Relationship of vitamin D with the anthropometric indicators and lifestyle of adults. Medellín. Colombia

Introduction: Serum vitamin D levels depend on sunlight, diet, and other factors. Objective: We aimed to determine serum vitamin D levels and evaluate their relationship with anthropometric indicators and lifestyle habits in apparently healthy volunteers. Materials and Methods: In this cross-sectional study (n=75), socio-demographic, anthropometric, and lifestyle habit-related data were collected. Serum vitamin D levels were determined with high performance liquid chromatography, food intake was measured by semiquantitative frequency and nutritional status was assessed by anthropometry. Chi-square test and also principal component analysis were used to analyze the relationship between some variables and vitamin D status. Spearman's test was used to determine correlations between quantitative variables. Results: 73% were women and 61% belonged to medium socio-economic level. Median vitamin D intake was 137 (83.1­227.3) IU/day. Based on body mass index (BMI), 44% individuals had overweight/obesity. The 68% exhibited deficient/insufficient vitamin D levels (Hypovitaminosis D). BMI classification and waist circumference (CW) were not related with vitamin D status; however, activities with higher sun exposure were highly related (p = 0.013). Sun exposure time explained variation in component 2 (16.60%), where most of the individuals with normal level were grouped. Sun exposure time was positively correlated with vitamin D status (r = 0.263; p = 0.023). Discussion: Excess weight and abdominal obesity are not always associated with hypovitaminosis D. Conclusions: The majority of individuals showed hypovitaminosis D but their status was not related with anthropometric indicators. A Sun exposure time was the only factor positively correlated with vitamin D status.

Introducción: Los niveles séricos de vitamina D dependen de la luz solar, la dieta y otros factores. Objetivo: Nuestro objetivo fue determinar los niveles séricos de vitamina D y evaluar su relación con indicadores antropométricos y estilos de vida en voluntarios aparentemente sanos. Materiales y métodos: En este estudio trasversal (n=75) se recogieron datos sociodemográficos, antropométricos y aquellos relacionados con hábitos y estilos de vida. La vitamina D se determinó por cromatografía liquida de alta eficiencia; la ingesta de alimentos, mediante frecuencia semicuantitativa, y el estado nutricional por antropometría. Para analizar la relación entre algunas variables y el estado de la vitamina D se usó la prueba de Chi cuadrado y también el análisis de componentes principales. Se empleó la prueba de Spearman para determinar la correlación entre variables cuantitativas. Resultados: El 73% eran mujeres y el 61% pertenecían a un estrato socioeconómico medio. La mediana de la ingesta de vitamina D fue de 137 (83,1­227,3) UI/día. Según el índice de masa corporal (IMC), el 44% de los individuos tenían sobrepeso/obesidad. El 68% mostro deficiencia/insuficiencia de vitamina D (hipovitaminosis D). La clasificación del IMC y la circunferencia abdominal no se relacionaron con el estado de la vitamina D; sin embargo, las actividades con una mayor exposición solar estuvieron altamente relacionadas (p=0,013). El tiempo de exposición solar explico la variación en el componente 2 (16,60%) donde se agruparon la mayoría de los individuos con niveles normales. El tiempo de exposición solar tuvo una correlación positiva con el estado de la vitamina D (r = 0,263; p = 0,023). Discusión: El exceso de peso y la obesidad abdominal no siempre se relacionan con la hipovitaminosis D. Conclusiones: La mayoría de los individuos presentaron hipovitaminosis D, pero su estado no se relacionó con los indicadores antropométricos. El tiempo de exposición al sol fue el único factor que se correlaciono positivamente con el estado de la vitamina D.

Introdução: Os níveis séricos de vitamina D dependem da luz solar, da dieta e de outros fatores. Objetivo: Nosso objetivo foi determinar os níveis séricos de vitamina D e avaliar sua relação com indicadores antropométricos e hábitos de vida em voluntários aparentemente saudáveis. Materiais e métodos: Neste estudo transversal (n=75), foram coletados dados sociodemográficos, antropométricos e relacionados a hábitos de vida. Os níveis séricos de vitamina D foram determinados por cromatografia liquida de alto desempenho, a ingestão de alimentos foi medida por frequência semiquantitativa e o estado nutricional foi avaliado por antropometria. O teste do qui-quadrado e a análise de componentes principais foram utilizados para analisar a relação entre algumas variáveis e o estado da vitamina D. O teste de Spearman foi usado para determinar as correlações entre as variáveis quantitativas. Resultados: 73% eram mulheres e 61% pertenciam a um nível socioeconômico médio. A ingestão media de vitamina D foi de 137 (83,1-227,3) UI/dia. Com base no índice de massa corporal (IMC), 44% dos indivíduos tinham sobrepeso/obesidade. Os 68% apresentaram níveis deficientes/insuficientes de vitamina D (hipovitaminose D). A classificação do IMC e a circunferência da cintura (CW) não foram relacionadas ao status da vitamina D; entretanto, as atividades com maior exposição ao sol foram altamente relacionadas (p = 0,013). O tempo de exposição ao sol explicou a variação no componente 2 (16,60%), onde a maioria dos indivíduos com nível normal foi agrupada. O tempo de exposição ao sol foi positivamente correlacionado com o status de vitamina D (r = 0,263; p = 0,023). Discussão: O excesso de peso e a obesidade abdominal nem sempre estão associados com a hipovitaminose D. Conclusões: A maioria dos indivíduos apresentou hipovitaminose D, mas seu status não foi relacionado com indicadores antropométricos. O tempo de exposição ao sol foi o único fator positivamente correlacionado com o status da vitamina D.

Consideraciones bioéticas sobre los incentivos a participantes voluntarios sanos en investigaciones Fase I

Los ensayos clínicos en Fase I se realzan con la participación de voluntarios sanos de prueban la seguridad y tolerabilidad de los productos farmacéuticos en investigación. En ellos, los participantes están expuestos a riesgos de medicamentos del estudio sin la posibilidad de un beneficio médico directo y, por lo general, deben pasar días o semanas en un centro de investigación. Los incentivos, como pagos monetarios se utilizan para incentivar la inscripción y compensar a los participantes por su tiempo. Estas características de los ensayos voluntarios sanos de fase I crean un contexto de investigación que difiere notablemente de la mayoría de las otras investigaciones clínicas, pues la mayoría de ellos son personas vulnerables económicamente. Este artículo presenta el objetivo de analizar factores bioéticos que inciden en el otorgamiento de incentivos a participantes voluntarios sanos en investigaciones Fase I.

Phase I Clinical Trials are conducted with the participation of healthy volunteers to test the safety and tolerability of pharmaceutical products. In them, participants are exposed to study drug risks without the possibility of direct medical benefit and usually must spend days or weeks at a research site. Incentives such as monetary payments are used to encourage enrollment and compensate participants for their time. These characteristics of Phase I healthy volunteer trials create a research context that differs markedly from most other clinical research, as most of them are financially vulnerable individuals. This paper aims to analyze bioethical factors that influence the granting of incentives to healthy volunteer participants in Phase I research.

Gastric emptying in patients with cholelithiasis and in patients following cholecystectomy: measurement by ultrasonography / 中华麻醉学杂志

Objective:To evaluate the gastric emptying in the patients with cholelithiasis and in the patients following cholecystectomy by ultrasonography.Methods:Thirty patients with cholelithiasis, 30 post-cholecystectomy patients and 30 healthy volunteers, of either sex, aged 18-64 yr, with body mass index of 18-30 kg/m 2, of American Society of Anesthesiologists Physical Status classification Ⅰor Ⅱ, were selected and divided into cholelithiasis group (group CH), post-cholecystectomy group (group PC) and healthy volunteer group (group HV). The indigestion scores of the enrolled subjects in the past 3 months were assessed; the subjects took a semi-solid test meal (300 kcal) in the fasting state, and the cross-sectional area (CSA) of the gastric sinus was measured using ultrasound at fasting (T 0) and 5, 15, 30, 45, 60, 90 and 120 min after the test meal was taken (T 1-7). The gastric emptying fraction at T 5, 6 was calculated. The gastric half-emptying time and remaining area of the gastric sinus at T 7 were also calculated. Results:Compared with group HV, dyspepsia scores were significantly increased within the past 3 months ( P<0.05), the CSA of the gastric sinus was increased at T 3-7, the gastric emptying fraction was decreased at T 5-6, the gastric half-emptying time was prolonged, and the remaining area of the gastric sinus was increased at T 7 in group CH and group PC ( P<0.05). Compared with group CH, the CSA of the gastric sinus was significantly increased at T 4-7, the gastric emptying fraction was decreased at T 5, 6, the gastric half-emptying time was prolonged, and the remaining area of the gastric sinus was increased at T 7 in group PC ( P<0.05). Conclusions:Gastric emptying time is longer in the patients with cholelithiasis and in the patients following cholecystectomy than in healthy subjects and is further prolonged after cholecystectomy in the patients.

Medidas de efeito das intervenções em vozes saudáveis: uma revisão de escopo / Measurements of the effect of interventions on heathly voices: a scope review

RESUMO Objetivo mapear as medidas de avaliação vocal utilizadas para verificar o efeito da intervenção em indivíduos vocalmente saudáveis. Estratégia de pesquisa trata-se de uma revisão de escopo baseada na questão de pesquisa: "Quais as medidas de avaliação vocal utilizadas para verificar o efeito da intervenção em indivíduos vocalmente saudáveis?" A busca foi realizada de forma eletrônica nas bases de dados MEDLINE (PubMed), LILACS (BVS), Scopus (Elsevier), Web of Science (Clarivate), Embase e Cochrane. Critérios de seleção a seleção dos estudos foi baseada na leitura dos títulos, resumos, palavras-chave e textos completos, aplicando-se os critérios de elegibilidade. Foram extraídos os dados relacionados às informações bibliográficas da publicação, características da amostra e da intervenção, os efeitos da intervenção nas medidas de autoavaliação, perceptivo-auditivas, acústicas, aerodinâmicas, eletroglotográficas, resultado do exame laríngeo, entre outros. Os dados foram resumidos e apresentados de forma quantitativa e descritiva. Resultados foram selecionados 97 artigos, entre os 979 estudos mapeados nesta revisão. A análise acústica foi a medida mais utilizada (n=70, 72,3%) para verificar os efeitos do treinamento vocal nos estudos selecionados, seguida pela eletroglotografia (n= 55, 56,7%), autoavaliação (n= 38, 39,2%), aerodinâmica (n= 33, 34,0%), julgamento perceptivo-auditivo (n= 22, 22,7%) e exame laríngeo (n= 16, 16,5%). Conclusão a análise acústica é a medida utilizada na maioria dos estudos para verificar o efeito da intervenção em indivíduos vocalmente saudáveis.

ABSTRACT Purpose to map the vocal assessment measures used to verify the effect of the intervention in vocally healthy individuals. Research strategy This is a scope review based on the research question: What vocal assessment measures are used to verify the effect of the intervention in vocally healthy individuals? The search was carried out electronically in MEDLINE (PubMed), LILACS (BVS), Scopus (Elsevier), Web of Science (Clarivate), Embase and Cochrane databases. Selection criteria The selection of studies was based on reading the titles, abstracts, keywords and full texts, applying the eligibility criteria. Data related to the publication's bibliographic information, sample and intervention characteristics, the effects of the intervention on self-assessment, auditory-perceptual, acoustic, aerodynamic, electroglottographic measures, laryngeal examination results, among others, were extracted. The data were summarized and presented in a quantitative and descriptive way. Results 97 articles were selected, among the 979 studies mapped in this review. Acoustic analysis was the most used measure (n=70, 72.3%) to verify the effects of vocal training in the selected studies, followed by electroglottography (n= 55, 56.7%), self-assessment (n= 38, 39 .2%), aerodynamics (n= 33, 34.0%), auditory-perceptual judgment (n= 22, 22.7%) and laryngeal examination (n= 16, 16.5%). Conclusion Acoustic analysis is the measure used in most studies to verify the effect of the intervention in vocally healthy individuals.

Does the Number of Stimuli Influence the Formation of the Endogenous Components of the Event-Related Auditory Evoked Potentials?

Abstract Introduction The number of stimuli is important to determine the quality of auditory evoked potential records. However, there is no consensus on that number in studies, especially in the sample studied. Objectives To investigate the influence of the number of rare stimuli on forming N2 and P3 components, with different types of acoustic stimuli. Methods Cross-sectional, descriptive, comparative study, approved by the ethics committee of the institution. The sample comprised 20 normal hearing adults of both sexes, aged 18 to 29 years old, with normal scores in the mental state examination and auditory processing skills. The event-related auditory evoked potentials were performed with nonverbal (1 kHz versus 2 kHz) and verbal stimuli (/BA/ versus /DA/). The number of rare stimuli varied randomly in the recordings, with 10, 20, 30, 40, and 50 presentations. Results P3 latency was significantly higher for nonverbal stimuli with 50 rare stimuli. N2 latency did not show any difference between the type and number of stimuli. The absolute P3 and N2-P3 amplitudes showed significant differences for both types of stimuli, with higher amplitude for 10 rare stimuli, in contrast with the other ones. The linear tendency test indicated significance only for the amplitude - as the number of rare stimuli increased, the amplitude tended to decrease. Conclusion The components were identifiable in the different numbers of rare stimuli and types of stimuli. The P3 and N2-P3 latency and amplitude increased with fewer verbal and nonverbal stimuli. Recording protocols must consider the number of rare stimuli.

Comparison of different frequencies of transcutaneous electrical diaphragmatic stimulation in healthy subjects: a randomized crossover clinical trial / Comparação de diferentes frequências da estimulação diafragmática elétrica transcutânea em indivíduos saudáveis: ensaio clínico randomizado cruzado

Most transcutaneous electric diaphragmatic stimulation (TEDS) studies use a stimulation frequency (SF) of 30 Hz, although the reason for this SF value is not completely understood. Objective:The purpose of this study was to compare the acute effect of two TEDS frequencies on the respiratory muscle strength and endurance, muscle activation, muscle thickness, diaphragmatic mobility, cardiovascular variables and safety in healthy subjects. Methods:Randomized crossover clinical trial with 20 healthy subjects subjected to two interventions: SF=30 Hz group and SF=80 Hz group. TEDS was applied at the diaphragm motor points with a symmetric biphasicpulsed current (pulse duration= 500 µs) for 30 minutes. The evaluated outcomes were systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), respiratory muscle strength by maximal inspiratory pressure (MIP), maximal expiratory pressure (MEP), inspiratory peak flux (PIF), diaphragm thickness during inspiration (DTI) and expiration (DTE), diaphragm mobility and activation, and endurance (S-Index). Results:SF-30 Hz showed a reduction with respect to baseline values for SBP (p=0.04), HR (p<0.001), DTE (p=0.02), IPF (p=0.01), and S-Index (p=0.03). SF-80 Hz showed a reduction with respect to baseline values for HR (p<0.001) and an increase in MEP (p<0.001). However, these changes were not clinically important and there were no between-groups differences for any of the evaluated outcomes. No complications were observed. Conclusion:TEDS with SF-80 Hz produces similar effects to SF-30 Hz in healthy subjects and bothfrequencies proved to be safe (NCT03844711).

A maioria dos estudos utilizam a estimulação diafragmática elétrica transcutânea (EDET) com frequência (F) de estímulo de 30Hz e testar diferentes frequências torna-se necessário para uma aplicação otimizada. Objetivo: Foi comparar o efeito agudo de duas frequências diferentes da EDET sobre a força muscular respiratória e endurance, ativação diafragmática, espessura muscular e mobilidade diafragmática, variáveis cardiovasculares e segurança em indivíduos saudáveis. Métodos: Estudo randomizado cruzado com 20 indivíduos saudáveis submetidos a duas intervenções: Grupo I com F= 30Hz e Grupo II com F= 80Hz. A aplicação foi nos pontos motores do diafragma, com duração do pulso de 500µs, durante 30 minutos. Foram avaliados a pressão arterial sistólica (PAS) e diastólica (PAD), frequência cardíaca (FC), força muscular respiratória pela pressão inspiratória máxima (PImax), pressão expiratória máxima (PEmax), endurance e espessura muscular em inspiração (EDI) e expiração (EDE), mobilidade e ativação diafragmática. Resultados: O GI apresentou redução significativa em comparação às condições basais para os desfechos de PAS (p= 0.04), FC (p<0.001), EDI (p= 0,02), PIF (p= 0.01), e S-Index (p= 0.03). O GII apresentou redução significativa em comparação às condições basais para FC (p<0.001) e aumento da PEmax (p<0.001). Porém, estas alterações não foram clinicamente importantes e não houve diferença entre os grupos para nenhum desfecho avaliado. Nenhuma intercorrência foi observada. Conclusão: A EDET com F-80Hz produz efeitos semelhantes a F-30Hz em indivíduos saudáveis e ambas as frequências provaram ser seguras (NCT03844711).

Bioequivalence of amlodipine besylate tablets in Chinese healthy subjects / 中国临床药理学与治疗学

AIM: To evaluate the bioequivalence of two kinds of amlodipine besylate tablets in Chinese healthy subjects under fasting and fed conditions. METHODS: Twenty-four healthy subjects were enrolled, and a random, open, single-dose, two preparations, two sequences and double-crossover design was used to give the test or reference preparations under fasting and postprandial conditions. The concentration of metformin in plasma was detected by LC-MS/MS, and the main pharmacokinetic parameters were calculated to evaluate the bioequivalence. RESULTS: In fasting state, the mean of C

Study on pharmacokinetics of osmotic pump tablets of hydrochloride venlafaxine in Chinese healthy volunteers / 中国药理学通报

Aim To evaluate the pharmacokinetics and bioequivalence of two osmotic pump tablets of hydrochloride venlafaxine in Chinese healthy volunteers.Methods The fed test each enrolled twenty-six Chinese healthy volunteers in a randomized-sequence, open-label, two-period crossover single-dose oral test and reference preparations of hydrochloride venlafaxine extended-release tablets.The plasma concentrations of venlafaxine and its active metabolites O-desmethylvenlafaxine were determined by a validated liquid chromatography-tandem mass spectrometry(LC-MS/MS)method, and the pharmacokinetic parameters and bioequivalence of the two tablets were analyzed using PhoenixTM WinNonlin 6.4 software.Results The pharmacokinetic parameters of venlafaxine after single dose for the test and reference tablets were as follows: Cmax(58.50±19.47)vs(60.14±22.18)μg•L-1, AUC0-t(1 074.1±526.7)vs(1 057.9±539.7)μg•h•L-1, AUC0-∞(1 084.7±536.8)vs(1 067.8±554.0)μ g•h•L-1.The pharmacokinetic parameters of O-desmethylvenlafaxine were as follows: Cmax(101.63±29.64)vs(101.45±31.62)μg•L-1, AUC0-t(2 694.0±834.5)vs(2 702.9±946.4)μg• h•L-1, AUC0-∞(2 753.9±885.5)vs(2 753.2±988.4)μg•h•L-1.The 90% confidence intervals of the geometric mean ratios of Cmax, AUC0-t, AUC0-∞ for the test preparation and the reference preparationwere all within the equivalent interval of 80.00%-125.00%.Conclusion The test and reference preparations of hydrochloride venlafaxine extended-release tablets are bioequivalent in Chinese healthy volunteers under fed conditions.

Volunteers for clinical trials: from the history of abuses and exploitation to the inclusion movement, and to an income resource / Voluntários para ensaios clínicos: de uma de história de abusos e exploração até o movimento de inclusão e fonte de renda / Voluntarios para ensayos clínicos: de una historia de abusos y explotación hasta el movimiento de inclusión y fuente de renta

Medical research is essential to develop new and better therapies, increase social standards and a better life for all of us. Scientific curiosity has helped to achieve many successful innovations, but history also demonstrates that research can lead to abuses of individuals neglecting autonomy and integrity of the human being. Since the 1960ies we have witnessed a continuous development of international regulations and ethics guidelines (soft law) in medical research, leading to a higher quality of scientific results. An important focus lies on recognizing human vulnerability and a therefore adapted informed consent procedure. Our modern clinical trials structure requires the inclusion of healthy volunteers in the first phases of the development of a new medicinal product, leading to new ethical questions and challenges. The Corona-Pandemic has accelerated vaccine development in a successful way also leading to a new importance of healthy volunteers in the medical research landscape.

A pesquisa médica é essencial para desenvolver novas e melhores terapias, aumentar os padrões sociais e uma vida melhor para todos nós. A curiosidade científica ajudou a alcançar muitas inovações bem-sucedidas, mas a história também demonstra que a pesquisa pode conduzira abusos de indivíduos, negligenciando a autonomia e a integridade do ser humano. Desde a década de 1960, temos testemunhado um desenvolvimento contínuo de regulamentos internacionais e de diretrizes éticas (soft law) em pesquisa médica, levando a resultados científicos de maior qualidade. Um foco importante está no reconhecimento da vulnerabilidade humana e, consequentemente, num procedimento de consentimento informado adaptado. A nossa estrutura moderna de ensaios clínicos requer a inclusão de voluntários saudáveis nas primeiras fases do desenvolvimento de um novo medicamento, suscitando novas questões e desafios éticos. A pandemia de coronavírus acelerou o desenvolvimento de vacinas de uma forma bem-sucedida, contribuindo também para uma maior importância de voluntários saudáveis no cenário da pesquisa médica.

La investigación médica es esencial para desarrollarterapias nuevas y mejores, aumentar los estándares sociales y una vida mejor para todos nosotros. La curiosidad científica ha ayudado a lograr muchas innovaciones exitosas, pero la historia también demuestra que la investigación puede conducir a abusos deindividuos que descuidan la autonomía y la integridad del ser humano.Desde la década de 1960 hemos sido testigos de un desarrollo continuo de las regulaciones internacionales y de las directriceséticas(soft law) en la investigación médica, lo que ha llevado a una mayor calidad de los resultados científicos. Un enfoque importante radica en el reconocimiento de la vulnerabilidad humana y, por lo tanto, en un procedimiento de consentimiento informado adaptado.Nuestra moderna estructura de ensayos clínicos requiere la inclusión de voluntarios sanos en las primeras fases del desarrollo de un nuevo medicamento, lo que genera nuevas cuestiones y desafíos éticos. La pandemia de coronavirus ha acelerado el desarrollo de vacunas de una manera exitosa, lo que también ha dado lugar a una nueva importancia de los voluntarios sanos en el panorama de la investigación médica.

Exploration of screening criteria for healthy volunteers in human bioequivalence clinical trials / 中国临床药理学与治疗学

Human bioequivalence testing is an important part of evaluating the quality of a formulation. Although these drugs have a large amount of safety data and clinical application data, they may still have ethical risks in healthy subjects. The definition of healthy volunteers, the general inclusion and exclusion criteria, auxiliary inclusion and exclusion criteria, and inclusion and exclusion criteria considering drug specificity are summarized. The basis for determining whether abnormal test values are clinically significant when screening healthy subjects and the considerations for improving the screening pass rate are discussed. It is expected to provide useful reference for the smooth implementation of human bioequivalence testing.

Correlação da ventilação voluntária máxima com a força e resistência dos músculos respiratórios em jovens / Correlation of maximum voluntary ventilation to the strength and resistance of young respiratory muscles

A ventilação voluntária máxima é um dos testes difundidos para avaliação da resistência da musculatura respiratória, mesmo sem ser validado para este fim. Na literatura ainda são encontradas controvérsias quanto a interpretação e aplicabilidade do uso da VVM na prática clínica. OBJETIVO: Verificar a correlação entre a ventilação voluntária máxima e a força e resistência dos músculos respiratórios em jovens hígidos. MATERIAIS E MÉTODOS: Estudo observacional de corte transversal realizado na Clínica. Foram incluídos indivíduos > 18 anos, de ambos os sexos e hígidos. Os participantes tiveram sua avaliação da força muscular respiratória através do manovacuômetro, no qual se obteve a Pimáx e Pemáx. A resistência foi avaliada através do teste de carga constante pelo Power Breathe, utilizando 60% da Pimáx. A ventilação voluntária máxima foi realizada pelo espirômetro. Para a correlação das variáveis Pimáx, Pemáx e VVM foi aplicado o teste de correlação de Pearson. O estudo foi aprovado pelo comitê de ética, CAAE 10849519.9.0000.5544. RESULTADOS: Foram avaliados 27 participantes, em que 59,3% eram do sexo masculino e 55,6% ativos. A ventilação voluntária máxima com a Pimáx e Pemáx, apresentaram respectivamente p = 0,04 e 0,02 e r = 0,53 e 0,57. CONCLUSÃO: O teste de ventilação voluntária máxima possui uma correlação moderada com a força muscular respiratória, e não obtém correlação com o teste de carga constante.

Maximum voluntary ventilation is one of the widespread tests for assessing respiratory muscle strength, even without being validated for this purpose. Controversies are still found in the literature regarding the interpretation and applicability of the use of MVV in clinical practice. OBJECTIVE: To verify the correlation between maximum voluntary ventilation and respiratory muscle strength and endurance in healthy youngsters. MATERIALS AND METHODS: Observational cross-sectional study conducted at the Clinic. Individuals> 18 years of age, of both sexes and healthy were included. Participants had their respiratory muscle strength assessment using a manovacuometer, in which Pimax and Pmax were obtained. The resistance was evaluated through the constant load test by Power Breathe, using 60% of the Pimáx. Maximum voluntary ventilation was performed by a spirometer. Pearson's correlation test was applied to correlate the variables Pimax, Pmax and VVM. The study was approved by the ethics committee, CAAE 10849519.9.0000.5544. RESULTS: 27 participants were evaluated, of which 59.3% were male and 55.6% were active. The maximum voluntary ventilation with Pimax and Pmax, presented respectively p = 0.04 and 0.02 and r = 0.53 and 0.57. CONCLUSION: The maximum voluntary ventilation test has a moderate correlation with respiratory muscle strength and has no correlation with the constant load test.

Evaluation of the analgesic activity of single and multiple oral doses of teneligliptin (20 mg/day), using hot air analgesiometer in healthy human volunteers: a randomized, double blind, placebo controlled, cross over study

Background DPP-4 inhibitors showed analgesic and anti-inflammatory activity in human and animal-studies. DPP-4 inhibitors improved nerve function and thermal nociception in animal models. Aim of the study was to explore analgesic activity of single and multiple doses of teneligliptin 20 mg/day using hot air analgesiometer in healthy human volunteers.Methods: After IEC approval and informed consent, subjects were randomized to receive either teneligliptin 20 mg or placebo in double-blinded manner with standard breakfast. Mean pain threshold and tolerance(sec) using hot air analgesiometer were recorded at baseline and 1 hr, 2 hrs post drug on day 1, for single dose study. Subsequently drugs were administered under supervision daily for 6 days and same procedure repeated on day8 for multiple-dose study. After 2 weeks washout, subjects crossed over in period 2 to receive other formulation and same procedure repeated to determine study parameters. Fasting blood-sugar (FBS) was monitored, ADRs recorded in CRF. Statistical analysis done with SPSS20.0.Results: Twelve-healthy subjects (8 males, 4 females) with mean age 33.08±4.69 years, mean BMI 22.6±1.37kg/m2 participated. Single dose teneligliptin produced significant increase in pain threshold (35.9%) and pain tolerance (25.1%) (p<0.001) at 1hour compared to baseline. With multiple doses, pain threshold increased by 37.1% and pain tolerance by 25.4% (p<0.001) at 1hour compared to baseline. The increase in pain threshold and tolerance values at 1 and 2 hours were similar. There was no significant change in pain threshold(p=0.4135) and tolerance (p=0.4476) at baseline on day1 and day 8. Placebo showed non-significant change in study parameters. Both treatments well tolerated. FBS of volunteers within normal limits during treatment period and no hypoglycemia reported.Conclusions: Results of our study suggest that teneligliptin20mg in healthy subjects demonstrated modest analgesic activity compared to baseline and placebo. Its role in painful diabetic conditions may be further explored.

Efeitos da autoliberação miofascial com foam roller ou roller massager sobre a dor e a função musculoesquelética após exercí­cios / Effects of self-myofascial release with foam roller or roller massager on soreness and musculoskeletic function after exercises

Introdução: A autoliberação miofascial com o Foam Roller (FR) ou Roller Massager (RM) pode ser uma intervenção que favorece a recuperação após exercícios. Objetivo: Revisar de forma integrativa os efeitos do FR ou RM sobre a dor e a funcionalidade musculoesquelética de voluntários saudáveis após a realização de exercícios. Métodos: Revisão integrativa da literatura. A busca foi realizada nas bases de dados Medline (PubMed), Cochrane Library, Biblioteca Virtual em Saúde e PeDro, sem restrições de ano de publicação ou idioma, através dos descritores em inglês "Healthy Volunteers"; "Exercise"; "Clinical Trial"; e das palavras-chave "Myofascial Release", "Foam Rolling", "Roller Massage". Resultados: Inicialmente a busca incluiu 84 estudos e posterior análise dos critérios de elegibilidade foram incluídos apenas quatro estudos. Nestes estudos a intervenção melhorou a percepção da dor e algumas variáveis funcionais, dentre estas, a amplitude de movimento, força, resistência, velocidade de reação e a potência após os exercícios. Conclusão: Os estudos demonstram que o FR ou RM reduziram a dor e melhoram algumas variáveis funcionais. No entanto, estes resultados ainda são inconsistentes pelo baixo número de estudos, carecendo de maior investigação para aumentar o nível de evidência e a aplicação da técnica nesta condição. (AU)

Introduction: Self-myofascial release with the Foam Roller (FR) or Roller Massager (RM) may be an intervention that favors recovery after exercise. Objective: To review in an integrative way the effects of FR or RM on pain and musculoskeletal function of healthy volunteers after exercise. Methods: Integrative literature review. The study was performed in the databases Medline (PubMed), Cochrane Library, Virtual Health Library and PeDro, without restrictions of year of publication or language, through the English descriptors "healthy volunteers"; "exercise"; "clinical trial"; and the key words "myofascial release", "foam rolling", "roller massage". Results: Initially the search included 84 studies and subsequent analysis of the eligibility criteria, only four studies were included. In these studies, the intervention improved the perception of pain and some functional variables, among them, the range of motion, strength, resistance, reaction speed and power after exercise. Conclusion: Studies show that FR or RM reduced pain and improved some functional variables. However, these results are still inconsistent due to the low number of studies, requiring further investigation to increase the level of evidence and the application of the technique in this condition. (AU)

Mechanism study of the transmission of moxibustion heat in human acupoint tissues / 针灸推拿医学（英文版）

Objective:To discuss the topical action characteristics of the biological transmission of moxibustion heat via temperature collection and numerical modeling.Methods:Temperature of moxibustion was measured at multiple points at a distance of 3 cm to obtain the moxibustion temperature field nephograms by the high-accuracy temperature measure array.Finite element analysis was used to imitate the three-dimensional dynamic distribution of temperature in acupoint tissues.Results:Through numerical analysis,the one-dimensional,two-dimensional and three-dimensional distributions of temperature in human acupoint tissues at 5 min of moxibustion were established.The result showed that moxibustion heat mainly transmitted from the surface of the tissue to the internal,and the influence of moxibustion heat decreased with the depth of the tissue.The analysis of the nephograms of acupoint tissue temperature at 5,10,15 and 20 min of moxibustion showed that with the increase of the moxibustion time,the temperature in acupoint tissues constantly rose,and the transmission depth of moxibustion heat also further expanded inside acupoint.Conclusion:By establishing the three-dimensional dynamic model of heat transmission inside acupoint tissues with the biological parameters of human tissues and the temperature values obtained,this study used finite element analysis software ANSYS 14.0 and discovered the rules in the transmission of heat in body tissues during moxibustion,and the features in moxibustion heat transmission (from the proximal to the distant) and heat penetration (from the surface to the internal).This study provides theoretical and experimental support for the application of moxibustion in clinical practice.

Análise cinemática da marcha pós protocolo de fadiga global de curta duração / Kinematic gait analysis post short-term global fatigue protocol

OBJETIVO: Avaliar os efeitos de um protocolo de fadiga global de curta duração sobre os parâmetros cinemáticos da marcha de indivíduos saudáveis. MÉTODOS: Fizeram parte da amostra 21 adultos jovens saudáveis. Foi realizada a análise de parâmetros da cinemática linear (velocidade, cadência, comprimento do passo, largura do passo e tempo do passo) e angular da marcha (flexão e extensão dos quadris; flexão e extensão dos joelhos; plantiflexão e dorsiflexão dos tornozelos) antes e após a realização de um protocolo de fadiga global de curta duração. Para a avaliação da marcha, foi utilizado um sistema de captura da trajetória tridimensional da marcha, composto por um sistema de cinemetria dotado de 7 câmeras integradas. O Protocolo de Fadiga de Agilidade Funcional de Curta Duração, que consiste em um protocolo de fadiga global de curta duração com séries de exercícios de agilidade funcional, foi utilizado para fadigar os participantes. Para as comparações entre as avaliações pré e pós-fadiga, os valores médios de cada avaliação foram utilizados e submetidos ao teste t pareado, e nível de significância adotado foi p<0,05. RESULTADOS: Não houveram diferenças estatisticamente significativas nos parâmetros angulares e lineares avaliados, exceto para cadência (p=0,03). CONCLUSÕES: O protocolo de fadiga global de curta duração não alterou os parâmetros angulares e cinemáticos da marcha em indivíduos jovens, exceto a cadência que se mostrou mais elevada após o protocolo de fadiga.

AIMS: Evaluate the effects of a short-term fatigue protocol on gait's kinematic parameters of healthy subjects. METHODS: 21 healthy young adults participated in the sample. The parameters of linear kinematics of gait (velocity, cadence, step length, step width, step time) and angular kinematics of gait (hip's flexion and extension; knee's flexion and extension; ankle's dorsiflexion and plantar flexion) were analyzed before and after performing a short-term fatigue protocol. For gait evaluation, a three-dimensional gait trajectory capture system was used, consisting of a kinematic system with 7 integrated cameras. The Short-Term Functional Agility Fatigue Protocol, which consists of a short-term global fatigue protocol with series of functional agility exercises, was used to fatigue participants. For comparisons between pre and post fatigue evaluations, the mean values to paired t test, and statistical significance was set as p<0.05. RESULTS: There were no statistically significant differences in the angular and linear parameters evaluated, except for cadence (p=0.03). CONCLUSIONS: The short-term global fatigue protocol did not alter the angular and kinematic gait parameters in young subjects, except for the cadence, that was higher after the fatigue protocol.

Orthogonal test on local temperature influenced by different parameters and manipulation types of An-pressing Xinshu (BL 15) / 针灸推拿医学（英文版）

Objective:To explore the optimal thermal effect parameter combination of An-pressing manipulation based on the pressing force, time and frequency, and to compare the thermal effect differences between the rhythmic and the continuous An-pressing manipulations. Methods:Three levels of light, moderate and heavy pressing forces were determined according to the An-pressing forces of the clinical tuina physicians; the pressing time and frequency parameters were determined according to the literatures about An-pressing manipulation. The volunteers were stimulated by the homemade An-pressing manipulation stimulator on the right Xinshu (BL 15), and then the three-factor and three-level orthogonal tests were carried out according to the test sequence specified by the L9(34) orthogonal table, and the temperature before and after pressing was recorded by an infrared thermal imaging system to screen the best parameters for the thermal effect of the An-pressing manipulation, thus to determine the optimal pressing parameters. The optimal parameters were then used for both continuous and rhythmic An-pressing manipulations to stimulate the bilateral Xinshu (BL 15). The temperature changes after pressing and the duration of the thermal effect (temperature difference ≤0.5℃ on both sides) were recorded by the infrared thermal imaging system, to explore the differences in the thermal effects of different An-pressing manipulations. Results:Among the three factors of pressing force, time and frequency, the influences of different pressing forces on temperature were significantly different (F=32.843,P=0.030), and the influence of 2.5 kg pressing force was the most significant; the effects of different pressing time on temperature were significantly different (F=54.102,P=0.018), and the pressing time of 7.5 min was the most significant; the influences of different pressing frequencies on temperature were not statistically significant (F=2.181,P=0.314), though the influence of 10 times/min pressing frequency was the largest. The influences on temperature difference of the rhythmic and the continuous An-pressing manipulations were significantly different (P=0.031 on the left side andP=0.045 on the right side), but there was no statistical difference in the duration of the thermal effect (P=0.690). Conclusion:The An-pressing manipulation parameters that significantly affect the temperature difference are pressing force and time. The optimal combination of thermal effect parameters is pressing force of 2.5 kg, time of 7.5 min, and frequency of 10 times/min. The local thermal effect of the rhythmic An-pressing manipulation is significantly greater than of the continuous An-pressing manipulation.

Red blood cell acetylcholinesterase activity among healthy dwellers of an agrarian region in Sri Lanka: a descriptive cross-sectional study

BACKGROUND@#Assessment of acetylcholinesterase-inhibitor insecticide (AChEII) toxicity depends on the measurement of red blood cell acetylcholinesterase (RBC-AChE) activity. Its interpretation requires baseline values which is lacking in scientific literature. We aim to find the measures of central tendency and variation for RBC-AChE activity among dwellers of Anuradhapura, where the use and abuse of AChEIIs were rampant for the last few decades.@*METHODS@#A descriptive cross-sectional study with a community-based sampling for 100 healthy non-farmers (male:female = 1:1) was done using pre-determined selection criteria. Duplicate measurements of RBC-AChE activity were performed according to the modified Ellman procedure. Pearson's correlation and regression analysis were sort for RBC-AChE activity against its possible determinants.@*RESULTS@#RBC-AChE activity had a mean of 449.8 (SD 74.2) mU/μM Hb with a statistical power of 0.847. It was similar to values of "healthy controls" from previous Sri Lankan toxicological studies but was low against international reference value [586.1 (SD 65.1) mU/μM Hb]. None of the possible determinants showed a significant strength of relationship with RBC-AChE activity.@*CONCLUSION@#The baseline RBC-AChE activity among people of Anuradhapura is low in comparison with international reference values. This arises a need to find a causative mechanism.

Experimental study on the influence of pressing force and time on thermal effect of An-pressing manipulation / 针灸推拿医学（英文版）

Objective:To observe the influence of pressing force and time on the thermal effect of An-pressing manipulation.Methods:Eight healthy volunteers were recruited to receive An-pressing manipulation at Xinshu (BL 15) on the right side.The pressing force and time were both divided into five levels:the force described as extremely mild,mild,moderate,strong and extremely strong and time given by 2.5 min,5.0 min,7.5 min,10.0 min and 15.0 min.The real-time change in local acupoint temperature as well as the change during 1.0-15.0 min after the manipulation were observed.Results:Compared with the baseline data,the real-time changes in the temperature after An-pressing Xinshu (BL 15) on the right side with different levels of force (from mild to strong) were respectively (1.88t0.64) ℃,(2.05±0.68) ℃,(2.25±0.59) ℃,(2.35±0.61) ℃ and (2.32±0.69) ℃;the changes in 15.0 min after the manipulation were respectively (-0.11±0.11) ℃,(0.03±0.14) ℃,(0.59±0.58) ℃,(1.38±0.70) ℃ and (2.09±0.98) ℃.The real-time temperature changes after the manipulation for different durations (from short to long) were respectively (1.94±0.37) ℃,(2.33±0.29) ℃,(2.49±0.31) ℃,(2.51±0.39) ℃ and (2.41±0.55) ℃;the changes in 15.0 min after the manipulation were respectively (0.53±0.49) ℃,(0.33±0.30) ℃,(0.52±0.33) ℃,(0.55±0.38) ℃ and (0.76±0.36) ℃.Conclusion:The thermal effect presented an increasing tendency with the extension of pressing time,and the temperature reached the top at 7.5 min;the thermal effect showed an increasing tendency with the rise of pressing force,and the temperature reached the top upon a moderate level of force.The pressing time can produce a greater influence on the real-time temperature than the pressing force;the pressing force can produce a greater influence on maintaining the temperature than the pressing time.

Study of the thermal pain threshold latency of acupoints based on Fei Teng Ba Fa / 针灸推拿医学（英文版）

Objective:By applying moxibustion to the eight confluent points in different periods of time,to observe the changes in thermal pain threshold latency of acupoints based on Fei Teng Ba Fa.Methods:A total of 468 healthy college student volunteers received moxibustion at the eight confluent points in three different periods of time,i.e.Chen (7:00-9:00),Wu (11:00-13:00) and Xu (19:00-21:00).The thermal pain threshold latency was adopted to measure the changes in pain threshold of the eight confluent points under different conditions (different periods of time,different genders,different acupoints and different states of the acupoints) based on Fei Teng Ba Fa.Results:Finally,thirty subjects dropped out and 438 subjects were included.The comparison of thermal pain threshold latencies of the eight confluent points in the same opening or closing state based on Fei Teng Ba Fa:latencies of the closing points and adjunct points were significantly different in different periods of time (P＜0.05);the latencies of the males were significantly longer than those of the females (P＜0.05);there was no significant difference in the latency between the left and right sides (P＞0.05);in the female group,there was a significant difference in the latency between the lower-limb points and the upper-limb points (P＜0.05).The comparison of thermal point threshold latencies of the eight confluent points in different opening or closing state:in the period of Wu (11:00-13:00),the latencies of the opening points were significantly longer than those of the closing points and adjunct points (P＜0.05);for men,their opening and closing points had significantly longer thermal pain threshold latencies than their adjunct points (P＜0.05);despite the gender,the latencies of the upper limb opening and closing points were significantly longer than the latency of the adjunct points (P＜0.05);in the female group,the latencies of the lower-limb opening points were significantly shorter than those of the lower-limb closing and adjunct points (P＜0.05).Conclusion:Based on Fei Teng Ba Fa,the pain thresholds of the eight confluent points vary in different periods of time,gender,acupoint location and opening/closing state,which can be taken as the evidence of making time-based acupuncture-moxibustion prescriptions.

Effect of An-pressing manipulation on the serum levels of T-AOC and CK-MM in volunteers with delayed onset muscle soreness in biceps brachii / 针灸推拿医学（英文版）

Objective:To observe the effect of An-pressing manipulation on biceps brachii with delayed onset muscle soreness (DOMS) in healthy male volunteers.Methods:A total of 30 male college student volunteers were randomly divided into a blank group,a model group and a treatment group,10 cases in each group.Subjects in the blank group did not receive any intervention;subjects in the model group received active weight-bearing eccentric exercise on the non-favored side of the upper limb to establish the models,while not receiving any treatment;subjects in the treatment group received both the same modeling and An-pressing manipulation treatment.The subjective rating of perceived exertion (RPE),subjective soreness sensation threshold and soreness grade were evaluated before modeling,immediately after modeling,and 24,48,72,96 and 120 h after modeling.Serum total antioxidant capacity (T-AOC) was measured before modeling,immediately after modeling,and 24,48 and 72 h after modeling.Serum creatine kinase MM isoenzyme (CK-MM) was measured before modeling and 24,48 and 72 h after modeling.Results:At 24,48,72 and 120 h after treatment,the soreness grades of the treatment group were lower than those of the model group (all P＜0.05).The RPE scores of the treatment group were lower than those of the model group (all P＜0.05) immediately after modeling,at 24,48,72,96 and 120 h after modeling.The subjective soreness sensation threshold of the treatment group was higher than that of the model group immediately after modeling,at 24,48,72 and 96 h after modeling (all P＜0.05).Immediately after modeling,T-AOC value in the treatment group was higher than that in the model group and blank group (both P＜0.05).CK-MM of the treatment group was lower than that of the model group at 48 h and 72 h after modeling (P＜0.05).Conclusion:An-pressing manipulation shows a certain therapeutic effect on biceps brachii with DOMS by strengthening the body's antioxidant and anti-damage abilities,which can effectively reduce the pain and accelerate the recovery from fatigue damage.