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1.
Article in English | MEDLINE | ID: mdl-39081241

ABSTRACT

Multimodal analgesia is defined as using several drugs or techniques simultaneously to target different pain pathways or receptors to avoid pain propagation. This study evaluated the pharmacokinetic profile and comparative bioavailability of etoricoxib 90 mg and tramadol 50 mg dosing alone (reference drugs) or in a novel fixed-dose combination (test drug) under fasting conditions in Mexican healthy volunteers. This was a randomized, open-label, 3-way, crossover, single-dose, prospective, and longitudinal study with a 14-day washout period. Eligible subjects were healthy Mexican adult volunteers. The drugs were dosing orally, according to the randomization sequence, after 10 hours of fasting and 4 hours before breakfast with 250 mL of water at room temperature. Serial blood samples were collected before and after dosing, both drugs were quantified using high-performance liquid chromatography coupled with tandem mass spectrometry. Forty-two subjects were enrolled and 38 completed the study (28 men and 14 women, mean age 25.2 years, mean weight 66.6 kg). Test products were considered to have comparative bioavailability if confidence intervals of natural log-transformed for (maximum plasma drug concentration (Cmax), (area under the plasma drug concentration-time curve form 0 up to last sampling time (AUC0-t), and (area under the plasma drug concentration-time curve from 0 up to infinity (AUC0-∞) data were within the range of 80%-125%. Non-serious adverse events were observed. The results demonstrate that the pharmacokinetic profile and bioavailability of the etoricoxib/tramadol fixed-dose combination are comparable to those of the reference products.

2.
Nutrients ; 16(13)2024 Jul 05.
Article in English | MEDLINE | ID: mdl-38999894

ABSTRACT

Pre-pregnancy body mass index (pBMI) is a predictor of gestational weight gain (GWG). However, other factors, such as adipokines and inflammation markers, may also be associated with GWG. The aim of the study was to determine the association of leptin, adiponectin, irisin, and C-reactive protein, with GWG in adolescents. A longitudinal study was conducted from 2018 to 2023 in adolescents with a clinically healthy pregnancy. The assessments included sociodemographic and clinical data, pBMI, percent of body fat, serum concentrations of leptin, adiponectin, irisin, and high-sensitivity C-reactive protein (hsCRP), and total GWG adequacy. Cox regression models were performed, the outcome variables were inadequate and excessive GWG. In 198 participants, being overweight/obesity was marginally associated with a protective effect against inadequate GWG (HR = 0.44, 95%CI = 0.18-1.06), regardless of maternal characteristics and adipokines. Leptin (HR = 1.014, 95%CI = 1.008-1.021), and body fat percent (HR = 1.11, 95%CI = 1.05-1.17) were associated with a higher risk of excessive GWG, independent of other maternal variables such as pBMI, while adiponectin was associated with a lower risk. These findings suggest that, in Mexican adolescents, adipose tissue and its adipokines during pregnancy may play a more significant role in the final GWG than body weight.


Subject(s)
Adipokines , Adipose Tissue , Body Mass Index , Gestational Weight Gain , Leptin , Humans , Female , Pregnancy , Leptin/blood , Adolescent , Mexico/epidemiology , Adipokines/blood , Longitudinal Studies , Adiponectin/blood , Biomarkers/blood , C-Reactive Protein/analysis , C-Reactive Protein/metabolism
3.
Article in English | MEDLINE | ID: mdl-39037059

ABSTRACT

Patients with diabetes face a 2-4-fold greater cardiovascular risk compared to those without diabetes. Both metformin and acetylsalicylic acid (aspirin) treatment have demonstrated a significant reduction in this risk. This single-center, open-label, sequence randomized, 2 × 2 crossover, single-dose clinical trial evaluated the pharmacokinetics profile and comparative bioavailability of a novel oral fixed-dose combination (FDC) of metformin/acetylsalicylic acid (500/100 mg tablet) versus the reference mono-drugs administered concomitantly, metformin 500 mg tablet and acetylsalicylic acid 100 mg tablet, in 22 healthy Mexican adult volunteers under fasting conditions. Blood samples were collected predose and at specified intervals across a 24-hour period following administration and were analyzed for metformin and salicylic acid using high-performance liquid chromatography coupled with tandem mass spectrometry. Test products were considered to have comparative bioavailability if confidence intervals of natural log-transformed (maximum plasma drug concentration (Cmax), (area under the plasma drug concentration-time curve form 0 up to last sampling time (AUC0 -t), and (area under the plasma drug concentration-time cruve from 0 up to infinity (AUC0 ∞) data were within the range of 80%-125%. The results obtained from the present clinical study demonstrate the comparative bioavailability of the FDC when compared with the coadministration of reference mono-drugs. There were no adverse events or adverse reactions reported throughout the study.

4.
Clin Drug Investig ; 44(6): 413-424, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38842764

ABSTRACT

BACKGROUND: Musculoskeletal disorders are an important cause of work absence. Clinical practice guidelines recommend nonsteroidal anti-inflammatory drugs (NSAIDs) for grade I-II cervical sprains. The combination of thiamine + pyridoxine + cyanocobalamin vitamins has been used, alone and in combination with NSAIDs, for pain and inflammation in musculoskeletal disorders. OBJECTIVE: The objective of this study was to demonstrate the analgesic synergy of dexketoprofen, and the combination of vitamins thiamine + pyridoxine + cyanocobalamin in a fixed-dose combination (FDC) for the treatment of acute pain caused by grade I-II cervical sprains. METHODS: We conducted a multicentre, prospective, randomized, double-blind, phase IIIb clinical study comparing two treatment groups: (1) dexketoprofen 25 mg/vitamin B (thiamine 100 mg, pyridoxine 50 mg and cyanocobalamin 0.50 mg) in an FDC (two or more active ingredients combined in a single dosage form) versus (2) dexketoprofen 25 mg monotherapy (single drug to treat a particular disease), one capsule or tablet orally, every 8 h for 7 days. Final mean, average change, and percentage change in pain perception (measured using a visual analogue scale [VAS]) were compared with baseline between groups. A p value < 0.05 was considered statistically significant. Analyses were conducted using SPSS software, v.29.0. RESULTS: A statistically significant reduction in pain intensity was observed from the third day of treatment with the FDC compared with monotherapy (- 3.1 ± - 1.5 and - 2.6 ± - 1.1 cm, respectively) measured using the VAS (p = 0.011). Regarding the degree of disability, using the Northwick Park Neck Pain Questionnaire (NPQ), statistical difference was observed for the final measurement (7.5%, interquartile range [IQR] 2.5, 10.5; vs. 7.9%, IQR 5.0, 13.8; p = 0.028). A lower proportion of adverse events was reported when using the FDC. CONCLUSIONS: The FDC of dexketoprofen/thiamine + pyridoxine + cyanocobalamin vitamins demonstrated superior efficacy and a better safety profile compared with dexketoprofen monotherapy for pain treatment in patients with grade I-II cervical sprains. CLINICAL TRIALS REGISTRATION: NCT05001555, registered 29 July 2021 ( https://clinicaltrials.gov/study/NCT05001555 ).


Subject(s)
Anti-Inflammatory Agents, Non-Steroidal , Drug Combinations , Ketoprofen , Pyridoxine , Thiamine , Tromethamine , Vitamin B 12 , Humans , Double-Blind Method , Thiamine/administration & dosage , Thiamine/analogs & derivatives , Thiamine/therapeutic use , Ketoprofen/administration & dosage , Ketoprofen/analogs & derivatives , Female , Adult , Pyridoxine/administration & dosage , Pyridoxine/therapeutic use , Male , Anti-Inflammatory Agents, Non-Steroidal/administration & dosage , Vitamin B 12/analogs & derivatives , Vitamin B 12/administration & dosage , Vitamin B 12/therapeutic use , Middle Aged , Tromethamine/administration & dosage , Prospective Studies , Vitamin B Complex/administration & dosage , Vitamin B Complex/therapeutic use , Pain Measurement/methods , Young Adult
5.
Gac Med Mex ; 160(1): 9-16, 2024.
Article in English | MEDLINE | ID: mdl-38753557

ABSTRACT

BACKGROUND: On December 31, 2019, one of the most serious pandemics in recent times made its appearance. Certain health conditions, such as obesity and diabetes mellitus, have been described to be related to COVID-19 unfavorable outcomes. OBJECTIVE: To identify factors associated with mortality in patients with COVID-19. MATERIAL AND METHODS: Retrospective cohort of 998,639 patients. Patient sociodemographic and clinical characteristics were analyzed, with survivors being compared with the deceased individuals. Cox proportional hazards model was used to identify variables predictive of COVID-19-associated mortality. RESULTS: Among the deceased patients, men accounted for 64.3%, and women, for 35.7%, with the difference being statistically significant. Subjects older than 80 years had a 13-fold higher risk of dying from COVID-19 (95% CI = 12,469, 13,586), while chronic kidney disease entailed a risk 1.5 times higher (95% CI = 1,341, 1,798), and diabetes mellitus involved a risk 1.25 times higher (95% CI = 1.238,1.276). CONCLUSIONS: Age, sex, diabetes mellitus and obesity were found to be predictors of COVID-19 mortality. Further research related to chronic obstructive pulmonary disease, cardiovascular diseases, smoking and pregnancy is suggested.


ANTECEDENTES: El 31 de diciembre de 2019, se inició una de las pandemias más graves de los últimos tiempos. Se ha descrito que ciertas condiciones de salud, como la obesidad y la diabetes mellitus, están relacionadas con desenlaces desfavorables por COVID-19. OBJETIVO: Identificar factores asociados a mortalidad en pacientes con COVID-19. MATERIAL Y MÉTODOS: Cohorte retrospectiva de 998 639 pacientes. Se analizaron las características sociodemográficas y clínicas de los pacientes, y se compararon supervivientes con fallecidos. Se utilizó el modelo de riesgos proporcionales de Cox para la identificación de variables predictivas de defunción por COVID-19. RESULTADOS: Entre los fallecidos, los hombres representaron 64.3 % y las mujeres 35.7 %, diferencia que resultó estadísticamente significativa. Las personas con más de 80 años presentaron un riesgo 13 veces mayor de morir por COVID-19 (IC 95 % = 12.469,13.586) y la enfermedad renal crónica, un riesgo de 1.5 (IC 95 % = 1.341, 1.798); la diabetes mellitus tuvo un riesgo de 1.25 (IC 95 % = 1.238,1.276). CONCLUSIONES: La edad, el sexo, la diabetes mellitus y la obesidad resultaron ser entidades predictivas de muerte por COVID-19. Se sugiere más investigación relacionada con enfermedad pulmonar obstructiva crónica, enfermedades cardiovasculares, tabaquismo y embarazo.


Subject(s)
COVID-19 , Diabetes Mellitus , Obesity , Humans , COVID-19/mortality , COVID-19/epidemiology , Mexico/epidemiology , Female , Male , Retrospective Studies , Risk Factors , Aged , Middle Aged , Aged, 80 and over , Adult , Obesity/mortality , Obesity/epidemiology , Obesity/complications , Diabetes Mellitus/epidemiology , Diabetes Mellitus/mortality , Age Factors , Sex Factors , Young Adult , Proportional Hazards Models , Adolescent , Cohort Studies , Renal Insufficiency, Chronic/mortality , Renal Insufficiency, Chronic/epidemiology
6.
Gac. méd. Méx ; Gac. méd. Méx;160(1): 10-18, ene.-feb. 2024. tab, graf
Article in Spanish | LILACS-Express | LILACS | ID: biblio-1557798

ABSTRACT

Resumen Antecedentes: El 31 de diciembre de 2019, se inició una de las pandemias más graves de los últimos tiempos. Se ha descrito que ciertas condiciones de salud, como la obesidad y la diabetes mellitus, están relacionadas con desenlaces desfavorables por COVID-19. Objetivo: Identificar factores asociados a mortalidad en pacientes con COVID-19. Material y métodos: Cohorte retrospectiva de 998 639 pacientes. Se analizaron las características sociodemográficas y clínicas de los pacientes, y se compararon supervivientes con fallecidos. Se utilizó el modelo de riesgos proporcionales de Cox para la identificación de variables predictivas de defunción por COVID-19. Resultados: Entre los fallecidos, los hombres representaron 64.3 % y las mujeres 35.7 %, diferencia que resultó estadísticamente significativa. Las personas con más de 80 años presentaron un riesgo 13 veces mayor de morir por COVID-19 (IC 95 % = 12.469,13.586) y la enfermedad renal crónica, un riesgo de 1.5 (IC 95 % = 1.341, 1.798); la diabetes mellitus tuvo un riesgo de 1.25 (IC 95 % = 1.238,1.276). Conclusiones: La edad, el sexo, la diabetes mellitus y la obesidad resultaron ser entidades predictivas de muerte por COVID-19. Se sugiere más investigación relacionada con enfermedad pulmonar obstructiva crónica, enfermedades cardiovasculares, tabaquismo y embarazo.


Abstract Background: On December 31, 2019, one of the most serious pandemics in recent times made its appearance. Certain health conditions, such as obesity and diabetes mellitus, have been described to be related to COVID-19 unfavorable outcomes. Objective: To identify factors associated with mortality in patients with COVID-19. Material and methods: Retrospective cohort of 998,639 patients. Patient sociodemographic and clinical characteristics were analyzed, with survivors being compared with the deceased individuals. Cox proportional hazards model was used to identify variables predictive of COVID-19-associated mortality. Results: Among the deceased patients, men accounted for 64.3%, and women, for 35.7%, with the difference being statistically significant. Subjects older than 80 years had a 13-fold higher risk of dying from COVID-19 (95% CI = 12,469, 13,586), while chronic kidney disease entailed a risk 1.5 times higher (95% CI = 1,341, 1,798), and diabetes mellitus involved a risk 1.25 times higher (95% CI = 1.238,1.276). Conclusions: Age, sex, diabetes mellitus and obesity were found to be predictors of COVID-19 mortality. Further research related to chronic obstructive pulmonary disease, cardiovascular diseases, smoking and pregnancy is suggested.

7.
Healthcare (Basel) ; 10(12)2022 Nov 30.
Article in English | MEDLINE | ID: mdl-36553935

ABSTRACT

The prevalence of undernutrition in Mexican children younger than 5 years old has been 14% since 2006. There are clinical practice guidelines for mild to moderate malnutrition in children in the Mexican health system; however, they are not applied. In addition, the knowledge and practices of health professionals (HP) to treat malnutrition in health centers are insufficient to perform adequate assessments and correct treatments. An impact evaluation of an interdisciplinary educational intervention was carried out on 78 HPs for the treatment of children with mild to moderate malnutrition of low resources, with 39 in the intervention group and 37 in the counterfactual group, estimated as the comparison group. A Food and Agriculture Organization (FAO)-validated questionnaire adapted to child malnutrition about knowledge, attitudes, and practices was applied before, after, and 2 months after a malnutrition workshop. The difference-in-differences analysis showed that the educational intervention group had a significant improvement in knowledge, attitudes, and practices before and after the intervention (grades of 54.6 to 79.2 respectively, p = 0.0001), compared with the comparison group (grades of 79.2 and 53.4, respectively, p = 0.0001), which was maintained over two months (grades of 71.8 versus 49.8, p = 0.0001, respectively). The multivariate analysis showed that the probability of improvement in learning by 30% was 95-fold higher in the educational intervention group versus the comparison group, OR = 95.1 (95% CI 14.9-603.0), and this factor was independent of sex, age, education, or hospital position. Despite the availability of clinical practice guidelines for the assessment and treatment for child malnutrition, education in malnutrition for HPs is effective and needed to achieve a significant improvement in children's health.

8.
Cardiol Res Pract ; 2022: 9464733, 2022.
Article in English | MEDLINE | ID: mdl-36124294

ABSTRACT

Introduction: Cardiovascular diseases are the leading cause of death worldwide. The combination of statins and cholesterol-absorption inhibitors promotes the decrease in risk factors, such as high concentrations of LDL (low-density lipoproteins). The aim of the study was to evaluate changes in the lipid profile and the effect on therapeutic goals, as well as the safety of dyslipidemia patients treated with Rosuvastatin/Ezetimibe (Trezete®). Materials and Methods: A real-world evidence study was conducted with retrospective data collection through a review of clinical records from dyslipidemia patients treated with Trezete® in routine medical practice. Clinical records included results of biochemical markers before treatment and at least one follow up between weeks 8 and 16. Results: The study included 103 patients' clinical records (55.4% men) with a mean age of 56.0 ± 13.0 years. More than 57% of the patients had mixed dyslipidemia and a median disease progression of 3.1 (IQR, 1.5; 9.1) years. Regarding LDL concentrations, 72.8% of the patients achieved therapeutic goals according to cardiovascular risk (CVR), which was statistically significant. Similarly, 94.1% achieved goals for total cholesterol (<200 mg/dL) and 56.0% for triglycerides (<150 mg/dL), a p value <0.001. No cardiovascular events were observed. Conclusion: Trezete® shows an important clinical impact on CVR-related target markers during the treatment of dyslipidemia patients. It is relevant to mention that a significant percentage of patients achieved therapeutic goals during the first months of treatment. Fixed-dose combination therapy has shown to be as safe as monotherapy treatment. ClinicalTrials.gov Identifier: NCT04862962.

9.
Ther Adv Infect Dis ; 9: 20499361211069264, 2022.
Article in English | MEDLINE | ID: mdl-35059196

ABSTRACT

INTRODUCTION: Several reports have emerged describing the long-term consequences of COVID-19 and its effects on multiple systems. METHODS: As further research is needed, we conducted a longitudinal observational study to report the prevalence and associated risk factors of the long-term health consequences of COVID-19 by symptom clusters in patients discharged from the Temporary COVID-19 Hospital (TCH) in Mexico City. Self-reported clinical symptom data were collected via telephone calls over 90 days post-discharge. Among 4670 patients, we identified 45 symptoms across eight symptom clusters (neurological; mood disorders; systemic; respiratory; musculoskeletal; ear, nose, and throat; dermatological; and gastrointestinal). RESULTS: We observed that the neurological, dermatological, and mood disorder symptom clusters persisted in >30% of patients at 90 days post-discharge. Although most symptoms decreased in frequency between day 30 and 90, alopecia and the dermatological symptom cluster significantly increased (p < 0.00001). Women were more prone than men to develop long-term symptoms, and invasive mechanical ventilation also increased the frequency of symptoms at 30 days post-discharge. CONCLUSION: Overall, we observed that symptoms often persisted regardless of disease severity. We hope these findings will help promote public health strategies that ensure equity in the access to solutions focused on the long-term consequences of COVID-19.

10.
Gels ; 7(4)2021 Dec 10.
Article in English | MEDLINE | ID: mdl-34940316

ABSTRACT

Rechargeable zinc-air batteries are promising for energy storage and portable electronic applications because of their good safety, high energy density, material abundance, low cost, and environmental friendliness. A series of alkaline gel polymer electrolytes formed from polyvinyl alcohol (PVA) and different amounts of terpolymer composed of butyl acrylate, vinyl acetate, and vinyl neodecanoate (VAVTD) was synthesized applying a solution casting technique. The thin films were doped with KOH 12M, providing a higher amount of water and free ions inside the electrolyte matrix. The inclusion of VAVTD together with the PVA polymer improved several of the electrical properties of the PVA-based gel polymer electrolytes (GPEs). X-ray diffraction (XRD), thermogravimetric analysis (TGA), and attenuated total reflectance- Fourier-transform infrared spectroscopy (ATR-FTIR) tests, confirming that PVA chains rearrange depending on the VAVTD content and improving the amorphous region. The most conducting electrolyte film was the test specimen 1:4 (PVA-VAVTD) soaked in KOH solution, reaching a conductivity of 0.019 S/cm at room temperature. The temperature dependence of the conductivity agrees with the Arrhenius equation and activation energy of ~0.077 eV resulted, depending on the electrolyte composition. In addition, the cyclic voltammetry study showed a current intensity increase at higher VAVTD content, reaching values of 310 mA. Finally, these gel polymer electrolytes were tested in Zn-air batteries, obtaining capacities of 165 mAh and 195 mAh for PVA-T4 and PVA-T5 sunk in KOH, respectively, at a discharge current of -5 mA.

11.
J Spinal Cord Med ; 43(3): 331-338, 2020 05.
Article in English | MEDLINE | ID: mdl-30207875

ABSTRACT

Objective: The objective of the present work was to determine the prognostic validity of the trunk control test for walking and independence in individuals with SCI.Design: A cohort, prospective study was carried out in all individuals with sub-acute SCI.Setting: All inpatients at the Mexico City based National Rehabilitation Institute (INR).Participants: Ninety individuals with a clinical diagnosis of sub-acute SCI, American Spinal Injury Association Impairment Scale (AIS) A-D, and that have not participated in a rehabilitation program were included. Thirty-five individuals had good initial trunk control and the remaining 55 had poor trunk control. All individuals participated in a standard rehabilitation program subsequently.Interventions: N/AOutcome Measures: The trunk control test was performed at baseline. At 1, 3, 6, 9 and 12 months after the first evaluation, walking and independence were assessed.Results: Survival Analysis revealed that 62.5% and 100% individuals with good trunk control at baseline assessment were respectively walking and independent in ADL at 12 months and 14% and 48% individuals with poor trunk control were walking and independent in ADL. Cox regression analysis revealed that individuals with good trunk control were 4.6 times more likely to walk independently at 12 months and 2.9 times more likely to be independent in activities of daily living.Conclusion: The present study revealed that the trunk control test is useful for providing a prognosis of independence and walking at 1 year in individuals with SCI, independently of the neurologic level and the severity of the injury.


Subject(s)
Outcome Assessment, Health Care/standards , Recovery of Function/physiology , Spinal Cord Injuries/diagnosis , Spinal Cord Injuries/physiopathology , Torso/physiopathology , Walking/physiology , Activities of Daily Living , Adult , Female , Humans , Male , Mexico , Middle Aged , Prognosis , Prospective Studies , Reproducibility of Results , Severity of Illness Index , Spinal Cord Injuries/rehabilitation
12.
Dement Geriatr Cogn Disord ; 47(4-6): 243-253, 2019.
Article in English | MEDLINE | ID: mdl-31408858

ABSTRACT

BACKGROUND: Endothelial dysfunction and subsequent inflammation contribute to the development of vascular cognitive impairment (VCI). Soluble intercellular adhesion molecule-1 (sICAM-1) is upregulated in endothelial dysfunction and promotes an inflammatory response; however, the relationship between sICAM-1 and VCI remains equivocal. OBJECTIVE: To determine whether sICAM-1 contributes to the prediction of VCI. METHODS: Community-dwelling older adults (n = 172) from the "Cohort of Obesity, Sarcopenia and Frailty of Older Mexican Adults" (COSFOMA) study were identified as VCI or controls using standard neuropsychological evaluations and neuroimaging. sICAM-1 was quantified using ELISA, and multivariate logistic regression determined the association between sICAM-1 and VCI. RESULTS: A total of 31 VCI cases were identified. sICAM-1 was higher in VCI (VCI: 450.7 [241.6] ng/mL vs. controls: 296.9 [140.9] ng/mL). sICAM-1 concentrations above the 90th percentile (464.1 ng/mL) were associated with VCI group membership in all models (OR: 6.9, 95% CI: 1.1-42.2). The final saturated model explained 64% of the variance in VCI group membership. CONCLUSION: High concentrations of sICAM-1 are independently associated with VCI group membership. Efforts to further characterize the relationship between indices of endothelial dysfunction and pathological changes to the aging brain should be further pursued.


Subject(s)
Biomarkers/blood , Cognitive Dysfunction/blood , Dementia, Vascular/blood , Intercellular Adhesion Molecule-1/blood , Aged , Aged, 80 and over , Case-Control Studies , Cognitive Dysfunction/diagnostic imaging , Cognitive Dysfunction/psychology , Dementia, Vascular/diagnostic imaging , Dementia, Vascular/psychology , Female , Frail Elderly , Humans , Independent Living , Male , Mexico , Neuroimaging , Neuropsychological Tests , Predictive Value of Tests , Socioeconomic Factors , Up-Regulation
13.
Adv Ther ; 36(2): 407-415, 2019 02.
Article in English | MEDLINE | ID: mdl-30565181

ABSTRACT

INTRODUCTION: Metformin tablets may be challenging to swallow not only for those patients with dysphagia but also for children and the elderly. A metformin solution was developed for easier administration and flexible dose adjustment mantained with the same bioavailability of tablets. The objective of this study was to assess the single-dose oral bioavailability of metformin hydrochloride administered as an oral solution (500 mg/5 mL) compared with metformin hydrochloride 500 mg tablets in fasting Mexican healthy volunteers. METHODS: A randomized, single dose, two-period, two-sequence, crossover study design with a 7-day washout interval was conducted. Subjects were randomly assigned to receive a single dose of 500 mg metformin hydrochloride, either as an oral solution (test drug) or as a tablet (reference drug), after 10 h of fasting. Plasma samples (16) were collected over a 16-h period after drug administration. Bioequivalence was declared when the ratio for the 90% confidence intervals (CI) of the difference in the means of the log-transformed area under the concentration-time curve from time 0 to the last observed concentration time (AUC0-t), the area under the concentration-time curve extrapolated to infinite time (AUC0-∞), and the maximum plasma concentration (Cmax) of the two products were within 0.80 and 1.25 interval. Plasma concentrations were analyzed using reverse phase chromatography by tandem mass spectrometry (LC-MS/MS). Safety and tolerability of metformin were also assessed in all subjects. RESULTS: 24 subjects were enrolled and completed the study (15 female and 9 male). Test and reference metformin hydrochloride were bioequivalent during the extent of exposure since AUC0-t and Cmax 90% CIs corresponded to 89.77-101.08% and 89.63-102.48%, respectively, both being within the pre-specified acceptance range criteria (80-125%). There were two adverse events (AE) with the reference formulation that were not related to the study drug. CONCLUSIONS: Bioequivalence in healthy volunteers in fasting conditions of the two metformin hydrochloride formulations (oral solution and tablets) was established, being the difference in means of AUC0-t, AUC0-∞ and Cmax within the acceptance range (80-125%). Oral solution formulation could offer the advantages of allowing adjusted doses and easier swallowing for every patient. Plain language summary is available for this article. TRIAL REGISTRATION: National Clinical Trials Registry (RNEC by its Spanish acronym), BD METF-Sil No. 86-15. Mexican Medicine Agency (COFEPRIS) Registry: 153300410B0368. FUNDING: Laboratorios Silanes, S.A. de C.V.


Subject(s)
Fasting , Hypoglycemic Agents/pharmacokinetics , Metformin/pharmacokinetics , Administration, Oral , Adult , Aged , Area Under Curve , Biological Availability , Chromatography, Liquid/methods , Cross-Over Studies , Delayed-Action Preparations , Female , Healthy Volunteers , Humans , Male , Metformin/administration & dosage , Mexico , Tablets , Tablets, Enteric-Coated , Tandem Mass Spectrometry
14.
J Gerontol A Biol Sci Med Sci ; 72(7): 951-957, 2017 Jul 01.
Article in English | MEDLINE | ID: mdl-28329793

ABSTRACT

BACKGROUND: Poor oral health has been associated with some components of frailty. The objective of this study was to identify the association between clinical measures of oral health and the incidence of frailty among community-dwelling older adults aged 70 or older in Mexico City. METHODS: A 3-year cohort study with a probabilistic representative sample of home-dwelling elders of one district of Mexico City was performed. Baseline and follow-up interview and oral clinical evaluations were carried out by standardized examiners in participants' homes. Dependent variable was incident frailty defined according to the frailty phenotype. Independent variables were the utilization of dental services, the presence of xerostomia, the number of natural teeth, use of removable dental prostheses, presence of severe periodontitis, and presence of root remnants. Sociodemographic, behavioral, and health measures were included as confounders. The association between oral health conditions and incident frailty was modeled using Poisson regression models with robust variance estimators. The models were adjusted for confounders and interactions. RESULTS: We identified a 14.8% cumulative incidence of frailty. Each additional tooth was associated with a lower probability of developing frailty by 5.0% (risk ratio = 0.90; 95% CI 1.02-1.10). The 3-year risk ratio of developing frailty was 2.13 times higher (95% CI 1.01-4.50) among participants having severe periodontitis. CONCLUSIONS: The number of teeth and the presence of severe periodontitis are associated with the development of frailty after controlling for confounders. Further studies are needed on this topic.


Subject(s)
Mouth Diseases/epidemiology , Aged , Aged, 80 and over , Frail Elderly/statistics & numerical data , Geriatric Assessment/methods , Health Status Disparities , Humans , Incidence , Male , Mexico/epidemiology , Oral Health/statistics & numerical data , Risk Assessment , Risk Factors , Statistics as Topic
15.
Fundam Clin Pharmacol ; 30(3): 276-81, 2016 Jun.
Article in English | MEDLINE | ID: mdl-26787266

ABSTRACT

Hypertension is highly prevalent; in Mexico, the 2012 National Health and Nutrition Survey reported a prevalence of hypertension of 31.5% in the adult population. Pharmacological treatment is the commonest intervention and has been shown to reduce cardiovascular mortality and morbidity, and total mortality. Accordingly, the type and number of antihypertensives used and the outcome - in terms of blood pressure (BP) control - are important. Therefore, our purpose is to learn the pattern of antihypertensive drug prescription and explore the determinants of BP control in an urban population in Mexico. A retrospective cross-sectional drug utilization study was conducted. Medical records from a community health centre were searched to identify those corresponding to patients diagnosed with hypertension; information upon antihypertensives used and control of the disease was carefully retrieved. A logistic regression model was built to know the main determinants of BP control. A sample of 345 clinical records of interest was identified. Most patients received antihypertensives (86.4%); the leading medications used were angiotensin-converting enzyme inhibitors, 63.8%; beta-blockers (26.5%), diuretics (19.8%), angiotensin-receptor blockers (15.8%) and calcium-channel blockers (6.4%). Only the age (≥55 years) and BMI (>30) of the patients, and the age of the doctors (≥55 years), had an important influence on BP control. Obesity is a particular and important determinant of uncontrolled hypertension; it is worth to act on body weight, on an individual basis. As lack of control has been also tied to elderly doctors, an education programme could be envisaged.


Subject(s)
Antihypertensive Agents/therapeutic use , Community Health Centers/trends , Drug Prescriptions , Drug Utilization/trends , Hypertension/drug therapy , Hypertension/epidemiology , Aged , Cross-Sectional Studies , Female , Humans , Hypertension/diagnosis , Male , Mexico/epidemiology , Middle Aged , Nutrition Surveys/methods , Nutrition Surveys/trends , Retrospective Studies
16.
Arch. argent. pediatr ; 113(3): 213-220, jun. 2015. graf, tab
Article in English, Spanish | LILACS, BINACIS | ID: lil-750466

ABSTRACT

Introducción. Las escalas pronósticas son de utilidad para el médico que ejerce en las unidades de cuidados intensivos neonatales. Existen escalas neonatales validadas, en su mayoría para neonatos de bajo peso al nacer. El objetivo fue crear y validar una escala predictora de mortalidad en neonatos que incluyera nuevas variables pronósticas. Población y métodos. Se realizó el estudio en un hospital materno-infantil de la ciudad de México, del Instituto Mexicano del Seguro Social. En la primera fase, se diseñó un estudio de casos y controles anidado en una cohorte (neonatos ingresados con criterios de gravedad durante el primer día de vida), en el que se identificó y construyó una escala con parámetros graduales de puntuación acumulativa de nueve variables independientes para predecir muerte: peso, acidemia metabólica, lactato, paO2/FiO2, p(A-a) O2, A/a, plaquetas y glucosa sérica. La validación se realizó en una cohorte prospectiva, de las mismas características, tomando como variable de desenlace la mortalidad hasta el séptimo día. Resultados. La cohorte incipiente estuvo conformada por 424 neonatos. Se seleccionaron 22 casos y 132 controles, y se identificaron 9 variables, que conformaron la escala nombrada escala de mortalidad neonatal-9 México. La cohorte de validación estuvo integrada por 227 neonatos. Se registraron 44 (19%) defunciones, con un área bajo la curva de 0,92. Con una puntuación de entre 16 y 18, se reportó un hazard ratio de 85 (11-102), una especificidad de 99%, un valor predictivo positivo de 71% y un valor predictivo negativo de 90%. Conclusiones. La escala propuesta es un instrumento fiable para predecir la gravedad en neonatos.


Introduction. Prognostic scales or scores are useful for physicians who work in neonatal intensive care units. There are several validated neonatal scores but they are mostly applicable to low birth weight infants. The aim of this study was to develop and validate a mortality prognostic score in newborn infants, that would include new prognostic outcome measures. Population and Methods. The study was conducted in a mother and child hospital in the city of Mexico, part of the Instituto Mexicano del Seguro Social (Mexican Institute of Social Security). In the first phase of the study, a nested case-control study was designed (newborn infants admitted on the basis of severity criteria during the first day of life), in which a scale was identified and developed with gradual parameters of cumulative score consisting of nine independent outcome measures to predict death, as follows: weight, metabolic acidemia, lactate, PaO2/FiO2, p(A-a) O2, A/a, platelets and serum glucose.Validation was performed in a matched prospective cohort, using 7-day mortality as an endpoint. Results. The initial cohort consisted of 424 newborn infants. Twenty-two cases and 132 controls were selected; and 9 outcome measures were identified, making up the scale named neonatal mortality score-9 Mexico. The validation cohort consisted of 227 newborn infants. Forty-four (19%) deaths were recorded, with an area under the curve (AUC) of 0.92. With a score between 16 and 18, an 85 (11-102) hazard ratio, 99% specificity, 71% positive predictive value and 90% negative predictive value were reported. Conclusions .The proposed scale is a reliable tool to predict severity in newborn infants.


Subject(s)
Humans , Infant, Newborn , Severity of Illness Index , Intensive Care Units, Neonatal , Infant Mortality , Risk Factors , Mexico
17.
Arch. argent. pediatr ; 113(3): 213-220, jun. 2015. ilus, graf, tab
Article in Spanish | BINACIS | ID: bin-134132

ABSTRACT

Introducción. Las escalas pronósticas son de utilidad para el médico que ejerce en las unidades de cuidados intensivos neonatales. Existen escalas neonatales validadas, en su mayoría para neonatos de bajo peso al nacer. El objetivo fue crear y validar una escala predictora de mortalidad en neonatos que incluyera nuevas variables pronósticas. Población y métodos. Se realizó el estudio en un hospital materno-infantil de la ciudad de México, del Instituto Mexicano del Seguro Social. En la primera fase, se diseñó un estudio de casos y controles anidado en una cohorte (neonatos ingresados con criterios de gravedad durante el primer día de vida), en el que se identificó y construyó una escala con parámetros graduales de puntuación acumulativa de nueve variables independientes para predecir muerte: peso, acidemia metabólica, lactato, paO2/FiO2, p(A-a) O2, A/a, plaquetas y glucosa sérica. La validación se realizó en una cohorte prospectiva, de las mismas características, tomando como variable de desenlace la mortalidad hasta el séptimo día. Resultados. La cohorte incipiente estuvo conformada por 424 neonatos. Se seleccionaron 22 casos y 132 controles, y se identificaron 9 variables, que conformaron la escala nombrada escala de mortalidad neonatal-9 México. La cohorte de validación estuvo integrada por 227 neonatos. Se registraron 44 (19%) defunciones, con un área bajo la curva de 0,92. Con una puntuación de entre 16 y 18, se reportó un hazard ratio de 85 (11-102), una especificidad de 99%, un valor predictivo positivo de 71% y un valor predictivo negativo de 90%. Conclusiones. La escala propuesta es un instrumento fiable para predecir la gravedad en neonatos.(AU)


Introduction. Prognostic scales or scores are useful for physicians who work in neonatal intensive care units. There are several validated neonatal scores but they are mostly applicable to low birth weight infants. The aim of this study was to develop and validate a mortality prognostic score in newborn infants, that would include new prognostic outcome measures. Population and Methods. The study was conducted in a mother and child hospital in the city of Mexico, part of the Instituto Mexicano del Seguro Social (Mexican Institute of Social Security). In the first phase of the study, a nested case-control study was designed (newborn infants admitted on the basis of severity criteria during the first day of life), in which a scale was identified and developed with gradual parameters of cumulative score consisting of nine independent outcome measures to predict death, as follows: weight, metabolic acidemia, lactate, PaO2/FiO2, p(A-a) O2, A/a, platelets and serum glucose.Validation was performed in a matched prospective cohort, using 7-day mortality as an endpoint. Results. The initial cohort consisted of 424 newborn infants. Twenty-two cases and 132 controls were selected; and 9 outcome measures were identified, making up the scale named neonatal mortality score-9 Mexico. The validation cohort consisted of 227 newborn infants. Forty-four (19%) deaths were recorded, with an area under the curve (AUC) of 0.92. With a score between 16 and 18, an 85 (11-102) hazard ratio, 99% specificity, 71% positive predictive value and 90% negative predictive value were reported. Conclusions .The proposed scale is a reliable tool to predict severity in newborn infants.(AU)

18.
Int Braz J Urol ; 41(2): 360-6, 2015.
Article in English | MEDLINE | ID: mdl-26005980

ABSTRACT

OBJECTIVES: To evaluate if the different results of prostate cancer risk between black and white Brazilian men may be associated with the varying methodology used to define participants as either Blacks or Whites. PATIENTS AND METHODS: We evaluated median PSA values, rate of PSA level ≥ 4.0 ng/ mL, indications for prostate biopsy, prostate cancer detection rate, biopsy/cancer rate, cancer/biopsy rate, and the relative risk of cancer between blacks versus whites, blacks versus non-blacks (browns and whites), non-whites (browns and blacks) versus whites, African versus non-African descendants, and African descendants or blacks versus non-African descendants and non-blacks. RESULTS: From 1544 participants, there were 51.4% whites, 37.2% browns, 11.4% blacks, and 5.4% African descendants. Median PSA level was 0.9 ng/mL in whites, browns, and non-African descendants, compared to 1.2 ng/mL in blacks, and African descendants or blacks, and 1.3 ng/mL in African descendants. Indications for prostate biopsy were present in 16.9% for African descendants, 15.9% of black, 12.3% of white, 11.4% for non-African descendants, and 9.9% of brown participants. Prostate cancer was diagnosed in 30.3% of performed biopsies: 6.2% of African descendants, 5.1% of blacks, 3.3% of whites, 3.0% of non-African descendants, and 2.6% of browns. CONCLUSIONS: Median PSA values were higher for Blacks versus Whites in all classification systems, except for non-white versus white men. The rate of prostate biopsy, prostate cancer detection rate, and relative risk for cancer was increased in African descendants, and African descendants or blacks, compared to non-African descendants, and non-African descendants and non-blacks, respectively.


Subject(s)
Black People/ethnology , Ethnology/classification , Prostate-Specific Antigen/blood , Prostatic Neoplasms/ethnology , Risk Assessment/methods , White People/ethnology , Biopsy , Black People/classification , Brazil/ethnology , Humans , Male , Middle Aged , Multivariate Analysis , Prostate/pathology , Prostatic Neoplasms/pathology , Reference Values , Risk Factors , White People/classification
19.
Arch Argent Pediatr ; 113(3): 213-20, 2015 06.
Article in English, Spanish | MEDLINE | ID: mdl-25996319

ABSTRACT

INTRODUCTION: Prognostic scales or scores are useful for physicians who work in neonatal intensive care units. There are several validated neonatal scores but they are mostly applicable to low birth weight infants. The aim of this study was to develop and validate a mortality prognostic score in newborn infants, that would include new prognostic outcome measures. POPULATION AND METHODS: The study was conducted in a mother and child hospital in the city of Mexico, part of the Instituto Mexicano del Seguro Social (Mexican Institute of Social Security). In the first phase of the study, a nested case-control study was designed (newborn infants admitted on the basis of severity criteria during the first day of life), in which a scale was identified and developed with gradual parameters of cumulative score consisting of nine independent outcome measures to predict death, as follows: weight, metabolic acidemia, lactate, PaO2/FiO2, p(A-a) O2, A/a, platelets and serum glucose.Validation was performed in a matched prospective cohort, using 7-day mortality as an endpoint. RESULTS: The initial cohort consisted of 424 newborn infants. Twenty-two cases and 132 controls were selected; and 9 outcome measures were identified, making up the scale named neonatal mortality score-9 Mexico. The validation cohort consisted of 227 newborn infants. Forty-four (19%) deaths were recorded, with an area under the curve (AUC) of 0.92. With a score between 16 and 18, an 85 (11-102) hazard ratio, 99% specificity, 71% positive predictive value and 90% negative predictive value were reported. Conclusions .The proposed scale is a reliable tool to predict severity in newborn infants.


Subject(s)
Critical Illness/mortality , Infant Mortality , Case-Control Studies , Female , Humans , Infant , Infant, Newborn , Male , Mexico/epidemiology , Prognosis , Prospective Studies
20.
Acta Crystallogr D Biol Crystallogr ; 71(Pt 4): 809-18, 2015 Apr.
Article in English | MEDLINE | ID: mdl-25849392

ABSTRACT

Biomineralization is the process by which living organisms produce minerals. One remarkable example is the formation of eggshells in birds. Struthiocalcins present in the ostrich (Struthio camellus) eggshell matrix act as biosensors of calcite growth during eggshell formation. Here, the crystal structure of struthiocalcin-1 (SCA-1) is reported in two different crystal forms. The structure is a compact single domain with an α/ß fold characteristic of the C-type lectin family. In contrast to the related avian ovocleidin OC17, the electrostatic potential on the molecular surface is dominated by an acidic patch. Scanning electron microscopy combined with Raman spectroscopy indicates that these intramineral proteins (SCA-1 and SCA-2) induce calcium carbonate precipitation, leading to the formation of a stable form of calcite in the mature eggshell. Finally, the implications of these two intramineral proteins SCA-1 and SCA-2 in the nucleation of calcite during the formation of eggshells in ratite birds are discussed.


Subject(s)
Egg Shell/chemistry , Proteins/chemistry , Struthioniformes , Amino Acid Sequence , Animals , Calcium Carbonate/chemistry , Crystallography, X-Ray , Models, Molecular , Molecular Sequence Data , Protein Conformation , Proteins/isolation & purification , Sequence Alignment , Struthioniformes/metabolism
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