RESUMO
Objective: This study tested the hypothesis that a neuroprotective combined therapy based on epidermal growth factor (EGF) and growth hormone-releasing hexapeptide (GHRP6) could be safe for acute ischemic stroke patients, admitting up to 30% of serious adverse events (SAE) with proven causality. Methods: A multi-centric, randomized, open-label, controlled, phase I-II clinical trial with parallel groups was conducted (July 2017 to January 2018). Patients aged 18-80 years with a computed tomography-confirmed ischemic stroke and less than 12 h from the onset of symptoms were randomly assigned to the study groups I (75 µg rEGF + 3.5 mg GHRP6 i.v., n=10), II (75 µg rEGF + 5 mg GHRP6 i.v., n=10), or III (standard care control, n=16). Combined therapy was given BID for 7 days. The primary endpoint was safety over 6 months. Secondary endpoints included neurological (NIHSS) and functional [Barthel index and modified Rankin scale (mRS)] outcomes. Results: The study population had a mean age of 66 ± 11 years, with 21 men (58.3%), a baseline median NIHSS score of 9 (95% CI: 8-11), and a mean time to treatment of 7.3 ± 2.8 h. Analyses were conducted on an intention-to-treat basis. SAEs were reported in 9 of 16 (56.2%) patients in the control group, 3 of 10 (30%) patients in Group I (odds ratio (OR): 0.33; 95% CI: 0.06-1.78), and 2 of 10 (20%) patients in Group II (OR: 0.19; 95% CI: 0.03-1.22); only two events in one patient in Group I were attributed to the intervention treatment. Compliance with the study hypothesis was greater than 0.90 in each group. Patients treated with EGF + GHRP6 had a favorable neurological and functional evolution at both 90 and 180 days, as evidenced by the inferential analysis of NIHSS, Barthel, and mRS and by their moderate to strong effect size. At 6 months, proportion analysis evidenced a higher survival rate for patients treated with the combined therapy. Ancillary analysis including merged treated groups and utility-weighted mRS also showed a benefit of this combined therapy. Conclusion: EGF + GHRP6 therapy was safe. The functional benefits of treatment in this study supported a Phase III study. Clinical Trial Registration: RPCEC00000214 of the Cuban Public Registry of Clinical Trials, Unique identifier: IG/CIGB-845I/IC/1601.
RESUMO
Se realizó un estudio descriptivo, transversal, retrospectivo con el objetivo de evaluar el comportamiento de la ingestión de bebidas alcohólicas en los adolescentes pertenecientes al consultorio 29 del Policlínico universitario Joaquín de Agüero, en el período comprendido de enero junio de 2012. Del universo de estudio se seleccionó un total de 85 adolescentes al azar, divididos en tres grupos etáreos que se corresponden con las tres etapas de la adolescencia: (10 13; 14 16; 17 19) para la selección de la misma se utilizó una encuesta y se tuvo en cuenta los criterios de inclusión y exclusión. El grupo de edad predominante fue el de 17 19 años, en ambos sexos, la cerveza fue la bebida más consumida. La motivación más frecuente fue la diversión, en tiempo libre y compartir con sus compañeros, las familias extensas y moderadamente funcionales según el funcionamiento familiar fueron las más frecuentes (AU)
A retrospective, cross section, descriptive study was carried out with the objective of evaluating the behavior of the ingestion of alcohol consumption in adolescents from the medical clinic 29 of Joaquin Agüero Polyclinic from January to June 2012. From the study universe a total of 85 adolescents was randomly selected, divided in three groups, that goes together with the three adolescence stages: (10- 13; 14- 16; 17- 19) for its selection a survey was used keeping in mind the inclusion and exclusion criteria. The predominant age was 17- 19 years, in both sexes, where the beer was the most drink. The most frequent motivation was the enjoyment, and to share with their friends. The extensive families and moderately functional according to the familiar functioning were the most frequent (AU)
