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BACKGROUND: This investigation examines the clinical benefits of prefrontal cortex transcranial direct current stimulation (tDCS) treatment of working memory (WM) dysfunction in chronic schizophrenia patients. RESEARCH DESIGN AND METHODS: 34 schizophrenia (SZ) patients were evaluated at baseline, and 29 patients were randomly assigned to either active tDCS intervention or sham tDCS intervention. tDCS intervention applied 10 consecutive sessions (20 minutes, 2 mA, two sessions a day) over 5 days. WM performance (N = 25), symptom severity (N = 29), and resting EEG (N = 17) were assessed from pre- to post-tDCS intervention. Additionally, symptom severity was noted over a 12-week follow-up period. RESULTS: WM accuracy significantly improved in the active tDCS group while WM accuracy in the sham tDCS group was unchanged. Significant symptom-severity reduction was sustained for one week after active tDCS intervention. Sustained resting gamma stability (RGS) was noted from baseline to post tDCS in the active-treatment group versus a significant elevation in pathological gamma power in the sham-tDCS group. CONCLUSIONS: Examining treatment effects on RGS in SZ could be critical in identifying effective novel treatment strategies that promote left-DLPFC excitability and enhance WM functioning. Further empirical support is warranted to support the clinical benefits over longer periods of time. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04637724. ETHICS APPROVAL REGISTRATION NO: 337-19.
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Esquizofrenia , Estimulação Transcraniana por Corrente Contínua , Humanos , Memória de Curto Prazo/fisiologia , Esquizofrenia/terapia , Cognição , Córtex Pré-Frontal , Método Duplo-CegoRESUMO
INTRODUCTION: Previous international mass-media campaigns for low back pain (LBP) have had conflicting impacts on the general population. The objective was to evaluate the impact of a national back pain campaign conducted between 2017 and 2019 on beliefs and behaviours of general practitioners and the general population in France. METHODS: Between 2017 and 2019, a mass-media campaign was used to disseminate positive messages about LBP using several media, along with a parallel campaign addressed to general practitioners. An email survey before the campaign and 6 and 18 months after the campaign started evaluated beliefs and behaviours among a representative sample of the 2 target populations (3500 people from the general population and 700 general practitioners before the campaign, and 2000 people and 300 general practitioners 6 and 18 months after). RESULTS: Overall, 56% of the general population respondents before the campaign and 74% and 75% at 6 and 18 months after adhered to the statement "One should maintain physical activity" when dealing with LBP. Conversely, the percentage adhering to the statement "The best treatment is resting" decreased significantly from 68% before the campaign to 45% at 6 and 18 months after. Physicians reported delivering more reassurance and giving more documentation to patients after the campaign. They prescribed less sick leave during the first consultation (65% before the campaign, 46% and 30% at 6 and 18 months after). CONCLUSION: A mass-media campaign aimed at the public and general practitioners in France significantly modified beliefs and behaviours about LBP.
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Clínicos Gerais , Dor Lombar , Humanos , Dor Lombar/diagnóstico , Dor Lombar/terapia , Conhecimentos, Atitudes e Prática em Saúde , Dor nas Costas , Inquéritos e QuestionáriosRESUMO
OBJECTIVE: To develop guidelines for low back pain management according to previous international guidelines and the updated literature. METHODS: A report was compiled from a review of systematic reviews of guidelines published between 2013 and 2018 and meta-analysis of the management of low back pain published between 2015 and 2018. This report summarized the state-of-the-art scientific knowledge for each predefined area of the guidelines from a critical review of selected literature. A multidisciplinary panel of experts including 17 health professionals involved in low back pain management and 2 patient representatives formulated preliminary guidelines based on the compilation report and a care pathway. The compilation report and preliminary guidelines were submitted to 25 academic institutions and stakeholders for the consultation phase. From responses of academic institutions and stakeholders, the final guidelines were developed. For each area of the guidelines, agreement between experts was assessed by the RAND/UCLA method. RESULTS: The expert panel drafted 32 preliminary recommendations including a care pathway, which was amended after academic institution and stakeholder consultation. The consensus of the multidisciplinary expert panel was assessed for each final guideline: 32 recommendations were assessed as appropriate; none was assessed as uncertain or inappropriate. Strong approval was obtained for 27 recommendations and weak for 5. CONCLUSION: These new guidelines introduce several concepts, including the need to early identify low back pain at risk of chronicity to provide quicker intensive and multidisciplinary management if necessary.
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Dor Lombar , Dor Musculoesquelética , Consenso , Procedimentos Clínicos , Humanos , Dor Lombar/diagnóstico , Dor Lombar/terapia , Revisões Sistemáticas como AssuntoRESUMO
BACKGROUND: HIV-infected patients have lower bone mineral density and a higher incidence of fractures than the general population of the same age and sex. To assess the impact of antiretroviral (ARV) drugs exposure on the risk of osteoporotic fractures, we conducted a nested case-control study. METHODS: Cases were individuals enrolled while ARV-naive, with a first prospectively recorded fracture between 2000 and 2010. Controls were randomly selected after matching for sex, age (±3 years), period of HIV diagnosis (<1997/≥1997), and clinical center. The risk of fracture was analyzed with conditional logistic regression models, using different ways to model ARV exposure. All exposure variables and potential confounders were included in multivariable models. RESULTS: Among 861 reviewed cases, 261 fractures were osteoporotic and 254 of cases were matched to at least one control (376 controls). The median year of fracture diagnosis was 2007 (interquartile range 2004-2009): 49% of patients had been exposed to tenofovir disoproxil fumarate (TDF) and 82% to protease inhibitors (PIs). After taking into account the transmission group, AIDS status, geographic origin, body mass index, current smoking status, alcohol consumption, exposure to systemic glucocorticoids, and the period of enrollment, there was no association between the risk of fracture and exposure to TDF [odds ratio for cumulative exposure: 1.04 (0.86-1.27), similar results for ever-exposed subjects], to nucleoside reverse transcriptase inhibitors, or to PIs [odds ratio for cumulative PI exposure: 1.02 (0.92-1.12)]. CONCLUSIONS: We found no evidence of an excess risk of fracture after exposure to TDF or PIs. This has important implications for the debate concerning tenofovir alafenamide versus generic TDF.
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Antirretrovirais/uso terapêutico , Fraturas Ósseas/induzido quimicamente , Infecções por HIV/tratamento farmacológico , Inibidores da Protease de HIV/uso terapêutico , Tenofovir/uso terapêutico , Adulto , Antirretrovirais/efeitos adversos , Estudos de Casos e Controles , Bases de Dados Factuais , Feminino , Fraturas Ósseas/epidemiologia , França/epidemiologia , Infecções por HIV/epidemiologia , Inibidores da Protease de HIV/efeitos adversos , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Razão de Chances , Tenofovir/efeitos adversosRESUMO
OBJECTIVE: The identification of helpful or unhelpful behavioral strategies for coping with pain would assist in optimizing the management of patients with chronic low back pain (CLBP). The objective was to develop and validate a questionnaire for categorizing behavioral strategies in patients with nonspecific CLBP. METHODS: (1) Development of a preliminary questionnaire based on a qualitative study in 25 patients with CLBP; (2) Item reduction and questionnaire validation by a multicenter international prospective study in patients with CLBP, with multiple correspondence analysis to identify behavioral profiles, whose characteristics and internal and external validities were assessed; 12-month study of treatments in 58 patients; (3) Evaluation of reproducibility in 30 patients. RESULTS: (1) The preliminary questionnaire had 87 items in eight pain-coping domains. (2) Three behavioral profiles were identified: effective coping, emotional distress, and kinesiophobia. The questionnaire was reduced to 21 items in seven domains. Cronbach's α indicated moderate internal consistency (0.47-0.66). External validity versus anxiety, depression, and coping strategies was good. As expected, functional restoration program was used more often by patients with kinesiophobia than by those with effective coping (50% vs. 25%, P<0.05). (3) Reproducibility was good (κ=0.70). CONCLUSION: This new, simple questionnaire allows the identification of three behavioral profiles, thus guiding the development of personalized management programs for NCLBP.
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Dor Crônica/terapia , Comportamentos Relacionados com a Saúde/fisiologia , Dor Lombar/psicologia , Manejo da Dor/métodos , Papel do Doente , Inquéritos e Questionários , Adulto , Idoso , Dor Crônica/fisiopatologia , Estudos de Coortes , Avaliação da Deficiência , Feminino , Humanos , Dor Lombar/diagnóstico , Dor Lombar/terapia , Masculino , Pessoa de Meia-Idade , Prognóstico , Estudos Prospectivos , Psicometria , Fatores de Risco , Resultado do TratamentoAssuntos
Composição Corporal/fisiologia , Dor Crônica/reabilitação , Dor Lombar/reabilitação , Modalidades de Fisioterapia , Recuperação de Função Fisiológica/fisiologia , Retorno ao Trabalho/estatística & dados numéricos , Absorciometria de Fóton/métodos , Adulto , Índice de Massa Corporal , Densidade Óssea/fisiologia , Dor Crônica/diagnóstico , Feminino , Seguimentos , Humanos , Estudos Longitudinais , Dor Lombar/diagnóstico , Masculino , Pessoa de Meia-Idade , Músculo Esquelético/fisiologia , Índice de Gravidade de Doença , Centros de Atenção Terciária , Resultado do TratamentoRESUMO
OBJECTIVES: Chronic low back pain (LBP) has an important impact on quality of life, through pain and functional incapacity, but also psychosocial distress. The social participation consequences of LBP have been less explored. The objective was to better understand experiences of patients living with chronic LBP, with a focus on impact on relationships with family, friends and work colleagues. METHODS: Monocentric qualitative study in a tertiary-referral centre in Paris, France. Participants had chronic mechanical LBP. Semi-structured interviews were conducted during 4 focus groups discussions focusing on living with LBP. Verbatim was categorized and coded using thematic content analysis. RESULTS: Twenty-five persons (11 men, 14 women) participated; ages ranged 25-81 years. Participants often reported a negative self-perception in social interactions, with shame and frustration regarding their difficulties to perform activities of daily living. They often felt misunderstood and unsupported, partly due to the absence of visible signs of the condition. Participants suffered from the negative collective image attached to LBP ("benign/psychological disease"). LBP resulted in some patients in a significant loss of social identity with perceived impossibility to perform one's social role at home and at work. In contrast, family and friends were sometimes a support and helped in pain management. CONCLUSION: A systematic assessment of social role is needed in LBP care.
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Dor Crônica/psicologia , Relações Interpessoais , Dor Lombar/psicologia , Qualidade de Vida , Participação Social , Atividades Cotidianas , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Medição da Dor , Pesquisa Qualitativa , Identificação Social , Apoio Social , Estresse PsicológicoRESUMO
BACKGROUND: Axial Spondyloarthritis (AxSpA) and chronic low back pain are rheumatic diseases that impact patients' health-related quality of life (HRQoL). In other chronic conditions, HRQoL was positively associated with dispositional optimism, a personality trait. The objective was to explore the relationship between optimism and HRQoL in these two diseases. METHOD: A cross-sectional study was performed in 2 tertiary care hospitals and 2 private practices in France. Patients had definite AxSpA or chronic low back pain according to the rheumatologist. A generic HRQoL questionnaire (Short Form, SF-12) with physical and mental composite scores (PCS and MCS respectively) and an optimism questionnaire (the Life Orientation Test-revised, LOT-R) were collected. Analyses included non-parametric correlations and multiple regression analyses to study the effect of optimism on PCS and MCS. RESULTS: In all, 288 (199 AxSpA and 89 low back pain) patients were included: mean age, 47.3 ± 11.9 years, 48.6 % were males. Pain levels (0-10) were 4.5 ± 2.4 and 4.3 ± 2.4 in AxSpA and LOW BACK PAIN patients, respectively. HRQoL was similarly altered in both diseases, for both physical and mental composite scores (mean PCS: 43.7 ± 8.2 vs. 41.9 ± 7.1; mean MCS: 45.9 ± 7.8 vs. 46.7 ± 8.1 for AxSpA and low back pain respectively). Optimism was moderate and similar in both populations. Optimism was positively correlated to MCS in both diseases (rho = 0.54 and 0.58, respectively, both p <0.01) and these relations persisted in multivariate analyses (beta = 1.03 and 1.40, both p <0.0001). CONCLUSIONS: Optimism was similar in these 2 chronic diseases and was an explanatory factor of the mental component of HRQoL, but not physical HRQoL. Physical HRQoL may reflect more the disease process than character traits.
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Dor Lombar/psicologia , Otimismo , Personalidade , Qualidade de Vida/psicologia , Espondilartrite/psicologia , Adaptação Psicológica , Adulto , Idoso , Doença Crônica/psicologia , Estudos Transversais , Feminino , França , Indicadores Básicos de Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Análise de RegressãoRESUMO
Charcot spine is rare condition whose association with Parkinson's disease (PD) has not been reported yet. The authors reported the cases of two patients with PD who developed Charcot spine. Both patients presented with a history of back pain and bilateral radicular leg pain. They had complete clinical and radiological assessment. Lumbar spine was involved in both patients. Clinical features and response to treatment were described. In the first case, circumferential fusion and stabilization were performed on the dislocated vertebral levels. A solid and stable fusion of the spine was obtained with satisfactory clinical outcome. Surgical treatment has been recommended to the other patient. In both cases, no other neurological etiology was found to account for Charcot spine. In conclusion, Charcot spine is associated with several neurological affections but has not previously been reported in association with Parkinson's disease.
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PURPOSE: Among the many questionnaires available to evaluate low back pain (LBP) patients, the Core Outcome Measures Index (COMI) has the unique advantage to investigate five dimensions using seven short questions. The aim of this study was to explore additional properties of the questionnaire in a French-speaking non-surgical population. METHODS: This study was conducted on 168 patients suffering from subacute or chronic LBP and followed up for 6 months in three French-speaking countries. In addition to basic psychometric properties (e.g., construct validity, floor and ceiling effect, reproducibility), internal validity was analyzed by a factor analysis using Cronbach's alpha. Responsiveness and sensitivity to change were assessed through minimal detectable change (MDC), effect size, and Minimal Clinically Important Improvement (MCII). We used an anchor-based method with receiver operating characteristic (ROC) curve analysis to assess MCII and the Patient Acceptable Symptom State. RESULTS: Construct validity, reliability (Cronbach's alpha = 0.87), reproducibility and the absence of floor and ceiling effects were confirmed. Factor analysis indicated a one-dimensional construct that validates the use of a sum score. The MDC (2.1) was inferior to the MCII (2.3). The limit below which the patient claims to be in a fair condition (Patient Acceptable Symptom State) was set at 3. CONCLUSIONS: The COMI is a self-report questionnaire with the capacity to easily and quickly explore several dimensions in patients with LBP that can be then summarized in a meaningful sum score. Additional knowledge provided by our study should encourage the widespread use of the COMI among the spine community.
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Avaliação da Deficiência , Dor Lombar/diagnóstico , Avaliação de Resultados em Cuidados de Saúde/normas , Psicometria/normas , Inquéritos e Questionários/normas , Adulto , Emprego , Feminino , Humanos , Idioma , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Psicometria/métodos , Curva ROC , Reprodutibilidade dos Testes , Autorrelato , Licença MédicaRESUMO
OBJECTIVE: Although osteopenia is common in HIV-infected patients, there is by now limited data on the evolution of bone mineral density in this population. We aimed to evaluate the course of osteopenia over a 2-year period in HIV-1-infected men, and to identify risk factors for abnormal bone mineral density (BMD) decline. METHODS: HIV-1-infected men on combined antiretroviral therapy (cART) screened in the ANRS 120 Fosivir trial, diagnosed with low BMD (-2.5 ≤T-score <-1), not receiving antiosteoporotic agents, with sequential dual-energy-X ray-absorptiometry (DXA) available at baseline were eligible for this study and had a second DXA performed between months 24 and 36. RESULTS: We enrolled 94 men with a median age of 46 years [interquartile range (IQR), 41-53], BMI 22 kg/m² (21-25) and a CD4 cell nadir of 164/µl (69-261). They were receiving cART for a median of 7.5 years (5.8-9.5). Over a median interval of 2.6 years (2.3-2.9) between the two DXA tests, the mean change in BMD was -0.5 ± 1.7% per year (P = 0.010) at the lumbar spine and -0.4 ± 1.8% per year (P = 0.033) at the hip. BMD fell by more than the smallest detectable difference (SDD) in, respectively, 25.5 and 27.7% of patients at the lumbar spine and hip. Tenofovir (TDF) exposure was independently associated with a larger decline in BMD at both sites [lumbar spine, OR = 2.4 (1.2-4.9); hip, OR = 2.8 (1.3-5.9)]. CONCLUSION: Although osteopenia overall modestly changes over 2 years in long-term cART-treated patients, a quarter of patients experienced a significant loss (>1 SDD) associated with TDF exposure.
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Antirretrovirais/efeitos adversos , Densidade Óssea/efeitos dos fármacos , Doenças Ósseas Metabólicas/induzido quimicamente , Infecções por HIV/tratamento farmacológico , HIV-1 , Absorciometria de Fóton , Adenina/efeitos adversos , Adenina/análogos & derivados , Adulto , Fármacos Anti-HIV/efeitos adversos , Doenças Ósseas Metabólicas/complicações , Infecções por HIV/complicações , Quadril/diagnóstico por imagem , Humanos , Vértebras Lombares/diagnóstico por imagem , Masculino , Pessoa de Meia-Idade , Organofosfonatos/efeitos adversos , Fatores de Risco , TenofovirRESUMO
OBJECTIVE: Mortality rates in patients with rheumatoid arthritis (RA) have been reported to be higher than for the general population. Fortunately, efficient therapies have reduced disease activity and may be able to diminish the excess mortality risk. This study was designed to investigate RA mortality over the last 50 years by systematic review of the literature and meta-analysis. METHODS: Data to January 2010 in the Medline, Cochrane and Embase databases were searched with the keywords "rheumatoid arthritis", "epidemiologic methods" and "mortality". Inclusion criteria were (i) longitudinal study, (ii) early RA patients, (iii) number of deaths and mean patient follow-up. Incidence mortality rates (IMR) were calculated and standardized mortality rates (SMR) were extracted when available. A meta-analysis by periods of inclusion and a Poisson regression were used to model IMR. Available SMR were computed as a meta-analysis. RESULTS: A total of 11 longitudinal studies starting from 1955 to 1995, representing 51,819 patients, met the inclusion criteria. Mean IMR was 2.7/100 person-years of follow-up (95% confidence interval [CI]: 2.2, 3.3) and ranged from 1.0 to 5.2/100 person-years. A decreasing IMR was found in the meta-analyses. Poisson regression analysis indicated a decrease in IMR of 2.3% per year (95%CI: 2.1; 2.6). SMR was available in 8 studies: the meta-SMR was 1.47 (95%CI: 1.19; 1.83) and no decrease was seen over time in the meta-regression. CONCLUSION: Mortality has decreased among RA patients over the past decades but remained higher than in the general population as assessed by the IMR and the SMR over time.
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Artrite Reumatoide/mortalidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Mortalidade/tendênciasRESUMO
The management of non-specific low back pain relies chiefly on analgesics, education, and physical exercises. Of the many risk factors for chronicity, the most relevant are psychosocial and occupational. Identifying homogeneous patient subgroups helps to develop personalized treatment strategies, thus improving the outcomes. Current clinical research is focusing on subgroup identification via simple validated questionnaires that are suitable for use in everyday practice. We suggest a management approach leading from the individual patient profile to the treatment strategy.
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Gerenciamento Clínico , Dor Lombar/terapia , Avaliação de Resultados em Cuidados de Saúde , Analgésicos/uso terapêutico , Doença Crônica , Exercício Físico , Humanos , Dor Lombar/epidemiologia , Educação de Pacientes como Assunto , Fatores de Risco , Inquéritos e QuestionáriosRESUMO
We analyzed data collected during screening for eligibility in the ANRS-120 FOSIVIR clinical trial to estimate the prevalence of osteoporosis in patients infected with human immunodeficiency virus 1 (HIV-1), to study its risk factors, and to develop a screening strategy. McNemar test was used to compare the estimated prevalence of osteoporosis, using 3 different definitions. We then derived a screening strategy for HIV-infected men. We analyzed data for 700 men and 192 women. The prevalence of osteoporosis differed markedly according to the definition used. Based on the "T-score ≤ -2.5" definition, 14.9% of men and 1.0% of women had osteoporosis. Factors associated with low bone mineral density comprised not only classical risk factors for osteoporosis such as low body mass index (BMI) or older age but also factors associated with HIV infection such as lower CD4 T-cell nadir in men and AIDS in women, and with antiretroviral treatment such as recent tenofovir therapy. In addition to postmenopausal women, we recommend osteoporosis screening for HIV-infected men older than 60 yr, men younger than 60 yr with BMI < 20 kg/m(2), and men younger than 60 yr with both BMI 20-23 kg/m(2) and a CD4 T-cell nadir ≤ 200/mm(3).
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Absorciometria de Fóton/métodos , Densidade Óssea , Infecções por HIV/complicações , HIV-1 , Programas de Rastreamento/métodos , Osteoporose/epidemiologia , Adulto , Idoso , Índice de Massa Corporal , Feminino , França/epidemiologia , Infecções por HIV/epidemiologia , Infecções por HIV/virologia , Humanos , Masculino , Pessoa de Meia-Idade , Osteoporose/complicações , Osteoporose/diagnóstico , Prevalência , Estudos Retrospectivos , Fatores de RiscoRESUMO
OBJECTIVE: This open-label, phase 3b study evaluated the effectiveness and tolerability of tapentadol prolonged release and tapentadol immediate release (for acute pain episodes) for severe, chronic low back pain with or without a neuropathic pain component that was inadequately managed in patients taking World Health Organization (WHO) Step I or II analgesics or who were not regularly treated with analgesics. RESEARCH DESIGN AND METHODS: Average baseline pain intensity was greater than 5 (11-point numerical rating scale-3 [NRS-3; 3-day average pain intensity]) with WHO Step I or II analgesics and greater than 6 with no regular analgesic regimen. WHO Step II analgesics were discontinued before starting study treatment; WHO Step I analgesics or co-analgesics were continued at the same dose. Patients received tapentadol prolonged release (50-250 mg bid) during a 5-week titration and 7-week maintenance period. Tapentadol immediate release was permitted for acute pain episodes (tapentadol prolonged release and immediate release maximum combined dose, ≤500 mg/day). The painDETECT questionnaire was used to define subsets of patients based on the probability of a neuropathic pain component to their low back pain as 'negative', 'unclear', or 'positive'. CLINICAL TRIAL REGISTRATION: NCT00983385. MAIN OUTCOME MEASURE: The primary endpoint was the change from baseline to week 6 in average pain intensity (NRS-3), using the last observation carried forward to impute missing scores. RESULTS: In the painDETECT negative (n = 49) and unclear/positive (n = 126) subsets, respectively, mean (SD) changes in pain intensity from baseline to week 6 were -2.4 (2.18) and -3.0 (2.07; both p < 0.0001). Among patients who had not received prior WHO Step II treatment, lower doses of tapentadol prolonged release were generally required with increasing likelihood of a neuropathic pain component. Based on the painDETECT questionnaire and the Neuropathic Pain Symptom Inventory (NPSI), tapentadol prolonged release treatment was also associated with significant improvements in neuropathic pain symptoms, with decreases in the number of pain attacks and the duration of spontaneous pain in the last 24 hours in patients with low back pain with a neuropathic pain component (painDETECT unclear or positive score at baseline or screening). The most common treatment-emergent adverse events (incidence ≥10%, n = 176) were nausea, dizziness, headache, dry mouth, fatigue, constipation, diarrhea, nasopharyngitis, and somnolence. CONCLUSIONS: Tapentadol prolonged release was well tolerated and effective for managing severe, chronic low back pain with or without a neuropathic pain component.
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Dor Crônica/tratamento farmacológico , Dor Lombar/tratamento farmacológico , Neuralgia/tratamento farmacológico , Fenóis/administração & dosagem , Fenóis/efeitos adversos , Idoso , Analgésicos/administração & dosagem , Analgésicos/efeitos adversos , Dor Crônica/complicações , Preparações de Ação Retardada/administração & dosagem , Preparações de Ação Retardada/efeitos adversos , Feminino , Humanos , Dor Lombar/complicações , Masculino , Adesão à Medicação/estatística & dados numéricos , Pessoa de Meia-Idade , Neuralgia/complicações , Qualidade de Vida , Índice de Gravidade de Doença , Tapentadol , Resultado do TratamentoRESUMO
Low bone mineral density (BMD) is common in HIV-infected patients. Bisphosphonates such as alendronate potently inhibit bone resorption and are effective against osteoporosis. The aim of the ANRS 120 Fosivir trial was to evaluate the effect of alendronate on low BMD in HIV-infected patients. HIV-1-infected adults with a t-score≤-2.5 at the lumbar spine and/or total hip, as assessed by dual x-ray absorptiometry, and no other known risk factors for low BMD, were randomized to receive either extended-release alendronate 70 mg weekly or placebo for 96 weeks, with stratification for gender. All the patients also received daily calcium carbonate (500 mg) and vitamin D (400 U). The primary endpoint for efficacy was the percentage change in BMD at the site with a t-score≤-2.5. Forty-four antiretroviral-treated patients (42 men, 2 women) were enrolled. The median age was 45 years, the median CD4 cell count was 422/mm(3), and viral load was <400 copies/ml in 84% of patients. Baseline characteristics were well balanced between the alendronate (n=20) and placebo (n=24) groups. At baseline, 15 patients (75%) in the alendronate group and 17 patients (71%) in the placebo group had a t-score≤-2.5 at the lumbar spine. In the main analysis, BMD at the site with a t-score≤-2.5 increased by 7.1% and 1.0%, respectively, in the alendronate (n=14) and placebo (n=20) groups at week 96 [mean difference, 6.1% (95% CI 2.8 to 9.3); p=0.0003]. Alendronate 70 mg weekly for 96 weeks improves BMD in HIV-1-infected patients on antiretroviral therapy.
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Síndrome da Imunodeficiência Adquirida/tratamento farmacológico , Alendronato/uso terapêutico , Fármacos Anti-HIV/uso terapêutico , Conservadores da Densidade Óssea/uso terapêutico , Densidade Óssea/efeitos dos fármacos , Osteoporose/tratamento farmacológico , Absorciometria de Fóton , Síndrome da Imunodeficiência Adquirida/complicações , Adulto , Alendronato/farmacologia , Conservadores da Densidade Óssea/farmacologia , Contagem de Linfócito CD4 , Método Duplo-Cego , Feminino , França , Quadril/diagnóstico por imagem , Humanos , Vértebras Lombares/diagnóstico por imagem , Masculino , Pessoa de Meia-Idade , Osteoporose/diagnóstico por imagem , Osteoporose/etiologia , Resultado do Tratamento , Carga ViralRESUMO
OBJECTIVE: Subclinical inflammation and radiographic progression have been described in rheumatoid arthritis (RA) patients whose disease is in remission or is showing a low level of activity. The aim of this study was to compare the ability of ultrasonography and magnetic resonance imaging (MRI) to predict relapse and radiographic progression in these patients. METHODS: Patients with RA of short or intermediate duration that was either in remission or exhibiting low levels of activity according to the Disease Activity Score (DAS) were included in the study. Over a period of 1 year, patients underwent clinical and biologic assessments every 3 months and radiographic assessments at baseline and 12 months. Radiographs were graded according to the modified Sharp/van der Heijde score (SHS). At baseline, patients underwent ultrasonography and MRI, which were graded using binary and semiquantitative scoring systems. Relapse was defined as a DAS of ≥2.4, and radiographic progression was defined as an increase in the SHS of ≥1. We tested the association of values by multivariate logistic regression. RESULTS: A total of 85 RA patients with a mean disease duration of 35.3 months were studied. RA was in remission in 47 of these patients, and 38 had low levels of disease activity. At 1 year, 26 of the 85 patients (30.6%) showed disease relapse, and 9 of the 85 patients (10.6%) showed radiographic progression. The baseline PD synovitis count (i.e., the number of joints at baseline for which the power Doppler [PD] signal indicated synovitis) predicted relapse (adjusted odds ratio [OR] 6.3; 95% confidence interval [95% CI] 2.0-20.3), and the baseline PD synovitis grade predicted disease progression (adjusted OR 1.4 [95% CI 1.1-1.9]). MRI was not predictive of outcomes. CONCLUSION: For RA patients whose disease is in remission or who have low levels of disease activity, PD signals on ultrasonography could predict relapse or radiographic progression and identify those whose disease is adequately controlled, which is especially helpful when considering treatment tapering or interruption.
Assuntos
Artrite Reumatoide/diagnóstico , Imageamento por Ressonância Magnética/métodos , Ultrassonografia Doppler em Cores/métodos , Artrite Reumatoide/sangue , Artrite Reumatoide/fisiopatologia , Artrografia , Biomarcadores/sangue , Progressão da Doença , Feminino , Nível de Saúde , Humanos , Articulações/diagnóstico por imagem , Articulações/patologia , Articulações/fisiopatologia , Masculino , Pessoa de Meia-Idade , Dor , Valor Preditivo dos Testes , Prognóstico , Estudos Prospectivos , Recidiva , Sinovite/sangue , Sinovite/diagnóstico , Sinovite/fisiopatologiaRESUMO
PURPOSE: To conduct a cross-cultural adaptation of the Core Outcome Measures Index (COMI) into French according to established guidelines. METHODS: Seventy outpatients with chronic low back pain were recruited from six spine centres in Switzerland and France. They completed the newly translated COMI, and the Roland Morris disability (RMQ), Dallas Pain (DPQ), adjectival pain rating scale, WHO Quality of Life, and EuroQoL-5D questionnaires. After ~14 days RMQ and COMI were completed again to assess reproducibility; a transition question (7-point Likert scale; "very much worse" through "no change" to "very much better") indicated any change in status since the first questionnaire. RESULTS: COMI whole scores displayed no floor effects and just 1.5% ceiling effects. The scores for the individual COMI items correlated with their corresponding full-length reference questionnaire with varying strengths of correlation (0.33-0.84, P < 0.05). COMI whole scores showed a very good correlation with the "multidimensional" DPQ global score (Rho = 0.71). 55 patients (79%) returned a second questionnaire with no/minimal change in their back status. The reproducibility of individual COMI 5-point items was good, with test-retest differences within one grade ranging from 89% for 'social/work disability' to 98% for 'symptom-specific well-being'. The intraclass correlation coefficient for the COMI whole score was 0.85 (95% CI 0.76-0.91). CONCLUSIONS: In conclusion, the French version of this short, multidimensional questionnaire showed good psychometric properties, comparable to those reported for German and Spanish versions. The French COMI represents a valuable tool for future multicentre clinical studies and surgical registries (e.g. SSE Spine Tango) in French-speaking countries.