Psychological Discomfort in Patients Undergoing Coronary Artery Bypass Graft (CABG) in West Bank: A Cohort Study.

Background/Objetives: Cardiovascular disease (CVD) remains a significant contributor to global morbidity and mortality rates. Coronary artery bypass graft (CABG) surgery is a critical intervention for patients with coronary artery disease, yet it poses psychological challenges that can impact recovery. Methods: This prospective cohort study, conducted across six hospitals in the West Bank/Palestine, aimed to assess changes in depression, anxiety, and stress levels among CABG patients and identify associated factors. The Arabic version of the Depression Anxiety Stress Scales (DASS-21) was administered before (one week) and after surgery (two and three weeks). Results: Of the 200 participants, 116 were men (58%). High levels of depression, anxiety, and stress were observed both before and after surgery, with statistically significant reductions in all these variables after surgery (p < 0.001). Regarding demographic factors, age displayed a weak positive correlation with depression (r = 0.283; p < 0.001), anxiety (r = 0.221; p = 0.002), and stress (r = 0.251; p < 0.001). Sex showed a weak correlation with stress pre-surgery (r = -0.160; p = 0.024). Conclusions: Patient outcomes could be improved by early identification and the provision of efficient treatments such as psychosocial therapy both before and after surgery.

A COVID-19 vaccine candidate composed of the SARS-CoV-2 RBD dimer and Neisseria meningitidis outer membrane vesicles.

SARS-CoV-2 infection is mediated by the interaction of the spike glycoprotein trimer via its receptor-binding domain (RBD) with the host's cellular receptor. Vaccines seek to block this interaction by eliciting neutralizing antibodies, most of which are directed toward the RBD. Many protein subunit vaccines require powerful adjuvants to generate a potent antibody response. Here, we report on the use of a SARS-CoV-2 dimeric recombinant RBD combined with Neisseria meningitidis outer membrane vesicles (OMVs), adsorbed on alum, as a promising COVID-19 vaccine candidate. This formulation induces a potent and neutralizing immune response in laboratory animals, which is higher than that of the dimeric RBD alone adsorbed on alum. Sera of people vaccinated with this vaccine candidate, named Soberana01, show a high inhibition level of the RBD-ACE2 interaction using RBD mutants corresponding to SARS-CoV-2 variants of concern and wild-type expressed using the phage display technology. To our knowledge, this is the first time that the immunostimulation effect of N. meningitidis OMVs is evaluated in vaccine candidates against SARS-CoV-2.

A randomized, double-blind phase I clinical trial of two recombinant dimeric RBD COVID-19 vaccine candidates: Safety, reactogenicity and immunogenicity.

BACKGROUND: The Receptor Binding Domain (RBD) of the SARS-CoV-2 spike protein is the target for many COVID-19 vaccines. Here we report results for phase I clinical trial of two COVID-19 vaccine candidates based on recombinant dimeric RBD (d-RBD). METHODS: We performed a randomized, double-blind, phase I clinical trial in the National Centre of Toxicology in Havana. Sixty Cuban volunteers aged 19-59 years were randomized into three groups (20 subjects each): 1) FINLAY-FR-1 (50 µg d-RBD plus outer membrane vesicles from N. meningitidis); 2) FINLAY-FR-1A-50 (50 µg d-RBD, three doses); 3) FINLAY-FR-1A-25 (25 µg d-RDB, three doses). The FINLAY-FR-1 group was randomly divided to receive a third dose of the same vaccine candidate (homologous schedule) or FINLAY-FR-1A-50 (heterologous schedule). The primary outcomes were safety and reactogenicity. The secondary outcome was vaccine immunogenicity. Humoral response at baseline and following each vaccination was evaluated using live-virus neutralization test, anti-RBD IgG ELISA and in-vitro neutralization test of RBD:hACE2 interaction. RESULTS: Most adverse events were of mild intensity (63.5%), solicited (58.8%), and local (61.8%); 69.4% with causal association with vaccination. Serious adverse events were not found. The FINLAY-FR-1 group reported more subjects with adverse events than the other two groups. After the third dose, anti-RBD seroconversion was 100%, 94.4% and 90% for the FINLAY-FR-1, FINLAY-FR-1A-50 and FINLAY-FR-1A-25 respectively. The in-vitro inhibition of RBD:hACE2 interaction increased after the second dose in all formulations. The geometric mean neutralizing titres after the third dose rose significantly in the group vaccinated with FINLAY-FR-1 with respect to the other formulations and the COVID-19 Convalescent Serum Panel. No differences were found between FINLAY-FR-1 homologous or heterologous schedules. CONCLUSIONS: Vaccine candidates were safe and immunogenic, and induced live-virus neutralizing antibodies against SARS-CoV-2. The highest values were obtained when outer membrane vesicles were used as adjuvant. TRIAL REGISTRY: https://rpcec.sld.cu/en/trials/RPCEC00000338-En.

Aproximación al estado del arte de los comités de monitoreo de datos en ensayos clínicos / Approach to the state of the art of data monitoring committees in clinical trials

Introducción: En 1967 se estableció, por primera vez, un comité de monitoreo de datos, en un estudio de mortalidad cardiovascular; desde entonces su uso se ha incrementado debido a su valor para garantizar la seguridad de los sujetos participantes en ensayos clínicos y la validez e integridad de los datos. Se realizó una exploración documental de los últimos 20 años, sobre aspectos relacionados con los requisitos de creación y funcionamiento de los comités de monitoreo de datos a nivel mundial, con los objetivos de mostrar el desarrollo alcanzado en el establecimiento de los comités de monitoreo de datos e identificar sus características fundamentales. Desarrollo: Existe un incremento en la producción documental sobre los comités de monitoreo de datos, liderado por angloparlantes de países desarrollados, con franco aumento de publicaciones sobre el tema en el último quinquenio, superior en 50 por ciento a los 15 años anteriores. Este fenómeno lo provoca el auge de la industria farmacéutica y biotecnológica, los altos costos de investigación y desarrollo de medicamentos, la necesidad de introducir nuevos fármacos y el incremento de las exigencias regulatorias. Se describen las características estructurales, requisitos clínicos y metodológicos para el establecimiento de los comités. Conclusiones: Existe alto desarrollo de los comités de monitoreo de datos en los ensayos clínicos, con tendencia al incremento de su uso en los últimos años. Los comités de monitoreo de datos se caracterizan por requerimientos clínicos y metodológicos para su establecimiento(AU)

Introduction: For the first time, in 1967, a data monitoring committee was established in a study of cardiovascular mortality. Since then its use has increased, due to its value to guarantee the safety of subjects participating in clinical trials, the validity and integrity of the data. A documentary exploration of the last 20 years was carried out, on aspects related to the requirements for the creation and operation of data monitoring committees worldwide, with the aim of showing the development achieved in the establishment of data monitoring committees and identify its fundamental characteristics. Development: There is an increase in documentary production on data monitoring committees, led by English speakers from developed countries, with a clear increase in publications on the subject, in the last five-year period, 50% higher than in the previous 15 years. This phenomenon is caused by the rise of the pharmaceutical and biotechnology industry, the high costs of drug research and development, the need to introduce new drugs and the increase in regulatory requirements. The structural characteristics, clinical and methodological requirements for the establishment of the committees are described. Conclusions: There is a high development of data monitoring committees in clinical trials, with a tendency to increase their use in recent years. Data monitoring committees are characterized by clinical and methodological requirements for their establishment(AU)

Evaluación oftalmológica de pacientes con úlcera de pie diabético / Ophthalmologic evaluation of patients with diabetic foot ulcer

Introducción: La prevalencia de diabetes aumenta paulatinamente a nivel mundial y con ello, se incrementa el riesgo de complicaciones microvasculares como la retinopatía diabética. El riesgo de ceguera se reduce con control metabólico estable, diagnóstico temprano y tratamiento adecuado. Objetivo: Comparar el resultado del examen oftalmológico realizado antes de iniciar el tratamiento con Heberprot-P, con el realizado a los cinco meses de iniciado, a diferentes dosis. Métodos: Se realizó un estudio observacional, retrospectivo, en 77 pacientes incluidos en cuatro ensayos clínicos de Heberprot-P. Se realizó análisis de las variables examen oftalmológico antes y después del tratamiento, tipo de diabetes y años de evolución. Resultados: Se observó predominio de los diabéticos tipo 2 respecto a los tipo 1 en una razón 11:1, con una media de 16,3 años de evolución de la diabetes. La mitad de los pacientes tenían retinopatía diabética no proliferativa, con predominio de la forma leve, en el examen realizado antes del tratamiento con Heberprot-P. Solo un paciente anciano con otras comorbilidades, desarrolló una retinopatía diabética proliferativa, luego de un examen previo en que se observó retinopatía diabética no proliferativa y edema macular diabético. Conclusiones: La aparición o progresión de retinopatía diabética es infrecuente en pacientes complicados con úlcera del pie diabético tratados con Heberprot-P, hasta cinco meses después de tratamiento(AU)

Introduction: The prevalence of diabetes gradually increases worldwide and with it, the risk of microvascular complications such as diabetic retinopathy. The risk of blindness is reduced with stable metabolic control, early diagnosis and adequate treatment. Objective: To compare the result of the ophthalmological examination performed before starting treatment with Heberprot-P, with that performed five months after initiation, at different doses. Methods: A retrospective observational study was conducted in 77 patients included in four clinical trials of Heberprot-P. Analysis of the ophthalmological examination variables before and after treatment, type of diabetes and years of evolution were performed. Results: Prevalence of type 2 diabetics was observed with respect to type 1 in an 11: 1 ratio, with an average of 16.3 years of diabetes evolution. Half of the patients had nonproliferative diabetic retinopathy, predominantly of the mild form, in the examination performed before treatment with Heberprot-P. Only one elderly patient with other comorbidities developed a proliferative diabetic retinopathy, after a previous examination in which non-proliferative diabetic retinopathy and diabetic macular edema were observed. Conclusions: The appearance or progression of diabetic retinopathy is uncommon in complicated patients with diabetic foot ulcer treated with Heberprot-P, up to five months after treatment(AU)

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 baclofeno consultadas al Centro Nacional de Toxicología en cinco años / Acute intoxications by baclofen consulted to Toxicology National Center in five years

Introducción: el baclofeno se indica como relajante muscular para el alivio de espasticidad grave y ejerce sus efectos como agonista selectivo del receptor GABA-B. Objetivo: caracterizar las intoxicaciones por baclofeno según reportes al Servicio de Información de Urgencia del Cenatox entre 2011 y 2015. Métodos: se realizó un estudio observacional retrospectivo con un universo de 16 notificaciones, en las que se estudiaron: el centro de salud que asistió al paciente, provincia de procedencia por año de estudio, grupo de edad, sexo, circunstancias del evento, manifestaciones clínicas y severidad de la intoxicación. Resultados: el año 2014 aportó la mayor cantidad de reportes y los niños las mayores frecuencias absolutas, no hubo diferencias en relación al sexo, aunque entre los hombres predominó la causa accidental y entre las féminas las intencionales suicidas. Todas las notificaciones procedieron de atención secundaria, aunque cinco de los pacientes habían sido previamente asistidos en áreas de salud. Todos los afectados presentaron manifestaciones neurológicas, la mayoría fueron reportados de grave y la mitad de los casos presentaron alteraciones cardiorrespiratorias con inestabilidad hemodinámica que llevó a la asistencia ventilatoria. La recuperación fue completa en todos los pacientes y no se reportaron fallecidos por esta causa durante el período de estudio. Conclusiones: la sobredosis de baclofeno es más común en niños y cursa con manifestaciones de neurotoxicidad e inestabilidad hemodinámica(AU)

Introduction: Baclofen is indicated as a muscle relaxant for the relief of severe spasticity and exerts its effects as a selective agonist of the GABA-B receptor. Objective: To characterize baclofen poisonings according to reports to the Cenatox emergency information service between 2011 and 2015. Methods: A retrospective observational study with a universe of 16 notifications, in which the health center that attended the patient and province of origin was studied by year of study, age group, gender, circumstances, clinical manifestations and severity of intoxication. Results: The bigger number of reports and the highest absolute frequencies occurred in the year 2014, there were no differences with regard to sex, although among the men, the accidental cause was predominant, and among women the suicides attemps were predominant. All reports came from secondary care, although five of the patients had previously been assisted in health care areas; all affected had neurological manifestations, most were reported as severe and half of the cases presented cardiorespiratory alterations with hemodynamic instability leading to ventilatory assistance. Recovery was complete in all patients and no deaths were reported for this cause during the study period. Conclusions: Baclofen overdose was more common in children and was characterized by neurotoxicity and hemodynamic instability(AU)

Reportes al Centro Nacional de Toxicología de mujeres en edad fértil expuestas a plaguicidas / Reports to the National Center for Toxicology of women of childbearing age exposed to pesticides

Introducción: el amplio uso de los plaguicidas químicos en la agricultura propicia la exposición semejante de mujeres y hombres a estos productos. Los riesgos por exposición a plaguicidas, tales como los de toxicidad aguda y crónica, efectos inmunológicos, hormonales, endocrinos y sobre la reproducción, no han recibido atención suficiente a nivel mundial. Objetivo: caracterizar los reportes al Centro Nacional de Toxicología de mujeres en edad fértil expuestas a plaguicidas entre 2009 y 2013. Métodos: se realizó un estudio observacional en una serie de 402 mujeres, se analizaron las variables edad, circunstancia, gravedad de la intoxicación y tipo de pesticida. Resultados: las mujeres en edad fértil atendidas representaron la mitad del total de expuestas, con edad promedio de 30,3 años, la mayor incidencia fue de los eventos leves con fines suicidas. Los plaguicidas más involucrados pertenecen al grupo otros/varios. Conclusiones: las mujeres más afectadas fueron las del grupo 12 a 24 años de edad, con intoxicaciones intencionales suicidas de leve intensidad, ocasionadas por plaguicidas del grupo otros/varios(AU)

Introduction: The widespread use of chemical pesticides in agriculture lead to similar exposure of women and men to these products. Risks from exposure to pesticides, such as acute and chronic toxicity, immunological, hormonal, endocrine and reproductive effects, have not received sufficient global attention. Objective: Characterize the reports to the National Center for Toxicology of women of childbearing age exposed to pesticides between years 2009 and 2013. Methods: An observational study was conducted in a sample of 402 women, in which the following variables were studied; age, circumstance, severity of intoxication and type of pesticide. Results: Women of childbearing age accounted for half of the total number of patients exposed, with a mean age of 30,3 years, with milder events being suicidal. The pesticides most involved belong to the group others/various. Conclusions: The most affected women were those in the 12 to 24 years of age, with intentional poisonings of mild intensity caused by pesticides of the group others/various(AU)

Pharmacokinetic and pharmacodynamic characterization of a novel formulation containing co-formulated interferons alpha-2b and gamma in healthy male volunteers.

BACKGROUND: More potent antitumor activity is desired in Interferon (IFN)-treated cancer patients. This could be achieved by combining IFN alpha and IFN gamma. The aim of this work was to characterize the pharmacokinetics and pharmacodynamics of a novel formulation containing a co-formulated combination of IFNs alpha-2b and gamma (CIGB-128-A). METHODS: A group of nine healthy male subjects received intramuscularly 24.5 × 106 IU of CIGB-128-A. IFN concentrations were evaluated for 48 h. Serum neopterin, beta2-microglobulin (ß2M) and 2'-5' oligoadenylate synthetase (2'-5' OAS), classical IFN-inducible serum markers, were measured during 192 h by enzyme immunoassay and body temperature was used as pharmacodynamic variable as well. RESULTS: Concerning pharmacokinetics, serum IFNs' profiles were better fitted to a mono-compartmental model with consecutive zero order and first order absorption, one bioavailability value. No interferences by simultaneous administered IFNs were observed in their typical similar systemic profiles. Neopterin and ß2M time profiles showed a delay that was efficiently linked to pharmacokinetics by means of a zero order absorption rate constant. Neopterin level was nine-fold higher than initial values, 48 h post-administration, an increment not described before. At this time, mean serum ß2M peaked around the double from baseline. Serum concentrations of the enzyme 2'-5' OAS was still elevated on the 8 day post-injection. The formulation was well tolerated. Most frequent adverse reactions were fever, headache, arthralgia and lymphopenia, mostly mild. CONCLUSIONS: The administration of co-formulated IFN alpha-2b and IFN gamma likely provides improved pharmacodynamic properties that may be beneficial to treat several malignancies. TRIAL REGISTRATION: Cuban Public Registry of Clinical Trials RPCEC00000118 , May 24, 2011.

Crecimiento bacteriano en la úlcera del pie diabético previo al uso de Heberprot-P / Bacterial growth in diabetic foot ulcer prior to Heberprot-P

Objetivo: determinar el comportamiento del crecimiento microbiológico en las úlceras de pie diabético, previo al uso del Heberprot-P. Métodos: estudio descriptivo mediante la revisión de las historias clínicas de 52 pacientes, incluidos en los ensayos clínicos fase I y II del Heberprot-P en la úlcera de pie diabético. Se tomaron 63 muestras y se consideró el estudio microbiológico realizado en cualquier momento de su evolución, en el período de estudio.Resultados: cuatro muestras resultaron negativas y 29 positivas a Staphylococcus aureus meticillin resistente, que fue el germen más frecuentemente cultivado, por lo que un tercio de los pacientes requirió tratamiento antimicrobiano. Conclusiones: se recomienda realizar estudio microbiológico a todos los pacientes con úlcera de pie diabético, previo al uso de Heberprot-P aun cuando no existan evidencias clínicas de infección local.(AU)

Objective: to determine the microbiological growth behavior in diabetic foot ulcers, pre Heberprot-P. Methods: descriptive study was conducted by reviewing the medical records of 52 patients enrolled in Heberprot-P clinical trials phase I and II of diabetic foot ulcer. 63 samples were taken and microbiological study was considered at any point in its evolution in the study period. Results: four samples were negative and 29 positive to Staphylococcus aureus meticillin resistant, which was the most frequently cultivated germ, so that one third of the patients required antibiotic treatment. Conclusions: microbiological study is recommended to all patients with diabetic foot ulcer, prior to the use of Heberprot-P even when there is no clinical evidence of local infection(AU)

Crecimiento bacteriano en la úlcera del pie diabético previo al uso de Heberprot-P / Bacterial growth in diabetic foot ulcer prior to Heberprot-P

OBJETIVO: determinar el comportamiento del crecimiento microbiológico en las úlceras de pie diabético, previo al uso del Heberprot-P. MÉTODOS: estudio descriptivo mediante la revisión de las historias clínicas de 52 pacientes, incluidos en los ensayos clínicos fase I y II del Heberprot-P en la úlcera de pie diabético. Se tomaron 63 muestras y se consideró el estudio microbiológico realizado en cualquier momento de su evolución, en el período de estudio. RESULTADOS: cuatro muestras resultaron negativas y 29 positivas a Staphylococcus aureus meticillin resistente, que fue el germen más frecuentemente cultivado, por lo que un tercio de los pacientes requirió tratamiento antimicrobiano. CONCLUSIONES: se recomienda realizar estudio microbiológico a todos los pacientes con úlcera de pie diabético, previo al uso de Heberprot-P aun cuando no existan evidencias clínicas de infección local.

OBJECTIVE: to determine the microbiological growth behavior in diabetic foot ulcers, pre Heberprot-P. METHODS: descriptive study was conducted by reviewing the medical records of 52 patients enrolled in Heberprot-P clinical trials phase I and II of diabetic foot ulcer. 63 samples were taken and microbiological study was considered at any point in its evolution in the study period. RESULTS: four samples were negative and 29 positive to Staphylococcus aureus meticillin resistant, which was the most frequently cultivated germ, so that one third of the patients required antibiotic treatment. CONCLUSIONS: microbiological study is recommended to all patients with diabetic foot ulcer, prior to the use of Heberprot-P even when there is no clinical evidence of local infection.

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

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

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)

Intoxicaciones agudas en la adolescencia / Acute intoxications in the adolescente

Fundamento: Las intoxicaciones en la adolescencia constituyen una causa común de solicitud de atención médica de urgencia. Objetivo: Conocer el comportamiento clínico epidemiológico de las intoxicaciones agudas en la adolescencia. Método: Se realizó un estudio observacional descriptivo, transversal y retrospectivo en el Hospital Pediátrico Provincial Docente Eduardo Agramonte Piña de Camagüey durante el quinquenio 20012005. Para el procesamiento de la información se utilizó el paquete estadístico SP: SS 10,0 para Windows, se halló estadística descriptiva, distribución de frecuencias, por cientos, razón, media aritmética, desviación promedio y para el análisis estadístico de la asociación entre variables cualitativas se utilizó el chi cuadrado (x2) y coeficiente de correlación. Resultados: Las intoxicaciones voluntarias fueron más frecuentes con intencionalidad suicida en adolescentes femeninas, la asociación entre estas variables fue estadísticamente significativa con p <0.05, como agentes causales más frecuentes se encontraron los medicamentos, en alcohol etílico y otros productos químicos, en más del 90 % de los pacientes el evento tóxico ocurrió en el hogar, el agente penetró por vía digestiva y fueron formas leves sin complicaciones. Conclusiones: Es recomendable la aplicación de medidas estratégicas en la atención primaria y la comunidad encaminadas a lograr la prevención del intento suicida en esta etapa de la vida(AU)

Background: Intoxications in the adolescence constitute a common cause of request in the urgency medical care. Objective: To know the epidemiological clinical behavior of the acute intoxications in the adolescence. Method: An observational descriptive, cross-sectional and retrospective study was conducted at Eduardo Agramonte Piña Educational Provincial Pediatric Hospital of Camagüey during 20012005. For the information processing the statistical package SP: SS 10.0 for Windows was utilized, descriptive statistics was found, frequency distributions, percents, reason, arithmetic mean, average deviation and for the statistical analysis of the association among qualitative variables the chi- square (x2) and correlation coefficient's was utilized. Results: The voluntary intoxications were more frequent with suicidal purpose in female adolescents, the association among these variables was statistically significant with p <0.05, as more frequent causal agents were found the drugs, in ethyl alcohol and other chemical products, in more than the 90% of the patients the toxic event occurred at home, the agent penetrated for the digestive tract and were mild forms without complications. Conclusions: It is recommendable the application of strategic measures in the primary care and in the community directed to achieve the prevention of the suicidal intent in this stage of life(AU)

Caracterización clínica epidemiológica de las intoxicaciones agudas en pediatría / Epidemiological clinical characterization of the acute intoxications in pediatrics

Se realizó un estudio observacional descriptivo, transversal y retrospectivo en el Hospital Pediátrico Docente “Eduardo Agramonte Piña” de Camagüey, desde el 1ro de enero de 2001 al 31 de diciembre de 2005, con el objetivo de caracterizar el comportamiento clínico epidemiológico de las intoxicaciones agudas. Para el procesamiento de la información se utilizó el paquete estadístico SP: SS 10,0 para Windows, se halló en estadística descriptiva distribución de frecuencias, por cientos, razón, media aritmética, desviación promedio y para el análisis estadístico de la asociación entre variables cualitativas se utilizó el chi cuadrado (x2) y coeficiente de correlación. Se revisó un total de 576 historias clínicas que cumplían los criterios de inclusión y se estudiaron las siguientes variables: año, tipo de intoxicación, edad, sexo, agente causal, complicaciones y estadía. Predominaron las intoxicaciones accidentales en varones menores de cinco años sobre las voluntarias en féminas adolescentes, con una tendencia al incremento del número de casos en los dos últimos años para casi la totalidad de los grupos etéreos, los medicamentos fueron los agentes causales más involucrados en ambos tipos de intoxicaciones y en el 89.7 por ciento de los casos cursan sin complicaciones con una estadía promedio general de 3.3 días(AU)

An observacional descriptive, cross-sectional and retrospective study was carried out at Eduardo Agramonte Piña Pediatric Teaching Hospital of Camagüey from January 1st 2001 to December 31st 2005, with the objective to characterize the epidemiological clinical behavior of acute intoxications. For the information processing the statistical package SP: SS 10.0 for Windows was used, in descriptive statistics distribution of frequencies, per cents, reason, arithmetic mean, deviation average were found and for statistical analysis of the association among qualitative variables the chi-square (x2) and correlation coefficient´s was utilized. A total of 576 clinical recordings that met the inclusion criteria were reviewed and the following variables: year, type of intoxication, age, sex, causal agent, complications and stage were studied. Accidental intoxications in males less than 5 years over the voluntary in female adolescents predominated, with an upward trend of the case numbers in the last two years for almost the totality of ethereal groups, drugs were the most involved causal agents in both types of intoxications and in the 89.7 percent of the cases that progress without complications with a general average stage of 3.3 day(AU)

Caracterizacióncclínica epidemiológica de las intoxicaciones agudas en pediatría / Epidemiological clinical characterization of the acute intoxications in pediatrics

Se realizó un estudio observacional descriptivo, transversal y retrospectivo en el Hospital Pediátrico Docente Eduardo Agramonte Piña de Camagüey, desde el 1ro de enero de 2001 al 31 de diciembre de 2005, con el objetivo de caracterizar el comportamiento clínico epidemiológico de las intoxicaciones agudas. Para el procesamiento de la información se utilizó el paquete estadístico SP: SS 10,0 para Windows, se halló en estadística descriptiva distribución de frecuencias, por cientos, razón, media aritmética, desviación promedio y para el análisis estadístico de la asociación entre variables cualitativas se utilizó el chi cuadrado (x2) y coeficiente de correlación. Se revisó un total de 576 historias clínicas que cumplían los criterios de inclusión y se estudiaron las siguientes variables: año, tipo de intoxicación, edad, sexo, agente causal, complicaciones y estadía. Predominaron las intoxicaciones accidentales en varones menores de cinco años sobre las voluntarias en féminas adolescentes, con una tendencia al incremento del número de casos en los dos últimos años para casi la totalidad de los grupos etéreos, los medicamentos fueron los agentes causales más involucrados en ambos tipos de intoxicaciones y en el 89.7 % de los casos cursan sin complicaciones con una estadía promedio general de 3.3 días.

An observacional descriptive, cross-sectional and retrospective study was carried out at "Eduardo Agramonte Piña" Pediatric Teaching Hospital of Camagüey from January 1st 2001 to December 31st 2005, with the objective to characterize the epidemiological clinical behavior of acute intoxications. For the information processing the statistical package SP: SS 10.0 for Windows was used, in descriptive statistics distribution of frequencies, per cents, reason, arithmetic mean, deviation average were found and for statistical analysis of the association among qualitative variables the chi-square (x2) and correlation coefficient´s was utilized. A total of 576 clinical recordings that met the inclusion criteria were reviewed and the following variables: year, type of intoxication, age, sex, causal agent, complications and stage were studied. Accidental intoxications in males less than 5 years over the voluntary in female adolescents predominated, with an upward trend of the case numbers in the last two years for almost the totality of ethereal groups, drugs were the most involved causal agents in both types of intoxications and in the 89.7% of the cases that progress without complications with a general average stage of 3.3 days.