Nasal administration of the neuroprotective candidate NeuroEPO to healthy volunteers: a randomized, parallel, open-label safety study.

BACKGROUND: Delivery of therapeutic agents as erythropoietin (EPO) into Central Nervous System through intranasal route could benefit patients with neurological disorders. A new nasal formulation containing a non-hematopoietic recombinant EPO (NeuroEPO) has shown neuroprotective actions in preclinical models. In the current study, the safety of NeuroEPO was evaluated for the first time in humans. METHODS: A phase I, randomized, parallel, open-label study was carried out in healthy volunteers. They received, intranasally, 1 mg of NeuroEPO every 8 h during 4 days (Group A) or 0.5 mg of NeuroEPO (Group B) with the same schedule. The working hypothesis was that intranasal NeuroEPO produce <10% of severe adverse reactions in the evaluated groups. Therefore, a rigorous assessment of possible adverse events was carried out, which included tolerance of the nasal mucosa and the effect on hematopoietic activity. Clinical safety evaluation was daily during treatment and laboratory tests were done before and on days 5 and 14 after starting treatment. RESULTS: Twenty-five volunteers, 56% women, with a mean age of 27 yrs. were included. Twelve of them received the highest NeuroEPO dose. Twenty types of adverse events occurred, with headache (20%) and increase of hepatic enzymes (20%) as the most reported ones. Nasopharyngeal itching was the most common local event but only observed in four patients (16%), all of them from the lowest dose group. About half of the events were very probably or probably caused by the studied product. Most of the events were mild (95.5%), did not require treatment (88.6%) and were completely resolved (81.8%). No severe adverse events were reported. During the study the hematopoietic variables were kept within reference values. CONCLUSIONS: NeuroEPO was a safe product, well tolerated at the nasal mucosa level and did not stimulate erythropoiesis in healthy volunteers. TRIAL REGISTRATION: Cuban Public Registry of Clinical Trials RPCEC00000157 , June 10, 2013.

Intoxicaciones agudas por plaguicidas consultadas al Centro Nacional de Toxicología durante el bienio 2007-2008 / Acute pesticide poisoning assited at the National Toxicology Centre from 2007-2008

Las intoxicaciones agudas por plaguicidas ocupan un lugar importante, precedidas solo por las reportadas por alimentos y medicamentos. El objetivo de este trabajo es caracterizar las intoxicaciones por plaguicidas consultadas al Centro Nacional de Toxicología en La Habana. Es un informe sobre los resultados de las 627 consultas atendidas a través del servicio de urgencia del centro durante el período 2007-2008. Se tuvieron en cuenta factores clínico epidemiológicos, como edad, sexo, circunstancias del evento, provincia de procedencia, fecha de ocurrencia y tipo de agente involucrado en el evento. Predominaron los intoxicados adultos, hombres y de circunstancia intencional, comúnmente por insecticidas organofosforados en las provincias La Habana y Holguín, con notificación uniforme de casos durante el período excepto en Holguín en abril por intoxicación masiva ocurrida en ese territorio(AU)

Acute pesticide poisonings have an important place, preceded only by food and medicine reported. The objective of this work is to characterize pesticide poisoning assisted at the National Poison Control Center in Havana. This is a report on the study results of 627 cases treated at the emergency service center from 2007-2008. Clinical epidemiological factors were considered, such as age, sex, circumstances of the event, province of origin, date of occurrence and type of agent involved in the event. Intoxicated male adults predominated, as well as intentional circumstances by organophosphate insecticides poisoning in Havana and Holguin provinces. Uniform reporting of cases during the period was performed except in Holgu¦n in April due to mass poisoning occurred in that territory(AU)

Intoxicaciones agudas por plaguicidas consultadas al Centro Nacional de Toxicología durante el bienio 2007-2008 / Acute pesticide poisoning assited at the National Toxicology Centre from 2007-2008

Las intoxicaciones agudas por plaguicidas ocupan un lugar importante, precedidas solo por las reportadas por alimentos y medicamentos. El objetivo de este trabajo es caracterizar las intoxicaciones por plaguicidas consultadas al Centro Nacional de Toxicología en La Habana. Es un informe sobre los resultados de las 627 consultas atendidas a través del servicio de urgencia del centro durante el período 2007-2008. Se tuvieron en cuenta factores clínico epidemiológicos, como edad, sexo, circunstancias del evento, provincia de procedencia, fecha de ocurrencia y tipo de agente involucrado en el evento. Predominaron los intoxicados adultos, hombres y de circunstancia intencional, comúnmente por insecticidas organofosforados en las provincias La Habana y Holguín, con notificación uniforme de casos durante el período excepto en Holguín en abril por intoxicación masiva ocurrida en ese territorio.

Acute pesticide poisonings have an important place, preceded only by food and medicine reported. The objective of this work is to characterize pesticide poisoning assisted at the National Poison Control Center in Havana. This is a report on the study results of 627 cases treated at the emergency service center from 2007-2008. Clinical epidemiological factors were considered, such as age, sex, circumstances of the event, province of origin, date of occurrence and type of agent involved in the event. Intoxicated male adults predominated, as well as intentional circumstances by organophosphate insecticides poisoning in Havana and Holguin provinces. Uniform reporting of cases during the period was performed except in Holguín in April due to mass poisoning occurred in that territory.

Caracterización del cáncer gástrico en pacientes del municipio Caimito / Characterization of gastric cancer in patients from the municipality of Caimito

Objetivo: caracterizar a los pacientes con cáncer gástrico y precisar su evolución con el tratamiento indicado. Métodos: se realizó un estudio observacional, descriptivo de 50 pacientes con diagnóstico de cáncer gástrico en el municipio Caimito durante 15 años. Las variables estudiadas fueron: edad, sexo, antecedentes patológicos personales de enfermedad gástrica, antecedentes familiares, laborales, nutricionales y de exposición a tóxicos y evolución según tratamiento indicado. Resultados: el mayor número de pacientes diagnosticados y fallecidos corresponden a los consejos populares Caimito y Costa Norte. Hubo 32 pacientes del sexo masculino y 18 del femenino. Se mantuvieron vivos al final del estudio cinco de los 20 pacientes que recibieron tratamiento quirúrgico, dos de los nueve tratados con cirugía más poliquimioterapia y uno de los tres tratados con radioterapia más cirugía. El 46 por ciento de los pacientes tuvo antecedentes de gastritis, el 22 por ciento de úlcera y el 60 por ciento historia familiar de tumores digestivos o no. Conclusiones: los pacientes afectados fueron fundamentalmente los ancianos del sexo masculino, con antecedentes personales de enfermedad gástrica, exposición a tóxicos y antecedentes familiares de enfermedad tumoral digestiva o extradigestiva. Tuvieron mejor pronóstico los que recibieron tratamiento quirúrgico solo o combinado (AU)

Objective: characterize patients with gastric cancer and describe their evolution with the treatment indicated. Methods: an observational descriptive study was conducted of 50 patients from the municipality of Caimito diagnosed with gastric cancer throughout 15 years. The variables studied were age; gender; personal history of gastric disease; family, occupational and nutritional history; antecedents of exposure to toxic substances, and evolution with the treatment indicated. Results: the largest number of patients diagnosed and deceased corresponds to the People's Councils of Caimito and Costa Norte. 32 patients were male and 18 female. The patients who remained alive at the end of the study period were five of the twenty who underwent surgical treatment, two of the nine who were treated with surgery plus polychemotherapy, and one of the three treated with radiotherapy plus surgery. 46 percent of the patients had a history of gastritis, 22 percent of ulcer and 60percent had family antecedents of tumors, either digestive or not. Conclusions: the patients affected were mainly male and elderly, with a history of gastric disease and exposure to toxic substances, and family antecedents of digestive or extradigestive tumoral disease. Patients who received surgical treatment, either alone or combined, had a better prognosis(AU)

Caracterización del cáncer gástrico en pacientes del municipio Caimito / Characterization of gastric cancer in patients from the municipality of Caimito

Objetivo: caracterizar a los pacientes con cáncer gástrico y precisar su evolución con el tratamiento indicado. Métodos: se realizó un estudio observacional, descriptivo de 50 pacientes con diagnóstico de cáncer gástrico en el municipio Caimito durante 15 años. Las variables estudiadas fueron: edad, sexo, antecedentes patológicos personales de enfermedad gástrica, antecedentes familiares, laborales, nutricionales y de exposición a tóxicos y evolución según tratamiento indicado. Resultados: el mayor número de pacientes diagnosticados y fallecidos corresponden a los consejos populares Caimito y Costa Norte. Hubo 32 pacientes del sexo masculino y 18 del femenino. Se mantuvieron vivos al final del estudio cinco de los 20 pacientes que recibieron tratamiento quirúrgico, dos de los nueve tratados con cirugía más poliquimioterapia y uno de los tres tratados con radioterapia más cirugía. El 46 por ciento de los pacientes tuvo antecedentes de gastritis, el 22 por ciento de úlcera y el 60 por ciento historia familiar de tumores digestivos o no. Conclusiones: los pacientes afectados fueron fundamentalmente los ancianos del sexo masculino, con antecedentes personales de enfermedad gástrica, exposición a tóxicos y antecedentes familiares de enfermedad tumoral digestiva o extradigestiva. Tuvieron mejor pronóstico los que recibieron tratamiento quirúrgico solo o combinado

Objective: characterize patients with gastric cancer and describe their evolution with the treatment indicated. Methods: an observational descriptive study was conducted of 50 patients from the municipality of Caimito diagnosed with gastric cancer throughout 15 years. The variables studied were age; gender; personal history of gastric disease; family, occupational and nutritional history; antecedents of exposure to toxic substances, and evolution with the treatment indicated. Results: the largest number of patients diagnosed and deceased corresponds to the People's Councils of Caimito and Costa Norte. 32 patients were male and 18 female. The patients who remained alive at the end of the study period were five of the twenty who underwent surgical treatment, two of the nine who were treated with surgery plus polychemotherapy, and one of the three treated with radiotherapy plus surgery. 46 percent of the patients had a history of gastritis, 22 percent of ulcer and 60percent had family antecedents of tumors, either digestive or not. Conclusions: the patients affected were mainly male and elderly, with a history of gastric disease and exposure to toxic substances, and family antecedents of digestive or extradigestive tumoral disease. Patients who received surgical treatment, either alone or combined, had a better prognosis

Parámetros bioéticos en el manejo del paciente drogodependiente / Parameters bioethical addict patient management

El consumo de drogas es una situación que se encuentra en ascenso a nivel mundial. Las cifras respectivas de los años de invalidez vinculadas al tabaco, alcohol y sustancias ilegales se elevan a 59, 58 y 20 millones de años cada 12 meses. Teniendo en cuenta los datos planteados se requiere enfrentar el problema desde todos los puntos y de manera intersectorial analizando a la persona de manera individual y social teniendo en cuenta los parámetros éticos y bioéticos que influyen en esta problemática. Este trabajo analizó los principales conflictos y dilemas éticos relacionados con el diagnóstico y tratamiento de pacientes adictos y valoró el papel de la competencia y los medios de sustitución en el manejo del adicto. El estudio fue descriptivo, evaluando el cumplimiento y deficiencias de los principios éticos en el manejo de este tipo de paciente. Se concluyó que los principales conflictos y dilemas éticos están con relación a problemas técnicos en el establecimiento del diagnóstico de drogodependencia, en el uso del diagnóstico de drogodependencia y en los fines y los medios en la asistencia a estos pacientes así como que la competencia, en algunas ocasiones requiere ser desplazada por las decisiones de sustitución(AU)

Drug use is a situation that is on the rise worldwide. The respective figures for the years of disability related to snuff, alcohol and illegal substances rise to 59, 58 and 20 million years every 12 months. Taking into account the data considered are required to face the problem from all points across sectors and analyze the person individually and taking into account social and ethical standards that affect this bioethical problem. This paper analyzes the main conflicts and ethical dilemmas related to the diagnosis and treatment of addicts and I appreciate the role of competition and media replacement in the management of the addict. The study was evaluating the performance and shortcomings of ethical principles in handling this type of patient. It was concluded that the main conflicts and ethical dilemmas are in relation to technical problems in establishing the diagnosis of drug dependence in the use of drug and diagnostic purposes and the media in assisting these patients as well as competition, sometimes needs to be displaced by substitution decisions(AU)