| Objective1.This study was designed to understand the knowledge,attitude and behavior of hepatitis E in maintenance hemodialysis patients at high risk of hepatitis E.It is to assess the knowledge of hepatitis E and prevent health education,and it is to explore the factors influencing the effect of health education.Finally,it is to provide basis for the education of knowledge and health education on hepatitis E for maintenance hemodialysis patients.2.The purpose of this study was to systematically evaluate the safety and immunogenicity of the recombinant hepatitis E vaccine(Hecolin(?))in maintenance hemodialysis patients,which is reasonable for hepatitis E vaccine in maintenance hemodialysis patients.Use to provide scientific basis.MethodsHealth education evaluationThis study selected patients from the Department of Nephrology Hemodialysis at Zhongshan Hospital,Xiamen University.Before the implementation of health education,MHD patients conducted a one-on-one interview based on the questionnaire after informed consent from the researchers,and collected 5 ml of peripheral blood for detection of HEV-IgG antibodies.From this study,300 patients with high levels of autonomy were selected as intervention groups.After the investigation,the health education interventions for the intervention group included health talks,1V1 health education,telephone interviews,and publicity materials.136 people were selected as the control group and no health education was conducted.After 12 months of health education,100 people were stratified according to gender and age.Questionnaires were collected and 5ml of peripheral blood were tested for HEV-IgG antibodies.Interim assessment of health education in the intervention group was conducted,and methods and contents of health education were adjusted according to the assessment results.In the second-phase(12-month)health education,both the intervention group and the control group were questioned after the second phase of the health education and collected 5 ml of peripheral blood HEV-IgG antibodies.Clinical trial designThis study is an open clinical trial.This study was conducted at the Zhongshan Hospital,Xiamen University,recruiting maintenance hemodialysis patients.On the premise of informed consent and signing of informed consent,the experimental group included about 30 antiHEV-IgM and antiHEV-IgG double-negative maintenance hemodialysis patients and used a standard inoculation procedure of 0/1/6m to inoculate the recombinant hepatitis V vaccine.(Hecolin(?)).The combination of systematic observation and automatic reporting after each dose of inoculation was used to understand adverse events/events.The control group was about 60 patients with MHD,and no intervention was taken,but safety observations were performed concurrently with the experimental group.The subjects in the test group collected blood once before the first needle and one month after the third needle to detect anti-HEV-IgG antibodies.The subjects in the test group collected blood once before the first needle and one month after the third needle to detect anti-HEV-IgG antibodies.The data of the age and sexmatched population were selected by comparing the immunogenicity data of the last one-month(7m)and the third-phase clinical trial PPS datasets of MHD patients according to the 0/1/6m immunization schedule and according to the ratio of 1:2.Results1.Health education and effectiveness evaluation1.1 Comparison of education effect between control group and intervention group There was no significant difference between the control group and the intervention group in the sex,age,education level,and occupation distribution of the population and they were well comparable.Before the health education,the difference between the control group and the intervention group in the knowledge level of the hepatitis E was not statistically significant;after the health education,the knowledge level of the hepatitis E increased significantly after intervention of the health education in the intervention group,and the qualification rate increased from 5.88%before intervention to 89.91%.The rate is 22.0%.After the intervention of health education intervention group,the results of the questionnaire survey were irrational,good,and excellent performance distribution was statistically significant(x2 = 495.29,P<0.001).1.2.Comparison of Knowledge,Attitude and Behavior before and after Health Education in Intervention GroupAfter health education,the average level of hepatitis E knowledge in the intervention group was significantly higher than before the health education,with regard to the entry question 1.2(whether hepatitis E is infectious),item 1.7(type of hepatitis E transmission),item 1.8(whether the hepatitis E can be passed Vaccination prevention is the best,with the lowest average scores for 1.6,1.8,and 1.10 for issues involving hepatitis E and vaccines.After the health education,the patients in the intervention group scored significantly higher in the attitude problems related to hepatitis E,and the overall average score of attitudes was higher than that before health education(F=5.32,P=0.021<0.05).Among them,there were 10 positive attitudes to the attitudes of choice.There was a statistically significant difference before health education,and 63.38%of patients had a positive attitude toward hepatitis E vaccination before the health education.After health education,90.0%of the patients took active actions on 9 items,and the vaccination rate was 11.0%.1.3.Analysis of Effects of Different Factors and Health EducationThe results of the study were analyzed by Gamma analysis.There was a negative correlation between the age factor and the questionnaire result rs=-0.317(G=-3.33,P=0.001)age and health education results.The correlation coefficient between education level and health education effectiveness is rs=0.189(G=3.14,P=0.02).There is a positive correlation between education results of health education.After the multi-factor Logistic regression model for the maintenance of hemodialysis patients after the health education of hepatitis E total score as:education level,age is the two factors affecting the effectiveness of MHD patients' health education.2.Evaluation of Safety and Immunogenicity of Recombinant Hepatitis E Vaccine in MHD PatientsThe safety follow-up was followed up for 7 months.The disease course of the MHD patients in the experimental group and the control group included the incidence of basic diseases such as nervous system,cardiovascular system,respiratory system,digestive system,infectious disease,and other hemodialysis complications.There was no statistical significance;there was no significant difference in the incidence of adverse reactions and grade 3 or more adverse reactions between the experimental group and the control group.Adverse reactions were mainly Grade 1 adverse reactions,and no treatment was needed.The main system adverse reactions were headache and cough.,muscle ache.There was no significant difference in the incidence of adverse events and grade 3 or higher adverse events between the experimental group and the control group.The positive rate of HEV-IgG antibody detection was 23%.The geometric mean HEV-IgG antibody concentration(GMC)was 14.47Wu/mL(95%Cl:13.14-15.80).The average antibody concentration was increased by 231.92 times(95%).%CI:159.74-304.10),the geometric mean concentration of antibody after pre-exemption was statistically significant(F=45.476,P<0.0001).Compared with the PPS dataset of phase III clinical trial,the age(±2 years old)and gender-matched population data were compared according to the ratio of 1:2,and the average antibody level was increased 468.67-fold.After the immunization with the MHD vaccine group and phase III clinical trials The difference in concentration was not statistically significant(t=-1.403,P=0.167).Conclusion1.Health education and effectiveness evaluationAfter the health education,MHD patients generally know and improve the knowledge of hepatitis E,take the initiative to learn and acquire relevant knowledge,and actively communicate the lack of initiative;the education level and age are the main factors affecting the health education of hepatitis E;the knowledge rate of hepatitis E vaccine is higher in patients with MHD Health education has improved,but after the health education,the vaccination rate of hepatitis E vaccination was 11.0%,and the vaccination rate was low.83.2%of them considered the safety of hepatitis E vaccine in the MHD population.Safety and immunity of recombinant Hepatitis E vaccine in MHD patientsThe main adverse reactions of MHD patients inoculated with recombinant hepatitis E vaccine were pain,induration,and redness at the site of inoculation,and there were consistency in major adverse reactions in the phase III clinical trials.There were no adverse events with clinical significance.After the vaccination,the positive rate of HEV-IgG antibody in the experimental group was 100.0%,and the geometric mean concentration of antibody was 14.319Wu/mL increased 231.92 times.The study of MHD vaccination with recombinant hepatitis E vaccine has good safety and immunogenicity. |
PDF Full Text Request