Lipoaspiração abdominal: evoluindo de alta para média definição / Abdominal liposuction: evolving from high to medium definition

Introdução: Atualmente, o conceito de lipoaspiração de alta definição (LAD ou Lipo HD), tem aceitação cada vez maior. Porém, percebemos a busca de pacientes por resultados com marcação não tão vigorosa, especialmente na região abdominal, o que temos chamado de lipoaspiração de média definição ou Lipo MD. O objetivo deste estudo é apresentar uma série de casos clínicos realizados pela técnica de Lipo MD, utilizando método convencional de lipoaspiração. Métodos: Estudo retrospectivo onde os pacientes foram submetidos à lipoaspiração para obter a definição abdominal, sob as linhas alba, semilunar e interseções tendíneas. Utilizamos no curativo, tubos de silicone cilíndricos e maleáveis. Resultados: Foram inclusos 107 casos, dos quais 85 completaram o seguimento de 6 meses. Após 6 meses, os resultados foram considerados bons por todos os pacientes e equipe médica. Discussão: O conceito de Lipo HD é recente e vem recebendo aceitação crescente. A busca por resultados mais naturais e suaves, levou ao desenvolvimento do termo lipoaspiração de média ou moderada definição (Lipo MD). Acreditamos que todo cirurgião plástico pode realizar este acabamento adicional de definição abdominal, com seu método de preferência de lipoaspiração, seja de baixa energia (seringa, aspirador e vibrolipoaspirador), ou alta energia (laserlipoaspiração ou lipoultrassônica), podendo utilizar tubos de silicone para maior aderência da pele à aponeurose e melhor definir os sulcos formados. Conclusão: Foi descrito técnica de lipoaspiração abdominal de média definição (Lipo MD), utilizando método convencional de lipoaspiração, nas linhas alba e semilunar, bem como das interseções tendíneas do músculo reto abdominal.

Introduction: Currently, the concept of high-definition liposuction (HDL or HD Lipo) is increasingly accepted. However, we noticed patients' search for results with not-sovigorous marking, especially in the abdominal region, what we have called medium-definition liposuction or MD Lipo. This study aims to present a series of clinical cases performed by the MD Lipo technique, using the conventional liposuction method. Methods: Retrospective study where patients underwent liposuction to obtain abdominal definition under the linea alba, semilunaris and tendinous intersections. We use cylindrical and malleable silicone tubes in the dressing. Results: One hundred and seven cases were included, of which 85 completed the 6-month follow-up. After 6 months, the results were considered good by all patients and medical staff. Discussion: The concept of HD Lipo is recent and has been receiving increasing acceptance. The search for more natural and smooth results led to developing the term medium or moderate definition liposuction (MD Lipo). We believe that every plastic surgeon can perform this additional abdominal definition finish with his preferred method of liposuction, either low energy (syringe, liposuction device and vibroliposuction device) or high energy (laser liposuction or ultrasonic liposuction). We can use silicone tubes to better adherence of the skin to aponeurosis and better define the grooves formed. Conclusion: The technique of medium definition abdominal liposuction (MD Lipo) has been described, using the conventional method of liposuction, in the alba and semilunaris lines and the tendinous intersections of the rectus abdominis muscle.

Translation and cultural adaptation of a specific instrument for measuring asthma control and asthma status: the Asthma Control and Communication Instrument / Tradução e adaptação cultural de um instrumento específico para medir o controle e estado da asma: Asthma Control and Communication Instrument

ABSTRACT Objective: To translate the Asthma Control and Communication Instrument (ACCI) to Portuguese and adapt it for use in Brazil. Methods: The ACCI was translated to Portuguese and adapted for use in Brazil in accordance with internationally accepted guidelines. The protocol included the following steps: permission and rights of use granted by the original author; translation of the ACCI from English to Portuguese; reconciliation; back-translation; review and harmonization of the back-translation; approval from the original author; review of the Portuguese version of the ACCI by an expert panel; cognitive debriefing (the clarity, understandability, and acceptability of the translated version being tested in a sample of the target population); and reconciliation and preparation of the final version. Results: During the cognitive debriefing process, 41 asthma patients meeting the inclusion criteria completed the ACCI and evaluated the clarity of the questions/statements. The clarity index for all ACCI items was > 0.9, meaning that all items were considered to be clear. Conclusions: The ACCI was successfully translated to Portuguese and culturally adapted for use in Brazil, the translated version maintaining the psychometric properties of the original version. The ACCI can be used in clinical practice because it is easy to understand and easily applied.

RESUMO Objetivo: Traduzir e adaptar culturalmente para a língua portuguesa falada no Brasil um instrumento que avalia a comunicação e o controle da asma, denominado Asthma Control and Communication Instrument (ACCI). Métodos: O ACCI foi traduzido e adaptado culturalmente com um protocolo que incluiu etapas internacionalmente aceitas: autorização e cessão de direitos de uso do ACCI de seu idealizador; tradução do ACCI da língua inglesa para a língua portuguesa; reconciliação; retradução; revisão e harmonização da retradução; aprovação do idealizador do ACCI; revisão da versão em português do ACCI por especialistas; desdobramento cognitivo (teste da clareza, compreensibilidade e aceitabilidade da versão traduzida em uma amostra da população-alvo) e reconciliação para a elaboração da versão final. Resultados: Na etapa do desdobramento cognitivo, foram entrevistados 41 indivíduos com asma que preencheram os critérios de inclusão. Todos responderam ao ACCI e avaliaram a clareza dos enunciados/questões e, para todos os itens, obteve-se um índice de clareza superior a 0,9, ou seja, todas as questões foram consideradas claras. Conclusões: A tradução e a adaptação cultural do ACCI para a língua portuguesa falada no Brasil foram bem-sucedidas e mantiveram as propriedades psicométricas do instrumento original. O ACCI pode ser utilizado na prática clínica por ser simples e de fácil compreensão e aplicação.

Translation and cultural adaptation of a specific instrument for measuring asthma control and asthma status: the Asthma Control and Communication Instrument.

OBJECTIVE: To translate the Asthma Control and Communication Instrument (ACCI) to Portuguese and adapt it for use in Brazil. METHODS: The ACCI was translated to Portuguese and adapted for use in Brazil in accordance with internationally accepted guidelines. The protocol included the following steps: permission and rights of use granted by the original author; translation of the ACCI from English to Portuguese; reconciliation; back-translation; review and harmonization of the back-translation; approval from the original author; review of the Portuguese version of the ACCI by an expert panel; cognitive debriefing (the clarity, understandability, and acceptability of the translated version being tested in a sample of the target population); and reconciliation and preparation of the final version. RESULTS: During the cognitive debriefing process, 41 asthma patients meeting the inclusion criteria completed the ACCI and evaluated the clarity of the questions/statements. The clarity index for all ACCI items was > 0.9, meaning that all items were considered to be clear. CONCLUSIONS: The ACCI was successfully translated to Portuguese and culturally adapted for use in Brazil, the translated version maintaining the psychometric properties of the original version. The ACCI can be used in clinical practice because it is easy to understand and easily applied.

Clinical effect of nemifitide, a novel pentapeptide antidepressant, in the treatment of severely depressed refractory patients.

Clinical data were evaluated from an open-label, single-center, pilot study in patients with chronic refractory depression. The primary efficacy criterion was the change from baseline using the Montgomery-Asberg Depression Rating Scale. The secondary efficacy criteria were the 17-item Hamilton Depression Rating Scale and the Clinical Global Impression-Improvement scale. Response to treatment (40-240 mg once per day by subcutaneous injection for 10-20 doses) was defined as more than 50% improvement in the Montgomery-Asberg Depression Rating Scale from baseline or Clinical Global Impression-Improvement < or =2 and lasting for at least two sequential weeks. Patients with a sustained response at the end point in the acute main treatment phase were enrolled for up to 2 years in a maintenance phase of the study to determine duration of response and to initiate retreatments upon relapse. Of the 25 patients with chronic refractory depression, 11 patients showed a response for Montgomery-Asberg Depression Rating Scale and one responded according to the secondary criterion Hamilton Depression Rating Scale. In seven of the 11 responders to Montgomery-Asberg Depression Rating Scale the effects were sustained for the remainder of the acute phase. Two additional sustained responders identified according to secondary criteria (Hamilton Depression Rating Scale or Clinical Global Impression-Improvement) were also enrolled in the maintenance phase. All nine sustained responders were retreated, as needed, in the maintenance phase of the study, ranging from 71 to 660 days. Mean duration of response following initial treatment and between retreatments was around 2 months. Pharmacokinetic data indicated dose-proportional systemic exposure to the drug.

Antidepressant-like effects of a novel pentapeptide, nemifitide, in an animal model of depression.

BACKGROUND: Nemifitide is a novel peptide analog of melanocyte-inhibiting factor (MIF) that has been reported to relieve depressive symptoms in a very short period. OBJECTIVES: The Flinders Sensitive Line (FSL) rat, a genetic animal model of depression with innate exaggerated immobility in the forced swim test, was used to obtain more detailed information about the antidepressant-like effects of nemifitide. METHODS: The FSL rats were treated chronically with various doses of nemifitide or reference antidepressants desipramine and fluoxetine for 5 or 14 days and the forced swim test was conducted 22-24 h after the last treatment. RESULTS: Nemifitide significantly increased swimming in the FSL rats at both low (0.025-0.3 mg/kg) and high (3.0-15.0 mg/kg) doses but not at intermediate (0.4-2.4 mg/kg) doses. Nemifitide (0.3 mg/kg) and desipramine (5.0 mg/ kg) significantly increased swimming in the FSL rats after just 5 days of treatment, but fluoxetine (5.0 mg/kg) did not. Nemifitide (0.3 mg/kg) and fluoxetine (5.0 mg/kg) had long-lasting effects, but desipramine (5.0 mg/kg) did not. CONCLUSIONS: These findings support the value of developing nemifitide and its analogs as potential antidepressants.

Clinical effectiveness of nemifitide, a novel pentapeptide antidepressant, in depressed outpatients: comparison of follow-up re-treatment with initial treatment.

Data from two Phase 2 clinical studies with nemifitide, a novel pentapeptide antidepressant, were evaluated. The initial double-blind, placebo-controlled study was performed on outpatients with DSM-IV criteria for major depressive disorder. An open-label extension study enrolled subjects either completing or having been discontinued due to lack of efficacy during the follow-up period of the initial study. In the extension study, both the investigator and the subjects were blinded to the previous treatment in the initial study. No clinically significant side-effects were observed in either study. Twenty-seven subjects have been entered and evaluated in the extension study. Eighteen of these 27 subjects (66.7%) responded to re-treatment in the extension study. Mean duration of effect between re-treatments was 3.3 months. The results of the extension study support investigating a range of doses of nemifitide from 18 to 72 mg/d in future clinical trials. Further studies are planned to determine the most effective nemifitide clinical treatment regimen.

Clinical pharmacokinetic studies with INN 00835 (nemifitide), a novel pentapeptide antidepressant.

Nemifitide (4-fluoro-L-phenylalanyl-trans-4-hydroxy-L-prolyl-L-arginylglycyl-L-tryptophanamide ditrifluoroacetate) is a novel antidepressant, currently in phase 2/3 clinical trials. The purpose of our phase 1 clinical trials (conducted over a three year period) was to provide safety and pharmacokinetic data to support its clinical development as an antidepressant drug. Single and multiple doses ranging from 18 to 320 mg were administered subcutaneously to healthy volunteers in five phase 1 studies. Plasma concentrations of unchanged parent drug were determined by a validated LC/MS/MS method in blood samples collected at timepoints between 10 min and 72 h after dosing. Nemifitide was rapidly absorbed (C(max) at 10 min) and eliminated (t(1/2) 15-30 min) in most subjects. Regression and power model analyses were used to evaluate the data. The results indicate that pharmacokinetic parameters: AUC(0-t), AUC (0-infinity) and C(max), were close to dose proportional in the dose range investigated. There was no evidence of systemic accumulation of drug following 5 daily doses. No serious adverse events or clinically significant systemic adverse events occurred at any of the doses investigated in the over 100 subjects dosed in these studies. Drug-related adverse events were limited to local and transient skin reactions (pain and/or erythema) at the injection site, especially at the high doses administered: 240 and 320 mg.

Cluster analysis of clinical data to identify subtypes within a study population following treatment with a new pentapeptide antidepressant.

Cluster analysis was used to evaluate the data from a placebo-controlled, double-blind clinical trial with a new pentapeptide antidepressant (INN 00835) in major depression. The objective of this paper is to examine the effect of separating the study population into homogeneous subgroups (clusters) with relatively similar response to treatment within subgroups, and significantly different response between subgroups. The list of variables for cluster analysis was selected only from the efficacy parameters investigated in the study. Three to six clusters were modelled to obtain the optimal number of clusters, based on a proportional contribution of subjects per cluster, and the maximum statistical difference between clusters. After separation, the variability of response among drug-treated subjects by cluster was attributed to plasma drug concentration. Platelet serotonin uptake, which is a putative biochemical marker of effective treatment of depression, also reproduced the same effect of separation as the initially established cluster variables.