点两组肝纤谱、甲胎蛋白、腹部彩超检查结果等均未发现肝纤维化、肝硬化或肝细胞癌等病变。6.不良事件发生率:各时点两组血常规、肾功能均无异常;治疗组无发热、皮疹、恶心、呕吐等不良反应发生。结论1.乙肝疫苗可显著提高恢复期慢性乙型肝炎患者血清HBs Ab水平,增强患者免疫力,但治疗24周内未观察到乙肝病毒清除结果。2.乙肝疫苗治疗与患者肝功能改善与否无直接因果关系。3.乙肝疫苗治疗恢复期乙型肝炎患者是安全的,可以延长疗程继续研究。
[Abstract]:Objective to study the efficacy, safety and feasibility of hepatitis B vaccine in the treatment of convalescent chronic hepatitis B. Methods 1. 54 patients with chronic hepatitis B in convalescence were randomly divided into treatment group (n = 25) and control group (n = 25). Two groups of patients with abnormal liver function were treated with routine hepatoprotective drugs. Time points and indexes: blood routine examination, liver and kidney function, liver fiber spectrum, alpha-fetoprotein, hepatitis B virus antigen and antibody marker HBV DNA, abdominal color ultrasound and so on were detected before treatment, 12 weeks and 24 weeks after treatment in both groups. Results SAS 9.2 statistical method was used. Result 1. Baseline characteristics comparison: treatment group and control group before treatment of age, gender differences were not statistically significant (P0.05). 2. Liver function comparison: 2.1 before treatment, 12 weeks of treatment, 24 weeks of treatment: the abnormal rates of alt in the treatment group were respectively: 8: 8; the abnormal rates of AST in the treatment group were 8: 8 and 8: 8; the GGT abnormality rate in the treatment group was 10. 3% and 13. 8%, respectively; the abnormal rate of alt in the control group was 10. 3% and 3. 4% respectively; the abnormal rate of AST in the control group was:% 813.86.9% 10.3; the GGT abnormality rate in the control group was 10. 83%, respectively. The abnormal rate of GGT in the control group was 10. 3%, respectively. The abnormal rate of GGT in the control group was 10. 813. 9% and 10. 3%, respectively. The ratio of 37.9 to 27.60.2.2 is the same as the comparison between the two groups at the same time, At 12 weeks after treatment, the mean value of GGT in GGT group was lower than that in control group (P < 0.05), while at other time points, there was no significant difference in alt AST and GGT between treatment group and control group (P = 0.05.3). Comparison of Serum HBV Antigen and Antibody markers 3.1 HBs Agn HBe Ag: the treatment group and the control group were negative at all time points .3.2 HBs Ab: comparison between groups, Before treatment, the mean and positive rates of HBs Ab in the treatment group were respectively 1: 125.9 卤210.8688 and that in the control group were 28. 29 卤87. 48 and 79. 31, respectively. There was no significant difference between the two groups (P = 0. 05). After 12 weeks and 24 weeks of treatment, the mean and positive rates of HBs Ab in the treatment group were: 1 887.5 卤761.24 and 96 卤554.2, respectively, and those in the control group were 30. 26 卤112.46, 68. 87 and 28. 6 卤106.99 and 65. 52, respectively. The mean and positive rates of HBs Ab in the treatment group were significantly higher than those in the control group (P = 0. 01). The mean value and positive rate of HBs Ab in treatment group were significantly higher than those before treatment at 12 weeks and 24 weeks after treatment (P < 0.05). There was no significant difference in the mean value and positive rate of HBs Ab between the treatment group and the treatment group at 12 weeks and 24 weeks (P < 0.05). There was no significant difference between the mean and positive rate of HBs Ab in the control group (P = 0.05.3.3). There was no significant difference in the mean and positive rate of HBe Ab between and within the groups (P = 0.05.4). Comparison of serum HBV-DNA concentration: HBV DNA in the treatment group and the control group remained below the lowest detection line at different time points without viral active replication. Incidence of hepatitis B virus associated liver disease: no liver fibrosis, liver cirrhosis or hepatocellular carcinoma were found in the two groups at each time point. The incidence of adverse events: blood routine at each time point, no abnormal renal function, no fever, rash, nausea, vomiting and other adverse reactions occurred in the treatment group. Conclusion 1. Hepatitis B vaccine can significantly increase the serum HBs Ab level and enhance the immunity of patients with chronic hepatitis B in convalescent stage, but no HBV clearance results were observed within 24 weeks of treatment. Hepatitis B vaccine treatment and patients with liver function improvement or not no direct causal relationship. 3. Hepatitis B vaccine treatment of convalescent hepatitis B patients is safe, can extend the course of study.
【学位授予单位】：重庆医科大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R512.62

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