Effectiveness and safety of tetanus vaccine administration by intramuscular vs. subcutaneous route in anticoagulated patients: Randomized clinical trial in primary care.

Autor:	Lago-Deibe FI; Sárdoma Health Center, Vigo Health Area, Galician Health Service, Vigo, Spain.; South Galicia Health Research Institute (Instituto de Investigación Sanitaria Galicia Sur), Vigo Health Area, Galician Health Service, Vigo, Spain.; Network for Research on Chronicity, Primary Care and Health Promotion (Red de Investigación en Cronicidad, Atención Primaria y Promoción de la Salud/RICAPPS), Vigo, Spain., Valladares-Cabaleiro M; Moaña Primary Care Emergency Center (Punto de Atención Continuada), Vigo Health Area, Galician Health Service, Moaña, Spain., Fernández-Domínguez MJ; South Galicia Health Research Institute (Instituto de Investigación Sanitaria Galicia Sur), Vigo Health Area, Galician Health Service, Vigo, Spain.; Network for Research on Chronicity, Primary Care and Health Promotion (Red de Investigación en Cronicidad, Atención Primaria y Promoción de la Salud/RICAPPS), Vigo, Spain.; Leiro Health Center, Ourense Health Area, Galician Health Service, Ourense, Spain., Fernández-Fernández I; Redondela Health Center, Vigo Health Area, Galician Health Service, Redondela, Spain., Clavería A; South Galicia Health Research Institute (Instituto de Investigación Sanitaria Galicia Sur), Vigo Health Area, Galician Health Service, Vigo, Spain.; Network for Research on Chronicity, Primary Care and Health Promotion (Red de Investigación en Cronicidad, Atención Primaria y Promoción de la Salud/RICAPPS), Vigo, Spain., Rodríguez-Pastoriza S; South Galicia Health Research Institute (Instituto de Investigación Sanitaria Galicia Sur), Vigo Health Area, Galician Health Service, Vigo, Spain., Roca-Pardinas J; Network for Research on Chronicity, Primary Care and Health Promotion (Red de Investigación en Cronicidad, Atención Primaria y Promoción de la Salud/RICAPPS), Vigo, Spain.; Department of Statistics and Operations Research, University of Vigo, Vigo, Spain.; Galician Research and Mathematical Technology Center (Centro de Investigación e Tecnoloxía Matemática de Galicia/CITMAga), Santiago de Compostela, Spain., Martín-Miguel MV; South Galicia Health Research Institute (Instituto de Investigación Sanitaria Galicia Sur), Vigo Health Area, Galician Health Service, Vigo, Spain.; Network for Research on Chronicity, Primary Care and Health Promotion (Red de Investigación en Cronicidad, Atención Primaria y Promoción de la Salud/RICAPPS), Vigo, Spain.; Vigo Family and Community Medicine and Nursing Teaching Unit, Vigo Health Area, Galician Health Service, Vigo, Spain.
Jazyk:	angličtina
Zdroj:	Frontiers in medicine [Front Med (Lausanne)] 2022 Dec 22; Vol. 9, pp. 1054988. Date of Electronic Publication: 2022 Dec 22 (Print Publication: 2022).
DOI:	10.3389/fmed.2022.1054988
Abstrakt:	Design: Prospective, double-blind clinical trial comparing tetanus-diphtheria vaccine administration routes, intramuscular (IM) vs. subcutaneous (SC) injection, in patients with oral anticoagulants. ISRCTN69942081. Study Population: Patients treated with oral anticoagulants, 15 health centers, Vigo (Spain). Sample size, 117 in each group. Outcome Variables: Safety analysis: systemic reactions and, at the vaccine administration site, erythematic, swelling, hematoma, granuloma, pain.Effectiveness analysis: differences in tetanus toxoid antibody titers.Independent variables: route, sex, age, baseline serology, number of doses administered. Analysis: Following the CONSORT guidelines, we performed an intention-to-treat analysis. We conducted a descriptive study of the variables included in both groups (117 in each group) and a bivariate analysis. Fewer than 5% of missing values. Imputation in baseline and final serology with the median was performed. Lost values were assumed to be values missing at random. We conducted a descriptive study of the variables and compared routes. For safety, multivariate logistic regression was applied, with each safety criterion as outcome and the independent variables. Odds ratios (ORs) were calculated. For effectiveness, a generalized additive mixed model, with the difference between final and initial antibody titers as outcome. Due to the bimodal distribution of the outcome, the normal mixture fitting with gamlssMX was used. All statistical analyses were performed with the gamlss.mx and texreg packages of the R free software environment. Results: A previously published protocol was used across the 6-year study period. The breakdown by sex and route showed: 102 women and 132 men; and 117 IM and 117 SC, with one dose administered in over 80% of participants. There were no differences between groups in any independent variable. The second and third doses administered were not analyzed, due to the low number of cases. In terms of safety, there were no severe general reactions. Locally, significant adjusted differences were observed: in pain, by sex (male, OR: 0.39) and route (SC, OR: 0.55); in erythema, by sex (male, OR: 0.34) and route (SC, OR: 5.21); and in swelling, by sex (male, OR: 0.37) and route (SC, OR: 2.75). In terms of effectiveness, the model selected was the one adjusted for baseline serology. Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. (Copyright © 2022 Lago-Deibe, Valladares-Cabaleiro, Fernández-Domínguez, Fernández-Fernández, Clavería, Rodríguez-Pastoriza, Roca-Pardinas and Martín-Miguel.)
Databáze:	MEDLINE
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