Bankart Repair With Subscapularis Augmentation in Athletes With Shoulder Hyperlaxity.

PURPOSE: The purpose of this study was to demonstrate that arthroscopic Bankart repair with associated arthroscopic subscapularis augmentation (ASA) could be a valid surgical option in the treatment of anterior shoulder instability, in collision and contact sports athletes, affected by shoulder hyperlaxity. METHODS: In total, 591 arthroscopic Bankart repairs plus ASA were performed in 6 shoulder centers from 2009 to 2017. Inclusion criteria were the following: collision and contact sports activities, recurrent anterior instability associated with hyperlaxity and glenoid bone loss (GBL) < 15%. Exclusion criteria were GBL > 15%, voluntary instability, multidirectional instability, pre-existing osteoarthritis and throwing athletes. The minimum follow-up was 24 months. Hyperlaxity was clinically evaluated according to Neer and Coudane-Walch tests. Before surgery, all patients underwent magnetic resonance imaging and computed tomography scanning. Pico area method was used to assess the percentage of GBL. Patients were operated on by 6 surgeons, and their functional outcomes were evaluated by 2 independent observers. The Western Ontario Shoulder Instability Index (WOSI), Rowe, American Shoulder and Elbow Surgeons (ASES) scores were used to assess results. RESULTS: Overall, 397 patients with evidence of shoulder hyperlaxity (positive sulcus sign in ER1 position and Coudane-Walch test > 85°) met all inclusion criteria. The mean WOSI score was 321; the mean Rowe score rose from 68.5 to 92.5 (P = .037), and the ASES score rose from 71.5 to 97.4 (P = .041). Seven patients (1.6%) had atraumatic redislocation, and 9 patients (2.2%) had post-traumatic redislocation. At final follow-up the mean functional deficit of external rotation was 15° with the arm in adduction (ER1 position) and 10° in abduction (ER2 position). CONCLUSIONS: The Bankart repair plus ASA has been demonstrated to be safe and effective for restoring joint stability in patients practicing collision and contact sports or affected by chronic anterior shoulder instability associated with GBL (<15%) and hyperlaxity, without compromising external rotation. LEVEL OF EVIDENCE: Level IV, case series.

Arthroscopic Subscapularis Augmentation of Bankart Repair in Chronic Anterior Shoulder Instability With Bone Loss Less Than 25% and Capsular Deficiency: Clinical Multicenter Study.

PURPOSE: To assess the short-term outcomes of the arthroscopic subscapularis augmentation (ASA) technique, consisting of a tenodesis of the upper third of the subscapularis tendon and a Bankart repair, and its effect on shoulder external rotation. METHODS: Patients selected for this study were involved in contact sports, with a history of traumatic recurrent shoulder dislocations and a minimum of 2-year follow-up. Inclusion criteria were patients with glenoid bone loss (GBL) ranging from 5% to 25%, anterior capsular deficiency, and Hill-Sachs lesion who underwent ASA technique. Exclusion criteria were GBL >25%, multidirectional instability, preexisting osteoarthritis, and overhead sports activities. Visual analog scale (VAS) scale for pain, Rowe score, and American Shoulder and Elbow Surgeons (ASES) scores were used to assess results. Loss of shoulder external rotation was measured with the arm at the side (ER1 position) or 90° in abduction (ER2 position). Analysis of variance and Fisher tests were used for data evaluation. Significance was established at P ≤ .05. RESULTS: One hundred ten patients (84 men and 26 women, mean age 27 years) were evaluated with a mean follow-up of 40.5 months (range: 24 to 65 months). In 98 patients, a Hill-Sachs lesion was observed and in 57 patients a capsular deficiency was present. Three patients (2.7%) had a traumatic redislocation. At final follow-up, the mean scores were as follows: VAS scale decreased from a mean of 3.5 to 0.5 (P = .015), Rowe score increased from 57.4 to 95.3 (P = .035), and ASES score increased from 66.5 to 96.5 (P = .021). The mean deficit of external rotation was 8° ± 2.5° in the ER1 position and 4° ± 1.5° in the ER2 position. CONCLUSIONS: The ASA procedure has been shown to be effective in restoring joint stability in patients practicing sports, affected by chronic anterior shoulder instability associated with anterior GBL (<25%), capsular deficiency, and Hill-Sachs lesions, with mild restriction of external rotation. LEVEL OF EVIDENCE: Level IV, therapeutic case series.

Arthroscopic Bankart repair and subscapularis augmentation: an alternative technique treating anterior shoulder instability with bone loss.

BACKGROUND: This study presents the preliminary results of a new arthroscopic technique consisting of the association of 2 procedures, capsulolabral repair and subscapularis augmentation tenodesis, in the treatment of traumatic anterior shoulder instability with both glenoid bone loss and a Hill-Sachs lesion. METHODS: Eighty-nine patients engaged in sports were enrolled in this retrospective case-series study with 2 to 5 years' follow-up. All patients underwent a computed tomography scan to assess the percentage of glenoid bone loss by the Pico method. A prior stabilization procedure had failed in 20 patients, who were then segregated into a different group. Visual analog scale (VAS), Rowe, and American Shoulder and Elbow Surgeons (ASES) scores were used to assess the results. RESULTS: Only 3 of 89 patients had a post-traumatic redislocation. The mean length of follow-up was 31.5 months (range, 25-60 months). The VAS, Rowe, and ASES scores showed significant improvements: The VAS score decreased from a mean of 3.1 to 0.5 (P = .0157), the Rowe score increased from 58.9 to 94.1 (P = .0215), and the ASES score increased from 68.5 to 95.5 (P = .0197). The mean deficit of external rotation was 6° with the arm at the side of the trunk, and the mean deficit was 3° with the arm in 90° of abduction. CONCLUSIONS: The described procedure is a reproducible and effective technique used to restore joint stability in patients engaged in sports who have incurred anterior recurrent shoulder dislocation associated with glenoid bone loss (<25%) and a Hill-Sachs lesion.

Levothyroxine absorption in morbidly obese patients before and after Roux-En-Y gastric bypass (RYGB) surgery.

BACKGROUND: Roux-en-Y gastric bypass (RYGB) modifies the anatomical structure of the upper intestine tract, reduces gastric acid secretion, and may impair LT4 absorption. The aim of this study was to evaluate the LT4 absorption in morbidly obese patients before and after RYGB. METHODS: Thirty morbidly obese patients were divided in two groups: The NS group included 15 patients before RYGB surgery (BMI = 43.1 ± 4 kg/m(2)), and the S group included 15 patients after surgery (BMI = 37.3 ± 4 kg/m(2)). Two baseline samples were collected, and 600 µg of oral LT4 tablets were administered. Blood samples were collected at 30, 60, 120, 180, 240, 300, and 1440 min. Serum-free T4 (FT4), total T4 (TT4), and TSH were measured at each time point. The increase in TT4, FT4, and TSH (ΔTT4, ΔFT4, and ΔTSH) was calculated, subtracting from the baseline mean value. RESULTS: The pharmacokinetics parameters regarding LT4 absorption, maximum ΔTT4, and area under the curve(AUC) of both ΔTT4 and ΔFT4 were significantly higher in the S group compared with the NS group (p < 0.05). It was observed, however, that there was a significant delay in the absorption of LT4 in the S group. Basal serum TSH and leptin levels were higher in the NS group (p = 0.016 and 0.026, respectively), whereas basal serum TT4, FT4, ΔTSH, and the AUC of ΔTSH were similar between groups. CONCLUSIONS: In this study, we have demonstrated that Roux-en-Y bypass surgery does not diminish LT4 absorption. A small but significant delayed absorption of LT4, however, was observed in patients after surgery.

Compliance with treatment: related-issues and insights for pharmacist intervention / Adesão ao tratamento: os relacionados com questões e perspectivas para a intervenção farmacêutico

Low patient compliance with pharmacotherapy remains one of the greatest challenges for success of treatments, especially in chronic diseases, since it can negatively influence treatment effectiveness and patient quality of life, increase health expenses and decrease productivity of the patient. Compliance is an important but complex issue in clinical practice. Its complexity begins with the difficulty in adopting terminology that can express its exact meaning. Moreover, many methods to evaluate compliance have been established but no consensus exists on which method should be considered the gold standard. Additionally, socioeconomic, disease and therapy-related factors, healthcare team and system related-factors and patient-related factors can simultaneously influence compliance levels. In this highly complex scenario, pharmacist interventions have been identified as an effective strategy to enhance patient compliance with treatment. The objectives of this paper were: (1) to provide useful information for pharmacists about issues related to compliance such as terminology and definitions; methods for measuring compliance and persistence; influencing factors and the impact of low compliance; and (2) to offer insight into how these healthcare professionals can effectively contribute toward improved compliance levels.

A baixa adesão dos pacientes ao tratamento medicamentoso de doenças crônicas continua sendo um dos maiores desafios da medicina, por comprometer a efetividade do tratamento, repercutindo na qualidade de vida, aumentando os gastos com saúde e diminuindo a produtividade do indivíduo doente. O tema adesão é tão relevante para a prática clínica quanto complexo, a começar pelas tentativas de adoção de uma terminologia que expresse com exatidão o seu significado. Além disso, vários métodos para sua determinação foram estabelecidos sem, contudo, se chegar a um consenso sobre qual seria o "ótimo". Adicionalmente, as condições socioeconômicas, as características da doença, os tratamentos empregados, o sistema de saúde e seus profissionais ou o próprio paciente são alguns dos distintos fatores que influenciam, simultaneamente, o nível de adesão do paciente ao tratamento. Neste cenário de alta complexidade, intervenções realizadas pelo profissional farmacêutico têm sido apontadas como estratégias efetivas para o aumento dos níveis de adesão do paciente ao tratamento. Os objetivos deste artigo são: (1) fornecer aos farmacêuticos algumas informacões úteis relacionadas ao assunto adesão tais como: terminologia e definições, métodos para medir adesão e persistência, fatores influenciadores e impacto da baixa adesão; (2) fornecer algumas idéias a respeito de como estes profissionais de saúde podem efetivamente contribuir para a melhora dos níveis de adesão.

Metabolic syndrome patient compliance with drug treatment.

OBJECTIVES: 1) To evaluate the compliance with drug treatment in patients with metabolic syndrome. 2) To determine association between access to and use of medicines, as well as the level of knowledge of cardiovascular risk factors and compliance. INTRODUCTION: Low compliance has been one of the greatest challenges for the successful treatment of chronic diseases. Although this issue has been widely studied in patients with isolated hypertension, diabetes and dyslipidemia, compliance studies involving patients with these concomitant diseases or with metabolic syndrome diagnosis are scarce. METHODS: This was a cross-sectional study involving patients who have been diagnosed with metabolic syndrome according to the IDF criteria. Patients were being treated in a Health-Medical School Center bound to the Public Brazilian Healthcare System. This study was conducted in two phases. Phase I was characterized by analyzing medical records and Phase II involved interviewing the patients. A variation of the Morisky-Green Test was used to evaluate compliance. Compliance was the dependent variable and the independent variables included access to medicines, the use of medicines and the level of knowledge concerning cardiovascular risk factors. RESULTS: Two hundred and forty-three patients were identified as being eligible for Phase II, and 75 were included in the study. The average level of compliance was 5.44 points (standard deviation of 0.68), on a scale ranging from 1.00 to 6.00 points. There was no statistically meaningful association between independent variables and compliance. The level of patient knowledge of diet and dyslipidemia was considered to be low. CONCLUSIONS: Patients involved in this study exhibited a high level of compliance with drug treatment. Further research is needed to better elucidate the compliance behavior of patients who have been diagnosed with metabolic syndrome.

Análise de custo do tratamento medicamentoso da artrite reumatóide / Cost analysis of drug therapy in rheumatoid arthritis

Com o objetivo de comparar custos de tratamento para artrite reumatóide com medicamentos modificadores do curso da doença (DMARDs) por um período de 48 meses, foram estudadas cinco diferentes etapas de tratamento fundamentadas em protocolos clínicos recomendados pela Sociedade Brasileira de Reumatologia com cinco ciclos de tratamento. Foi aplicado modelo analítico de decisão baseado na Análise de Markov, considerando as probabilidades do permanecer em algumas destas etapas ou transitar entre elas de acordo com a resposta à terapia. Foram usados os custos diretos com medicamentos, matérias médico-hospitalares para sua administração e exames laboratoriais necessários para o monitoramento do paciente. O modelo revelou que o ciclo que representa o uso do metotrexato em monoterapia foi o mais custo/efetivo (R$ 113.900,00 por paciente em 48 meses), seguido pelo paciente refratário (R$ 1.554.483,43), aquele que utiliza a tripla terapia e depois o biológico (R$ 1.701.286,76), o paciente intolerante ao metotrexato (R$ 2.629.919,14), e por fim o resultado daquele que iniciaria o tratamento já com o infliximabe mais metotrexato (R$ 9.292.879,31). A análise de sensibilidade demonstrou que os resultados encontrados são robustos, mesmo com a variação da eficácia do metrotrexate e do infliximabe.

With the aim to compare the cost of treatment for rheumatoid arthritis therapy with desease-modifying antirheumatic drugs (DMARDs) for a 48-month period, were studied five different treatment stage based on clinical protocols recommended by the Brazilian Society of Rheumatology, and then five therapy cycles. The analytical model based on the Markov Analysis, considered chaces for the patient continue in some stages or change between them according with a positive effect on outcomes. Only direct costs were comprised in the analyzed data, like drugs, materials and tests used for monitoring these patients. The results of the model show that the stage in with metotrexato drug is used like monotherapy was cost-effective (R$ 113,900.00 for patient during 48 months), followed by refractory patient (R$ 1,554,483.43), those that use therapy triplicate followed by infleximabe drug (R$ 1,701,286.76), the metotrexato intolerant patient (R$ 2,629,919.14), and final the result from that use metotrexato and infliximabe in the beginning (R$ 9,292,879.31). The sensitivity analysis confirm this results, when alternate the efficacy of metotrexato and infliximabe.

Metabolic syndrome patient compliance with drug treatment

OBJECTIVES: 1) To evaluate the compliance with drug treatment in patients with metabolic syndrome. 2) To determine association between access to and use of medicines, as well as the level of knowledge of cardiovascular risk factors and compliance. INTRODUCTION: Low compliance has been one of the greatest challenges for the successful treatment of chronic diseases. Although this issue has been widely studied in patients with isolated hypertension, diabetes and dyslipidemia, compliance studies involving patients with these concomitant diseases or with metabolic syndrome diagnosis are scarce. METHODS: This was a cross-sectional study involving patients who have been diagnosed with metabolic syndrome according to the IDF criteria. Patients were being treated in a Health-Medical School Center bound to the Public Brazilian Healthcare System. This study was conducted in two phases. Phase I was characterized by analyzing medical records and Phase II involved interviewing the patients. A variation of the Morisky-Green Test was used to evaluate compliance. Compliance was the dependent variable and the independent variables included access to medicines, the use of medicines and the level of knowledge concerning cardiovascular risk factors. RESULTS: Two hundred and forty-three patients were identified as being eligible for Phase II, and 75 were included in the study. The average level of compliance was 5.44 points (standard deviation of 0.68), on a scale ranging from 1.00 to 6.00 points. There was no statistically meaningful association between independent variables and compliance. The level of patient knowledge of diet and dyslipidemia was considered to be low. CONCLUSIONS: Patients involved in this study exhibited a high level of compliance with drug treatment. Further research is needed to better elucidate the compliance behavior of patients who have been diagnosed with metabolic syndrome.

Estudo comparativo de duas formulaçöes orais dee ciclosporina com forma farmacêutica diferente / Comparative study of two oral cyclosporine formulations with different pharmaceutical form

Este estudo avaliou a biodisponibilidade comparativa de dois produtos de ciclosporina do mercado brasileiro com forma e formulação farmacêuticas diferentes. As amostras de sangue foram coletadas durante 24h após a administração de uma única dose de 200mg de cada produto. O desenho do estudo foi controlado, randomizado e cruzado com dois períodos e dois tratamentos. Foram estudados 24 voluntários, em função da variabilidade intra- e interindivídual da formulação SMEDDS (Self Micro Emulsifying Drug Delívery System) de referência. Os dados obtidos das determinações por HPLC da ciclosporina demonstram que Gengraf 11 (ciclosporina em formulção não-SMEDDS, Laboratórios Abbott, EUA), também denominada Ciclosporína Genérica Abbott unicamente no Brasil, não foi bioequívalente ao Sandimmun Neoral (ciclosporina em formulação SMEDDS, Novartis, Suíça) apresentando uma estatística significativamente menor taxa de absorção. Particularmente, os intervalos de confiança de 95(por cento) calculados para as razões entre os valores médios do teste e referência não se mantiveram dentro dos intervalos aceitos de 0, 80-1,25 para as AUC e 0,70-1,43 para o C. O resultado deste estudo não sustenta a intercambiabilidade livre dos dois produtos estudados em receptores de transplantes crônicos e estabilizados, precisando de protocolos clínicos e laboratoriais de conversão validados.

Definições, conceitos e aspectos operacionais utilizados em farmacovigilância / Definitions, concepts and operational aspects utilized in drug surveillance

O artigo expõe definições e conceitos utilizados na área de farmacovigilância, métodos de pesquisa para a identificação de reações adversas a medicamentos, notificação e organização de sistemas de farmacovigilância. De modo geral, as ações de farmacovigilância assumem dois aspectos diversos conforme o objetivo a ser atingido: (i) ações dos profissionais de saúde, que mantêm contato direto com o paciente e (ii) organização de sistemas de coleta, análise, processamento de informaçao e disseminação dos resultados, que incluem os sistemas nacionais de farmacovigilância e o Centro Colaborativo de Monitorização Internacional de Medicamentos da Organização Mundial da Saúde. Para se estabelecer a verdadeira...

Farmacoeconomia: conceitos e aspectos operacionais / Pharmacoeconomy: concepts and operational aspects

Farmacoeconomia é a aplicação da economia ao estudo dos medicamentos, visando à otimização do uso de recursos financeiros sem que ocorra prejuizo na qualidade do tratamento. Seu estudo pode envolver aspectos "macro", aplicando técnicas de epidemiologia, bem como estudo de grupo de especialistas, em que são tomadas decisões por consenso, após avaliação de risco/benefício/custo de equivalentes terapêuticos. Na área "micro" da farmacoeconomia, a atenção visa apenas a um ou poucos medicamentos, focalizando uma doença ou um sintoma, e utiliza técnicas e termos derivados da economia, como avaliação custo-benefício, custo-efetividade, custo-utilidade e minimização de custos com o uso de medicamentos...

Monitoramento de reações adversas da interferona alfa no tratamento ambulatorial da hepatite C crônica / Adverse drug reaction monitoring in chronic hepatitis C outpatients treated with alpha interferon

Pacientes com hepatite C crônica foram monitorados quanto às reaçoes adversas da interferona alfa (tratamento completo de um ano), por meio de entrevistas pós-consulta médica feitas por faramcêutico e apoiadas em aplicação de questionário dirigido e relato espontâneo. Foram observados e analisados o aparecimento, persistência, progressão ou regressão dos efeitos adversos durante e após o tratamento. Os sinais e sintomas mais freqüentes foram: desânimo, irritabilidade, cansaço, dores no corpo (todos os pacientes), cefaléia (96 porcento), boca seca (96 porcento), alterações do sono (91 porcento), queda de cabelos (87 porcento),boca seca (83 porcento) e visão turva (74 porcento). Após o tratamento...

Cost of drugs manufactured by the University Hospital - role of the Central Pharmacy

The hospital pharmacy in large and advanced institutions has evolved from a simple storage and distribution unit into a highly specialized manipulation and dispensation center, responsible for the handling of hundreds of clinical requests, many of them unique and not obtainable from commercial companies. It was therefore quite natural that in many environments, a manufacturing service was gradually established, to cater to both conventional and extraordinary demands of the medical staff. That was the case of Hospital das Clinicas, where multiple categories of drugs are routinely produced inside the pharmacy. However, cost-containment imperatives dictate that such activities be reassessed in the light of their efficiency and essentiality. METHODS: In a prospective study, the output of the Manufacturing Service of the Central Pharmacy during a 12-month period was documented and classified into three types. Group I comprised drugs similar to commercially distributed products, Group II included exclusive formulations for routine consumption, and Group III dealt with special demands related to clinical investigations. RESULTS: Findings for the three categories indicated that these groups represented 34.4 percent, 45.3 percent, and 20.3 percent of total manufacture orders, respectively. Costs of production were assessed and compared with market prices for Group 1 preparations, indicating savings of 63.5 percent. When applied to the other groups, for which direct equivalent in market value did not exist, these results would suggest total yearly savings of over 5 100 000 US dollars. Even considering that these calculations leave out many components of cost, notably those concerning marketing and distribution, it might still be concluded that at least part of the savings achieved were real. CONCLUSIONS: The observed savings, allied with the convenience and reliability with which the Central Pharmacy performed its obligations, support the contention that internal manufacture of pharmaceutical formulations was a cost-effective alternative in the described setting

Compliance: sobre o encontro paciente/médico / Compliance: about pacient and physian meeting

Discute aspectos que permitem aos profissionais da saúde, dentro dos princípios éticos, obterem a confiança do paciente e a correta observância do tratamento. Enfatiza fatores que influenciam a confiança, seguindo a sequência de atendimento do consultório, quando o médico faz a prescrição e as recomendações sobre modo de administração, tempo de utilização do medicamento e medidas complementares de tratamento (CAC)

Pescriçäo médica: necessidade de cooperaçäo do paciente / Medical prescription: requirement of patient compliance

A preocupaçäo crescente sobre o uso de medicamentos tem estimulado novos interesses no modo pelo qual os médicos prescrevem os mesmos. A falha comum observada entre os pacientes em seguir as instruçöes médicas cria um problema para os terapeutas, que precisam saber se o paciente está ou näo seguindo suas recomendaçöes. Assim, a falta de adesäo do paciente à prescriçäo constitui-se importante e fascinante problema na Medicina.

Cooperaçäo do paciente com seu regime terapêutico / Patient's cooperation with his or therapeutics regimen

O frequente malogro dos pacientes em seguir as instruçöes médicas cria um problema para os médicos que necessitam conhecer se os seus pacientes estäo ou näo seguindo seus conselhos. A falta de adesäo pelo paciente, relacionada ao seu regime terapêutico constitui-se em importante e fascinante problema médico. Relatos indicam que os pacientes näo seguem fielmente as instruçöes médicas e que os médicos näo säo hábeis em determinar os níveis de cooperaçäo de seus pacientes. A adesäo à medicaçäo pode ser definida em termos do ajuste entre a presciçäo e a conduta de quem vai tomar os medicamentos. A necessidade por mais e melhores pesquisas é muito importante, agora que reconhecemos as consequências de näo adesäo