Guidelines for submitting adverse event reports for publication.

Publication of case reports describing suspected adverse effects of drugs and medical products that include herbal and complementary medicines, vaccines and other biologicals and devices is important for postmarketing surveillance. Publication lends credence to important signals raised in these adverse event reports. Unfortunately, deficiencies in vital information in published cases can often limit the value of such reports by failing to provide enough details for either (i) a differential diagnosis or provisional assessment of cause-effect association, or (ii) a reasonable pharmacological or biological explanation. Properly described, a published report of one or more adverse events can provide a useful signal of possible risks associated with the use of a drug or medical product which might warrant further exploration. A review conducted by the Task Force authors found that many major journals have minimal requirements for publishing adverse event reports and some have none at all. Based on a literature review and our collective experience in reviewing adverse event case reports in regulatory, academic and industry settings, we have identified information that we propose should always be considered for inclusion in a report submitted for publication. These guidelines have been endorsed by the International Society for Pharmacoepidemiology (ISPE) and the International Society of Pharmacovigilance (ISoP) and are freely available on the societies' web sites. Their widespread distribution is encouraged. ISPE and ISoP urge biomedical journals to adopt these guidelines and apply them to case reports submitted for publication. They also encourage schools of medicine, pharmacy, and nursing to incorporate them into the relevant curricula that address the detection, evaluation and reporting of suspected drug or other medical product adverse events.

Síndrome de Guillain barre asociado a infección por sars-cov-2: a propósito de un caso / Guillain-Barré Syndrome Associated with SARS-CoV-2 infection: A pediatric presentation

Introducción: la pandemia de SARS-CoV-2 exige una medicina fiable, basada en evidencia para poder comprender y tratar oportunamente las nuevas manifestaciones de esta enfermedad, previniendo así las complicaciones y la mortalidad infantil. Materiales y método: femenina de seis años ingresada en urgencias con síntomas neurológicos de entumecimiento en extremidades inferiores y superiores, ataxia, somnolencia y disartria. Después de un análisis de sangre, un examen del líquido cefalorraquídeo y una prueba de electromiografía, la paciente fue diagnosticada con síndrome de Guillain-Barré e infección concomitante por COVID-19. Resultados y discusión: se obtuvieron resultados positivos, tanto para el anticuerpo IgM como para la RT-PCR, para infección por SARS-CoV-2. No se encontró evidencia de celularidad en el examen del líquido cefalorraquídeo, pero se observó un alto nivel de proteína de 100 mg/dL y un nivel anormal de glucosa (58 mg/dL) en este paciente. Por último, se administró una terapia consistente en dexametasona 3,5 mg/kg, paracetamol 315 mg/kg, azitromicina 105 mg/kg y 50 mg/kg de inmunoglobulina intravenosa. Conclusión: considerando este caso clínico, reforzamos la hipótesis de la asociación entre el síndrome de Guillain-Barré y la infección por el virus SARS-CoV-2, como ya han documentado otros autores, tanto en adultos como en pacientes pediátricos.

Introduction: Ongoing SARS-CoV-2 pandemic calls for trustworthy, evidence-based medicine to be able to comprehend and treat opportunely new manifestations of this disease, therefore preventing complications and children mortality. Materials and methods: This case report adresses a unique presentation of Guillain-Barre syndrome (GBS) & COVID-19. Results: The patient was a 6-year-old girl admitted to the emergency room with neurological symptoms numbness in lower and upper extremities, ataxia, drowsiness, and dysarthria. After blood work, cerebrospinal fluid examination, and electromyography test, the patient was diagnosed with Guillain-Barre syndrome and concomitant COVID-19 infection. Both IgM antibody and RT-PCR were positive for SARS-coV-2 infection and no evidence of cellularity was found in cerebrospinal fluid examination, but a high protein level of 100 mg/dL and an abnormal glucose level (58mg/dL) was observed within this patient. Lastly, a therapy consisted of dexamethasone 3.5mg/kg, acetaminophen 315 mg/kg, azithromycin 105mg/kg and 50 mg/kg of intravenous immune globulin was administered. Conclusion: Considering this clinical case, we reinforce the hypothesis of the association between Guillain-Barré syndrome and SARS-CoV-2 virus infection, as has already been documented by other authors in both adults and pediatrics patients.

Guidelines for submitting adverse event reports for publication.

Publication of case reports describing suspected adverse effects of drugs and medical products that include herbal and complementary medicines, vaccines, and other biologicals and devices is important for postmarketing surveillance. Publication lends credence to important signals raised in these adverse event reports. Unfortunately, deficiencies in vital information in published cases can often limit the value of such reports by failing to provide enough details for either (i) a differential diagnosis or provisional assessment of cause-effect association, or (ii) a reasonable pharmacological or biological explanation. Properly described, a published report of one or more adverse events can provide a useful signal of possible risks associated with the use of a drug or medical product which might warrant further exploration. A review conducted by the Task Force authors found that many major journals have minimal requirements for publishing adverse event reports, and some have none at all. Based on a literature review and our collective experience in reviewing adverse event case reports in regulatory, academic, and industry settings, we have identified information that we propose should always be considered for inclusion in a report submitted for publication. These guidelines have been endorsed by the International Society for Pharmacoepidemiology (ISPE) and the International Society of Pharmacovigilance (ISoP) and are freely available on the societies' websites. Their widespread distribution is encouraged. ISPE and ISoP urge biomedical journals to adopt these guidelines and apply them to case reports submitted for publication. They also encourage schools of medicine, pharmacy, and nursing to incorporate them into the relevant curricula that address the detection, evaluation, and reporting of suspected drug or other medical product adverse events.

Relación de la gingivitis crónica con algunas afecciones del sistema osteomioarticular según holograma del microsistema de dientes alemán / Relationship of chronic gingivitis with some conditions of the osteomyoarticular system according to hologram of the German dental microsystem

Se realizó un estudio descriptivo y transversal de 77 pacientes de ambos sexos y edades entre 20-45 años con alguna afección del sistema osteomioarticular, atendidos en la consulta estomatológica de la parroquia Leoncio Martínez de Caracas, Venezuela, desde enero hasta Junio de 2009, a fin de relacionar la gingivitis crónica con algunas afecciones de este sistema según holograma del microsistema de dientes alemán. En la casuística, el meridiano más afectado fue pulmón-intestino grueso; predominaron las dolencias del sistema osteomioarticular en el lado izquierdo y la mayoría de campos de interferencia con la gingivitis crónica estuvieron en la parte derecha de la cavidad bucal. Asimismo, se hallaron alteraciones en la columna vertebral de los afectados con gingivitis leve, moderada y avanzada(AU)

A descriptive and cross-sectional study was conducted in 77 patients of both sexes and ages between 20-45 years with some condition of the osteomyoarticular system, attended in the dental department of the parish Leoncio Martínez from Caracas, Venezuela, from January to June 2009, in order to relate chronic gingivitis to some conditions of this system according to hologram of the German dental microsystem. In the case material the most affected meridian was lung-large intestine; osteomyoarticular system conditions prevailed on the left and most of the interference fields with chronic gingivitis were on the right side of the oral cavity. Also, abnormalities in the spine of those patients with mild, moderate and severe gingivitis were found(AU)

Relación de la gingivitis crónica con algunas afecciones del sistema osteomioarticular según holograma del microsistema de dientes alemán / Relationship of chronic gingivitis with some conditions of the osteomyoarticular system according to hologram of the German dental microsystem

Se realizó un estudio descriptivo y transversal de 77 pacientes de ambos sexos y edades entre 20-45 años con alguna afección del sistema osteomioarticular, atendidos en la consulta estomatológica de la parroquia Leoncio Martínez de Caracas, Venezuela, desde enero hasta Junio de 2009, a fin de relacionar la gingivitis crónica con algunas afecciones de este sistema según holograma del microsistema de dientes alemán. En la casuística, el meridiano más afectado fue pulmón-intestino grueso; predominaron las dolencias del sistema osteomioarticular en el lado izquierdo y la mayoría de campos de interferencia con la gingivitis crónica estuvieron en la parte derecha de la cavidad bucal. Asimismo, se hallaron alteraciones en la columna vertebral de los afectados con gingivitis leve, moderada y avanzada

A descriptive and cross-sectional study was conducted in 77 patients of both sexes and ages between 20-45 years with some condition of the osteomyoarticular system, attended in the dental department of the parish Leoncio Martínez from Caracas, Venezuela, from January to June 2009, in order to relate chronic gingivitis to some conditions of this system according to hologram of the German dental microsystem. In the case material the most affected meridian was lung-large intestine; osteomyoarticular system conditions prevailed on the left and most of the interference fields with chronic gingivitis were on the right side of the oral cavity. Also, abnormalities in the spine of those patients with mild, moderate and severe gingivitis were found

Programa Educativo Sonríe al futuro para adolescentes / Educational Program Smile to the future for teenagers

Se realizó una intervención educativa, denominada Sonríe al futuro, para modificar conocimientos sobre salud bucal y lograr hábitos conductuales favorables con respecto a la higiene bucal en adolescentes de 15 a 18 años del Preuniversitario Rafael María de Mendive de Santiago de Cuba. El universo estuvo conformado por 125 educandos de décimo grado del mencionado centro escolar y la muestra seleccionada fue de 60 alumnos distribuidos en 4 grupos con 15 integrantes cada uno, a los cuales se les aplicaron 2 cuestionarios sobre los temas que trató la intervención, antes y después de la información brindada. La actividad contó con un instructivo capacitante basado en actividades educativas y técnicas participativas que garantizaron la participación activa de los estudiantes en la adquisición de los conocimientos. Además, permitió conocer los cambios producidos como consecuencia de las labores educativas realizadas(AU)

An educational intervention Smile to the future was conducted to modify the knowledge of oral health and to achieve positive behavioral habits regarding oral hygiene in teenagers between 15 and 18 years of age from Rafael María de Mendive Senior High School in Santiago de Cuba. The universe was formed by 125 tenth grade students from that school and the sample of 60 students selected was divided into 4 groups with 15 members each, to whom two questionnaires were applied on topics discussed in this intervention before and after the information provided. The instruction was based on educational activities and participatory techniques that ensured the active participation of students in acquiring the knowledge. Moreover, it allowed to know the changes occurring as consequence of the educational works carried out(AU)

Guidelines for submitting adverse event reports for publication.

Publication of case reports describing suspected adverse effects of drugs and medical products that include herbal and complementary medicines, vaccines, and other biologicals and devices is important for postmarketing surveillance. Publication lends credence to important signals raised in these adverse event reports. Unfortunately, deficiencies in vital information in published cases can often limit the value of such reports by failing to provide sufficient details for either (i) a differential diagnosis or provisional assessment of cause-effect association, or (ii) a reasonable pharmacological or biological explanation. Properly described, a published report of one or more adverse events can provide a useful signal of possible risks associated with the use of a drug or medical product which might warrant further exploration. A review conducted by the Task Force authors found that many major journals have minimal requirements for publishing adverse event reports, and some have none at all. Based on a literature review and our collective experience in reviewing adverse event case reports in regulatory, academic, and industry settings, we have identified information that we propose should always be considered for inclusion in a report submitted for publication. These guidelines have been endorsed by the International Society for Pharmacoepidemiology (ISPE) and the International Society of Pharmacovigilance (ISoP) and are freely available on the societies' web sites. Their widespread distribution is encouraged. ISPE and ISoP urge biomedical journals to adopt these guidelines and apply them to case reports submitted for publication. They also encourage schools of medicine, pharmacy, and nursing to incorporate them into the relevant curricula that address the detection, evaluation, and reporting of suspected drug or other medical product adverse events.

Efecto de la Euphrasia como medicamento homeopático en las conjuntivitis / Effect of Euphrasia as a homeopathic drug in conjunctivitis

Se realizó un estudio prospectivo y transversal en el policlínico "Tomás Romay" de Artemisa en los 2 primeros meses del año 2002, para evaluar los resultados del tratamiento homeopático con Euphrasia en las conjuntivitis. Se utilizó un placebo para comparar estos resultados. En la muestra seleccionada se encontró mayor predominio del sexo femenino y las edades comprendidas entre 19 y 34 años. Los síntomas más frecuentemente detectados fueron el ojo rojo con un 98,5 por ciento y la cefalea con un 29,8 por ciento. Se apreció una adecuada concordancia entre diagnóstico presuntivo y estudio citológico ocular. El tratamiento con Euphrasia tuvo buenos resultados en el 82,8 por ciento de los casos, en contraste con el grupo control donde se utilizó el placebo y donde sólo mejoraron el 31,2 por ciento de los enfermos. En este estudio la exposición a la luz, bien fuera natural o artificial, agravó la sintomatología de la conjuntivitis(AU)

Efecto de la Euphrasia como medicamento homeopático en las conjuntivitis / Effect of Euphrasia as a homeopathic drug in conjunctivitis

Se realizó un estudio prospectivo y transversal en el policlínico "Tomás Romay" de Artemisa en los 2 primeros meses del año 2002, para evaluar los resultados del tratamiento homeopático con Euphrasia en las conjuntivitis. Se utilizó un placebo para comparar estos resultados. En la muestra seleccionada se encontró mayor predominio del sexo femenino y las edades comprendidas entre 19 y 34 años. Los síntomas más frecuentemente detectados fueron el ojo rojo con un 98,5 por ciento y la cefalea con un 29,8 por ciento. Se apreció una adecuada concordancia entre diagnóstico presuntivo y estudio citológico ocular. El tratamiento con Euphrasia tuvo buenos resultados en el 82,8 por ciento de los casos, en contraste con el grupo control donde se utilizó el placebo y donde sólo mejoraron el 31,2 por ciento de los enfermos. En este estudio la exposición a la luz, bien fuera natural o artificial, agravó la sintomatología de la conjuntivitis