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1.
Homeopathy ; 2024 Mar 20.
Artículo en Inglés | MEDLINE | ID: mdl-38508222

RESUMEN

BACKGROUND: Chronic non-specific low back pain (CNSLBP) lacks identifiable anatomical pathology and effective pharmacological treatment. Alternative approaches in homeopathy, specifically clinical homeopathy, utilize ultra-diluted (potentized) biological products. In Brazil, standardized biotherapics from sheep tissues, particularly fifty-millesimal (LM) potencies of sheep Lumbar Vertebra, have shown promise in alleviating CNSLBP. OBJECTIVES: Our objective is to present the study protocol of a clinical trial that will assess the efficacy and safety of the biotherapic Lumbar Vertebra LM2 in the short-term management of CNSLBP and to estimate its therapeutic duration. METHODS: A randomized, double-blind, crossover, placebo-controlled clinical trial spanning 8 weeks per participant was designed. Participants will include 120 individuals (aged 20 to 60 years) with clinically diagnosed CNSLBP by the study's physiotherapist. Exclusion criteria are radicular pain, signs of radiculopathy, specific lumbar spine disorders, pregnancy, or puerperium (up to 60 days after delivery). The medical intervention includes participants being randomly assigned to one of two treatment sequences: homeopathy-placebo or placebo-homeopathy. The treatments will consist of Lumbar Vertebra LM2 oral solution, topical cream, and indistinguishable placebos. Each treatment period will span 2 weeks, with a 4-week washout interval between them. Primary outcome is the assessment of changes in self-reported pain levels using the numeric rating scale (NRS) score, analyzed with a random effects model across both treatment periods. Secondary outcomes are assessment of changes in self-reported disability levels using the Oswestry Disability Index (ODI), analyzed with a random effects model across both treatment periods, and pain and disability variations, evaluated by the NRS score and ODI respectively, after the first and second treatment periods. Adverse events will be assessed at weeks 2 and 8. Pain medications will be used concomitantly. Adherence will be evaluated by the weight of medication returned/standard weight. DISCUSSION: The BIOVERT (Bioactive Vertebra) trial protocol is designed to investigate a homeopathic strategy for short-term CNSLBP treatment. Favorable outcomes for homeopathy could prompt subsequent studies evaluating the long-term effectiveness of LM potencies of Lumbar Vertebra for CNSLBP. TRIAL REGISTRATION: UMIN Clinical Trials Registry - ID: UMIN000051957.

2.
Transfus Apher Sci ; 62(2): 103578, 2023 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-36114122

RESUMEN

In May 2020, after years of demands by activists and in light of COVID-19-related blood shortages, the Brazilian Federal Supreme Court abolished the rules that demanded a 12-month celibacy period for men who have sex with men (MSM) to donate blood. The objective of this open web survey was to assess the perceptions and practices regarding blood donation and blood donation rules among members of the Brazilian LGBT+ community. The data collection was conducted between October 2019 and March 2020, before the changes in the rules for blood donation and before the onset of the COVID-19 pandemic in Brazil. A total of 1639 adult individuals, self-declared as LGBT+ , participated (54.3 % MSM, 2.2 non-MSM, 43.5 % women). As expected, most of the study participants did not agree with the 12-month deferral period for MSM donate blood. Blood donation was already practiced by MSM, even before the abolition of the restrictions on donation. Among MSM and women, 38.7 % and 41.0 % have already donated blood, respectively. A significant number of participants reported lying in screening interviews at blood banks in order to be able to donate, and many said they knew people who were MSM and disobeyed the rules for donation, even though they knew them. Therefore, the practice of blood donation was already present among these people, even before the restriction policy change, confirming the need for revised rules for blood donation.


Asunto(s)
COVID-19 , Infecciones por VIH , Minorías Sexuales y de Género , Masculino , Adulto , Humanos , Femenino , Homosexualidad Masculina , Donación de Sangre , Brasil , Pandemias , Donantes de Sangre , Infecciones por VIH/prevención & control , COVID-19/epidemiología
3.
BMC Pediatr ; 22(1): 334, 2022 06 10.
Artículo en Inglés | MEDLINE | ID: mdl-35689212

RESUMEN

BACKGROUND: The commonly used dynamometers can be ineffective in evaluating handgrip in patients with Duchenne muscular dystrophy (DMD), especially children with generalized muscle weakness. The aim of this study was to analyze whether the modified sphygmomanometer is an effective instrument for handgrip strength evaluation in patients with DMD, during different stages of the disease. METHOD: The handgrip strength of 33 patients was evaluated by the Jamar dynamometer and the modified sphygmomanometer. Motor function was evaluated by the Motor Function Measurement (MFM) scale. Four evaluations, with a six-month interval between each, were performed: Evaluation 1 (N = 33), Evaluation 2 (N = 24), Evaluation 3 (N = 15), and Evaluation 4 (N = 8). A linear regression model with mixed effects was used for the longitudinal data and descriptive analysis of strength for all four evaluations. RESULT: The first evaluation data presented very high correlations between the dynamometer and the modified sphygmomanometer (r = 0.977; p < 0.001). The longitudinal analysis showed a significant difference between Evaluation 1 and the other handgrip strength evaluations obtained using the dynamometer (p < 0.05) but not the modified sphygmomanometer (p > 0.05). Null values were obtained only when using the dynamometer device. CONCLUSION: The modified sphygmomanometer seems to be more suitable than the dynamometer for measuring handgrip strength in all stages of DMD.


Asunto(s)
Fuerza de la Mano , Distrofia Muscular de Duchenne , Niño , Fuerza de la Mano/fisiología , Humanos , Fuerza Muscular/fisiología , Debilidad Muscular , Distrofia Muscular de Duchenne/diagnóstico
4.
Public Health Nutr ; 24(18): 6450-6465, 2021 12.
Artículo en Inglés | MEDLINE | ID: mdl-34212834

RESUMEN

OBJECTIVE: To estimate the prevalence of anaemia in Brazilian children up to 83·9 months old. DESIGN: Systematic review and meta-analysis, using databases PubMed, Scopus, SciELO, Lilacs, Google Scholar, Periódicos Capes, Arca, Biblioteca Virtual em Saúde, Microsoft Academic Search and Cochrane Library using search terms: anaemia, prevalence, child and Brazil. PROSPERO Registration number: CRD42020208818. SETTING: Cross-sectional, cohort, case-control and intervention studies published between 2007 and 2020 were searched, excluding those who assessed children with an illness or chronic condition. The main outcome was anaemia prevalence. Random effects models based on the inverse variance method were used to estimate pooled prevalence measures. Sensitivity analyses removed studies with high contribution to overall heterogeneity. PARTICIPANTS: From 6790 first screened, 134 eligible studies were included, totalling 46 978 children aged zero to 83·9 months analysed, with adequate regions representativeness. RESULTS: Pooled prevalence of anaemia was 33 % (95 % CI 30, 35). Sensitivity analyses showed that withdrawal of studies that contributed to high heterogeneity did not influence national average prevalence. CONCLUSIONS: Childhood anaemia is still a serious public health problem in Brazil, exposing 33 % of Brazilian children to the anaemia repercussions. The main limitation of the study is the estimation of national prevalence based on local surveys, but a large number of studies were included, with representation in all regions of the country, giving strength to the results. In Brazil, more public policies are needed to promote supplementation, fortification and access to healthy eating to reduce the high level of anaemia among children.


Asunto(s)
Anemia , Anemia/epidemiología , Brasil/epidemiología , Estudios de Casos y Controles , Niño , Preescolar , Estudios Transversales , Humanos , Lactante , Recién Nacido , Prevalencia
5.
Int J Sports Med ; 42(12): 1113-1121, 2021 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-33890263

RESUMEN

We aimed to analyse cardiac autonomic control by assessing the post-exercise heart rate recovery (HRR) and physical fitness in children and adolescents with spina bifida (SB), compared to participants with typical development. A total of 124 participants, 42 with spina bifida (SB group) and 82 typical developmental controls (CO group) performed the arm cranking exercise test with a gas analysis system. HRR was determined at the first (HRR_1) and second (HRR_2) minute at recovery phase. Data are shown as [mean difference (95% CI)]. The SB group showed reduced HR reserve [14.5 (7.1-22.0) bmp, P<0.01], slower HRR_1 [12.4 (7.4-17.5) bpm, P<0.01] and HRR_2 [16.3 (10.6-21.9) bpm; P<0.01], lower VO2peak [VO2peak relative: 7.3 (4.2-10.3) mL·min-1·kg-1, P<0.01; VO2peak absolute: 0.42 (0.30-0.54) L·min-1, P<0.01], and lower O2 pulse [2.5 (1.8-3.2) mL·bpm, P<0.01] and ventilatory responses [13.5 (8.8-18.1) L·min-1, P<0.01] than the CO group. VE/VO2 was not different between groups [-2.82 (-5.77- -0.12); P=0.06], but the VE/VCO2 [-2.59 (-4.40-0.78); P<0.01] and the values of the anaerobic threshold corrected by body mass [-3.2 (-5.8- -0.6) mL·min-1·kg-1, P=0.01] were higher in the SB group than in the CO group. We concluded that children and adolescents with SB have reduced physical fitness and a slower HRR response after maximal effort.


Asunto(s)
Frecuencia Cardíaca/fisiología , Consumo de Oxígeno/fisiología , Aptitud Física/fisiología , Disrafia Espinal/fisiopatología , Adolescente , Niño , Prueba de Esfuerzo , Femenino , Humanos , Masculino
6.
Transfus Apher Sci ; 59(5): 102822, 2020 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-32487510

RESUMEN

There is a consensus on the importance of education of the population for blood donation. Considering that health sciences undergraduate students will play an important role of opinion makers in their social/professional networks in the future, the present study aimed to investigate the knowledge, attitude and practice of the blood donation and religious beliefs among students of a public Brazilian university. All students enrolled in courses of Ribeirão Preto Medical School in 2019 were invited (N = 550). The questionnaire was composed by sociodemographic and behavioral variables, an instrument regarding blood donation attitude and practice, the Blood Donation Knowledge Questionnaire (BDKQ-Brazil) and the Duke University Religious Index (DUREL). Multinomial logistic regression was used to estimate sex- and age-adjusted odds ratios for the relations between sociodemographic/behavioral characteristics and blood donation practice. The association between the responses to the BDKQ-Brazil and blood donation practice was performed using Fisher's Exact Test. Three hundred and forty students were included (81.5% females). Blood donation has been a common practice for part of the students, who have almost entirely shown a positive attitude towards donation and a high rate of self-efficacy regarding their practice. However, less than expected knowledge was observed. Regarding religious beliefs, lower scores of non-organizational and intrinsic religiosity were detected among those male students who never donated blood. Our results suggest the need to develop educational activities for students aiming, in addition to their awareness of the practice of donation, the spread of information regarding blood donation in the future.


Asunto(s)
Donantes de Sangre/psicología , Conocimientos, Actitudes y Práctica en Salud , Religión y Psicología , Adolescente , Adulto , Estudios Transversales , Femenino , Humanos , Masculino , Estudiantes , Universidades , Adulto Joven
7.
Vox Sang ; 114(1): 38-46, 2019 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-30485453

RESUMEN

BACKGROUND AND OBJECTIVES: The objective of the present study was to investigate the fear of blood, injections and fainting as barriers to blood donation in a sample of primary healthcare users in a Brazilian municipality. MATERIALS AND METHODS: This is a cross-sectional survey of primary care patients in 12 randomly selected healthcare facilities in Ribeirão Preto, Brazil in 2015-2016. Key variables were lifetime blood donation history, intentions to donate blood among non-donors and current donation practice. To assess fear of blood in general (FBG), fear of injections in general (FIG) and fear of fainting due to fear of injection (FFI), we used the Blood Injection/Fear Scale (BIFS). We tested associations between variables using regression models and conditional inference trees (CIT). RESULTS: A total of 1055 primary healthcare users participated (79·7% female, mean age 40·6 years [SD = 15·2]), 63·4% never donated blood, 13·3% reported they are unable to donate, 6·1% donated only once, 17·2% donated multiple times. Women had higher scores for FIG and FBG. FFI was associated with middle socioeconomic status. Those who never intended to donate exhibited the highest scores in the three dimension of fear. By CIT analysis, being female and high scores for FBG are associated with decreased blood donation. Among males, blood donation frequency is low among those aged 33 years and under. CONCLUSION: Fear of blood, injections and fainting are barriers to blood donation in Brazil. Efforts to recruit and retain blood donors should convey information on blood donation processes and address misconceptions that may increase fear.


Asunto(s)
Donantes de Sangre/psicología , Trastornos Fóbicos/epidemiología , Síncope/epidemiología , Adulto , Anciano , Donantes de Sangre/estadística & datos numéricos , Brasil , Femenino , Humanos , Masculino , Persona de Mediana Edad
8.
Homeopathy ; 108(2): 102-107, 2019 05.
Artículo en Inglés | MEDLINE | ID: mdl-30736083

RESUMEN

BACKGROUND: Hot flashes are common in women during menopause, and are an important cause of discomfort, increasing the number of medical appointments. Hormone replacement therapy is an effective treatment, but it can bring undesirable consequences. Alternative treatments exist but they are not universally accepted or effective. The ingestion of malagueta peppers (popular name for fruits of Capsicum frutescens L., Solanaceae) causes sensations similar to those experienced by women during hot flashes. Using the homeopathic law of similars (let like be cured by like), we hypothesized that a homeopathic remedy made of malagueta peppers can be effective in alleviating menopausal hot flashes. We named this remedy Malagueta. METHODS: This randomized, placebo-controlled, double-blind, phase-2 clinical trial was designed to test the hypothesis that, in menopausal women, the homeopathic medicine Malagueta (30 CH), compared with placebo, will significantly reduce the intensity of hot flashes, after 4 weeks of treatment. The primary outcome was the intensity of hot flashes, measured by the Measure Yourself Medical Outcome Profile (MYMOP) instrument. A total of 40 women were enrolled in the study, 20 in each group. RESULTS: The effect of Malagueta on the primary outcome, the intensity of hot flashes, assessed by MYMOP, was superior to that of placebo over the 4 weeks of treatment, with worsening in both groups after treatment was interrupted (after week 4, p < 0.001 in ordinal logistic regression). The odds ratio for treatment response (reduction of at least three MYMOP categories) was 2.78 (95% confidence interval, 0.77 to 10.05). Treatment with Malagueta, compared with placebo, also reduced the intensity of the secondary symptoms (p = 0.001) and improved level of activity (p = 0.025) and well-being (p = 0.008). CONCLUSION: The homeopathic medicine of Capsicum frutescens (Malagueta) was superior to placebo in reducing the intensity of hot flashes in menopausal women after 4 weeks of treatment.


Asunto(s)
Capsicum , Sofocos/tratamiento farmacológico , Menopausia , Fitoterapia , Preparaciones de Plantas/uso terapéutico , Método Doble Ciego , Femenino , Homeopatía , Humanos , Persona de Mediana Edad , Calidad de Vida , Índice de Severidad de la Enfermedad , Resultado del Tratamiento
9.
Pediatr Phys Ther ; 31(2): 185-190, 2019 04.
Artículo en Inglés | MEDLINE | ID: mdl-30907836

RESUMEN

PURPOSE: This study aimed to develop a prediction model for peak oxygen uptake ((Equation is included in full-text article.)O2peak) in children with spina bifida (SB), considering peak workload (Wpeak), peak heart rate, age, sex, anthropometric measures, walking level, physical activity level, and level of the lesion. METHODS: Data of 26 participants with SB performing a graded arm crank test were used to develop the prediction model. An unrelated data set of participants with SB was used for validation. RESULTS: The following equation was developed to predict (Equation is included in full-text article.)O2peak of participants with SB: (Equation is included in full-text article.)O2peak (mL/min) = 194+18 × Wpeak - 110 × sex (adjusted R(2) = 0.933, SEE = 96 mL/min). Bland-Altman analysis showed a nonsignificant mean difference between the measured and predicted values of (Equation is included in full-text article.)O2peak (-0.09 L/min) and limits of agreement of -0.4036 and 0.2236 L/min. CONCLUSIONS: The prediction model shows promising results; however, further validation using the same protocol is warranted before implementation in clinical practice.


Asunto(s)
Ergometría/métodos , Ergometría/normas , Consumo de Oxígeno/fisiología , Disrafia Espinal/fisiopatología , Adolescente , Factores de Edad , Brazo , Pesos y Medidas Corporales , Niño , Ejercicio Físico , Prueba de Esfuerzo/métodos , Prueba de Esfuerzo/normas , Tolerancia al Ejercicio , Femenino , Frecuencia Cardíaca/fisiología , Humanos , Masculino , Reproducibilidad de los Resultados , Factores Sexuales , Carga de Trabajo
10.
Virol J ; 15(1): 112, 2018 07 24.
Artículo en Inglés | MEDLINE | ID: mdl-30041676

RESUMEN

BACKGROUND: Chikungunya (CHIKV) virus is an important mosquito-borne virus causing outbreaks of acute febrile illness with arthropathy. The detection of specific antibodies against CHIKV is used for diagnosis after the acute viremic phase of the disease. However, a major challenge for serologic diagnosis of CHIKV and other alphaviruses is the cross-reactivity of antibodies to common antigens among these viruses. In the present study, we have developed an enzyme-linked immunosorbend assay using a recombinant envelope protein 2 of CHIKV produced in Escherichia coli system, as a capture antigen. RESULTS: High titers (1600 to 12,800) of anti-CHIKV antibodies were detected in human sera analyzed by the CHIKV assay, suggesting it may detect low levels of the antibodies presence. On the other side, cross-reactivity was not observed in mouse hyperimmune sera to Mayaro virus and other alphaviruses analyzed by the CHIKV immunosorbend assay, suggesting it is a CHIKV-specific test. Fifty-nine human serum samples of CHIKV infection suspected cases were tested for immunoglobulin G (IgG) and M (IgM) antibodies detection using the CHIKV immunosorbend assay. A total of 44% (26/59) of samples were positive for IgG to CHIKV, determining 89.66% sensitivity and 100% specificity when the assay is compared to a CHIKV-specific neutralization assay. In addition, 40.6% (24/59) of samples were positive for IgM, determining 92.48% sensitivity and 79.04% specificity by a Bayesian method in the absence of a gold standard. Moreover, CHIKV immunosorbend assay showed similar sensibilities to a commercial immunochromatography assay (Lumiquick, USA) for CHIKV IgG and IgM detection. CONCLUSION: In short, we have developed a rapid, simple, specific and sensitive CHIKV immunosorbend assay for IgG and IgM detection and our results showed potential applicability on the diagnosis of infections by this virus.


Asunto(s)
Antígenos Virales/inmunología , Fiebre Chikungunya/diagnóstico , Fiebre Chikungunya/inmunología , Virus Chikungunya/inmunología , Ensayo de Inmunoadsorción Enzimática , Proteínas del Envoltorio Viral/inmunología , Anticuerpos Neutralizantes/inmunología , Anticuerpos Antivirales/inmunología , Humanos , Inmunoglobulina G/sangre , Inmunoglobulina G/inmunología , Inmunoglobulina M/sangre , Inmunoglobulina M/inmunología , Pruebas de Neutralización , Proteínas Recombinantes , Sensibilidad y Especificidad
11.
Homeopathy ; 107(2): 143-149, 2018 05.
Artículo en Inglés | MEDLINE | ID: mdl-29579763

RESUMEN

INTRODUCTION: Previous findings from a pragmatic trial suggest that usual care compared with usual care plus individualised homeopathy is not a feasible design to address homeopathic interventions for asthma. OBJECTIVE: The main purpose of this article was to investigate the feasibility of the randomised withdrawal design as a strategy to assess the effectiveness of a standardised clinical-pharmaceutical homeopathic protocol (Organon.modus) on perennial asthma in adolescents. METHODS: Randomised withdrawal, double-blind, parallel, placebo-controlled, 12-week study. Patients: 12 to 17 years old adolescents, with the diagnosis of perennial asthma, using inhalatory beclomethasone (plus fenoterol for wheezing episodes), who achieved 3 months of well-controlled asthma, after a variable period of individualised homeopathic treatment according to Organon.modus protocol. Setting: a secondary care medical specialist centre. Intervention: continuation with the individualised homeopathic medicine or with indistinguishable placebo during 12 weeks of beclomethasone step-down. Primary outcome: number of days of well-controlled asthma. Secondary measures: number of days of fenoterol use, number of visits to an emergency service (without hospitalisation) and percentage of patients excluded due to an exacerbation characterising a partly controlled asthma. Tolerability was assessed by Adverse Events, registered at every visit. RESULTS: Nineteen patients were randomised to continue treatment with homeopathy and 21 with placebo. Effectiveness measures for the homeopathy and placebo groups respectively were median number of days of good clinical control: 84 versus 30 (p = 0.18); median number of days of fenoterol use per patient: 3 versus 5 (p = 0.41); visits to an emergency room: 1 versus 6 (p = 0.35); percentage of exclusion due to partly controlled asthma: 36.8% versus 71.4% (p = 0.05). Few Adverse Events were reported. CONCLUSIONS: This pilot study supports the feasibility of the double-blind randomised withdrawal design in studies investigating homeopathy on teenage asthma, when performed by specialists following a standardised clinical-pharmaceutical homeopathic protocol. CLINICAL TRIAL REGISTRATION: RBR-6XTS8Z.


Asunto(s)
Asma/terapia , Homeopatía/métodos , Adolescente , Asma/tratamiento farmacológico , Método Doble Ciego , Estudios de Factibilidad , Femenino , Humanos , Masculino , Materia Medica/uso terapéutico , Efecto Placebo , Placebos , Resultado del Tratamiento
12.
J Med Virol ; 89(4): 748-752, 2017 04.
Artículo en Inglés | MEDLINE | ID: mdl-27589576

RESUMEN

Human parvovirus 4 (PARV4), a Tetraparvovirus, has been largely found in HIV, HBV, or HCV infected individuals. However, there is no data for the PARV4 occurrence in Human T-lymphotropic virus (HTLV-1/2) infected individuals, despite similar transmission routes. Here, PARV4 viremia was evaluated in 130 HTLV infected patients under care of a Brazilian HTLV outpatient clinic. PARV4 viremia was detected in 6.2% of the HTLV-1 infected patients. Most PARV4 positives showed no evidence for parenterally transmitted infections. It is suggested that in Brazil, transmission routes of PARV4 are more complex than in Europe and North America and resemble those in Africa. J. Med. Virol. 89:748-752, 2017. © 2016 Wiley Periodicals, Inc.


Asunto(s)
Infecciones por HTLV-I/complicaciones , Infecciones por HTLV-II/complicaciones , Infecciones por Parvoviridae/epidemiología , Parvovirus/aislamiento & purificación , Adulto , Anciano , Brasil/epidemiología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Prevalencia , Viremia/epidemiología , Adulto Joven
13.
J Relig Health ; 56(6): 2180-2193, 2017 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-28342142

RESUMEN

The objective of this cross-sectional study is to examine the association between religious involvement and tobacco use in a large representative sample of users of primary healthcare units of Ribeirão Preto, Southeast Brazil. Current and past smoking habits were determined among 1055 users of primary healthcare units. Participants' religiosity was measured using the DUREL questionnaire. The prevalence of smoking among men was 16.8% [95% confidence interval (CI) 12.0-22.5] and among women was 12.6% (95% CI 10.4-15.0). Among the current smokers, 40.9% were light smokers, 24.6% were moderate smokers, and 34.5% were heavy smokers. The mean number of cigarettes smoked per day was 13.5. Respondents who have a religion had a lower smoking prevalence than people who had no religion. Current smoking prevalence tended to be higher among people who do not practice their religion than people who practice their religion. Smoking status is also associated with self-reported religiosity, organizational religious activity and some aspects of intrinsic religiosity. Religiosity is an important factor in influencing the smoking behavior in Brazilian users of the public health services.


Asunto(s)
Atención Primaria de Salud , Religión y Medicina , Fumar/epidemiología , Adulto , Brasil/epidemiología , Estudios Transversales , Femenino , Humanos , Masculino , Persona de Mediana Edad , Prevalencia , Autoinforme , Encuestas y Cuestionarios
14.
Stat Med ; 35(15): 2525-42, 2016 07 10.
Artículo en Inglés | MEDLINE | ID: mdl-26840012

RESUMEN

Generic drugs have been commercialized in numerous countries. Most of these countries approve the commercialization of a generic drug when there is evidence of bioequivalence between the generic drug and the reference drug. Generally, the pharmaceutical industry is responsible for the bioequivalence test under the supervision of a regulatory agency. This procedure is concluded after a statistical data analysis. Several agencies adopt a standard statistical analysis based on procedures that were previously established. In practice, we face situations in which this standard model does not fit to some sets of bioequivalence data. In this study, we propose an evaluation of bioequivalence using univariate and bivariate models based on an extended generalized gamma distribution and a skew-t distribution, under a Bayesian perspective. We introduce a study of the empirical power of hypothesis tests for univariate models, showing advantages in the use of an extended generalized gamma distribution. Three sets of bioequivalence data were analyzed under these new procedures and compared with the standard model proposed by the majority of regulatory agencies. In order to verify that the asymmetrical distributions are usually better fitted for the data, when compared with the standard model, model discrimination methods were used, such as the Deviance Information Criterion (DIC) and quantile-quantile plots. The research concluded that, in general, the use of the extended generalized gamma distribution may be more appropriate to model bioequivalence data in the original scale. Copyright © 2016 John Wiley & Sons, Ltd.


Asunto(s)
Teorema de Bayes , Medicamentos Genéricos , Equivalencia Terapéutica , Interpretación Estadística de Datos , Humanos , Distribuciones Estadísticas
15.
Clin Exp Pharmacol Physiol ; 43(7): 685-9, 2016 07.
Artículo en Inglés | MEDLINE | ID: mdl-27120710

RESUMEN

Lamotrigine (LTG) is one of the most widely used antiepileptic drugs. Confusion still exists in the literature as to the relative influence of age, body weight, and concomitant drug therapy on LTG pharmacokinetics. So, the objective of this study is to evaluate the influence of patient-related factors and comedication on LTG apparent oral clearance (CL/F). A therapeutic drug-monitoring database was used to identify steady-state plasma LTG concentrations in 210 patients. LTG CL/F values were calculated for each patient according to the equation CL/F (L/h per kg) = LTG daily dose (mg/kg)/Css (steady state concentration) (mg/L) × 24 h. A linear-regression model was used to assess the influence of gender, dose, age, and body weight in LTG CL/F. The influence of comedication on LTG CL/F was investigated by applying the Bonferroni post-test. The lowest LTG CL/F was found in patients comedicated with valproate (VPA) (mean, 0.0183 L/h per kg), followed by patients receiving VPA + enzyme inducers (0.0271 L/h per kg), patients on LTG monotherapy (0.0298 L/h per kg) and patients comedicated with enzyme inducers (0.056 L/h per kg) LTG CL/F correlated significantly with LTG dose (P < 0.01), but showed no significant relationship with gender, weight, and age. LTG CL/F is influenced by the type of antiepileptic comedication. The correlation with dose may be a spurious finding related to the fact that physicians, in adjusting dosage according to clinical response, are more likely to use larger doses in patients with high clearance values.


Asunto(s)
Anticonvulsivantes/farmacocinética , Anticonvulsivantes/uso terapéutico , Epilepsia/tratamiento farmacológico , Epilepsia/metabolismo , Triazinas/farmacocinética , Triazinas/uso terapéutico , Adulto , Peso Corporal/efectos de los fármacos , Relación Dosis-Respuesta a Droga , Interacciones Farmacológicas/fisiología , Quimioterapia Combinada/métodos , Femenino , Humanos , Cinética , Lamotrigina , Masculino , Ácido Valproico/uso terapéutico , Adulto Joven
17.
Nutr Cancer ; 67(6): 926-32, 2015.
Artículo en Inglés | MEDLINE | ID: mdl-26134076

RESUMEN

The aim of the study was to evaluate the effect of zinc supplementation on the antibody titer and the 23-valent pneumococcal seroconversion after vaccination in patients undergoing chemotherapy for colorectal cancer. The study included 25 patients undergoing postsurgery chemotherapy for colorectal adenocarcinoma (chemo group). Subjects were assessed in the perioperative period (prevaccination), before chemotherapy (4th wk) and after 3 cycles of chemotherapy (16th wk). Thirty-two healthy volunteers (control group) were included in the study. Participants received the 23-valent pneumococcal conjugate vaccine, and capsules containing zinc (Zn) sulfate (70 mg daily) or identical placebo capsules (containing wheat starch with no added Zn) for 16 wk and were randomly allocated on one of the following groups: chemo-Zn (n = 10), chemo-placebo (n = 15), control-Zn (n = 21), and control-placebo (n = 11). The antipneumococcal antibody titer against 6 polysaccharides was analyzed by ELISA and compared using linear mixed models. The seroconversion rate was compared using Fisher's exact test. An immune response to the vaccination against pneumococcus was observed in all participants. In the 16th wk, the polysaccharide 6 concentration was lower in the chemo-Zn group [2.96 (1.74-5.03) µg/mL] compared with the Chemo-Placebo group [10.75 (5.37-21.54) µg/mL] and the seroconversion rate was lower in the chemo-placebo (36%) compared with the control-placebo (85%) (P = 0.027). Zinc supplementation did not change the antibody titer after vaccination. However, the lower seroconversion rate observed in the chemo-placebo suggests an influence of zinc in the vaccinal protection.


Asunto(s)
Neoplasias Colorrectales/tratamiento farmacológico , Suplementos Dietéticos , Streptococcus pneumoniae/inmunología , Sulfato de Zinc/administración & dosificación , Anciano , Anticuerpos Antibacterianos/sangre , Método Doble Ciego , Femenino , Voluntarios Sanos , Humanos , Masculino , Persona de Mediana Edad , Vacunas Neumococicas/administración & dosificación , Vacunas Neumococicas/inmunología , Estudios Prospectivos , Vacunación , Vacunas Conjugadas/inmunología
18.
Artículo en Inglés | MEDLINE | ID: mdl-38719720

RESUMEN

Many countries have modified their policies on banning or deferring blood donation by men who have sex with men (MSM) in light of ethical concerns and new evidence about transfusion risks. In Brazil, MSM were not eligible to donate blood unless they had been celibate for the previous 12 months. However, in May 2020, the Brazilian Federal Supreme Court overturned this restriction. Many authors have attempted to stress possible risks of transfusion-transmitted infection under various scenarios of changes in bans or restrictions on donations by MSM using mathematical models, but we consider that it is a difficult task due to the wide variety of sexual behaviors, attitudes, and practices. Among these factors, we highlight sex under the influence of illicit drugs, and the fact that people with an undetectable human immunodeficiency virus viral load have the potential to transmit should their blood be transfused. Despite these possible risks, we believe that some MSM can donate blood regardless of the time elapsed since their last sexual contact, especially because blood donations by MSM were occurring even when there were time-based deferral rules. Blood banks should always seek to use screening algorithms to identify high-risk sexual behaviors using gender-neutral criteria, and education about transfusion risks should be offered to healthcare workers and MSM.

19.
Artículo en Inglés | MEDLINE | ID: mdl-38195199

RESUMEN

INTRODUCTION: One of the most popular ways to meet new people in the modern world is through dating apps. However, its use may facilitate casual sexual encounters and quick partner changes, both of which associated to endangering sexual health in different populations. OBJECTIVE: To describe the use of mobile dating apps among undergraduate students at a major Brazilian public university and investigate its associations with sexual risk behaviors and sociodemographic factors. METHODS: This is a cross-sectional study based on a web survey. The link for participation was made available to students enrolled in undergraduate courses in the eight units of the University of São Paulo, Campus Ribeirão Preto. Use of dating apps, sociodemographic/behavioral profile, and sexual risk behaviors were among the variables studied. The distribution of apps users was calculated for each variable of interest, and prevalence ratios (PRs) were used for comparisons. PRs were reported with 95% confidence intervals. RESULTS: A total of 487 students participated, with 32.9% reporting using dating apps. Male participants were more likely to use. The use of dating apps was associated with having multiple sexual partners and risky behaviors such as smoking, alcohol consumption, and substance abuse. CONCLUSION: It is critical to describe the pattern of app use in undergraduate students and understand their influence on sexual health in order to avoid stigmatizing users. Additionally, this information can be helpful in directing the creation of strategies for using these apps as resources to promote health, such as the information-sharing regarding the sexual health.

20.
J Pediatr (Rio J) ; 100 Suppl 1: S48-S56, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-37918812

RESUMEN

OBJECTIVE: To present the different aspects that may be involved in the genesis and maintenance of obesity in children and adolescents. DATA SOURCE: Narrative review of articles published in the PubMed, Scielo, Lilacs, Scopus and Google Scholar databases, using the search terms: overweight, obesity, pre-conception, prenatal, infants, schoolchildren, children, and adolescents. The search was conducted in studies written in Portuguese, English and Spanish, including narrative, integrative or systematic reviews, meta-analyses, cross-sectional, case-control and cohort studies, published between 2003 and 2023. DATA SYNTHESIS: A total of 598 studies were initially screened and 60 of them, which showed the main biopsychosocial aspects related to greater risks of excessive adiposity in the pediatric age, were included in the review. The data were presented taking into account the incidence of risk factors and their consequences in six periods: pre-conception, pre-natal, infant, preschool, school age, and adolescence. CONCLUSIONS: The causal factors described in the scientific literature that have been shown to be related to obesity in childhood and adolescence are presented.


Asunto(s)
Obesidad Infantil , Adolescente , Niño , Preescolar , Humanos , Lactante , Adiposidad , Estudios Transversales , Sobrepeso/epidemiología , Obesidad Infantil/epidemiología , Obesidad Infantil/etiología , Factores de Riesgo , Recién Nacido , Literatura de Revisión como Asunto , Metaanálisis como Asunto
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