Vacinação contra hepatite B em renais crônicos antes ou após o tratamento hemodialítico: ensaio clínico piloto randomizado

Abstract

Introduction: Controlling the spread of hepatitis B virus infection in the dialysis population has been an important goal in the management of end-stage renal disease, due to exposure to blood products and compromised immune status. Despite a decrease in the incidence of HBV infection, these patients usually show an impaired immune response to the vaccine against the hepatitis B virus. Objective: To compare the increase in the titre of antibodies against Hepatitis B conferred by vaccination before or after hemodialysis. Material and method: This is a quantitative research with an experimental approach, a pilot randomized clinical trial (RCT), carried out with people who undergo hemodialysis in the age group between 18 and 40 years using the Hepatitis B vaccine. if two groups of individuals simultaneously, with the distinction between the participants divided into two groups: one experimental and one control; The experimental group (EG) received the intervention of interest, patients submitted to the hepatitis B vaccine before the hemodialysis procedure, and the control group (CG) were the patients submitted to the vaccine after hemodialysis, standard therapy for the intervention. Data analyzes were performed using the free software R (R version 4.2.2). The study was approved by the Research Ethics Committee through a favorable opinion under nº 5.340.073 under protocol CAAE-55210822.0.0000.5013, as well as by ReBEC, with approval ID RBR-9vvb89s. Results: 25 people with a mean age of 29.88 years (SD ± 6.45) participated in the study. The EG had 12 participants (48%) and 13 people in the CG (52%). All participants achieved antibody titers (≥ 10 mIU/mL), with a mean anti-Hbs IgG of 674.92 mIU/mL (sd ±369.22) after the entire intervention. The Experimental group had a higher average of anti-HBs (763.08 mIU/mL) compared to the control group (593.55 mIU/mL). There was no influence of the variables gender, color, education, underlying disease, blood type, RH factor, use of alcohol and presence of anemia, BMI, duration of session, blood flow and months of hemodialysis. Conclusion: This pilot clinical trial indicates that there is a tendency to achieve hepatitis B antibody titre before hemodialysis. The need to carry out a multicenter study is evidenced to confirm the hypothesis raised by the β error.