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Estimulação transcraniana por corrente continua na fase aguda do episódio depressivo maior: uma meta-análise de dados individuais / Transcranial direct current stimulation for acute major depressive episodes: meta-analysis of individual patient dataAdriano Henrique de Matos Moffa 30 May 2016 (has links)
Introdução: A Estimulação Transcraniana por Corrente Contínua (ETCC) é uma intervenção não farmacológica com resultados discordantes quanto à sua eficácia para o tratamento do Episódio Depressivo Maior (EDM). Possivelmente devido a heterogeneidade dos estudos, as três meta-análises publicadas até agora sobre o assunto apontam para uma pequena vantagem a favor da técnica, dependendo da variável de desfecho analisada (melhora de depressão ou resposta). Todas essas meta-análises utilizaram dados agregados. Focamo-nos, no presente estudo, na realização de uma revisão sistemática da literatura e de uma meta-análise baseada em dados individuais de pacientes (MA-DIP) com Depressão Maior (DM) submetidos à ETCC na fase aguda. Este tipo de análise é mais preciso na avaliação da eficácia de uma intervenção e na obtenção dos preditores de respostas de tratamento, já que as características individuais de cada sujeito são consideradas ao invés das médias e frequências, como nas meta-análises de dados agregados. Objetivos: (1) avaliar a eficácia da ETCC na fase aguda da DM, (2) identificar preditores de resposta, remissão e melhora da depressão específicos e (3) avaliar a aceitabilidade da intervenção. Resultados: Os dados foram colecionados de 6 ensaios clínicos randomizados placebo controlados, totalizando 289 sujeitos. A ETCC ativa foi estatisticamente superior à estimulação simulada em relação à resposta (34% vs. 19%, respectivamente; RC=2,44, IC 95% = 1,38-4,32, NNT=7), remissão (23,1% vs. 12,7%, respectivamente; RC= 2,38, IC 95% = 1,22 - 4,64, NNT=9) e melhora da depressão (coeficiente = 0,35, IC 95% =0,12 0,57). Demonstrou-se que após ajustes para outros preditores e confundidores, depressão resistente a tratamento e doses mais altas de ETCC foram, respectivamente, inversa e diretamente associadas com a eficácia da ETCC. Conclusões: O tamanho de efeito do tratamento com ETCC foi comparável àqueles reportados, em outros estudos, para a Estimulação Magnética Transcraniana repetitiva (EMTr) e para o tratamento farmacológico (com antidepressivos tricíclicos e inibidores seletivos de recaptação de serotonina) na atenção primária para depressão. Os parâmetros mais importantes para otimização em ensaios clínicos futuros são a refratariedade da depressão e a dose da ETCC / Introduction: Transcranial direct current stimulation (tDCS) is a nonpharmacological intervention for depression. Randomised, sham-controlled clinical trials (RCTs) conducted hitherto have presented mixed results regarding its efficacy. Although recent meta-analyses suggest some efficacy when measuring depression symptoms using a continuous outcome, these meta-analyses were limited in their results as they used an aggregate data approach. We aimed therefore to perform an individual patient data (IPD) meta-analysis. In contrast to an aggregate data meta-analysis, an IPD approach uses the raw data of each participant within a study. IPD is more accurate in estimating the efficacy of an intervention since aggregate data meta-analyses present only summary estimates of efficacy. IPD meta-analysis is also superior to the aggregate data approach for obtaining predictors of treatment outcome, as the characteristics of each patient are assessed instead of the mean and frequency values obtained in the traditional aggregate data meta-analysis. Objectives (a) To provide precise estimates of tDCS efficacy based on continuous (depression improvement) and categorical (response and remission rates) outcomes, (b) to identify variables associated with tDCS efficacy and (c) to estimate the treatment acceptability. Results: Data were gathered from six randomised sham-controlled trials, enrolling 289 patients. Active tDCS was significantly superior to sham for response (34% v. 19%, respectively, odds ratio (OR) = 2.44, 95% CI 1.384.32, number needed to treat (NNT) = 7), remission (23.1% v. 12.7%, respectively, OR = 2.38, 95% CI 1.224.64, NNT = 9) and depression improvement ( coefficient 0.35, 95% CI 0.120.57). Mixed effects models showed that, after adjustment for other predictors and confounders, treatment-resistant depression and higher tDCS doses were, respectively, negatively and positively associated with tDCS efficacy. Conclusions: The effect size of tDCS treatment was comparable with those reported for repetitive transcranial magnetic stimulation (rTMS) and antidepressant drug treatment in primary care. The most important parameters for optimisation in future trials are depression refractoriness and tDCS dose
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Avaliação da efetividade de um protocolo de cuidados odontológicos no alívio da dor, sintomas bucais e melhora da qualidade de vida em pacientes com câncer de cabeça e pescoço em cuidados paliativos: ensaio clínico não-controlado / Assessment of the effectiveness of a dental care protocol in relieving pain and oral symptoms and improving the quality of life of head and neck cancer patients in palliative care: non-controlled clinical trialSumatra Melo da Costa Pereira Jales 27 September 2011 (has links)
INTRODUÇÃO: Doentes com câncer de cabeça e pescoço têm sérias restrições funcionais e grande comprometimento das funções bucais. Esses problemas tornam-se complexos quando o câncer é incurável, exigindo exclusivamente cuidados paliativos. Nesta condição, os sintomas habituais agravam-se necessitando de atenção e cuidados especiais. Foi realizado um ensaio clínico não-controlado, incluindo doentes com câncer avançado de cabeça e pescoço exclusivamente em cuidados paliativos, com o objetivo de caracterizar a sua condição clínica orofacial; avaliar a funcionalidade, a qualidade de vida relacionada à saúde e a efetividade de um protocolo de cuidados odontológicos (preventivos, curativos e paliativos) no controle da dor e das queixas orofaciais, na qualidade de vida, prognóstico e sobrevida desses doentes. MÉTODOS: Avaliação Odontológica através da Ficha Clínica da Equipe de Dor Orofacial/ATM - HCFMUSP, Prontuário médico, Escala Visual Analógica (EVA), Índice gengival, Avaliação quanto à presença de cálculo dentário, Avaliação da mobilidade dentária, Escala de Numérica de Dor (END), Classificação do odor das feridas, Avaliação do edema lingual, Índice CPO-D, Questionário de Qualidade de Vida da Universidade de Washington (UW-QOL), Escala de Desempenho Funcional de Karnofsky (KPS) e o Palliative Prognostic Index (PPI). RESULTADOS: Foram incluídos 40 doentes, entre setembro de 2006 e abril de 2009, com média de idade de 60,4±10,8 anos, sendo 90% do gênero masculino; quanto ao tumor, 100,0% eram carcinomas; 65,0% localizavam-se na orofaringe; 52,5% apresentavam metástases; quanto à condição clínica, 72,5% tinham doenças cardiovasculares; 45,0% eram traqueostomizados; 22,5% utilizavam sonda nasogástrica; a média do escore do KPS pré-tratamento odontológico foi de 69,5±14,5. As queixas principais mais relatadas foram: dor em 67,5% e disfagia em 22,5%, com uma mediana de 3,0 queixas por doente. Os sinais mais encontrados foram as lesões bucais em 70,0%, lesões extrabucais em 52,5% e a babação em 45,5%; odor nas feridas tumorais foi observado em 25,0%; edema lingual em 32,5%; infecções oportunistas em 30,0%; O sintoma mais relatado à questão direta foi a dor em 82,5%, com tempo mediano de duração de 8,0 meses. A média da EVA foi de 5,4 ± 3,4; 54,5% apresentavam dor em outras regiões corpóreas; 70,0% faziam uso do terceiro degrau da escada analgésica da OMS, com uma mediana de 2,0 medicações analgésicas por doente; o CPO-D médio foi de 26,1±8,7; mobilidade dentária foi observada em 10,2%; o escore médio da qualidade de vida pré-tratamento odontológico foi de 50,2±14,5. O gênero feminino apresentou melhor qualidade de vida relacionada à atividade (p=0,031), deglutição (p=0,043) e ao escore total (p=0,020). Os doentes com localização tumoral em orofaringe comparativamente a cavidade bucal apresentaram pior qualidade de vida relacionada ao ombro (p=0,028). Os doentes com tempo de diagnóstico inferior a 12 meses apresentaram melhor qualidade de vida relacionada à aparência (p=0,031), saliva (p=0,004) e ao escore total (p=0,031). Os doentes com tempo de dor inferior a 12 meses apresentaram melhor qualidade de vida relacionada ao escore total (p=0,030). Os doentes que ingeriam os alimentos por boca possuíam uma melhor qualidade de vida relacionada à aparência (p=0,023), deglutição (p=0,031) e ao escore total (p=0,010). Os doentes que apresentavam babação possuíam uma pior qualidade de vida relacionada à aparência (p=0,027), recreação (p=0,048) e ao escore total (p=0,034). Os doentes que se locomoviam normalmente possuíam uma melhor qualidade de vida relacionada à atividade (p=0,004) e ao escore total (p=0,001). Todos os doentes receberam tratamentos preventivos e paliativos. Tratamento curativo foi realizado em 30,0% dos doentes. Após o tratamento odontológico houve melhora subjetiva de 100,0% das lesões bucais nãotumorais e da candidíase bucal dos doentes; redução do número de queixas principais (p<0,001) bem como dos locais destas queixas (p<0,001); redução do número total de medicações (p=0,052) e do número de medicações analgésicas (p=0,032); redução da intensidade de dor (EVA) (p=0,015); redução da capacidade funcional (KPS) (p=0,008); não se observou alteração em relação ao PPI (p=0,890); em relação a avaliação da qualidade de vida através do UW-QOL observou-se melhora para a aparência (p=0,049) e tendência de piora para o ombro (p=0,058). Na análise de regressão logística multivariada, o KPS pré-tratamento odontológico foi preditor independente de piora da qualidade de vida (OR=0,928; IC95%=0,864-0,996; p=0,039). No período do estudo, 70,0% (n=28) dos doentes foram a óbito. Apresentaram tempo mediano de sobrevida de 4,0 meses (IC95%=2,5-5,5), em 17 meses a probabilidade de sobrevida foi de 6,0%. Foram fatores preditores independentes de óbito: o domínio mastigação do UW-QOL pós-tratamento odontológico (p=0,034), a questão geral A do UW-QOL pós-tratamento odontológico (p<0,001) e o escore total da qualidade de vida (p=0,015). CONCLUSÕES: Após o tratamento odontológico houve redução da intensidade da dor, do número de medicação sistêmica utilizada para o controle da dor e do número de queixas; a melhora da mastigação teve impacto positivo na sobrevida, sendo que os doentes que melhoraram a qualidade de vida tiveram sobrevida superior em duas vezes. Além disso, o gênero masculino foi mais acometido; a orofaringe foi a localização mais frequente; a dor e a disfagia foram as queixas mais relatadas; lesões bucais ou extrabucais estavam presentes em todos os doentes que apresentavam higiene bucal precária e infecções odontogênicas ou oportunistas; a qualidade de vida foi superior no gênero feminino; pior nos doentes com tempo de diagnóstico e de dor superior a 12 meses; pior nos doentes que apresentavam babação; pior nos que não se alimentavam por via oral e pior nos que não deambulavam; A funcionalidade pré-tratamento odontológico foi preditora independente de qualidade de vida. / INTRODUCTION: Patients with head and neck cancer have severe functional restrictions. Oral function is critically compromised. These problems become complex when the cancer is untreatable and the patient receives only palliative care. In this circumstance, the usual symptoms worsen and require special attention and care. A non-controlled clinical trial was done with advanced head and neck cancer patients receiving only palliative care. The objectives were to characterize their clinical orofacial condition; assess their functionality; assess their health-related quality of life; and assess the effectiveness of a dental care protocol (preventive, curative and palliative) in controlling pain and orofacial and quality of life complaints, and its effectiveness on prognosis and survival. METHODS: Dental assessment followed the clinical protocol used by the Orofacial/TMJ Pain Team - HCFMUSP. Data were also collected from the patients\' medical records. Further assessment included administration of the Visual Analogue Scale (VAS), Gingival Index, Numeric Pain Scale (NPS), University of Washington quality of life questionnaire (UW-QOL), Karnofsky Performance Scale (KPS) and Palliative Prognostic Index (PPI); assessment of dental calculus, tooth mobility, tongue swelling, decaying, missing and filled teeth (DMFT); and lesion odor classification. RESULTS: A total of 40 patients were included between September 2006 and April 2009, with a mean age of 60.4±10.8 years. Of these, 90% were males. All patients had carcinomas, 65.0% were in the oropharynx and 52.5% had metastasized. Most (72.5%) of the patients also had cardiovascular diseases, 45.0% had undergone a tracheotomy and 22.5% used a nasogastric probe. The mean KPS score before dental treatment was 69.5±14.5. The main complaints were: pain (67.5%) and dysphagia (22.5%), with a median of three complaints per patient. The most common signs were oral lesions (70.0%), extraoral lesions (52.5%), drooling (45.5%), malodorous lesions (25.0%), tongue swelling (32.5%) and opportunistic infections (30.0%). The most common complaint when prompted was pain (82.5%). The median duration of pain was 8.0 months. The mean VAS score was 5.4 ± 3.4; 54.5% presented pain in other body areas; 70.0% required strong opioids to control pain (Step 3 WHO Analgesic Ladder), with a median of two painkillers per patient; the mean DMFT score was 26.1±8.7; tooth mobility was seen in 10.2% of the patients; the mean quality-of-life score before dental treatment was 50.2±14.5. Females presented better activity-related quality of life (p=0.031), deglutition (p=0.043) and total score (p=0.020). Patients with oropharynx tumors had worse shoulder-related quality of life than patients with oral tumors (p=0.028). Patients diagnosed in the previous 12 months presented better appearancerelated quality of life (p=0.031), saliva (p=0.004) and total score (p=0.031). Patients who had been experiencing pain for less than 12 months presented higher total QOL score (p=0.030). Patients who could still eat presented better appearance-related quality of life (p=0.023), deglutition (p=0.031) and total score (p=0.010). Patients who drooled presented worse appearancerelated quality of life (p=0.027), recreation (p=0.048) and total score (p=0.034). Patients who could walk normally presented better activity-related quality of life (p=0.004) and total score (p=0.001). All patients received preventive and palliative treatments. Curative treatment was provided for 30.0% of the patients. Dental treatment subjectively improved 100.0% of nontumorous oral lesions and oral candidiasis; reduced the number of main complaints (p<0.001) and the location associated with these complaints (p<0.001); reduced the total number of medications (p=0.052) and pain killers (p=0.032) needed by the patient; reduced the number of complaints (p<0.001) and pain intensity (VAS) (p=0.015); and improved functional capacity (KPS) (p=0.008). PPI did not change (p=0.890). According to the UW-QOL, appearance improved (p=0.049) and the shoulder tended to get worse (p=0.058). According to multivariate logistic regression, KPS before dental treatment independently predicted worse quality of life (OR=0.928; CI95%=0.864-0.996; p=0.039). During the study, 70.0% (n=28) of the patients died. Mean survival was 4.0 months (CI95%=2.5-5.5). In 17 months, the odds of survival were 6.0%. Factors that independently predicted death were the UW-QOL mastication domain after dental treatment (p=0.034), UWQOL general question A after dental treatment (p<0.001) and total QOL score (p=0.015). CONCLUSIONS: After dental treatment there was a reduction in pain intensity, number of systemic medications used for controlling pain and number of complaints. Improved mastication had a positive impact on survival. Patients whose QOL improved survived for twice as long; males prevailed; the oropharynx was the most common location; pain and dysphagia were the most common complaints; oral and extraoral lesions were present in all patients with poor oral hygiene and odontogenic or opportunistic infections; females had better quality of life; patients who had been diagnosed and felt pain for more than 12 months had worse QOL; patients who drooled or could not eat or walk also had worse QOL. Functionality before dental treatment was an independent predictor of QOL.
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Laser-acupuntura adjuvante à terapia oclusal reversível: um ensaio clínico controlado em pacientes com desordens temporomandibularesFerreira, Luciano Ambrosio 25 March 2011 (has links)
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Previous issue date: 2011-03-25 / A desordem temporomandibular de sintomatologia crônica é acompanhada por uma diversidade de manifestações clínicas e emocionais que interagem de maneira desfavorável na percepção dolorosa dos pacientes. Considerando tal interação, o presente ensaio clínico propôs verificar a eficácia da terapia adjuvante de laser-acupuntura no controle sintomatológico destes pacientes através de uma avaliação duplo-cega controlada por placebo. O estudo foi conduzido em uma amostra de 40 indivíduos do gênero feminino, situados entre as idades de 20 e 40 anos, com diagnóstico de dor miofascial e artralgia crônicas, determinadas pelos Critérios de Diagnóstico para Pesquisas das Desordens Temporomandibulares (RDC/DTM). Os indivíduos foram aleatoriamente divididos em dois grupos: o experimental, que recebeu a terapia de laser-acupuntura adjuvante à intervenção oclusal por placa neuromiorrelaxante (PNMR); enquanto o grupo controle recebeu laser placebo associado à PNMR. Ambas as abordagens foram instituídas por um período de três meses, conduzidas por um mesmo terapeuta, cirurgião-dentista e acupunturista. A terapia de laser-acupuntura aconteceu uma vez por semana, por doze sessões e seguiu os seguintes parâmetros: radiação infravermelha com potência de 50mW, direcionada continuamente por 90 segundos aos pontos de acupuntura: ST6, SI19, GB20, GB43, LI4, LR3, TE3 e EX-HN3, definindo uma energia de 4,5J, uma densidade por ponto de 1250W/cm2 e uma densidade total de 112,5J/cm2. O desfecho principal incluiu a avaliação da evolução da sintomatologia física por meio da verificação mensal da intensidade da dor espontânea e da palpação muscular e articular, indicadas em uma escala visual analógica (EVA). Avaliou-se também a intensidade de sintomas de depressão e somatização por meio do RDC/DTM eixo II, aplicado antes e após a instituição terapêutica. Todas as avaliações foram conduzidas por um avaliador cego. Os resultados revelaram que a partir do primeiro mês das intervenções o grupo experimental exibiu valores de intensidade de dor expressivamente menores (p≤0,05) que o grupo controle, para todas as estruturas examinadas. Ao final das intervenções observou-se a remissão da sintomatologia dolorosa (EVA= 0) no grupo experimental e uma redução dos sintomas no grupo controle (EVA entre 2 e 4). Em relação aos aspectos psicossociais, os níveis de sintomas de somatização e depressão foram modificados com as intervenções
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adotadas nos dois grupos, no entanto, o grupo experimental apresentou uma significativa diminuição frente ao grupo controle (p ≤ 0,05). A laser-acupuntura adjuvante à terapia oclusal reversível foi eficaz na remissão da sintomatologia física de desordem temporomandibular, além de atuar reduzindo os sintomas físicos inespecíficos e de depressão associados ao estresse e à dor crônica. / The temporomandibular chronic symptoms are accompanied by various clinical and emotional expressions that interact unfavorably on patients’ pain perception. Considering the statement, this clinical trial proposed to verify laser-acupuncture therapy efficacy to the patients’ symptoms through a double-blind evaluation controlled by placebo. The study was conducted on a sample of 40 female subjects, located between the ages of 20 and 40 years, with chronic myofascial pain and arthralgia diagnose, as determined by Research to Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD). Subjects were randomly divided into two groups: the experimental group that received the laser acupuncture therapy adjunct to reversible occlusal splint therapy (ROST), while the control group received placebo laser associated with ROST. Both approaches have been imposed for three months, driven by the same therapist, dentist and acupuncturist. Laser acupuncture therapy was applied once a week, for twelve sessions, defined by the parameters: infrared laser radiation, 50mW power output, directed punctuality for 90 seconds to acupuncture points: ST6, SI19, GB20, GB43, LI4, LR3, NT3 and EX-HN3, defining 4.5J energy, 1250W/cm2 density point and 112.5 J/cm2 total density. The primary outcome measure included an assessment of the physical symptoms evolution through the monthly check of the intensity of spontaneous and palpation pain, indicated on a visual analogue scale (VAS). The symptoms intensity of depression and somatization was evaluated by the RDC / TMD axis II, administered before and after therapy institution. All evaluations were conducted by a blind assessor. The result shows values of pain intensity significantly lower in experimental group (p ≤ 0.05) since the first month intervention for all structures examined. At the end of the interventions was observed remission of painful symptoms (VAS = 0) in the experimental group and a partial reduction of symptoms in the control group (VAS between 2 and 4). Regarding psychosocial factors, levels of somatization and depression symptoms were modified with the interventions taken in both groups, however, the experimental group showed a significant decrease (p ≤ 0,05) compared to the control group. The laser acupuncture as an adjunct therapy to reversible occlusal splint was effective in remission of temporomandibular disorder physics symptoms, also reducing nonspecific physical
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symptoms and depression associated with stress and chronic pain.
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Influência do pré-tratamento dentinário na estabilidade da interface adesiva / Influence of pre-treatment of dentin in stability of the adhesive interfaceMontagner, Anelise Fernandes 29 August 2013 (has links)
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Previous issue date: 2013-08-29 / The aim of this study was to evaluate the influence of chlorhexidine digluconate and sodium hypoclorite application on dentin after acid ecthing on the performance of adhesive restorations subjected to aging of the adhesive interface. For this, three studies were performed (in vitro, in situ and a systematic review). The in vitro study aimed to evaluate the effect of chlorhexidine digluconate (CHX) and sodium hypochlorite (NaOCl) on the microtensile bond strength values (μTBS) in dentin after cariogenic challenge and aging. Thirty sound human molars were selected and randomly assigned into 3 dentin pre-treatments (control, 2% chlorhexidine and 10%
NaOCl) and 4 different types of aging (control -C-, biofilm without cariogenic challenge -NCC-, biofilm with cariogenic challenge -CC- and 18-month water storage -WS-). The same etch-and-rinse adhesive system (Adper Single Bond 2, 3M ESPE) and composite resin (Z250, 3M ESPE) were used for all the groups (n=30). For NCC and CC groups, dental biofilm in microcosm derived from saliva of a healthy donor
was added on the samples. The biofilm grew up in a defined medium enriched with mucin (DMM), with or without 10% sucrose, according to the group. After the experimental period, all the samples were cleaned up and microtensile test was carried out. The data, in MPa, were subjected to ANOVA and a post-hoc Tukey Test (p < 0.05). The pre-treatment did not influence the μTBS, for all the aging conditions (p = 0.188); however the type of aging statistically affected the bond strength (p = 0.000). The bond strength values showed the following trend: C = NCC < CC = WS. Cariogenic challenge and water storage aging affected the bond strength stability
and the former seems to be a suitable short-term methodology to assess the degradation of the resin-dentin. The in vivo study aimed to evaluate the effect of chlorhexidine (CHX) application in etched dentin on the 6-month retention of
restorations of noncarious cervical lesions (NCCLs). A randomized controlled splitmouth and blind trial was carried out. Patients (n = 42) with at least two noncarious
cervical lesions were included. NCCLs were randomly assigned according to the type of tooth into two groups: control (application of a placebo solution) or experimental
group (application of 2% CHX for 60s after acid etching). Class V restorations (n = 169) were performed with an etch-and-rinse adhesive system (Adper Single Bond 2) and a composite resin (Filtek Z350) according to the manufacturer instructions, by 10 previously trained operators. The restorations were evaluated by a calibrated examiner at 1 week (baseline) and 6-month using the FDI criteria. The outcome was retention of the restoration. The analysis of factors associated to the failure of restoration was carried out through Fisher s Exact Test (α = 0.05). After 6 months of follow-up, 3.4% (CI 95% 1.3 - 7.3) of the Class V restorations failed. There was no
significant difference between control and CHX (p = 0.920). Regarding the cavity s variables, deeper (p = 0.024) and wider cavities (p = 0.004) showed more failures, and wedge-shaped cavities failed more than saucer-shaped ones (p = 0.033).
Regarding the patient s variables, restorations in patients with lower salivation 8 showed a higher percentage of failure (p = 0.034). Both treatments provided acceptable clinical performance of the restorations. The use of CHX as a coadjuvant in dentin adhesion did not influence the retention of Class V restorations after 6 months of follow-up. The systematic review aimed to systematically review the literature for in vitro and ex vivo studies that evaluated the resin-dentin bond strength immediately and longitudinal with the use of MMP inhibitor on the adhesive procedure. The systematic review was conducted sourcing the following databases (Pubmed, TRIP, LILACS, Scielo, Cochrane and ISI web Science) with no publication year or language limit. From 1.336 potentially eligible studies, 48 were selected for full text analysis and 30 were included for review. Two independently reviewers selected the studies, abstracted information and assessed the risk of bias on standardize scales. The results showed high heterogeneity in some comparisons and showed no difference for CHX 2% and control at baseline, however after 6-month of aging the CHX 2% and 0.2% presented a trend showing higher bond strength values than control groups (p < 0.05). The literature review was possible to observe the
trend towards the decreased of the bond strength through time most for the control groups than for the experimental one. From of the 30 studies included, only 5 studies
(16.6%) presented medium risk of bias while 25 (83.4%) showed high risk of bias and none showed low risk of bias. The use of MMPs inhibitor did not negatively affect the immediate bond strength, and it influenced the bond strength values long-time regarding the dentin adhesion stability. / O objetivo deste estudo foi avaliar a influência da aplicação do digluconato de clorexidina (CRX) e hipoclorito de sódio (NaOCl) em dentina, após o condicionamento ácido, na performance da interface adesiva submetida a envelhecimento da interface adesiva. Para isto, foram realizados 3 estudos (in vitro, in vivo e revisão sistemática). O estudo in vitro objetivou avaliar o efeito do prétratamento da dentina nos valores de resistência de união (RU) após diferentes tipos de envelhecimentos da interface adesiva. A dentina de todos os espécimes foi submetida ao condicionamento com ácido fosfórico por 15s e em seguida a 3 tipos de pré-tratamento: água destilada (controle - soluçao placebo - 60s), digluconato de clorexidina 2% - 60s, ou hipoclorito de sódio 10% - 60s. O sistema desivo (Single Bond 2 3M/ESPE) foi aplicado na superfície dentinária conforme indicação do fabricante. Palitos resina-dentina foram obtidos e submetidos a 4 níveis de envelhecimento: controle (CO), biofilme sem desafio cariogênico (BSD), biofilme com desafio cariogênico (BCD) e armazenamento em água por 18 meses (AGU). Nos grupos com biofilme, modelo de microcosmo foi utilizado e o biofilme foi crescido em meio definido enriquecido com mucina, com (BCD) ou sem (BSD) sacarose por 14 dias. Após o período experimental os espécimes foram limpos e preparados para o teste de microtração e o padrão de fratura foi analisado. Os valores de RU, em MPa, foram submetidos a ANOVA e teste post hoc Tukey (p < 0,05). O pré-tratamento não influenciou nos valores de RU, para todos os envelhecimentos avaliados (p = 0,188), entretanto o tipo de envelhecimento estatisticamente influenciou os valores de RU (p = 0,000). O envelhecimento CO foi similar ao BSD, com valores RU maiores que o BCD e AGU. A interface adesiva foi
negativamente afetada pelo desafio cariogênico e pela degradação em água. No estudo in vivo, com objetivo de avaliar a retenção de restaurações classe V em dentina tratada ou não com CRX, um ensaio clínico controlado randomizado, boca dividida e triplo-cego foi conduzido. Pacientes (n = 42) com no mínimo 2 lesões cervicais não cariosas (LCNC) foram selecionados. As LCNC foram randomizadas em 2 grupos: tratamento controle e tratamento experimental (CRX 2% - 60s). Restaurações (n = 169) foram realizadas com Single Bond 2 (3M EPSE) e Filtek Z350 por 10 operadores previamente treinados. As restaurações foram avaliadas por um examinador calibrado em 1 semana e 6 meses após, usando os critérios da FDI. A análise dos fatores associados às falhas nas restaurações foi conduzida através
do teste exato de Fisher (α = 0,05). Após 6 meses de acompanhamento, 3,4% (IC95% 1,3 - 7,3) das restaurações falharam devido a retenção. Não houve diferença significante entre os tratamentos controle e CRX para retenção (p = 0,920) e para manchamento marginal (p = 0,734). Em relação às variáveis relativas à cavidade, cavidades com maior profundidade (p = 0,024) e com maior altura (p = 0,004)
6 apresentaram maior ocorrência de falhas. Ainda, cavidades em formato de V apresentaram mais falhas que aquelas em formato de U (p = 0,033). Quanto as variáveis relativas aos pacientes, restaurações em pacientes que apresentavam
boca seca falharam em maior porcentagem (p = 0,034). O uso de clorexidina como um coadjuvante na adesão a dentina não influenciou na retenção das restaurações após 6 meses de acompanhamento. E a revisão sistemática teve o objetivo de
revisar a literatura acerca de estudos in vitro que avaliaram a RU resina-dentina imediata e após envelhecimento com o uso de inibidores de MMPs no procedimento adesivo. A revisão sistemática foi conduzida em 6 databases (Pubmed, TRIP,
LILACS, Scielo, Cochrane and ISI web Science) sem limite de ano ou língua. De 1.336 estudos potencialmente elegíveis, 48 foram selecionados para análise de todo texto e 30 estudos foram incluiídos na revisāo. Dois revisores selecionaram os
estudos, extraíram as informações e dados e verificaram o risco de viés em escalas padronizadas. Os resultados demostraram uma grande heterogeneidade em algumas comparações e nāo mostraram diferenças entre clorexidina 2% e o grupo controle sem envelhecimento, porém após 6 meses de envelhecimento observou-se uma tendência a favor dos grupos controle (p < 0,05). Todavia, foi possível observar
na revisāo de literatura descritiva a tendência da diminuiçāo dos valores de RU (porcentagem) ao longo do tempo, mais para o grupo controle do que para o grupo experimental. De 30 estudos incluídos, apenas 5 estudos (16,6%) apresentaram
médio risco de viés, enquanto 25 estudos (83,4%) mostraram alto risco de vieés e nenhum mostrou baixo risco. Os inibidores de MMPs nāo afetaram negativamente a RU da resina a dentina sem envelhecimento, e nāo influenciaram os valores de RU após envelheciemento.
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Epävakaan persoonallisuuden hoitomallitutkimus Oulun mielenterveyspalveluissaLeppänen, V. (Virpi) 01 December 2015 (has links)
Abstract
Borderline personality disorder (BPD) is a common mental disorder involving a substantial decrease in functional ability, self-destructive behavior and extensive burden on the health care system. This study project aimed to create a well-structured and easily applicable treatment model for patients with severe BPD. The effectiveness of the treatment model was evaluated in a randomized controlled trial.
The study group consisted of 71 patients with a mean age of 32 years. During the intervention period (1 Aug 2010 - 31 Jul 2011) 24 patients received new treatment (Community Treatment by Experts, CTBE) while 47 patients received treatment as usual (TAU). Patients in the CTBE group had 40 individual therapy sessions and 40 psychoeducational group sessions, where they were taught the key concepts of schema therapy (ST). Requirements for the therapists providing individual therapy were as follows: willingness to treat patients with BPD, commitment to weekly individual sessions with patients and commitment to participation fortnightly in a CTBE supervision consultation group, but no former psychotherapy training was required. Psychiatric treatment of the TAU group was variable.
Changes in BPD symptoms, health-related quality of life, early maladaptive schemas and schema modes were measured at the beginning and at the end of the one-year intervention. At the end of the year there were 20 patients (83%) in the CTBE group and 33 patients (70%) in the TAU group. After the intervention the patients in the CTBE group had less self-destructive behavior, impulsivity, and paranoid ideation or dissociative symptoms than patients in the TAU group, which means the CTBE treatment model was able to reduce the most serious symptoms of BPD. It is possible that the reduction in self-destructive behavior of CTBE patients is linked to the fact that certain early maladaptive schemas, such as rejection, mistrust and social isolation, decreased during the intervention. Similar changes were not seen in the TAU group patients. The study showed the CTBE treatment to be more efficient than TAU treatment. In addition, the CTBE model is applicable to public mental health services using existing professionals. / Tiivistelmä
Epävakaa persoonallisuus on tavallinen mielenterveyden häiriö, johon liittyy huomattavaa toimintakyvyn alenemista, itsetuhoisuutta ja runsasta terveyspalvelujen käyttöä. Tässä tutkimusprojektissa luotiin Oulun kaupungin mielenterveyspalveluihin uusi hoitomalli vaikeaoireisille epävakaasta persoonallisuudesta kärsiville potilaille. Hoitomallin tehokkuutta arvioitiin satunnaistetulla kontrolloidulla tutkimuksella.
Tutkimusjoukon muodosti 71 potilasta, keski-iältään 32 vuotta. Interventiovuoden ajan (1.8.2010–31.7.2011) 24 potilasta sai uuden hoitomallin mukaista hoitoa (ns. hoitomalliryhmä) ja 47 potilasta tavanomaista psykiatrista hoitoa (ns. verrokkiryhmä). Hoitomalliryhmän potilaat kävivät vuoden aikana viikoittain yksilöhoidossa (40 käyntiä) ja psykoedukatiivisessa ryhmässä (40 istuntoa), jossa potilaille mm. opetettiin skeematerapian keskeisiä käsitteitä. Yksilöhoidon toteuttaneilta työntekijöiltä ei edellytetty psykoterapiakoulutusta. Sen sijaan heiltä edellytettiin kiinnostusta epävakaan persoonallisuuden hoitoa kohtaan sekä halua sitoutua interventiovuoden ajaksi viikoittaisiin yksilötapaamisiin ja kahden viikon välein kokoontuvaan työnohjaustyyppiseen konsultaatioryhmään. Tavanomainen psykiatrinen hoito oli vaihtelevaa.
Interventiovuoden alussa ja lopussa mitattiin epävakaan persoonallisuushäiriön oireita, terveyteen liittyvää elämänlaatua sekä varhaisia haitallisia skeemoja (tunnelukkoja) ja skeemamoodeja (minätiloja). Interventiovuoden päätyttyä hoitomalliryhmässä oli jäljellä 20 potilasta (83 %) ja verrokkiryhmässä 33 potilasta (70 %). Hoitomalliryhmän potilailla oli interventiovuoden jälkeen vähemmän itsetuhoisuutta, impulsiivisuutta ja paranoidisia ajatuksia tai dissosiatiivisia oireita kuin verrokkiryhmän potilailla, eli hoitomallilla pystyttiin vähentämään kaikkein vakavimpia epävakaaseen persoonallisuushäiriöön liittyviä oireita. On mahdollista, että itsetuhoisuuden väheneminen hoitomalliryhmässä liittyy siihen, että tietyt haitalliset skeemat, kuten hylkäämisen, epäluottamuksen ja sosiaalisen eristäytymisen skeemat, lievenivät hoidon aikana. Tavanomaista psykiatrista hoitoa saaneilla potilailla ei tapahtunut vastaavia muutoksia. Tutkimusprojekti osoitti, että hoitomallin mukainen epävakaan persoonallisuuden hoito on tehokkaampaa kuin tavanomainen psykiatrinen hoito. Lisäksi hoitomalli on sovellettavissa julkisen sektorin psykiatriseen palvelujärjestelmään ja käytettävissä oleviin henkilökuntaresursseihin.
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Trial design and analysis of endpoints in HIV vaccine trials / Schéma d’étude et analyses des données des essais vaccinaux du VIHRichert, Laura 28 October 2013 (has links)
Des données complexes sont fréquentes dans les essais cliniques récents et nécessitent des méthodes statistiques adaptées. La recherche vaccinale du VIH est un exemple d’un domaine avec des données complexes et une absence de critères de jugement validés dans les essais précoces. Cette thèse d’Université concerne des recherches méthodologiques sur la conception et les aspects statistiques des essais cliniques vaccinaux du VIH, en particulier sur les critères de jugement d’immunogénicité et les schémas d’essai de phase I-II. A l’aide des données cytokiniques multiplex, nous illustrons les aspects méthodologiques spécifiques à une technique de mesure. Nous proposons ensuite des définitions de critères de jugement et des méthodes statistiques adéquates pour l'analyse des données d'immunogénicité multidimensionnelles. En particulier, nous montrons l’intérêt des scores multivariés non-paramétriques, permettant de résumer l’information à travers différents marqueurs d’immunogénicité et de faire des comparaisons inter- et intra-groupe. Dans l’objectif de contribuer à la conception méthodologique des nouveaux essais vaccinaux, nous présentons la construction d’un schéma d’essai optimisé pour le développement clinique précoce. En imbriquant les phases I et II d’évaluation clinique, ce schéma permet d’accélerer le développement de plusieurs stratégies vaccinales en parallèle. L’intégration d’une règle d’arrêt est proposée dans des perspectives fréquentistes et Bayesiennes. Les méthodes mises en avant dans cette thèse sont transposables à d’autres domaines d’application avec des données complexes, telle que les données d’imagerie ou les essais d’autres immunothérapies. / Complex data are frequently recored in recent clinical trials and require the use of appropriate statistical methods. HIV vaccine research is an example of a domaine with complex data and a lack of validated endpoints for early-stage clinical trials. This thesis concerns methodological research with regards to the design and analysis aspects of HIV vaccine trials, in particular the definition of immunogenicity endpoints and phase I-II trial designs. Using cytokine multiplex data, we illustrate the methodological aspects specific to a given assay technique. We then propose endpoint definitions and statistical methods appropriate for the analysis of multidimensional immunogenicity data. We show in particular the value of non-parametric multivariate scores, which allow for summarizing information across different immunogenicity markers and for making statistical comparisons between and within groups. In the aim of contributing to the design of new vaccine trials, we present the construction of an optimized early-stage HIV vaccine design. Combining phase I and II assessments, the proposed design allows for accelerating the clinical development of several vaccine strategies in parallel. The integration of a stopping rule is proposed from both a frequentist and a Bayesian perspective. The methods advocated in this thesis are transposable to other research domains with complex data, such as imaging data or trials of other immune therapies.
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Consideration of multiple events for the analysis and prediction of a cancer evolution / Prise en compte d'événements multiples pour analyser et prédire l'évolution d'un cancerKrol, Agnieszka 23 November 2016 (has links)
Le nombre croissant d’essais cliniques pour le traitement du cancer a conduit à la standardisation de l’évaluation de la réponse tumorale. Dans les essais cliniques de phase III des cancers avancés, la survie sans progression est souvent appliquée comme un critère de substitution pour la survie globale. Pour les tumeurs solides, la progression est généralement définie par les critères RECIST qui utilisent l’information sur le changement de taille des lésions cibles et les progressions de la maladie non-cible. Malgré leurs limites, les critères RECIST restent l’outil standard pour l’évaluation des traitements. En particulier, la taille tumorale mesurée au cours de temps est utilisée comme variable ponctuelle catégorisée pour identifier l’état d’un patient. L’approche statistique de la modélisation conjointe permet une analyse plus précise des marqueurs de réponse tumorale et de la survie. En outre, les modèles conjoints sont utiles pour les prédictions dynamiques individuelles. Dans ce travail, nous avons proposé d’appliquer un modèle conjoint trivarié pour des données longitudinales (taille tumorale), des évènements récurrents (les progressions de la maladie non-cible) et la survie. En utilisant des mesures de capacité prédictive, nous avons comparé le modèle proposé avec un modèle pour les progressions tumorales, définies selon les critères standards et la survie. Pour un essai clinique randomisé porté sur le cancer colorectal, nous avons trouvé une meilleure capacité prédictive du modèle proposé. Dans la deuxième partie, nous avons développé un logiciel en libre accès pour l’application de l’approche de modélisation conjointe proposée et les prédictions. Enfin, nous avons étendu le modèle à une analyse plus sophistiquée de l’évolution tumorale à l’aide d’un modèle mécaniste. Une équation différentielle ordinaire a été mise en œuvre pour décrire la trajectoire du marqueur biologique en tenant compte les caractéristiques biologiques de la croissance tumorale. Cette nouvelle approche contribue à la recherche clinique sur l’évaluation d’un traitement dans les essais cliniques grâce à une meilleure compréhension de la relation entre la réponse tumorale et la survie. / The increasing number of clinical trials for cancer treatments has led to standardization of guidelines for evaluation of tumor response. In phase III clinical trials of advanced cancer, progression-free survival is often applied as a surrogate endpoint for overall survival (OS). For solid tumors, progression is usually defined using the RECIST criteria that use information on the change of size of target lesions and progressions of non-target disease. The criteria remain the standard tool for treatment evaluation despite their limitations. In particular, repeatedly measured tumor size is used as a pointwise categorized variable to identify a patient’s status. Statistical approach of joint modeling allows for more accurate analysis of the tumor response markers and survival. Moreover, joint models are useful for individual dynamic predictions of death using patient’s history. In this work, we proposed to apply a trivariate joint model for a longitudinal outcome (tumor size), recurrent events (progressions of non-target disease) and survival. Using adapted measures of predictive accuracy we compared the proposed joint model with a model that considered tumor progressions defined within standard criteria and OS. For a randomized clinical trial for colorectal cancer patients, we found better predictive accuracy of the proposed joint model. In the second part, we developed freely available software for application of the proposed joint modeling and dynamic predictions approach. Finally, we extended the model to a more sophisticated analysis of tumor size evolution using a mechanistic model. An ordinary differential equation was implemented to describe the trajectory of the biomarker regarding the biological characteristics of tumor size under a treatment. This new approach contributes to clinical research on treatment evaluation in clinical trials by better understanding of the relationship between the markers of tumor response with OS.
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Dermatophytoses en milieu scolaire au Mali / Dermatophytoses among schoolchildren in MaliCoulibaly, Oumar 19 December 2014 (has links)
Pour déterminer les caractéristiques épidémiologiques des dermatophytoses chez les élèves, nous avons effectué trois enquêtes transversales entre décembre 2009 et février 2012 dans des écoles primaires publiques situées dans trois zones éco-climatiques différentes du Mali. Sur un échantillon aléatoire de 590 élèves (âge moyen de 9,7 ans ; 286 garçons), la prévalence clinique des dermatophytoses était de 59,2%. La teigne du cuir chevelu (39.3%) représentait la forme clinique la plus fréquente ; la prévalence des autres dermatophytoses était de 13,6% avec une prédominance de l'atteinte de la peau glabre (81,3%). Une forte prévalence (59,5%) des cas confirmés de teigne a été enregistrée dans la zone climatique soudano-guinéenne. Nous avons mis en évidence le genre masculin et la résidence dans la zone bioclimatique Soudano-guinéenne comme facteurs de risque indépendants associés à la teigne du cuir chevelu. Les espèces de dermatophytes identifiées étaient T. soudanense (41,3%), M. audouinii (36,5%), T. violaceum (3,7%), T. mentagrophytes (2,1%) et l'association de T. soudanense avec M. audouinii (14,8%) ou T. mentagrophytes (1,6%). Sur 41 instruments de coiffure prélevés, 73,2%, étaient contaminés par deux espèces anthropophiles : T. soudanense (53,3%) et M. audouinii (46,7%). Au plan thérapeutique, nous avons évalué l'activité de la squalamine, contre des dermatophytes in vitro. Cette molécule a présenté des CMIs variant de 4 à 16 mg/l. Nous avons ensuite montré une bonne tolérance et une efficacité partielle de la squalamine en topique dans le traitement de la teigne du cuir chevelu dans un essai clinique de phase II, randomisé, en double aveugle, contrôlé par placebo. / To determine the epidemiological characteristics of dermatophytoses in Malian schoolchildren, we conducted three cross-sectional surveys between December 2009 and February 2012 in three public primary schools located in three climatic zones. A randomly selected sample of 590 schoolchildren (mean age: 9.7 years, 286 males) participated in this study. Overall, three hundred and twelve participants were diagnosed to have dermatophytosis lesions, giving a 52.9 % prevalence of clinical dermatophytoses. Tinea capitis was the most common clinical presentation, with a 39.3% prevalence, whereas the prevalence other dermatophytoses was 13.6%. A high (59.5%) prevalence rate of confirmed cases of tinea capitis was observed in the Sudano-Guinean climatic zone. Male gender and living in this climatic zone were independent risks factors associated with tinea capitis. Mycological culture found T. soudanense (41.3%), M. audouinii (36.5%), T. violaceum (3.7%), T. mentagrophytes (2.1%), and the combination of T. soudanense with M. audouinii (14.8%) or T. mentagrophytes (1.6%). In addition, we found a high contamination rate (73.2%), with two anthropophilic dermatophytes: T. soudanense (53.3%) and M. audouinii (46.7%), of hairdressing tools in peri-urban area of Bamako. Regarding anti-dermatophyte therapy, we showed a significant in vitro activity of squalamine against clinical dermatophyte isolates, with MICs ranging from 4 to 16 mg/l. In a phase II, randomized, double-blind, placebo-controlled, clinical trial, a topical treatment with squalamine ointment was well tolerated and exhibited a partial clinical activity in the treatment of tinea capitis.
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The effect of four different manipulative techniques on Iliotibial Band Friction Syndrome (ITBFS) in terms of primary and secondary outcome measuresBotes, Jacques Andre January 2016 (has links)
Submitted in partial compliance with the requirements for the Master’s Degree in Technology: Chiropractic, Durban University of Technology, Durban, South Africa, 2016. / Background: Iliotibial band friction syndrome is a common dysfunction seen in athletes. Athletes develop biomechanical changes yet still continue with their sport. However, this syndrome limits their ability to participate at peak performance. This study determined which participants benefitted in terms of biomechanical and clinical outcomes in one of four groups: ankle joint, superior tibio-fibular joint, sacroiliac joint or a combination manipulation group (which contained any two of the three joint restrictions).
Methods: This Durban University of Technology Institutional Research and Ethics Committee approved prospective clinical trial, utilised stratified sampling, with 48 participants across four groups: ankle (14); superior tibio-fibular (11), sacroiliac (12) and combination (11). The participants underwent six treatments in three weeks. Data collection occurred before consultations one, three, five and seven. The data included primary measures of the knee score questionnaire (KSQ), the algometer, the visual analogue scale (VAS) and the secondary measures of the Feiss line, the heel leg alignment, bilateral leg length, Q angle and tibio-femoral angle. All data was computed utilising the ANOVA testing, with a p-value <0.05 being significant and a 95% confidence interval. Pearson’s correlations were completed for intragroup associations between primary and secondary outcome measures.
Results: The intragroup analysis revealed that all groups had significant changes in the KSQ and VAS, with the exception of the sacroiliac joint manipulation group (KSQ outcome not significant). Intergroup analysis revealed no differences between the groups with the exception of the combination group, which showed a significant increase in the tibio-femoral angle. Most commonly, the Pearson’s correlation revealed that changes in leg length were related to differences in primary outcome measures, irrespective of the group being tested.
Conclusion: The outcomes of this study indicated that manipulation of the distal kinematic chain improved alignment and clinical outcomes to a greater degree than manipulating proximal restrictions. It is suggested with caution (due to limited sample size) that patients should first have their distal kinematic chain manipulated before more proximal joints are manipulated to achieve better outcomes. / M
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Estudo comparativo entre os custos dos tratamentos clínico, cirúrgico ou percutâneo em portadores de doença multiarterial coronária estável - 5 anos de seguimento / Comparative cost analysis for surgical, angioplasty, or medical therapeutics for coronary artery disease - 5-year follow-upRicardo D'Oliveira Vieira 06 June 2013 (has links)
Estudo comparativo entre os custos dos tratamentos clínico, cirúrgico ou percutâneo em portadores de doença multiarterial coronária estável - 5 anos de seguimento [tese]. São Paulo: Faculdade de Medicina, Universidade de São Paulo, 2013. INTRODUÇÃO: As principais opções terapêuticas para a doença multiarterial coronária incluem cirurgia de revascularização miocárdica (CRM), intervenção coronária percutânea (ICP) e tratamento clínico (TC). Essas três estratégias terapêuticas apresentam eficácia similar em determinados subgrupos de pacientes. No presente momento, estudos direcionados à análise econômica são escassos, e contemplam, principalmente, os custos comparativos entre as intervenções cirúrgica e percutânea. OBJETIVOS: Analisar, prospectivamente, o custo comparativo das três formas terapêuticas da doença multiarterial coronária estável, durante cinco anos de seguimento. MÉTODOS: Foi computado o custo terapêutico global de 611 pacientes do ensaio clínico The Second Medicine, Angioplasty, or Surgery Study (MASS II), baseado na remuneração provida pelo sistema de saúde suplementar do Instituto do Coração do HC/FMUSP, tomando-se os valores em moeda nacional corrente. Realizou-se, posteriormente, análise de custo-efetividade para o tempo livre de eventos clínicos e o tempo livre de eventos acrescido de tempo livre de angina. RESULTADOS: O TC apresentou 3.79 e 2.07 QALY (quality-adjusted lifeyears); o ICP apresentou 3.59 e 2.77 QALY; e o CRM apresentou 4.4 e 2.81 QALY, respectivamente, para sobrevida livre de eventos e sobrevida livre de eventos e angina. Os custos para sobrevida livre de eventos foram R$ 16.327,80 para TC, R$ 35.940,60 para ICP e R$ 32.873,40 para CRM. A análise pareada dos custos para sobrevida livre de eventos mostrou que houve diferença significante favorecendo TC contra ICP (P < 0,01), e em comparação com CRM (P < 0,01); e CRM versus ICP (P = 0,01). Os custos para sobrevida livre de eventos e angina foram R$ 29.795,40, R$ 46.495,80 e R$ 44.305,20, respectivamente. A comparação pareada dos custos livres de eventos mais livres de angina demonstrou que houve diferença significante favorecendo TC contra ICP (P = 0,04), e em comparação com CRM (P < 0,001). Não houve diferença entre CRM e ICP (P > 0,05). CONCLUSÃO: A análise comparativa entre as diferentes opções terapêuticas desta amostra revelou que TC foi mais custo-efetivo que CRM, e esta, por sua vez, mais custo-efetivo que ICP / BACKGROUND: The therapeutic options for multivessel coronary artery disease are coronary artery bypass graft surgery (CABG), percutaneous coronary intervention (PCI), or medical treatment alone (MT). These three therapeutic strategies present similar efficacy for specific subgroups. At the present moment, economic outcome trials are scant, and contemplate comparative cost between surgical or percutaneous intervention. OBJECTIVE: To analyze, prospectively, the comparative cost from three therapeutic strategies in multivessel coronary artery disease, at 5-year of follow-up. METHODS: We analyzed cumulative costs of 611 patients from clinical trial The Second Medicine, Angioplasty, or Surgery Study (MASS II). The economic analysis is based on remuneration provided by the supplementary health system of the Heart Institute of the Clinical Hospital of FMUSP, expressing these values in Brazilian currency. It was compared to the cumulative costs of each therapeutic strategy in the 5-year follow-up period. A cost-effectiveness analysis was then conducted for event-free survival and event plus angina-free survival. Cost-effectiveness analysis was performed by quality-adjusted life- year (QALY) analysis. RESULTS: Respectively, for event-free survival and event plus angina-free survival, MT presented 3.79 quality-adjusted life-years (QALY) and 2.07 QALY; PCI presented 3.59 and 2.77 QALY; and CABG demonstrated 4.4 and 2.81 QALY. The event-free costs were R$ 16327.80 for MT; R$ 35940.60 for PCI; and R$ 32873.40 for CABG. The paired comparison of the event-free costs showed that there was a significant difference favoring MT versus PCI (P < 0.01) and versus CABG (P < 0.01) and CABG versus PCI (P =0.01). The event-free plus angina-free costs were R$ 29795.40, R$ 46495.80 e R$ 44305.20, respectively. The paired comparison of the event-free plus angina-free costs showed that there was a significant difference favoring MT versus PCI (P =0.04), and versus CABG (P < 0.001); there was no difference between CABG and PCI (P > 0.05). CONCLUSION: The comparative analysis among the different therapeutic strategies demonstrated that MT was more cost-effective than CABG, and this than PCI
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