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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.
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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.
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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 ).
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Anti-Inflamatórios não Esteroides , Combinação de Medicamentos , Cetoprofeno , Piridoxina , Tiamina , Trometamina , Vitamina B 12 , Humanos , Método Duplo-Cego , Tiamina/administração & dosagem , Tiamina/análogos & derivados , Tiamina/uso terapêutico , Cetoprofeno/administração & dosagem , Cetoprofeno/análogos & derivados , Feminino , Adulto , Piridoxina/administração & dosagem , Piridoxina/uso terapêutico , Masculino , Anti-Inflamatórios não Esteroides/administração & dosagem , Vitamina B 12/análogos & derivados , Vitamina B 12/administração & dosagem , Vitamina B 12/uso terapêutico , Pessoa de Meia-Idade , Trometamina/administração & dosagem , Estudos Prospectivos , Complexo Vitamínico B/administração & dosagem , Complexo Vitamínico B/uso terapêutico , Medição da Dor/métodos , Adulto JovemRESUMO
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.
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The health crisis caused by the new coronavirus SARS-CoV-2 highlights the need to identify new treatment strategies for this viral infection. During the past year, over 400 coronavirus disease (COVID-19) treatment patents have been registered; nevertheless, the presence of new virus variants has triggered more severe disease presentations and reduced treatment effectiveness, highlighting the need for new treatment options for the COVID-19. This study evaluates the Metformin Glycinate (MG) effect on the SARS-CoV-2 in vitro and in vivo viral load. The in vitro study was conducted in a model of Vero E6 cells, while the in vivo study was an adaptive, two-armed, randomized, prospective, longitudinal, double-blind, multicentric, and phase IIb clinical trial. Our in vitro results revealed that MG effectively inhibits viral replication after 48 h of exposure to the drug, with no cytotoxic effect in doses up to 100 µM. The effect of the MG was also tested against three variants of interest (alpha, delta, and epsilon), showing increased survival rates in cells treated with MG. These results are aligned with our clinical data, which indicates that MG treatment reduces SARS-CoV2-infected patients´ viral load in just 3.3 days and supplementary oxygen requirements compared with the control group. We expect our results can guide efforts to position MG as a therapeutic option for COVID-19 patients.
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Tratamento Farmacológico da COVID-19 , Metformina , Humanos , Metformina/farmacologia , Metformina/uso terapêutico , Estudos Prospectivos , RNA Viral , SARS-CoV-2 , Carga ViralRESUMO
The FDA's approval of peptide drugs such as Ziconotide or Exendin for pain relief and diabetes treatment, respectively, enhanced the interest to explore novel conotoxins from Conus species venom. In general, conotoxins can be used in pathologies where voltage-gated channels, membrane receptors, or ligands alter normal physiological functions, as in metabolic diseases such as Type 2 diabetes. In this study, the synthetic cal14.2b (s-cal14.2b) from the unusual Californiconus californicus demonstrated bioactivity on NIT-1 insulinoma cell lines stimulating insulin secretion detecting by high performance liquid chromatography (HPLC). Accordingly, s-cal14.2b increased the CaV1.2/1.3 channel-current by 35 ± 4% with a recovery τ of 10.3 ± 4 s in primary cell culture of rat pancreatic ß-cells. The in vivo results indicated a similar effect of insulin secretion on mice in the glucose tolerance curve model by reducing the glucose from 500 mg/dL to 106 mg/dL in 60 min, compared to the negative control of 325 mg/dL at the same time. The PET-SCAN with radiolabeling 99mTc-s-cal14.2b demonstrated biodistribution and accumulation in rat pancreas with complete depuration in 24 h. These findings show the potential therapeutic use of s-cal14.2b in endocrinal pathologies such as early stages of Type 2 Diabetes where the pancreas's capability to produce insulin is still effective.
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Californiconus californicus, previously named Conus californicus, has always been considered a unique species within cone snails, because of its molecular, toxicological and morphological singularities; including the wide range of its diet, since it is capable of preying indifferently on fish, snails, octopus, shrimps, and worms. We report here a new cysteine pattern conotoxin assigned to the O1-superfamily capable of inhibiting the growth of Mycobacterium tuberculosis (Mtb). The conotoxin was tested on a pathogen reference strain (H37Rv) and multidrug-resistant strains, having an inhibition effect on growth with a minimal inhibitory concentration (MIC) range of 3.52â»0.22 µM, similar concentrations to drugs used in clinics. The peptide was purified from the venom using reverse phase high-performance liquid chromatography (RP-HPLC), a partial sequence was constructed by Edman degradation, completed by RACE and confirmed with venom gland transcriptome. The 32-mer peptide containing eight cysteine residues was named O1_cal29b, according to the current nomenclature for this type of molecule. Moreover, transcriptomic analysis of O-superfamily toxins present in the venom gland of the snail allowed us to assign several signal peptides to O2 and O3 superfamilies not described before in C. californicus, with new conotoxins frameworks.
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Antibacterianos/farmacologia , Conotoxinas/farmacologia , Mycobacterium tuberculosis/efeitos dos fármacos , Peptídeos/farmacologia , Animais , Conotoxinas/genética , Caramujo Conus , Farmacorresistência Bacteriana/efeitos dos fármacos , Resistência a Múltiplos Medicamentos/efeitos dos fármacos , Mycobacterium tuberculosis/crescimento & desenvolvimento , Peptídeos/genética , Tuberculose Resistente a Múltiplos MedicamentosRESUMO
The liver is a main target tissue of the biguanide metformin which activates AMP-activated protein kinase (AMPK). We previously reported that administration of metformin glycinate showed a greater decrease of glycated hemoglobin A1c than a placebo in patients with type 2 diabetes mellitus (T2DM). In this study, we compared the effects of metformin hydrochloride, the oral antidiabetic drug of first choice, with those of metformin glycinate in hepatocytes from non-diabetic and diabetic mice and humans. Both formulations were equally potent regard to the reduction of basal and glucagon-induced glucose production and mRNA levels of gluconeogenic enzymes (Pck1 and G6pc) in hepatocytes from C57/Bl6 mice and humans. On the contrary, phosphorylation of AMPK and its substrate acetyl CoA carboxylase (ACC) was faster in hepatocytes treated with metformin glycinate. Likewise, we found stronger reduction in hepatocytes from obese/diabetic db/db mice of glucagon-induced glucose output and more sustained AMPK phosphorylation after treatment with metformin glycinate. Importantly, insulin sensitization regarding phosphorylation of AKT (Ser473) was enhanced in hepatocytes from db/db mice or humans pretreated with metformin glycinate. In conclusion, our data indicate that metformin glycinate may be an alternative therapy against insulin resistance during obesity and/or T2DM.
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Proteínas Quinases Ativadas por AMP/metabolismo , Diabetes Mellitus Tipo 2/tratamento farmacológico , Glucose/metabolismo , Hepatócitos/metabolismo , Insulina/metabolismo , Metformina/administração & dosagem , Proteínas Quinases Ativadas por AMP/genética , Acetil-CoA Carboxilase/genética , Acetil-CoA Carboxilase/metabolismo , Animais , Diabetes Mellitus Tipo 2/enzimologia , Diabetes Mellitus Tipo 2/genética , Diabetes Mellitus Tipo 2/metabolismo , Feminino , Hemoglobinas Glicadas/metabolismo , Hepatócitos/efeitos dos fármacos , Humanos , Fígado/efeitos dos fármacos , Fígado/metabolismo , Masculino , Camundongos , Camundongos Endogâmicos C57BL , Camundongos Obesos , FosforilaçãoRESUMO
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.
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Jejum , Hipoglicemiantes/farmacocinética , Metformina/farmacocinética , Administração Oral , Adulto , Idoso , Área Sob a Curva , Disponibilidade Biológica , Cromatografia Líquida/métodos , Estudos Cross-Over , Preparações de Ação Retardada , Feminino , Voluntários Saudáveis , Humanos , Masculino , Metformina/administração & dosagem , México , Comprimidos , Comprimidos com Revestimento Entérico , Espectrometria de Massas em TandemRESUMO
The stability, binding, and tissue penetration of variable new-antigen receptor (VNAR) single-domain antibodies have been tested as part of an investigation into their ability to serve as novel therapeutics. V13 is a VNAR that recognizes vascular endothelial growth factor 165 (VEGF165). In the present study V13 was used as a parental molecule into which we introduced mutations designed in silico. Two of the designed VNAR mutants were expressed, and their ability to recognize VEGF165 was assessed in vitro and in vivo. One mutation (Pro98Tyr) was designed to increase VEGF165 recognition, while the other (Arg97Ala) was designed to inhibit VEGF165 binding. Compared to parental V13, the Pro98Tyr mutant showed enhanced VEGF165 recognition and neutralization, as indicated by inhibition of angiogenesis and tumor growth. This molecule thus appears to have therapeutic potential for neutralizing VEGF165 in cancer treatment.
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The response of the adaptive immune system is usually less intense in premature neonates than term neonates. The primary objective of this study was to determine whether immunological parameters vary between preterm (PT) neonates (≥32 weeks of gestational age) and very preterm (VPT) neonates (<32 weeks of gestational age). A cross-sectional study was designed to prospectively follow PT and VPT neonates at risk of developing sepsis. Plasma concentrations of IFN-γ, TNF-α, IL-6, IL-4, and IL-10 were detected using flow cytometry. C-reactive protein (C-RP) and the complex SC5b-9 were detected in the plasma using commercial kits. A total of 83 patients were included. The laboratory results and clinical histories showed that 26 patients had sepsis; 14 were VPT, and 12 were PT. The levels of C-RP, SC5b-9 (innate immune response mediators), and IL-10 or IL-4 (anti-inflammatory cytokines) were elevated during sepsis in both groups. IFN-γ, TNF-α, and IL-6 (proinflammatory cytokines) were differentially elevated only in PT neonates. The VPT neonates with sepsis presented increases in C-RP, SC5b-9, and anti-inflammatory cytokines but not in proinflammatory cytokines, whereas PT neonates showed increases in all studied mediators of inflammation.
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Inflamação/sangue , Inflamação/imunologia , Sepse/sangue , Sepse/imunologia , Proteína C-Reativa/metabolismo , Complexo de Ataque à Membrana do Sistema Complemento , Estudos Transversais , Feminino , Humanos , Imunidade Inata/imunologia , Lactente Extremamente Prematuro , Recém-Nascido , Recém-Nascido Prematuro/sangue , Recém-Nascido Prematuro/metabolismo , Inflamação/metabolismo , Interferon gama/sangue , Interleucina-10/sangue , Interleucina-4/sangue , Interleucina-6/sangue , Masculino , Fator de Necrose Tumoral alfa/sangueRESUMO
AIM: This study evaluated the effect of metformin glycinate on glycated hemoglobin A1c (A1C) concentration and insulin sensitivity in drug-naive adult patients with type 2 diabetes mellitus (T2DM). SUBJECTS AND METHODS: A randomized, double-blind, placebo-controlled clinical trial was carried out in 20 patients with drug-naive T2DM. Ten subjects received metformin glycinate (1,050.6 mg) once daily during the first month and force-titrated twice daily during the second month. Ten additional patients received placebo as the control group. Before and after the intervention, metabolic profile including A1C and insulin sensitivity (euglycemic-hyperinsulinemic clamp technique) was estimated. RESULTS: A1C concentrations decreased significantly with metformin glycinate administration (8.0 ± 0.7% vs. 7.1 ± 0.9%, P = 0.008) before and after the intervention, respectively. There were significant differences in changes from baseline of A1C between groups (0.0 ± 0.7% vs. -1.0 ± 0.5% for placebo and metformin glycinate groups, respectively; P = 0.004). A reduction of ≥1% in A1C levels was reached in 60.0% of patients with metformin glycinate administration (P = 0.02). Insulin sensitivity was not modified by the intervention. CONCLUSIONS: Administration of metformin glycinate during a 2-month period showed a greater decrease in A1C concentrations than placebo in a selected group of drug-naive adult patients with T2DM.
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Glicemia/efeitos dos fármacos , Diabetes Mellitus Tipo 2/tratamento farmacológico , Hemoglobinas Glicadas/efeitos dos fármacos , Hipoglicemiantes/farmacologia , Resistência à Insulina , Metformina/farmacologia , Adulto , Algoritmos , Glicemia/metabolismo , Diabetes Mellitus Tipo 2/sangue , Diabetes Mellitus Tipo 2/epidemiologia , Método Duplo-Cego , Feminino , Técnica Clamp de Glucose , Hemoglobinas Glicadas/metabolismo , Humanos , Hipoglicemiantes/uso terapêutico , Masculino , Metformina/uso terapêutico , México/epidemiologia , Pessoa de Meia-Idade , Resultado do TratamentoRESUMO
OBJECTIVE: To demonstrate whether patients undergoing capsulotomy Nd: YAG laser developed intraocular hypertension after the procedure. METHODS: Prospective, pre-experimental before and after 2 measurements with post-test in patients with posterior capsular opacity from the Ophthalmology Service. Measurements of intraocular pressure (IP) before capsulotomy Nd: YAG laser, and three hours and one week later. RESULTS: We studied 47 patients, 29.8 % were men and 70.2 % women. We compared between visual acuity before and one week later (Wilcoxon test p = 0.00). IP after three hours and one week later, comparisons with Friedman test were done (p =0. 002). We compared the IP prior and one week later (Wilcoxon test, with p =0.815). IP before and three hours later were obtained (p = 0.001) and IP three hours and one week later (p = 0.004). CONCLUSIONS: We found an increase in IP in the first hours after the capsulotomy Nd: YAG laser, which decrease gradually until reaching the values presented before the procedure, in not more than a week period. It is a quick and safe procedure to treat posterior capsular opacity.
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Tuberculose Pulmonar/diagnóstico , Adolescente , Adulto , Idoso , Criança , Estudos Transversais , Feminino , Humanos , Testes Imunológicos , Masculino , Pessoa de Meia-Idade , Fatores de Tempo , Tuberculose Pulmonar/sangue , Adulto JovemRESUMO
OBJECTIVE: Evaluate the performance of clinical data and the rapid influenza diagnostic test (RIDT) in diagnosing influenza H1N1, and analyze the cost-benefit of using this diagnostic tool. METHODS: The RIDT was used for patients who came to four hospitals in Mexico City with an influenza-like illness (ILI) in October and November 2009. The diagnostic performance of the ILI clinical data and the RIDT was compared to that of the real-time reverse transcription polymerase chain reaction (rRT-PCR) test. The rRT-PCR test was conducted in a reference laboratory and blinded to the results of the RIDT. An economic evaluation also was conducted to estimate the budgetary impact of using the RIDT. RESULTS: The study included 78 patients, 39 of whom tested positive for influenza H1N1 and 6 tested positive for seasonal influenza A, according to the results of the rRT-PCR. The ILI clinical data yielded a sensitivity of 96% and specificity of 21%; the RIDT yielded a sensitivity of 76% and specificity of 82%; and the ILI clinical data and RIDT together yielded a sensitivity of 96% and specificity of 100%. The positive likelihood quotient for ILI-headaches was 31.5 and that of ILI-odynophagia, 330. The use of RIDT yielded savings of US$12.6 per each suspected case. CONCLUSIONS: Use of the RIDT to aid in the diagnosis of influenza H1N1 increases certainty and lowers the average cost per suspected and infected patient.
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Imunoensaio/economia , Vírus da Influenza A Subtipo H1N1/isolamento & purificação , Influenza Humana/diagnóstico , Exame Físico/economia , Adolescente , Adulto , Idoso , Assistência Ambulatorial/economia , Antígenos Virais/análise , Antivirais/economia , Antivirais/uso terapêutico , Criança , Pré-Escolar , Sistemas Computacionais/economia , Análise Custo-Benefício , Erros de Diagnóstico , Diagnóstico Precoce , Feminino , Hospitalização/economia , Hospitais Urbanos , Humanos , Imunoensaio/métodos , Lactente , Vírus da Influenza A Subtipo H1N1/genética , Vírus da Influenza A Subtipo H1N1/imunologia , Influenza Humana/tratamento farmacológico , Influenza Humana/virologia , Masculino , México , Pessoa de Meia-Idade , Reação em Cadeia da Polimerase Via Transcriptase Reversa/economia , Método Simples-Cego , Inquéritos e Questionários , Fatores de Tempo , Adulto JovemRESUMO
OBJETIVO: Evaluar el desempeño de los datos clínicos y la prueba rápida (PR) en el diagnóstico de influenza H1N1, y analizar el costo-beneficio que representa el uso de esta herramienta diagnóstica. MÉTODOS: Se aplicó la PR a pacientes que acudieron a cuatro hospitales en la ciudad de México con sintomatología similar a influenza (SSI) durante el período octubre y noviembre de 2009. Se comparó el desempeño diagnóstico de la SSI más la PR contra el de la reacción en cadena de la polimerasa en transcripción reversa en tiempo real (rRT-PCR). La rRT-PCR fue procesada en un laboratorio de referencia y cegado al resultado de la PR. Además, se llevó a cabo una evaluación económica a partir de la cual se estimó el impacto presupuestal relacionado con la utilización de la PR RESULTADOS: Se incluyó a 78 pacientes, de los cuales 39 fueron positivos para influenza H1N1 y 6 para influenza A estacional, de acuerdo al resultado de la rRT-PCR. La SSI mostró una sensibilidad de 96 por ciento y una especificidad de 21 por ciento, la PR de 76 por ciento y 82 por ciento y el conjunto de SSI más PR de 96 por ciento y 100 por ciento, respectivamente. El Cociente de Verosimilitud positivo de la SSI-cefalea fue de 31,5 y el de SSI-odinofagia fue de 330. El uso de PR mostró un ahorro de US$ 12,6 por cada caso sospechoso. CONCLUSIONES: El uso de la PR como auxiliar en el diagnóstico de influenza H1N1 incrementa la certeza y reduce el costo promedio por paciente sospechoso e infectado.
OBJECTIVE: Evaluate the performance of clinical data and the rapid influenza diagnostic test (RIDT) in diagnosing influenza H1N1, and analyze the cost-benefit of using this diagnostic tool. METHODS: The RIDT was used for patients who came to four hospitals in Mexico City with an influenza-like illness (ILI) in October and November 2009. The diagnostic performance of the ILI clinical data and the RIDT was compared to that of the real-time reverse transcription polymerase chain reaction (rRT-PCR) test. The rRT-PCR test was conducted in a reference laboratory and blinded to the results of the RIDT. An economic evaluation also was conducted to estimate the budgetary impact of using the RIDT. RESULTS: The study included 78 patients, 39 of whom tested positive for influenza H1N1 and 6 tested positive for seasonal influenza A, according to the results of the rRT-PCR. The ILI clinical data yielded a sensitivity of 96 percent and specificity of 21 percent; the RIDT yielded a sensitivity of 76 percent and specificity of 82 percent; and the ILI clinical data and RIDT together yielded a sensitivity of 96 percent and specificity of 100 percent. The positive likelihood quotient for ILI-headaches was 31.5 and that of ILI-odynophagia, 330. The use of RIDT yielded savings of US$12.6 per each suspected case. CONCLUSIONS: Use of the RIDT to aid in the diagnosis of influenza H1N1 increases certainty and lowers the average cost per suspected and infected patient.
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Humanos , Masculino , Feminino , Lactente , Pré-Escolar , Criança , Adolescente , Adulto , Pessoa de Meia-Idade , Idoso , Adulto Jovem , Imunoensaio/economia , Vírus da Influenza A Subtipo H1N1/isolamento & purificação , Influenza Humana/diagnóstico , Exame Físico/economia , Assistência Ambulatorial/economia , Antígenos Virais/análise , Antivirais/economia , Antivirais/uso terapêutico , Sistemas Computacionais/economia , Análise Custo-Benefício , Erros de Diagnóstico , Diagnóstico Precoce , Hospitalização/economia , Hospitais Urbanos , Imunoensaio/métodos , Vírus da Influenza A Subtipo H1N1/genética , Vírus da Influenza A Subtipo H1N1/imunologia , Influenza Humana/tratamento farmacológico , Influenza Humana/virologia , México , Inquéritos e Questionários , Reação em Cadeia da Polimerase Via Transcriptase Reversa/economia , Método Simples-Cego , Fatores de TempoRESUMO
The purpose of this study was to determine the effect of treatment, with Metformin alone or with the combination of Glimepiride/Metformin, on coronary endothelial function in asymptomatic patients with recently diagnosed type 2 diabetes mellitus (DM) Methods: 16 asymptomatic patients with type DM2 and 15 healthy controls (HC) were studied. At baseline and after treatment, myocardial blood flow (MBF) was measured with 13N-ammonia Possitron Emission Tomography (PET) at rest, during cold pressor testing (CPT) and during pharmacologic stress with adenosine. The endothelial dependent vasodilation index (EDVI), myocardial flow reserve (MFR) and the percentage of the change between rest MBF and CPT MBF (%deltaMBF) were calculated as markers of endothelial function. MBF was normalized to the rate pressure product (RPP). RESULTS: EDVI and %deltaMBF were significantly lower in diabetic patients before treatment in comparison with HC demonstrating endothelial dysfunction in the former. Treatment with Glimepiride/Metformin significantly increased EDVI and %deltaMBF in diabetic patients from baseline, thus showing an improvement in coronary endothelial function.
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Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Endotélio Vascular , Endotélio Vascular , Hipoglicemiantes , Metformina , Tomografia por Emissão de Pósitrons , Compostos de Sulfonilureia , Quimioterapia Combinada , Endotélio Vascular , Hipoglicemiantes , Metformina , Compostos de SulfonilureiaRESUMO
UNLABELLED: The purpose of this study was to determine the effect of treatment, with Metformin alone or with the combination of Glimepiride/Metformin, on coronary endothelial function in asymptomatic patients with recently diagnosed type 2 diabetes mellitus (DM) Methods: 16 asymptomatic patients with type DM2 and 15 healthy controls (HC) were studied. At baseline and after treatment, myocardial blood flow (MBF) was measured with 13N-ammonia Possitron Emission Tomography (PET) at rest, during cold pressor testing (CPT) and during pharmacologic stress with adenosine. The endothelial dependent vasodilation index (EDVI), myocardial flow reserve (MFR) and the percentage of the change between rest MBF and CPT MBF (%deltaMBF) were calculated as markers of endothelial function. MBF was normalized to the rate pressure product (RPP). RESULTS: EDVI and %deltaMBF were significantly lower in diabetic patients before treatment in comparison with HC demonstrating endothelial dysfunction in the former. Treatment with Glimepiride/Metformin significantly increased EDVI and %deltaMBF in diabetic patients from baseline, thus showing an improvement in coronary endothelial function.
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Diabetes Mellitus Tipo 2/tratamento farmacológico , Diabetes Mellitus Tipo 2/fisiopatologia , Endotélio Vascular/efeitos dos fármacos , Endotélio Vascular/diagnóstico por imagem , Hipoglicemiantes/farmacologia , Metformina/farmacologia , Tomografia por Emissão de Pósitrons , Compostos de Sulfonilureia/farmacologia , Adulto , Quimioterapia Combinada , Endotélio Vascular/fisiopatologia , Feminino , Humanos , Hipoglicemiantes/administração & dosagem , Masculino , Metformina/administração & dosagem , Pessoa de Meia-Idade , Compostos de Sulfonilureia/administração & dosagemRESUMO
AIM: The aim of this study was to compare the efficacy of glimepiride/metformin combination versus glibenclamide/metformin for reaching glycemic control in patients with uncontrolled type 2 diabetes mellitus. PATIENTS AND METHODS: A randomized, double-blind, multicenter clinical trial was performed in 152 uncontrolled type 2 diabetic patients. Serum fasting and postprandial glucose, hemoglobin A1c (A1C), high-density lipoprotein cholesterol, and triglycerides were measured. After random allocation, all patients received two pills of glimepiride (1 mg)/metformin (500 mg) or glibenclamide (5 mg)/metformin (500 mg) po once a day. Dosage was increased to a maximum of four pills in order to reach the glycemic control goals (fasting glucose
Assuntos
Diabetes Mellitus Tipo 2/tratamento farmacológico , Glibureto/administração & dosagem , Hipoglicemiantes/administração & dosagem , Metformina/administração & dosagem , Compostos de Sulfonilureia/administração & dosagem , Glicemia/efeitos dos fármacos , Índice de Massa Corporal , Combinação de Medicamentos , Feminino , Glibureto/efeitos adversos , Humanos , Hiperglicemia/tratamento farmacológico , Hipoglicemia/induzido quimicamente , Hipoglicemiantes/efeitos adversos , Masculino , Metformina/efeitos adversos , Pessoa de Meia-Idade , Compostos de Sulfonilureia/efeitos adversos , Resultado do TratamentoRESUMO
Se informa un caso de fiebre y granulomas hepáticos característicos, cuyo diagnóstico final fue fiebre Q. El interés de tal caso radica, por un lado, en que no cuenta con antecedentes epidemiológicos y, por otro, tampoco con la presentación clínica típica
Assuntos
Humanos , Masculino , Pessoa de Meia-Idade , Granuloma/diagnóstico , Granuloma/etiologia , Granuloma/patologia , Hepatite/diagnóstico , Hepatite/etiologia , Hepatite/patologia , Hepatopatias/diagnóstico , Febre Q/complicações , Febre Q/diagnóstico , Febre Q/terapia , Biópsia , Fígado/patologia , Tetraciclina/administração & dosagem , Tetraciclina/uso terapêutico , Fatores de TempoRESUMO
"La carga viral en plasma es la medida de la cantidad de virus de inmunodeficiencia humana". "La prueba de carga viral se ha convertido en una medida de pronóstico y de seguimiento en el paciente infectado por VIH-1. La medición de la carga viral es predictor del tiempo en que dicho individuo desarrollará el SIDA y de su sobrevida. Determina la verdadera efectividad de los esquemas de tratamiento antirretroviral y en muchas ocasiones es el parámetro que se utiliza para valorar el inicio del tratamiento". (AU). Existen cuatro métodos para determinar la carga viral: bDNA, NASBA, RT/PCR e Hybrid. Las apartados del artículo son: Carga viral; Usos e indicaciones. Linfocitos TCD4