[Analysis of reports of otoxicity, with symptoms of tinnitus, in the database of the Spanish Pharmacovigilance System for medicinal products for human use.] / Análisis de las notificaciones de ototoxicidad, con sintomatología de acúfenos, en la base de datos del Sistema Español de Farmacovigilancia de medicamentos de uso humano.

OBJECTIVE: 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 carried 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 be 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.

OBJETIVO: Una de las reacciones adversas del consumo de fármacos puede ser la ototoxicidad, tanto a nivel coclear como vestibular. Esto puede producir una clínica incapacitante por hipoacusia o sordera, acúfenos o tinnitus, o bien un síndrome vertiginoso. El objetivo de este trabajo fue analizar las notificaciones de RAM ototóxicas registradas en la base de datos FEDRA del Sistema Español de Farmacovigilancia de medicamentos de uso humano (SEFV-H), manifestadas como acúfeno, describiendo factores epidemiológicos y pronósticos, así como principios activos y grupos terapéuticos asociados. METODOS: Se realizó un estudio observacional retrospectivo sobre los registros de la base de datos FEDRA del SEFV-H, con sintomatología de acúfenos por ototoxicidad entre los años 1984 y 2017. Se usó el programa SPSS v.20.0. para la estadística descriptiva e inferencial, buscando factores relacionados con la aparición, gravedad o recuperación del acúfeno. RESULTADOS: Se obtuvieron un total de 662 notificaciones de pacientes con 899 fármacos sospechosos. Un 64% de los pacientes eran mujeres. La edad media fue de 55,8 años. Un 8,5% de los acúfenos se etiquetaron como graves, suponiendo una discapacidad persistente o significativa. Evaluando la causalidad con el algoritmo de Karch-Lasagna modificado o el algoritmo del SEFV-H, se encontró una asociación causal probable o definida en el 48,6% de los casos. En la clasificación ATC, el grupo más frecuente de fármacos causantes fue el N (sistema nervioso). Se obtuvo, entre otros datos, que la gravedad era mayor significativamente en hombres y que el grupo de edad influía en la recuperación del acúfeno. CONCLUSIONES: La aparición de acúfenos por una ototoxicidad medicamentosa puede condicionar una limitación importante en el paciente. Se debe realizar una monitorización de la función vestibular y coclear en pacientes sometidos a tratamientos con potencial ototóxico. La labor de la farmacovigilancia se muestra fundamental, debiéndose difundir sus resultados y estimular las notificaciones de las reacciones adversas a medicamentos para identificar los riesgos farmacológicos.

Análisis de las notificaciones de ototoxicidad, con sintomatología de acúfenos, en la base de datos del sistema español de farmacovigilancia de medicamentos de uso humano / Analysis of reports of otoxicity, with symptoms of tinnitus, in the database of the Spanish Pharmacovigilance System for medicinal products for human use

OBJETIVO: Una de las reacciones adversas del consumo de fármacos puede ser la ototoxicidad, tanto a nivel coclear como vestibular. Esto puede producir una clínica incapacitante por hipoacusia o sordera, acúfenos o tinnitus, o bien un síndrome vertiginoso. El objetivo de este trabajo fue analizar las notificaciones de RAM ototóxicas registradas en la base de datos FEDRA del Sistema Español de Farmacovigilancia de medicamentos de uso humano (SEFV-H), manifestadas como acúfeno, describiendo factores epidemiológicos y pronósticos, así como principios activos y grupos terapéuticos asociados. MÉTODOS: Se realizó un estudio observacional retrospectivo sobre los registros de la base de datos FEDRA del SEFV-H, con sintomatología de acúfenos por ototoxicidad entre los años 1984 y 2017. Se usó el programa SPSS V.20.0. para la estadística descriptiva e inferencial, buscando factores relacionados con la aparición, gravedad o recuperación del acúfeno. RESULTADOS: Se obtuvieron un total de 662 notificaciones de pacientes con 899 fármacos sospechosos. Un 64% de los pacientes eran mujeres. La edad media fue de 55,8 años. Un 8,5% de los acúfenos se etiquetaron como graves, suponiendo una discapacidad persistente o significativa. Evaluando la causalidad con el algoritmo de Karch-Lasagna modificado o el algoritmo del SEFV-H, se encontró una asociación causal probable o definida en el 48,6% de los casos. En la clasificación ATC, el grupo más frecuente de fármacos causantes fue el N (sistema nervioso). Se obtuvo, entre otros datos, que la gravedad era mayor significativamente en hombres y que el grupo de edad influía en la recuperación del acúfeno. CONCLUSIONES: La aparición de acúfenos por una ototoxicidad medicamentosa puede condicionar una limitación importante en el paciente. Se debe realizar una monitorización de la función vestibular y coclear en pacientes sometidos a tratamientos con potencial ototóxico. La labor de la farmacovigilancia se muestra fundamental, debiéndose difundir sus resultados y estimular las notificaciones de las reacciones adversas a medicamentos para identificar los riesgos farmacológicos

OBJECTIVE: 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 carried 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 be 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

Quistes aracnoideos intraselares. Presentación de 2 casos y revisión bibliográfica / Intrasellar arachnoid cysts. Two case reports and literature review

Los quistes aracnoideos intraselares son una patología muy rara, con muy pocos casos descritos en la literatura científica. Su fisiopatología permanece todavía poco clara, con diferentes hipótesis sobre su formación. El diagnóstico diferencial con otras lesiones quísticas selares puede ser extremadamente complicado. Presentamos 2 casos clínicos de 2 quistes aracnoideos sintomáticos que fueron tratados quirúrgicamente mediante abordaje transesfenoidal, así como los resultados de una revisión bibliográfica (AU)

Intrasellar arachnoid cysts are an uncommon pathology, with only a few cases reported in scientific literature. Their physiopathology is still unknown, with different hypothesis about their development. Differential diagnosis with other cystic sellar lesions is difficult. We report two cases of two intrasellar arachnoid cysts that were treated surgically usingtranssphenoidal approach and present a review of the literature (AU)

[Intrasellar arachnoid cysts. Two case reports and literature review]. / Quistes aracnoideos intraselares. Presentación de 2casos y revisión bibliográfica.

Intrasellar arachnoid cysts are an uncommon pathology, with only a few cases reported in scientific literature. Their physiopathology is still unknown, with different hypothesis about their development. Differential diagnosis with other cystic sellar lesions is difficult. We report two cases of two intrasellar arachnoid cysts that were treated surgically using transsphenoidal approach and present a review of the literature.

Rinolicuorrea de etiología atípica: encefalocele espontáneo temporal bilateral / Atypical etiology of rhinorrhea: spontaneous bilateral temporal encephalocele

La herniación espontánea de tejido cerebral a través de un defecto óseo y dural a nivel temporal es una rara entidad, siendo todavía más infrecuente que esta circunstancia se produzca de forma bilateral. La presentación suele ser en forma de otorrea intermitente y persistente en el tiempo. La manifestación como rinolicuorraquia es muy poco habitual. El objetivo es presentar este inusual caso de un encefalocele espontáneo bilateral por defecto bilateral del tegmen tympani (AU)

Spontaneous herniation of brain parenchyma through a dural and osseous defect in the temporal bone is a rare entity and a bilateral form is even more infrequent. It usually presents as an intermittent but persistent otorrhea. Manifestation as nose cerebrospinal fluid (CSF) leak is very uncommon. Our objective is presenting this unusual case report of a spontaneous bilateral encephalocele with a bilateral tegmen tympani defect (AU)

[Atypical etiology of rhinorrhea: spontaneous bilateral temporal encephalocele]. / Rinolicuorrea de etiología atípica: encefalocele espontáneo temporal bilateral.

Spontaneous herniation of brain parenchyma through a dural and osseous defect in the temporal bone is a rare entity and a bilateral form is even more infrequent. It usually presents as an intermittent but persistent otorrhea. Manifestation as nose cerebrospinal fluid (CSF) leak is very uncommon. Our objective is presenting this unusual case report of a spontaneous bilateral encephalocele with a bilateral tegmen tympani defect.

Estudio anatómico del orificio esfenopalatino / Sphenopalatinum foramen: an anatomical study

Introducción: La localización de la arteria esfenopalatina es fundamental en el tratamiento endoscópico de la epistaxis posterior severa. El orificio esfenopalatino, que le da salida, es variable en ubicación y relaciones anatómicas. Objetivo: Realizar un estudio descriptivo osteológico de la región del orificio esfenopalatino, describiendo la anatomía de dicha región, tamaño, localización, relaciones con cornetes y coanas, así como la existencia de orificios accesorios. Material y métodos: La exploración y el estudio anatómico de la zona se llevó a cabo en 32 hemicráneos humanos. Resultados: La localización más frecuente del orificio esfenopalatino resultó la transición entre el meato medio y superior en el 56,25%, 18 especímenes, seguido del meato superior, 37,5% (12 hemicráneos) y solamente en 2 casos el orificio se abría exclusivamente en meato medio. En el 50% de los casos encontramos la existencia de orificios accesorios, cuya localización más frecuente fue inferior al orificio en el meato medio. La cresta etmoidal se encontraba presente en todos los cráneos estudiados, produciendo un resalte anterior en el orificio esfenopalatino. Conclusión: Existen variaciones anatómicas en el orificio esfenopalatino en cuanto a localización, número y relaciones anatómicas que modificarán la entrada de la arteria esfenopalatina y sus ramas en la fosa nasal. Habiendo encontrado una marca constante localizadora del orificio esfenopalatino, la cresta etmoidal, situada en el borde anterior del orificio (AU)

Introduction: The position of the sphenopalatine artery is essential for the endoscopic treatment of severe posterior epistaxis. This artery passes through its own foramen, which has awide range of locations and anatomic relations. Objective: To carry out a descriptive osteological study on the sphenopalatine foramen area. Its anatomy, size, position and relations with turbinates and choanae are described, as well as the existence of accessory foramina. Material and methods: Exploration and anatomical study was carried out in 32 human hemicrania. Results: The area between middle and superior meatus was considered the most common location of the sphenopalatine foramen in 56.24% of the cases (18 specimens), followed by the superior meatus, with 37.5% (12 hemi-skulls). The foramen was located in middle meatus injust two cases. We found accessory foramina in 50% of the cases, most commonly positioned below the middle meatus. The ethmoidal crest appeared in every skull, producing an anteriorosseous projection on the sphenopalatine foramen. Conclusion: There are variations in position, number and anatomic relations that may cause changes in the sphenopalatine artery orifice and its branches into the nasal fossa. The ethmoidal crest, located on the anterior side of the sphenopalatine foramen, can be considered a permanent landmark to find the foramen (AU)

[Sphenopalatinum foramen: an anatomical study]. / Estudio anatómico del orificio esfenopalatino.

INTRODUCTION: The position of the sphenopalatine artery is essential for the endoscopic treatment of severe posterior epistaxis. This artery passes through its own foramen, which has a wide range of locations and anatomic relations. OBJECTIVE: To carry out a descriptive osteological study on the sphenopalatine foramen area. Its anatomy, size, position and relations with turbinates and choanae are described, as well as the existence of accessory foramina. MATERIAL AND METHODS: Exploration and anatomical study was carried out in 32 human hemi-crania. RESULTS: The area between middle and superior meatus was considered the most common location of the sphenopalatine foramen in 56.24% of the cases (18 specimens), followed by the superior meatus, with 37.5% (12 hemi-skulls). The foramen was located in middle meatus in just two cases. We found accessory foramina in 50% of the cases, most commonly positioned below the middle meatus. The ethmoidal crest appeared in every skull, producing an anterior osseous projection on the sphenopalatine foramen. CONCLUSION: There are variations in position, number and anatomic relations that may cause changes in the sphenopalatine artery orifice and its branches into the nasal fossa. The ethmoidal crest, located on the anterior side of the sphenopalatine foramen, can be considered a permanent landmark to find the foramen.

La arteria etmoidal anterior en el laberinto etmoidal: Revisión bibliográfica sobre variantes anatómicas y referencias para la cirugía endoscópica / Anterior ethmoidal artery at ethmoidal labyrinth: Bibliographical review of anatomical variants and references for endoscopic surgery

Introducción: La arteria etmoidal anterior presenta muchas variaciones anatómicas en su trayecto. Tampoco existen referencias claras para localizarla, por esto, es fácil producir una lesión iatrógena. El objetivo de este trabajo es realizar una búsqueda bibliográfica para analizar las variantes y referencias endoscópicas reseñadas en la literatura científica para localizarla. Material y métodos: Se ha realizado una revisión en la base de datos Medline y Embase, buscando tanto trabajos anatómicos como radiológicos. Tras la revisión se recogen los resultados de los principales estudios. Resultados: Se recogen 13 estudios que analizan en total 1.388 arterias etmoidales anteriores. Se encuentra ausente entre un 2–14%. Es identificable entre un 95–100% en una TC. Se sitúa entre la 2ª y la 3ª lamela etmoidal en un 74,2% y a nivel basicraneal en un 66,6%. La neumatización etmoidal se relaciona con la situación de la arteria etmoidal anterior a nivel de la base de cráneo. Entre el 83–85,3% se localiza a nivel del receso suprabullar. Se exponen varias distancias y ángulos medidas para poder localizarla. Conclusiones: La TC es útil para una planificación prequirúrgica. Se localiza más frecuentemente entre la 2.a y 3.a lamela etmoidal y a nivel basicraneal. Factores como la neumatización etmoidal o el grado de Keros pueden predecir su relación con el nivel basicraneal. La arteria etmoidal anterior, la axila del cornete medio y el borde superomedial de la nariz forman una línea recta, siendo una referencia sencilla y útil en la cirugía endoscópica (AU)

Introduction: The anterior ethmoidal artery (AEA) has a trajectory with multiple anatomical variations. In addition, there are no clear references to locate it, so it is easy to produce an iatrogenic lesion. The goal of this study was to carry out a bibliographical review to analyse variants and endoscopic reference reports in the scientific literature. Material and methods: A review in Medline and Embase data bases was carried out, looking for AEA-related anatomical and radiological studies. After the revision, the principal study results, together with several distances and angles useful for locating the AEA, are presented in this study. Results: There were 13 main articles that analysed a total of 1388 AEA. It was absent from 2 to 14%. It was identifiable in computed tomography (CT) between 95 and 100%. It was located between the second and third ethmoidal lamella in 74.2% and at the skull base level in 66.6%. Ethmoidal sinuses pneumatisation was related to AEA location at the skull base. Between 83 and 85.3%, it was found at the suprabullar recess. Conclusions: CT is useful for presurgery planning. AEA are more frequent between the second and third lamella and at skull level. Ethmoidal pneumatisation and Keros grades could be predictive factors for AEA relationship with the skull base level. The AEA, the axilla of the middle turbinate and the superomedial edge of the nose are in a straight line, being a simple and useful reference in endoscopic sinus surgery (AU)

[Anterior ethmoidal artery at ethmoidal labyrinth: Bibliographical review of anatomical variants and references for endoscopic surgery]. / La arteria etmoidal anterior en el laberinto etmoidal: Revisión bibliográfica sobre variantes anatómicas y referencias para la cirugía endoscópica.

INTRODUCTION: The anterior ethmoidal artery (AEA) has a trajectory with multiple anatomical variations. In addition, there are no clear references to locate it, so it is easy to produce an iatrogenic lesion. The goal of this study was to carry out a bibliographical review to analyse variants and endoscopic reference reports in the scientific literature. MATERIAL AND METHODS: A review in Medline and Embase data bases was carried out, looking for AEA-related anatomical and radiological studies. After the revision, the principal study results, together with several distances and angles useful for locating the AEA, are presented in this study. RESULTS: There were 13 main articles that analysed a total of 1388 AEA. It was absent from 2 to 14%. It was identifiable in computed tomography (CT) between 95 and 100%. It was located between the second and third ethmoidal lamella in 74.2% and at the skull base level in 66.6%. Ethmoidal sinuses pneumatisation was related to AEA location at the skull base. Between 83 and 85.3%, it was found at the suprabullar recess. CONCLUSIONS: CT is useful for presurgery planning. AEA are more frequent between the second and third lamella and at skull level. Ethmoidal pneumatisation and Keros grades could be predictive factors for AEA relationship with the skull base level. The AEA, the axilla of the middle turbinate and the superomedial edge of the nose are in a straight line, being a simple and useful reference in endoscopic sinus surgery.

Laringectomía horizontal supraglótica láser CO2: nuestra experiencia en seis años / CO2 laser surgery of supraglottic carcinoma: Our experience over 6 years

Introducción y objetivos: El objetivo del estudio es analizar los resultados oncológicos y funcionales de la microcirugía láser en el tratamiento del carcinoma supraglótico de laringe. Material y métodos: Cincuenta y tres pacientes fueron incluidos en este estudio retrospectivo entre el año 2000 y 2006. El periodo de seguimiento fue superior a 2 años y la media fue de 49 meses. Resultados: La extensión tumoral fue T1 en 12 pacientes (22,6%), T2 en 37 (69,8%) y T3 en 4 pacientes (7,5%). En 47 pacientes (88,7%) se realizaron vaciamientos cervicales ganglionares. Diecinueve pacientes (35,8%) recibieron radioterapia (RT) postoperatoria. Las estimaciones de la supervivencia causa-específica con el método de Kaplan-Meier fueron de 80%, 74,11% y 65% a los 2, 3 y 5 años, respectivamente. La preservación de la función laríngea fue posible en el 90,56% (48 de 53) y el control local fue del 81,13%. Durante el periodo de seguimiento 13,2% de los pacientes desarrollaron recidiva local, 11,3% recidiva regional y 5,7% recidiva locorregional. Los pacientes comenzaron a deglutir de forma temprana tras la cirugía con un tiempo medio de 5,83 días y la estancia media hospitalaria fue de 14,69 días. El 20,75% sufrieron neumonía y el 11,32% hemorragia. Únicamente un paciente (1,88%) precisó una laringectomía total por imposibilidad para la deglución. Conclusiones: Con una selección cuidadosa de pacientes, la laringectomia supraglótica con láser es un tratamiento seguro y efectivo para el cáncer supraglótico de laringe (AU)

Introduction and objetives: The study goal was to analyze the oncologic and functional outcomes of transoral laser microsurgery in the treatment of carcinoma of the supraglottic larynx. Material and methods: A total of 53 patients were included in this retrospective review between 2000 and 2006. The follow-up period was more than 2 years and the mean follow-up for all patients was 49 months. Results: Tumour extension was as follows: T1 in 12 (22.6%), T2 in 37 (69.8%) and T3 in 4 (7.5%). Forty-seven patients (88.7%) had neck dissections. Nineteen patients (35.8%) received adjuvant radiotherapy. Kaplan-Meier estimates for disease-specific survival were 80%, 74.11% and 65%, at 2, 3 and 5 years, respectively. The overall functional laryngeal preservation rate was 90.56%. (48 of 53), and local control 81.13%. During follow up, 13.2% of patients developed local recurrence, 11.3% regional recurrence and 5.7% loco-regional recurrence. Patients started swallowing early after surgery, with a mean time of 5.83 days, and the mean hospital stay was 14.69 days. Complications included 20.75% who suffered pneumonia and 11.32% with bleeding. Only one patient (1.88%) received total laryngectomy due to the impossibility of swallowing. Conclusions: With careful selection of patients, laser supraglottic laryngectomy is a safe and effective treatment for cancer of the supraglottic larynx (AU)

CO2 laser surgery of supraglottic carcinoma: our experience over 6 years.

INTRODUCTION AND OBJECTIVES: The study goal was to analyze the oncologic and functional outcomes of transoral laser microsurgery in the treatment of carcinoma of the supraglottic larynx. MATERIAL AND METHODS: A total of 53 patients were included in this retrospective review between 2000 and 2006. The follow-up period was more than 2 years and the mean follow-up for all patients was 49 months. RESULTS: Tumour extension was as follows: T1 in 12 (22.6%), T2 in 37 (69.8%) and T3 in 4 (7.5%). Forty-seven patients (88.7%) had neck dissections. Nineteen patients (35.8%) received adjuvant radiotherapy. Kaplan-Meier estimates for disease-specific survival were 80%, 74.11% and 65%, at 2, 3 and 5 years, respectively. The overall functional laryngeal preservation rate was 90.56%. (48 of 53), and local control 81.13%. During follow up, 13.2% of patients developed local recurrence, 11.3% regional recurrence and 5.7% loco-regional recurrence. Patients started swallowing early after surgery, with a mean time of 5.83 days, and the mean hospital stay was 14.69 days. Complications included 20.75% who suffered pneumonia and 11.32% with bleeding. Only one patient (1.88%) received total laryngectomy due to the impossibility of swallowing. CONCLUSIONS: With careful selection of patients, laser supraglottic laryngectomy is a safe and effective treatment for cancer of the supraglottic larynx.