Manifest anxiety and quality of life in schoolchildren with ADHD during confinement due to the COVID-19 pandemic.

The pandemic generated by COVID-19 forced the governments of all countries to enter into quarantine, modifying the daily coexistence among family members.

Ansiedad manifiesta y calidad de vida en escolares con TDAH durante el confinamiento por la pandemia del COVID-19 / Manifest anxiety and quality of life in schoolchildren with adhd during covid-19 pandemic confinement

La pandemia generada por COVID-19 obligó a los gobiernos de todos los países entrar en cuarentena, modificando la convivencia diaria entre los miembros de la familia. Objetivo. Evaluar la Ansiedad manifiesta y la Calidad de vida en escolares con TDAH durante el confinamiento por la pandemia del COVID-19.Método. Estudio transversal comparativo, observacional, no experimental de 105 escolares con TDAH y 80 formado por el Grupo Control evaluados con la Escala de Ansiedad manifiesta en niños Revisada (CMAS-R). Y la calidad de vida con el cuestionario (AUQUEI).Los escolares fueron diagnosticados con TDAH en el Laboratorio de Neurociencias del Instituto Nacional de Rehabilitación, y tratados con terapia Cognitivo Conductual (TCC)para control de sus síntomas conductuales, antes de la Pandemia y fueron invitados a través del consentimiento informado de sus padres a participar en esta investigación. Resultados. El cuestionario CMAS-R mostró diferencias significativas en sus cinco dimensiones entre los grupos con diferente subtipo de TDAH y el grupo control. Y el cuestionario AUQUEI mostró diferencias en 4 de sus 5 dimensiones entre escolares con y grupo control 3 de 5 factores entre los subtipos combinado e hiperactivo impulsivo y grupo control y entre el subtipo combinado y el hiperactivo Impulsivo. Hubo correlaciones entre: Ocio, Ansiedad Fisiológica, Calidad de vida total e Inquietud/Hipersensibilidad; así como entre Separación, Rendimientos y Ansiedad total en el subtipo TDAH-Combinado y Grupo Control. Conclusiones. Se observó aumento en los indicadores de ansiedad y disminución en su calidad de vida, en los escolares con TDAH. (AU)

The pandemic generated by COVID-19 forced the governments of all countries to enter into quarantine,modifying the daily coexistence among family members. Objective: To evaluate manifest anxiety and quality oflife in school children with ADHD during confinement due tothe COVID-19 pandemic. Methods. Comparative, observational, non-experimental cross-sectional study of 105 schoolchildren with ADHD and80 in the Control Group evaluated with the “Manifest Anxiety in Children Scale-Revised (CMAS-R)”. And the quality oflife with the questionnaire (AUQUEI).The school children were diagnosed with ADHD in the Neurosciences Laboratory of the National Rehabilitation Institute, and treated with Cognitive Behavioral Therapy (CBT)to control their behavioral symptoms, before the Pandemicand were invited through the informed consent of their parents to participate in this research. Results. The CMAS-R questionnaire showed significant differences in its five dimensions between the groups withdifferent ADHD subtypes and the control group. And the AUQUEI questionnaire showed differences in 4 of its 5 dimensions between school children with and control group 3of 5 factors between the combined and hyperactive impulsive subtypes and control group and between the combined subtype and the hyperactive impulsive subtype. There were correlations between: Leisure, Physiological Anxiety, Total Quality of Life and Restlessness/Hypersensitivity; as well as between Separation, Achievement and TotalAnxiety in the ADHD-Combined subtype and Control Group. Conclusions. An increase in anxiety indicators and a decrease in their quality of life were observed in schoolchildren with ADHD. (AU)

Bioavailability of two oral-tablet and two oral-suspension formulations of naproxen sodium/paracetamol (acetaminophen): single-dose, randomized, open-label, two-period crossover comparisons in healthy Mexican adult subjects.

BACKGROUND: Naproxen sodium/paracetamol (acetaminophen) is a combination for the treatment of symptomatic pain and fever marketed both as a prescription and an over-the-counter product in Mexico. OBJECTIVE: The aim of these 2 studies was to compare the bioavailability and to determine the bioequivalence of 2 test formulations (an oral-tablet formulation containing the combination of naproxen sodium/paracetamol 275/300 mg and an oral-suspension formulation containing the combination of naproxen sodium/paracetamol 375/300 mg per 15 mL) with their corresponding listed reference-drug formulations in Mexico (a list issued by Mexican health authorities). METHODS: Two separate, single-dose, randomized, open-label, 2-period crossover, postmarketing studies were conducted. For each study, a different set of eligible subjects was selected comprising healthy Mexican adults of either sex, and subjects were randomly assigned to receive 1 test formulation of the combination of naproxen sodium/paracetamol followed by the corresponding reference-drug formulation, or vice versa, with a 1-week washout period between doses. After a 12-hour overnight fast, subjects received a single dose of naproxen sodium/paracetamol 275/300-mg tablet or naproxen sodium/paracetamol 375/300 mg per 15 mL suspension, depending on the study. For the analysis of pharmacokinetic parameters, including C(max), AUC from time 0 (baseline) to 48 hours (AUC(0-48)), and AUC from baseline to infinity (AUC(0-infinity)), blood samples were drawn at baseline and at 0.16, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours after administration. The formulations were considered bioequivalent if the geometric mean ratios (test/reference) of the C(max) and AUC were within the predetermined range of 80% to 125%. Tolerability was determined by clinical assessment, monitoring vital signs, laboratory analysis results, and subject interviews regarding adverse events. RESULTS: A total of 26 subjects (15 men, 11 women; mean [SD] age, 29 [8] years [range, 20-50 years]; weight, 63.1 [9] kg [range, 51.4-84.4 kg]; height, 164 [9] cm [range, 149-179 cm]; and body mass index [BMI], 23.53 [2.18] kg/m(2) [range, 18.54-26.82 kg/m(2)]) were enrolled to receive the suspension-dosage formulation; 13 subjects received the suspension-test formulation first. A total of 26 subjects (13 men, 13 women; mean [SD] age, 29 [8] years [range, 18-43 years]; weight, 64.3 [7.7] kg [range, 50.6-80.7 kg]; height, 165 [9] cm [range, 151-181 cm]; and BMI, 23.64 [2.43] kg/m(2) [range, 18.02-26.42 kg/m(2)]) were enrolled to receive the tablet-dosage formulation; 13 subjects received the tablet-test formulation first. No significant period or sequence effects were detected based on analysis of variance. For the suspension-dosage formulation, the 90% CIs for naproxen C(max), AUC(0-48), and AUC(0-infinity) were 93.06% to 104.00%, 93.50% to 98.44%, and 92.14% to 98.99%, respectively, and were 90.09% to 105.90%, 88.58% to 99.34%, and 91.43% to 101.55%, respectively, for paracetamol. For the tablet-dosage formulation, the 90% CIs for naproxen C(max), AUC(0-48), and AUC(0-infinity) were 102.83% to 117.15%, 96.59% to 104.26%, and 96.01% to 102.90%, respectively, and were 94.04% to 121.09%, 95.48% to 105.64%, and 96.64% to 105.42%, respectively, for paracetamol. CONCLUSIONS: In these 2 small studies in healthy Mexican adult subjects, a single dose of naproxen sodium/paracetamol 275/300 mg of the test formulation of the tablet-dosage formulation or a single dose of naproxen sodium/paracetamol 375/300 mg per 15 mL of the test formulation of the suspension-dosage formulation was found to be bioequivalent to the corresponding reference formulations according to the regulatory definition of bioequivalence based on the rate and extent of absorption. All formulations were generally well tolerated.