000098181 001__ 98181
000098181 005__ 20210902121906.0
000098181 0248_ $$2sideral$$a121616
000098181 037__ $$aART-2020-121616
000098181 041__ $$aspa
000098181 100__ $$aLisbona-Alquezar, M.P.
000098181 245__ $$aAnálisis de las notificaciones de ototoxicidad, con sintomatología de acúfenos, en la base de datos del sistema español de farmacovigilancia de medicamentos de uso humano
000098181 260__ $$c2020
000098181 5060_ $$aAccess copy available to the general public$$fUnrestricted
000098181 5203_ $$aBackground: One of the adverse drug reactions (ADR) can be the Ototoxicity, either in a cochlear level or in a vestibular one. This may cause an incapacitating symptomatology due to a hearing impairment or deafness, tinnitus, or a vertiginous syndrome. The objective of this work was to analyze the notifications of ototoxic ADRs registered in the FEDRA database of the Spanish Pharmacovigilance System for Medicinal products for Human Use (SEFV-H), manifested as tinnitus, describing epidemiological and prognostic factors, as well as active principles and associated therapeutic groups.
Methods: An observational retrospective study based on the incoming registers in the FEDRA database of the SEFV-H, with tinnitus symptomatology due to ototoxicity between 1984 and 2017 has been earned out. SPSS v.20.0 program has been used for the descriptive and inferential statistics searching elements related to the emergence, seriousness or recuperation of the tinnitus.
Results: A total of 662 patients notifications were obtained with 899 suspected drugs. 64% of the patients were women. The average age was 55.8 years old. An 8.5% of the tinnitus were classified as serious, meaning a significant and persistent disability. Evaluating the causality through the modified Karch-Lasagna algorithm (SEFV-H algorithm). a causal group credible or well defined, was discovered in 48.6% In the ATC ranking, the most frequent group of cause drugs was the N. nervous system. It was concluded. among others, that the seriousness is more significant in men and that the elder group have a great influence in the tinnitus recovery.
Conclusions: The appearance of tinnitus brought on by medical ototoxicity may determine an important limitation on the patient. A vestibular and cochlear function monitoring must he carried out on patients under treatment with high ototoxicity drugs. The task of the pharmacovigilance seems to be essential. by spreading its results and stimulating the ADR notifications in order to identify pharmacological threats.
000098181 540__ $$9info:eu-repo/semantics/openAccess$$aby-nc-nd$$uhttp://creativecommons.org/licenses/by-nc-nd/3.0/es/
000098181 590__ $$a0.756$$b2020
000098181 591__ $$aPUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH$$b169 / 176 = 0.96$$c2020$$dQ4$$eT3
000098181 592__ $$a0.218$$b2020
000098181 593__ $$aPublic Health, Environmental and Occupational Health$$c2020$$dQ4
000098181 593__ $$aMedicine (miscellaneous)$$c2020$$dQ4
000098181 655_4 $$ainfo:eu-repo/semantics/article$$vinfo:eu-repo/semantics/publishedVersion
000098181 700__ $$0(orcid)0000-0002-6485-1926$$aLanuza-Gimenez, J.$$uUniversidad de Zaragoza
000098181 700__ $$0(orcid)0000-0002-7239-1966$$aNavarro-Peman, M.C.$$uUniversidad de Zaragoza
000098181 700__ $$aEsteban-Jimenez, O.
000098181 700__ $$aFernandez-Alquezar, O.
000098181 700__ $$0(orcid)0000-0002-6475-9361$$aFernandez-Liesa, R.$$uUniversidad de Zaragoza
000098181 7102_ $$11013$$2653$$aUniversidad de Zaragoza$$bDpto. Cirugía$$cÁrea Otorrinolaringología
000098181 7102_ $$11005$$2315$$aUniversidad de Zaragoza$$bDpto. Farmacología y Fisiolog.$$cÁrea Farmacología
000098181 773__ $$g94 (2020), e202012154 [14 pp]$$pRev. esp. salud pública$$tREVISTA ESPANOLA DE SALUD PUBLICA$$x1135-5727
000098181 85641 $$uhttps://www.mscbs.gob.es/biblioPublic/publicaciones/recursos_propios/resp/revista_cdrom/VOL94/ORIGINALES/RS94C_202012154.pdf$$zTexto completo de la revista
000098181 8564_ $$s704435$$uhttps://zaguan.unizar.es/record/98181/files/texto_completo.pdf$$yVersión publicada
000098181 8564_ $$s2981082$$uhttps://zaguan.unizar.es/record/98181/files/texto_completo.jpg?subformat=icon$$xicon$$yVersión publicada
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000098181 951__ $$a2021-09-02-10:39:29
000098181 980__ $$aARTICLE