本文選題：恢復期慢性乙型肝炎 + 乙肝疫苗�。� 參考：《重慶醫(yī)科大學》2017年碩士論文

【摘要】：目的研究乙肝疫苗對恢復期慢性乙型肝炎的治療效果、安全性和可行性。方法1.54例恢復期慢性乙型肝炎患者被隨機分為治療組和對照組:治療組25例,采用乙肝疫苗治療:20μg/次,每4周肌肉注射1次,24周為一療程;對照組29例,無特殊治療;兩組肝功能異�；颊呓o予常規(guī)保肝藥物治療。2.檢測時點和指標:兩組患者均于治療前、治療12周、治療24周時分別檢測血常規(guī)、肝腎功、肝纖譜、甲胎蛋白、乙肝病毒抗原抗體標志物、HBV DNA、腹部彩超等指標。3.結果分析采用SAS 9.2版統(tǒng)計學方法。結果1.基線特征比較:治療組與對照組治療前的年齡、性別均無統(tǒng)計學差異(P0.05)。2.肝功能比較:2.1在治療前、治療12周、治療24周:治療組ALT異常率分別為:8%,8%,8%;治療組AST異常率分別為:8%,8%,8%;治療組GGT異常率分別為:8%,8%,12%;對照組ALT異常率分別為:10.3%,3.4%,13.8%;對照組AST異常率分別為:13.8%,6.9%,10.3%;對照組GGT異常率分別為:24.1%,37.9%,27.6%。2.2不同時點組間比較,僅治療12周時GGT治療組均值低于對照組,P值0.05,有統(tǒng)計學差異;其他時點,治療組與對照組ALT、AST以及GGT比較均無統(tǒng)計學差異,P值0.05。3.血清乙肝病毒抗原抗體標志物比較:3.1 HBs Ag、HBe Ag:治療組與對照組各時點均為陰性。3.2 HBs Ab:組間比較,治療前HBs Ab均值與陽性率治療組分別為:125.9±210.86,88%;對照組分別為:28.29±87.48,79.31%;兩組間比較均無顯著差異,P值0.05。治療12周、治療24周治療組HBs Ab均值與陽性率分別為:887.5±761.24及96%,1000±554.2及96%;對照組分別為:30.26±112.46及68.87%,28.6±106.99及65.52%,治療組均較對照組顯著升高,P值0.01。組內比較,治療組HBs Ab在治療12周、治療24周分別與治療前比較,均值與陽性率均顯著升高,P值0.05。治療12周與治療24周比較,治療組HBs Ab均值與陽性率均無顯著性差異,P值0.05。對照組HBs Ab均值與陽性率各時點間均無顯著性差異,P值0.05。3.3 HBe Ab、HBc Ab:各個時點組間或組內比較,HBe Ab、HBc Ab均值與陽性率均無顯著性差異,P值0.05。4.血清HBV-DNA濃度比較:治療組、對照組不同時間點HBV DNA始終維持在最低檢測線之下,無病毒活動性復制。5.乙肝病毒相關性肝病發(fā)生率:各時點兩組肝纖譜、甲胎蛋白、腹部彩超檢查結果等均未發(fā)現(xiàn)肝纖維化、肝硬化或肝細胞癌等病變。6.不良事件發(fā)生率:各時點兩組血常規(guī)、腎功能均無異常;治療組無發(fā)熱、皮疹、惡心、嘔吐等不良反應發(fā)生。結論1.乙肝疫苗可顯著提高恢復期慢性乙型肝炎患者血清HBs Ab水平,增強患者免疫力,但治療24周內未觀察到乙肝病毒清除結果。2.乙肝疫苗治療與患者肝功能改善與否無直接因果關系。3.乙肝疫苗治療恢復期乙型肝炎患者是安全的,可以延長療程繼續(xù)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 鹵210.8688 and that in the control group were 28. 29 鹵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 鹵761.24 and 96 鹵554.2, respectively, and those in the control group were 30. 26 鹵112.46, 68. 87 and 28. 6 鹵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.
【學位授予單位】：重慶醫(yī)科大學
【學位級別】：碩士
【學位授予年份】：2017
【分類號】：R512.62

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