Usefulness of vancomycin treatment individualization via Bayesian algorithms: a 5-year study in critical patients.

Aim: Compare two vancomycin dosing strategies in critical patients with methicillin-resistant Staphylococcus aureus (MRSA) infections, considering the heterogeneity of the dosing regimens administered and their implications for toxicity and efficacy. Materials & methods: Longitudinal retrospective observational study in two patient cohorts (standard dosing vs dosing via Bayesian algorithms). Results: The group of Bayesian algorithms received substantially higher and significantly heterogeneous doses, with an absence of nephrotoxicity. The speed of decrease observed in CRP and PCT was greater for the Bayesian strategy (p = 0.045 and 0.0009, respectively). Conclusion: Applying Bayesian algorithms to vancomycin dosage individualization allows for administering much higher doses than with standard regimens, facilitating a quicker clinical response in the absence of nephrotoxicity.

[Box: see text].

GC-MS Profile, Antioxidant Activity, and In Silico Study of the Essential Oil from Schinus molle L. Leaves in the Presence of Mosquito Juvenile Hormone-Binding Protein (mJHBP) from Aedes aegypti.

Schinus molle is a medicinal plant used as an anti-inflammatory and for rheumatic pain in the traditional medicine of Peru. On the other hand, Aedes aegypti is the main vector of several tropical diseases and the transmitter of yellow fever, chikungunya, malaria, dengue, and Zika virus. In this study, the aim was to investigate the antioxidant activity in vitro and the insecticidal activity in silico, in the presence of the mosquito juvenile hormone-binding protein (mJHBP) from Aedes aegypti, of the essential oil from S. molle leaves. The volatile phytochemicals were analyzed by gas chromatography-mass spectrometry (GC-MS), and the profile antioxidants were examined by DPPH, ABTS, and FRAP assays. The evaluation in silico was carried out on mJHBP (PDB: 5V13) with an insecticidal approach. The results revealed that EO presented as the main volatile components to alpha-phellandrene (32.68%), D-limonene (12.59%), and beta-phellandrene (12.24%). The antioxidant activity showed values for DPPH = 11.42 ± 0.08 µmol ET/g, ABTS = 134.88 ± 4.37 µmol ET/g, and FRAP = 65.16 ± 1.46 µmol ET/g. Regarding the insecticidal approach in silico, alpha-muurolene and gamma-cadinene had the best biding energy on mJHBP (ΔG = -9.7 kcal/mol), followed by beta-cadinene (ΔG = -9.5 kcal/mol). Additionally, the volatile components did not reveal antioxidant activity, and its potential insecticidal effect would be acting on mJHBP from A. aegypti.

Asociación entre procrastinación y estrés académico en estudiantes peruanos de segundo año de medicina

Introducción: Los estudiantes universitarios de la carrera de medicina son una población expuesta a una alta carga académica, alta exigencia, gran demanda de tiempo y existen factores que pueden afectar la eficacia del desempeño académico, tales como el estrés y la procrastinación. Objetivo: Evaluar la asociación entre estrés y procrastinación en una muestra piloto de estudiantes de medicina en una universidad de Lima-Perú. Material y métodos: Se realizó un estudio analítico transversal, en donde se reclutó a estudiantes de medicina del curso Metodología de la Investigación en una universidad de la capital peruana. En ellos se midió el estrés y la procrastinación, ambos con test validados previamente, luego se relacionó estas variables y se las ajustó por su sexo y edad. Para la estadística analítica se utilizó los modelos lineales generalizados y se consideró a los valores p ≤ 0,05 como estadísticamente significativos. Resultados: Al realizar el análisis multivariado se encontró que hubo relación entre la procrastinación y el género masculino de los encuestados (p = 0,001), la edad (p = 0,035) y el estrés (p = 0,022). Conclusiones: La procrastinación mantiene en la muestra estudiada una importante asociación con el estrés que tienen los estudiantes, así como, con su género y edad(AU)

Introduction: University medical students are a population exposed to a high academic load, high level of exigency, high demand of time and there are factors that can affect the effectiveness of academic performance, such as stress and procrastination. Objective: Evaluate the association between stress and procrastination in a pilot sample of medical students at a university in Lima, Peru. Material and methods: A cross-sectional analytical study was conducted, where medical students from the Research Methodology course were recruited at a university in the Peruvian capital. In them, stress and procrastination were measured, both with previously validated tests, then these variables were related and adjusted according to their sex and age. For analytical statistics, generalized linear models were used and p-values ≤ 0.05 were considered statistically significant. Results: When performing the multivariate analysis, it was found that there was a relationship between procrastination and male gender (p = 0.001), age (p = 0.035) and stress (p = 0.022) of the respondents. Conclusions: Procrastination maintains in the sample studied an important association with the stress that students have, as well as with their gender and age(AU)

Family and social environment associated with traits of antisocial personality disorder in the prison population of Peru.

INTRODUCTION: The prison environment in Peru is one of the worst in the continent. In situations such as these, where there is considerable stress, many inmates can develop antisocial disorders, especially if they come from a conflictive family setting. OBJECTIVES: To determine the association between family relationships, social environment and features of antisocial personality disorder (ASPD) in the Peruvian prison population in 2016. MATERIAL AND METHOD: Analytical cross-sectional study based on a sub-analysis of the First National Penitentiary Census of Peru in 2016. The sample is the prison population (≥18 years old) that participated in said census, which was carried out in 66 correctional facilities nationwide and reached a coverage of 98.8%. RESULTS: Of the 77,086 prisoners, 76,152 participated in the analysis. The prevalence of antisocial traits was 96% and half of the population met two criteria for the disorder. Independently associated factors were, being male (RPa: 1.35; 1.30-1.40), born outside the capital (RPa: 0.89; 0.88-0, 91), friends in the neighborhood who committed offences (RPa: 1.01; 1.00-1.02) and not living with a father (RPa: 1.00; 1.00-1.01). DISCUSSION: The prevalence of antisocial personality disorder traits in the Peruvian prison population was 96%. We found greater association with the male sex, in those born in Lima and in those who escaped from their home before the age of 15.

Carvacrol: An In Silico Approach of a Candidate Drug on HER2, PI3Kα, mTOR, hER-α, PR, and EGFR Receptors in the Breast Cancer.

Carvacrol is a phenol monoterpene found in aromatic plants specially in Lamiaceae family, which has been evaluated in an experimental model of breast cancer. However, any proposed mechanism based on its antitumor effect has not been reported. In our previous study, carvacrol showed a protective effect on 7,12-dimethylbenz[α]anthracene- (DMBA-) induced breast cancer in female rats. The main objective in this research was to evaluate by using in silico study the carvacrol on HER2, PI3Kα, mTOR, hER-α, PR, and EGFR receptors involved in breast cancer progression by docking analysis, molecular dynamic, and drug-likeness evaluation. A multilevel computational study to evaluate the antitumor potential of carvacrol focusing on the main targets involved in the breast cancer was carried out. The in silico study starts with protein-ligand docking of carvacrol followed by ligand pathway calculations, molecular dynamic simulations, and molecular mechanics energies combined with the Poisson-Boltzmann (MM/PBSA) calculation of the free energy of binding for carvacrol. As result, the in silico study led to the identification of carvacrol with strong binding affinity on mTOR receptor. Additionally, in silico drug-likeness index for carvacrol showed a good predicted therapeutic profile of druggability. Our findings suggest that mTOR signaling pathway could be responsible for its preventive effect in the breast cancer.

Histopathological evaluation of latex of Bellaco-Caspi, Himatanthus sucuuba (Spruce) Woodson on wound healing effect in BALB/C mice.

BACKGROUND AND AIM: Himatanthus sucuuba (Spruce) Woodson (Apocynaceae) is a medicinal plant known as "Bellaco-Caspi" widely distributed in Loreto, Peru. In the Peruvian traditional medicine, the latex of the plant is used for the treatment of wounds, inflammation, ulcers, and other ailments. This study aims to evaluate the wound healing effect of the latex of H. sucuuba in BALB/C albino mice. MATERIALS AND METHODS: Thirty BALB/C male mice were used for wound healing study. In the experimental procedures, wound skin incision was performed at 2.0 cm in length until subcutaneous on the paravertebral of each animal. Under locally anesthetized with procaine cream, the treatment was conducted. All the mice were divided into three groups, the control group (A), zinc oxide cream (B), and H. sucuuba latex (C). The entire surface of the wound was treated for all the groups, and the treatments were performed daily for 15 days. The experiments were stopped on days 1, 7, and 15, respectively. RESULTS: The histopathological study of tissues revealed significant changes in wound healing effect in H. sucuuba latex compared to the control and B groups. Consequently, the mice treated with latex showed a significant reduction in epithelialization time and collagen formation. Furthermore, the latex showed a dose-dependent significant reduction of inflammation in the first 24 h of treatment. CONCLUSION: BALB/C mice treated with the latex of H. sucuuba possess a wound healing effect that can scientifically prove the traditional use of the plant as a wound healing agent.

TOCOSH FLOUR (Solanum tuberosum L.): A Toxicological Assessment of Traditional Peruvian Fermented Potatoes.

Potato tocosh is a naturally processed potato for nutritional and curative purposes from traditional Peruvian medicine. The aim of this study was to investigate the acute and sub-acute toxicity of tocosh flour (TF). For sub-acute toxicity, TF was administered orally to rats daily once a day for 28 days at doses of 1000 mg/kg body weight (BW). Animals were observed for general behaviors, mortality, body weight variations, and histological analysis. At the end of treatment, relative organ weights, histopathology, hematological and biochemical parameters were analyzed. For acute toxicity, TF was administered orally to mice at doses of 2000 and 5000 mg/kg BW at a single dose in both sexes. Body weight, mortality, and clinical signs were observed for 14 days after treatment. The results of acute toxicity showed that the median lethal dose (LD50) value of TF is higher than 2000 g/kg BW but less than 5000 mg/Kg BW in mice. Death and toxicological symptoms were not found during the treatment. For sub-acute toxicity, we found that no-observed-adverse-effect levels (NOAEL) of TF in rats up to 1000 g/kg BW. There were statistically significant differences in body weight, and relative organ weight in the stomach and brain. No differences in hematological and biochemical parameters were observed when compared with the control group. For sub-acute toxicity, histopathological studies revealed minor abnormalities in liver and kidney tissues at doses of 5000 mg/Kg. Based on these results, TF is a traditional Peruvian medicine with high safety at up to 1000 mg/kg BW for 28 days in rats.

Simple and robust speckle detection method for fire and heat detection in harsh environments.

Standard laser-based fire detection systems are often based on measuring the variation of optical signal amplitude. However, mechanical noise interference and loss from dust and steam can obscure the detection signal, resulting in faulty results or the inability to detect a potential fire. The presented fire detection technology will allow the detection of fire in harsh and dusty areas, which are prone to fires, where current systems show limited performance or are unable to operate. It is not the amount of light or its wavelength that is used for detecting fire, but how the refractive index randomly fluctuates due to heat convection from the fire. In practical terms, this means that light obstruction from ambient dust particles will not be a problem as long as a small fraction of the light is detected and that fires without visible flames can still be detected. The standalone laser system consists of a Linux-based Red Pitaya system, a cheap 650 nm laser diode, and a positive-intrinsic-negative photo-detector. Laser light propagates through the monitored area and reflects off a retroreflector generating a speckle pattern. Every 3 s, time traces and frequency noise spectra are measured, and eight descriptors are deduced to identify a potential fire. Both laboratory and factory acceptance tests have been performed with success.

Individualized Protease Inhibitor Monotherapy: The Role of Pharmacokinetics and Pharmacogenetics in an Aged and Heavily Treated HIV-Infected Patient.

Antiretroviral therapy has changed the history of HIV infection from a lethal disease to a chronic infection, with the emergence of long-term adverse effects. Herein we present a case of a heavily treated HIV-infected man in whom antiretroviral toxicity had been observed. The lopinavir/ritonavir plasma concentrations at standard doses were significantly above the recommended levels. Pharmacogenetic analysis revealed a polymorphism in the DRD3 gene associated with a decrease in the rate of drug metabolism. Additionally, the patient's low body mass index could have contributed to a greater degree of patient exposure to the drug. After the withdrawal of tenofovir disoproxil and the establishment of individualized protease inhibitor monotherapy at reduced doses, a decrease in the intensity of adverse events was observed, while the clinical outcomes were maintained. The pharmacokinetic-pharmacogenetic analysis was shown to be a tool of huge interest for the management and durability of antiretroviral therapy.

Free-field reciprocity calibration of measurement microphones at frequencies up to 150 kHz.

Microphones are typically calibrated in a free field at frequencies up to 40 kHz using primary and secondary methods. This upper frequency is sufficiently high as to cover most sound measurement applications related with airborne noise assessment. However, other applications such as measurement of noise emitted by ultrasound cleaning machines, failure detection in aeronautic structures, and the investigation of the perception mechanisms of ultrasound may require that the sensitivity of the microphone is known at frequencies up to 150 kHz. In any of these applications, it is critical to establish a well-defined traceability chain to SI units to support any measurement result. In order to extend the frequency range of absolute free-field calibration, typical reciprocity measurement systems and measurement methods must undergo a series of changes and adaptations which may include using other types of microphones rather than laboratory standard microphones, changing the type of measurement signal, improving the methods for eliminating unwanted reflections from walls, cross-talk, distortion, etc. Herein, a strategy for the changes and adaptations to the existing measurement methodologies, and the determination of the microphone parameters is outlined, the results of its implementation are discussed, and calibrations results are presented and discussed.

Preventive effect of Oenothera rosea on N-methyl-N-nitrosourea-(NMU) induced gastric cancer in rats.

BACKGROUND: Currently, gastric cancer (GC) is considered a public health problem worldwide. Using medicinal plants for the prevention of chronic diseases such as cancer constitutes new alternatives in traditional medicine. Oenothera rosea (OR) could be an option, but it needs to be evaluated. AIM: The main objective of this study was to evaluate the protective effect of OR extract on N-methyl-N-nitrosourea (NMU)-induced GC in rats. METHODS: In total, 80 male Holtzman rats were randomized into five groups. Group A received the saline solution (5mL/kg), group B received NMU 500 µg/kg (cancer inductor) by oral administration for 16 weeks, and groups C, D, and E were treated with OR extract (100, 200, and 300 mg/kg, respectively) and NMU in order to evaluate the preventive effect on cancer induced by NMU for 16 weeks. Blood and histological samples of stomachs were collected to determine histopathological, biochemical, and hematological parameters between different experimental groups. RESULTS: Groups C, D, and E presented less histopathological changes such as anaplastic and hyperplastic cells, compared with group B. Hematological and biochemical parameters were recorded, and superoxide dismutase, malondialdehyde, and nitric oxide levels were statistically less than those of NMU group (P<0.05, P<0.01, and P<0.01). CONCLUSION: Considering the histopathological signs and the antioxidant activity in vivo as well as hematological and biochemical parameters of ethanolic extract of OR, we concluded that its administration in rats has a protective effect on GC, which is induced experimentally. This species could be studied in clinical trials for patients with GC in the future.

Efecto de la administración crónica del látex liofilizado de Croton lechleri Muell. Arg. "sangre de drago" en Rattus norvegicus var. Albinus / Effect of chronic administration of latex lyophilised Croton lechleri Muell. Arg. "sangre de drago" in Rattus norvegicus var. Albinus

Objetivo: Determinar si la administración crónica (90 días) del látex liofilizado de Croton lechleri Muell. Arg. "Sangre de drago" modifica los parámetros hematológicos y bioquimicos en Rattus norvegicus var albinus. Materiales y métodos: Se utilizó ratas con un peso corporal (p.c.) entre 150 g a 170 g, distribuidos en Grupo A (control) y Grupos B y C (experimentales), de 20 especímenes cada uno (10 hembras y 10 machos) a las que se administró por vía oral NaCl 0.9% y una dosis diaria de 100 y 200 mg de látex liofilizado/Kg p.c. respectivamente, durante 90 días. Se tomaron muestras de sangre cada 15 días para determinar parámetros hematológicos (hematocrito, linfocitos, leucocitos y segmentados) y bioquímicos (glucosa, urea, creatinina, colesterol total y perfil hepático). Resultados: Todos los valores se encontraron dentro del rango normal. Se encontraron diferencias significativas al comparar los grupos de estudio en los resultados de glucosa (Control vs Grupo I: p<0.001 y Grupo II: p=0.003) y creatinina (Grupo II vs Grupo I: p=0.008 y control: p<0.001). Los valores de bilirrubina total y proteínas totales variaron significativamente durante el tiempo de estudio (p=0.001 y p<0.001, respectivamente). El resto de parámetros no presentaron variaciones significativas por grupos (p>0.05). Conclusión: El látex liofilizado de Croton lechleri Muell. Arg. no generó toxicidad en los parámetros hematológicos y bioquímicos estudiados en Rattus norvegicus var Albinus.

The calibration of a prototype occluded ear simulator designed for neonatal hearing assessment applications.

An innovative family of ear simulators has been conceived for the calibration and traceability of audiometric equipment. Each device within the family has been designed for a particular key age group, covering neonates through to adults. The age-specific ear simulators are intended to improve the quality of hearing assessment measurements for all test subject age groups, and will be proposed as the next generation of standardised ear simulators for audiometric applications. The family of ear simulators shares a common design and modeling approach, and the first prototype devices for neonatal applications have been manufactured. The objectives of this study were to develop calibration methods, verify conformance to the design goals, demonstrate that the device is capable of being calibrated reliably, and show that its performance is ultimately suitable for international standardisation and eventual adoption into clinical practices. Four national measurement institutes took part in a round-robin calibration comparison and an analysis of the results showed that these objectives were achieved.

Gene-gene interactions between DRD3, MRP4 and CYP2B6 polymorphisms and its influence on the pharmacokinetic parameters of efavirenz in HIV infected patients.

Genetic factors have a significant impact on the PK variability of EFV, much higher than other non-genetic factors, such as demography. In this work we have performed a comprehensive PG analysis of genes encoding the major metabolizing enzymes and transporters of EFV, establishing a clear relationship between the PK parameters and genetic factors, which explain 50% of the variability in EFV PK parameters. The most relevant associations for metabolizing enzymes were found in CYP2B6 (rs3745274), in agreement with previous studies. The influence of transporters on the kinetics of EFV was also proved with significant correlations between the PK parameters of EFV and MRP4 (rs1751034, rs2274407). Analysis of gene-gene interactions with CYP2B6 was particularly useful to reinforce the role of MRP4 and to reveal unknown associations, such as that of DRD3. However, the role of DRD3 cannot be a direct effect but an indirect one due to physical proximity of NAT and the DRD3 locus in the genome.

A pharmacist's role in the individualization of treatment of HIV patients.

The pharmacological treatment of HIV is complex and varies considerably among patients, as does the response of patients to therapy, requiring treatment plans that are closely tailored to individual needs. Pharmacists can take an active role in individualizing care by employing their knowledge of pharmacokinetics and pharmacogenetics and by interacting directly with patients in counseling sessions. These strategies promote the following: maintenance of plasma concentrations of antiretroviral agents within therapeutic ranges, prediction of pharmacological response of patients with certain genetic characteristics, and clinical control of HIV through the correct use of antiretroviral treatments. Together, these strategies can be used to tailor antiretroviral therapy to individual patients, thus improving treatment efficacy and safety.

CYP3A4 polymorphism and lopinavir toxicity in an HIV-infected pregnant woman.

Cytochrome P450 (CYP) 3A4 has been considered to be the most important enzyme system for metabolism of lopinavir/ritonavir (LPV/r), a widely used HIV protease inhibitor (PI) recommended during pregnancy. Herein we present a clinical case of a pregnant HIV-infected woman who was taking standard doses of LPV/r, 400/100 mg twice daily. The trough plasma concentrations for LPV were fourfold above that recommended for PI-pretreated patients and toxicity associated with LPV/r and PI regimens was observed. These high concentrations continued after delivery in spite of a dosage reduction. The pharmacogenetic analysis revealed a genetic polymorphism in the CYP3A4 gene that encodes a non-functional protein. The pharmacokinetic study could indicate the occurrence of a phenomenon of non-linear pharmacokinetics which would justify why dosage reduction after pregnancy did not proportionally affect the patient's degree of exposure to the drug. In addition, an increment in CYP3A activity during pregnancy could explain lower LPV/r exposure during this period compared to postpartum, despite the impaired activity of CYP3A4 caused by the polymorphism.

Dose reduction of efavirenz: an observational study describing cost-effectiveness, pharmacokinetics and pharmacogenetics.

AIM: Antiretroviral treatment implies a high cost to the healthcare system. The aim of this study was to evaluate the clinical and economic impact of efavirenz (EFV) dose adjustment by monitoring plasma concentrations and pharmacogenetic analysis of the 516G>T CYP2B6 polymorphism. MATERIALS & METHODS: One hundred and ninety HIV patients treated with EFV were studied. Plasma EFV concentrations were measured by HPLC with ultraviolet detection, and pharmacogenetic analysis was performed by Real Time (RT)-PCR. RESULTS: One hundred and ninety patients initially treated with a standard dose of EFV (600 mg/day) were studied. In 31 (16.3%) patients, EFV dose was reduced. A total of 87.1% of patients were heterozygous/homozygous carriers (GT/TT). CD4(+) count increased while the minimum steady-state plasma concentration and adverse effects decreased significantly after dose adjustment. Considering only the dose reduction, the adjustments accounted for a saving of 43,539 €/year. CONCLUSION: The individualization of EFV dosage guided by genotyping 516G>T CYP2B6 and therapeutic drug monitoring could increase the efficiency of EFV use in antiretroviral treatment.

Population pharmacokinetic/pharmacogenetic model of lopinavir/ritonavir in HIV-infected patients.

AIM: This study aims to develop a population pharmacokinetic/pharmacogenetic model for lopinavir/ritonavir (LPV/r) in European HIV-infected patients. MATERIALS & METHODS: A total of 693 LPV/r plasma concentrations were assessed and 15 single-nucleotide polymorphisms were genotyped. The population pharmacokinetic/pharmacogenetic model was created using a nonlinear mixed-effect approach (NONMEM® v.7.2.0., ICON Development Solutions, Dublin, Ireland). RESULTS: Covariates significantly related to LPV/r apparent clearance (CL/F) were ritonavir trough concentration (RTC), BMI, high-density lipoprotein cholesterol (HDL-C) and certain single-nucleotide polymorphisms in genes encoding for metabolizing enzymes, which are representable as follows: CL/F = (0.216BMI + 0.0125HDL-C) × 0.713RTC × 1.26rs28371764[C/T] × 0.528rs6945984[C/C] × 0.302 CYP3A4[1461insA/del] Conclusion: The LPV/r standard dose appears to be appropriate for the rs28371764[C/T] genotype. However, lower doses should be recommended for the rs6945984[C/C] and CYP3A4[1461insA/del] genotypes and even for those patients without any of these variants, as the standard dose seems to be higher than that which is required in order to achieve therapeutic levels.

Toxicogenetics of lopinavir/ritonavir in HIV-infected European patients.

AIMS: We present a genetic association study in 106 European HIV-infected individuals aimed at identifying and confirming polymorphisms that have a significant influence on toxicity derived from treatment with lopinavir/ritonavir (LPV/r). PATIENTS & METHODS: Genotyping was performed by matrix-assisted laser desorption/ionization-time of flight and KASPar® (KBiosciences, Hoddesdon, UK); LPV/r plasma concentrations were quantified using HPLC with an UV detection system and the pharmacokinetic parameters were estimated using Bayesian algorithms. Genetic association analysis was performed with PASW Statistics 18 (SPSS Inc., IL, USA) and R for Windows (Microsoft, WA, USA). RESULTS: Suggestive relationships have been established between lipid plasma levels and total bilirubin and SNPs in CETP, MCP1, ABCC2, LEP and SLCO1B3 genes and between diarrhea and SNPs in IL6 gene. CONCLUSION: Replication analysis should confirm the novel results obtained in this study prior to its application in the clinical practice to achieve a safer LPV/r-based combined antiretroviral therapy.

Análisis de eficacia, seguridad y racionalidad de la combinación a dosis fija (CDF) de dos hipoglicemiantes orales (metformina + glimepirida) en publicaciones biomédicas, 2000-2012 / Analysis of efficacy, safety and rationality of the fixed dose combination (FDC) of two oral hypoglycemic agents (metformin + glimepiride) in biomedical publications, 2000-2012

Analizar los resultados de eficacia, seguridad y racionalidad de la combinación a dosis fija (CDF) de dos hipoglicemiantes orales (metformina + glimepirida) en publicaciones biomédicas, 2000-2012. Método: Se usó un estudio cuantitativo, revisión documental y retrospectivo, en el cual la unidad de análisis y la muestra fueron los estudios clínicos controlados aleatorizados (ECCA) y número total de publicaciones biomédicas desde el 2000-2012 respectivamente. Se realizó la búsqueda en bases de datos de evidencia científica: pubmed, EMBASE, Lilacs, "The ACP Journal Club", "Bandolier", "BMJ Evidence Updates", "The Cochrane Database of Systematic Reviews", etc., según los recomendado por el Centro de Medicina Basada en la Evidencia (MBE) de la "Duke University Medical Center Library" y Oxford University. Los criterios para evaluar la eficacia, seguridad y racionalidad fueron basados en las guías técnicas de la Administración de Alimentos y Medicamentos (FDA) de los Estados Unidos de América, Agencia Europea de Medicamentos (EMA) y OMS; para la valoración de la calidad de la publicación se usó JADAD y CONSORT. Resultados: No se encontró publicaciones de la CDF glimepirida/ metformina que hayan considerado criterios de eficacia y seguridad recomendado por la FDA y EMA. Para el análisis se consideró dos (02) publicaciones de eficacia y seguridad de la CDF, los que presentan baja calidad metodológica de acuerdo al cuestionario de Oxford Quality Score, Jadad (<3 puntos), y según CONSORT, sólo se transparentaron entre 48 por ciento a 76 por ciento de los 25 ítems recomendados para publicaciones biomédicas de estudios clínicos. Al valorar cada uno de los 02 artículos considerados, en el primero sólo un pequeño número de pacientes (n<=8) logró una reducción <=7 por ciento de HbA1c y se determinó un NNT de 22 cuando fue comparado con glimepirida después de 3 meses de tratamiento con glimepirida/metformina, y en el segundo artículo se determinó un NNT de 6 y 5...

Identificar e analizar os resultados da eficacia, sequrança e racionalidade da combinação a doses fixas (CDF) de dois hipoglicemiantes orais (metformina + glimepirida) reportadas em publiçacóes biomédicas, entre os anos de 2000 a 2012. Método: Usou-se um estudo quantitativo, revisão documental e retrospectivo; no qual a unidade da análise e da mostra foram os estudos clínicos controlados aleatorizados (ECCA) e o número total de publicacóes biomédicas desde 2000 até 2012 respectivamente. Realizou-se a busca nas bases de dados de evidencia científica: pubmed, EMBASE, Lilacs, "The ACP Journal Club", "Bandolier", "BMJ Evidence Updates", "The Cochrane Database of Systematic Reviews", etc, segundo as recornendcóes do Centro de Medicina Basada en la Evidencia (MBE, em Inglés Evidence Based Medice) da "Duke University Medical Center Library" e Oxford University. Os criterios para avaliar a eficacia, sequrança e racionalidade foram baseados nas guías técnicas da Administração de Alimentos e Medicamentos (FDA, em Ingles Food and Drug Administration) dos Estados Unidos da América, Agencia Europeia de Medicamentos (EMA, em Ingles European Medicine Agency) e OMS (Orqanizacáo Mundial da Saúde); para a valorizacáo da qualidade da publicacáo foi usado JADAD (JADAD, Ar. Oxford, 1996) e CONSORT (Consolidated Standart of Reporting Trials). Resultados: Não foi encontrada publicacóes da CDF glimepirida/metformina que tenham considerado criterios de eficacia e sequranca recomendado pela FDA e EMA. Para a análise foi considerado duas (02) publicacóes de efiçacia e sequrança da CDF, os que apresentam baixa qualidade metodológica de acordo ao questionário de Oxford Quality Score, Jadad (<3 pontos), e segundo CONSORT, só se transparentaram entre 48 por cento a 76 por cento dos 25 itens recomendados para publicacóes biomédicas de estudos clínicos. Ao valorar cada um dos dois artigos considerados, no primero só um pequeno número de pacientes (n<=58) logrou uma redução...