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PURPOSE: This paper aims to understand the distinctive biopsychosocial aspects and patient perspectives on chronic low back pain in Lebanon, an Arab country with a unique and rich cultural heritage. METHOD: Qualitative, semi-structured interviews with 12 Lebanese patients purposefully sampled from various governorates. The interviews included participants from different geographic areas and religions. The data underwent analysis through an inductive thematic approach guided by a bounded relativist ontology, a subjectivist epistemology, and a descriptive phenomenological framework. The coding process was managed by computer-assisted qualitative data analysis software (QSR NVivo version 12.0). RESULTS: The researchers identified and constructed two themes: (1) Chronic low back pain: understanding the impact, coping strategies, and communication patterns in lived experiences within the Lebanese context. This theme sheds light on the complexities of pain management and societal influences in Lebanon. (2) Explanatory model of patients living with chronic low back pain in Lebanon. This theme allowed an exploration of the multifaceted narratives of chronic low back pain. CONCLUSION: This study found that Lebanese individuals attribute chronic low back pain to biomedical factors despite some recognizing psychosocial elements. It emphasizes the need to educate patients on the biopsychosocial model, facilitate better care, and dispel misconceptions.
The exploration of patients' pain perception may provide an opportunity to better develop and design culturally sensitive pain neuroscience education material for Arab-speaking and Lebanese physical therapists.The rehabilitation process should incorporate a balanced biopsychosocial approach, addressing both physical and psychosocial elements of pain, to provide more effective care and outcomes for Lebanese patients who predominantly attribute chronic low back pain to biomedical factors.Lebanese healthcare professionals need to improve communication with Lebanese patients regarding the nature of chronic low back pain, using clear communication to help dispel misconceptions and enhance rehabilitation outcomes.
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PURPOSE: The purpose of this paper was first to gain an in-depth understanding of the barriers and facilitators to implementing the BPS model and pain neuroscience education in the current Lebanese physical therapy health care approach and explore its acceptability. METHOD: A qualitative semi-structured interview using purposive sampling was conducted with eight Lebanese physical therapists practising in different governorates. The transcribed text from the interviews was analyzed using inductive thematic analysis. RESULTS: Two topics were generated and constructed by the researchers: (1) "barriers to the implementation of pain neuroscience education, with subthemes including (a) "current health care approach," (b) "basic curriculum and continuing education," (c) "patients' barriers"; (2) "facilitators to the implementation of pain neuroscience education," with subthemes containing (a) "interest in the BPS model, (b) "therapeutic alliance," and (c) "motivation for future training on BPS approach." CONCLUSION: The analysis of the results showed that Lebanese physical therapists currently hold a strong biomedical view of chronic pain, assessment, and treatment. However, despite the presence of barriers and challenges, they are aware and open to consider the implementation and future training about the BPS model and pain neuroscience education in their approach.IMPLICATIONS FOR REHABILITATIONThe exploration of potential barriers and facilitators to the bio-psychosocial model and pain neuroscience education implementation may provide an opportunity for better development and design of a culturally sensitive pain neuroscience education material for Arab-speaking and Lebanese physical therapists.The exploration of barriers and facilitators to the implementation of pain neuroscience education will help to improve pain education and ensure better clinical pain management.The most important barriers were the dominant characteristic of the Lebanese physical therapist's health approach, which is focused on a biomechanically oriented model, and their lack of knowledge to approach chronic pain from a biopsychosocial perspective.
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Dor Crônica , Neurociências , Fisioterapeutas , Humanos , Dor Crônica/terapia , Dor Crônica/psicologia , Pesquisa Qualitativa , Atenção à SaúdeRESUMO
OBJECTIVE: This systematic review summarizes the relevant literature on the effectiveness of tailored interventions in non-specific low back pain (NSLBP). METHODS: The search strategy has been executed in December 2019 in the electronic databases PubMed, Web of Science and Embase. Study selection, data extraction and quality assessment were done independently by two authors. RESULTS: A total six eligible studies were identified. Five out of six articles used a classification system to subgroup patients. All active patient tailored interventions had similar or better results than the non-patient tailored interventions, most importantly on pain (short- and mid-term, not for long term follow-up). Two motor control interventions revealed sustained or increased effects at 12 months follow-up for disability. For cost-effectiveness, medication use and work absenteeism, results were inconclusive. Global rating of change evaluation confirmed significant between-group results at 10 weeks to 4 months follow-up, but results were not maintained at 12-month evaluation. DISCUSSION & CONCLUSION: Our findings support the preliminary evidence for the use of patient tailored treatment for reductions in pain and disability. However, our results are of very low to moderate quality evidence and the observed effects strongly depend on the subgroups and the chosen interventions. More high-quality RCT's with homogenous designs and larger sample sizes are needed.
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Dor Lombar , Humanos , Dor Lombar/terapiaRESUMO
PURPOSE: Examining whether socio-demographic variables, pain or functionality are related to the degree of clinic-based therapy adherence in patients suffering from nonspecific chronic spinal pain (nCSP). DESIGN: Secondary analysis of a randomized clinical trial. SETTING: University hospital of Ghent and Brussels. METHODS: Dutch speakers, 18-65 years old, experiencing nCSP for at least 3 months. 120 participants were randomly allocated to two interventional groups, of which 94 completed all therapy sessions. MAIN OUTCOME MEASURES: Degree of clinic-based adherence, defined as the amount of completed therapy sessions. RESULTS: Demographic data (sex, age or education) were not significantly associated with adherence in the total sample or the neuroscience group. For the traditional physiotherapy group, educational level was associated with attendance of at least 50% of the therapy sessions. Regarding pain-, belief- and function-related measures, only the association between change in kinesiophobia and adherence was significant for the traditional physiotherapy group. CONCLUSIONS: Factors related to therapy adherence in the total group or the neuroscience group could not be found. Educational level and change in kinesiophobia were however related to therapy adherence in the traditional physiotherapy group.
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Dor nas Costas/terapia , Catastrofização , Dor Crônica/terapia , Cervicalgia/terapia , Cooperação do Paciente , Modalidades de Fisioterapia , Adolescente , Adulto , Idoso , Dor nas Costas/psicologia , Dor Crônica/psicologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Cervicalgia/psicologia , Países Baixos , Limiar da Dor/psicologia , Fatores SocioeconômicosRESUMO
Brain alterations are hypothesized to be present in patients with chronic whiplash-associated disorders (CWAD). The aim of this case-control study was to examine alterations in cortical thickness and white matter (WM) structure, and the presence of brain microhemorrhages in a patient group encountering chronic neck pain of traumatic origin (i.e., CWAD) when compared with a patient group characterized by nontraumatic chronic neck pain [i.e., chronic idiopathic neck pain (CINP)], and healthy controls. Furthermore, we aimed to investigate associations between brain structure on one hand and cognitive performance and central sensitization (CS) on the other hand. T1-weighted, diffusion-weighted and T2*-weighted magnetic resonance images of the brain were acquired in 105 women (31 controls, 37 CINP, 37 CWAD) to investigate regional cortical thickness, WM structure, and microhemorrhages, respectively. Next, cognitive performance, and CS encompassing distant hyperalgesia and conditioned pain modulation (CPM) efficacy were examined. Cortical thinning in the left precuneus was revealed in CWAD compared with CINP patients. Also, decreased fractional anisotropy, together with increased values of mean diffusivity and radial diffusivity could be observed in the left cingulum hippocampus and tapetum in CWAD compared with CINP, and in the left tapetum in CWAD patients compared with controls. Moreover, the extent of WM structural deficits in the left tapetum coincided with decreased CPM efficacy in the CWAD group. This yields evidence for associations between decreased endogenous pain inhibition, and the degree of regional WM deficits in CWAD. Our results emphasize the role of structural brain alterations in women with CWAD compared with CINP.
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Córtex Cerebral/diagnóstico por imagem , Dor Crônica/diagnóstico por imagem , Cervicalgia/diagnóstico por imagem , Traumatismos em Chicotada/diagnóstico por imagem , Substância Branca/diagnóstico por imagem , Adolescente , Adulto , Estudos de Casos e Controles , Córtex Cerebral/patologia , Dor Crônica/etiologia , Dor Crônica/psicologia , Cognição , Estudos Transversais , Feminino , Humanos , Processamento de Imagem Assistida por Computador , Imageamento por Ressonância Magnética , Pessoa de Meia-Idade , Cervicalgia/etiologia , Cervicalgia/psicologia , Tamanho do Órgão , Traumatismos em Chicotada/complicações , Traumatismos em Chicotada/psicologia , Adulto JovemRESUMO
INTRODUCTION: Universities are developing and implementing implant dentistry training to prepare dental professionals for the growing treatment needs. This study describes how implant dentistry is taught at the KU Leuven and focuses on implant-related clinical outcomes. Perspectives of participating undergraduate students are analysed with a view to improve oral implant dentistry training. MATERIALS AND METHODS: Implant dentistry training at the KU Leuven consists of theoretical lectures, pre-clinical hands-on workshops and clinical (surgical/prosthetic) experience. Questionnaires were used to investigate the perceptions of students on the educational programme. Radiographs were taken at implant insertion, at healing abutment connection, at restoration/prosthesis insertion and after 1 and 2 years of functional loading. The marginal bone level was measured from the implant-abutment connection to the first visible bone-to-implant contact. RESULTS: One hundred and twelve implants were placed by 56 undergraduate students (61.5% of the total students) in 56 patients. After a follow-up time of 3 years, the cumulative implant survival rate, at implant level, was 97.1%. The mean marginal bone loss after 1 and 2 years in function was 0.35 mm and 0.39 mm, respectively. Eighty percentage of students were satisfied with the training, and they considered this sufficient preparation to perform implant placement under close supervision. CONCLUSIONS: The clinical outcome of implant treatment performed by undergraduate students under close supervision is similar to that reported by experienced clinicians/research teams. Clinical, surgical as well as restorative experience in addition to theoretical and pre-clinical training seems beneficial when implementing implant dentistry in the undergraduate programmes.
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Implantes Dentários , Falha de Restauração Dentária , Educação em Odontologia , Prótese Dentária Fixada por Implante , Seguimentos , Humanos , EstudantesRESUMO
The aim of this study is to systematically review whether the presence of altered central pain modulation pre-surgical influences outcome after total knee replacement (TKR) in patients with knee osteoarthritis (OA), and if so which indices of central pain modulation predict poor outcome after TKR. To identify relevant articles, PubMed and Web of Science were searched. The search strategy was a combination of key words related to "Knee Osteoarthritis and Total Knee Replacement", "Central Pain Modulation" and "Post-Surgical Outcome Measures". Articles fulfilling the inclusion criteria were screened for methodological quality and results were analyzed and summarized. Sixteen prospective cohort studies were included. Strong evidence is available that presence of catastrophic thinking and poor coping strategies predict more pain after TKR and that there is no association between fear of movement and post-surgical pain or function. Evidence on other psychosocial influences is limited or conflicting. Literature on the influence of other signs of altered central pain modulation on post-surgical outcome is scarce. It is plausible that pre-surgical signs of altered central pain modulation, such as joint pain at rest or widespread pain sensitization, predict more post-surgical pain. Surgeons should be attentive for patients with signs of altered central pain modulation before surgery as they might be at risk for unfavorable outcome. A broader therapeutic approach aiming to desensitize the central nervous system can be adapted in these patients. Further research is however needed to identify the influence of central pain modulation pre-surgical in predicting outcome after TKR.
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Artralgia/cirurgia , Artroplastia do Joelho , Sensibilização do Sistema Nervoso Central/fisiologia , Osteoartrite do Joelho/cirurgia , Dor Pós-Operatória/fisiopatologia , Artralgia/fisiopatologia , Humanos , Osteoartrite do Joelho/fisiopatologia , Período Pré-OperatórioRESUMO
Docetaxel is extensively used in chemotherapy for the treatment of breast cancer. Little attention has been given to oedema as a possible side effect of docetaxel-containing therapies. Until now, no review was conducted to evaluate docetaxel-containing therapies versus docetaxel-free therapies on the magnitude of the risk of developing oedema. In this systematic review, we investigated the risk of developing oedema in patients being treated for breast cancer with or without docetaxel. In this systematic literature review, we searched PubMed and Web of Knowledge for studies on breast cancer patients treated with chemotherapy containing docetaxel. We included clinical trials comparing docetaxel versus docetaxel-free chemotherapy. Oedema had to be reported and measured as a key outcome or an adverse effect. Methodological checklists were used to assess the risk of bias within the selected studies. Seven randomised clinical trials were included. Six trials were of moderate methodological quality. All trials showed an increased rate of oedema in the docetaxel-treatment arm. The trial of weakest methodological quality reported the highest incidence of oedema. The results moderately suggest that adjuvant chemotherapy containing docetaxel is related to a significantly increased risk of developing oedema, compared with docetaxel-free chemotherapy.
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Antineoplásicos/uso terapêutico , Neoplasias da Mama/terapia , Edema/epidemiologia , Linfedema/epidemiologia , Mastectomia , Complicações Pós-Operatórias/epidemiologia , Taxoides/uso terapêutico , Quimioterapia Adjuvante , Docetaxel , Feminino , Humanos , Fatores de RiscoRESUMO
Traditional understanding of osteoarthritis-related pain has recently been challenged in light of evidence supporting a key role of central sensitization in a subgroup of this population. This fact may erroneously lead musculoskeletal therapists to conclude that hands-on interventions have no place in OA management, and that hands-off interventions must be applied exclusively. The aim of this paper is to encourage clinicians in finding an equilibrium between hands-on and hands-off interventions in patients with osteoarthritis-related pain dominated by central sensitization. The theoretical rationale for simultaneous application of manual therapy and pain neuroscience education is presented. Practical problems when combining these interventions are also addressed. Future studies should explore the combined effects of these treatment strategies to examine whether they increase therapeutic outcomes against current approaches for chronic osteoarthritis-related pain.
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Sensibilização do Sistema Nervoso Central , Manipulações Musculoesqueléticas/métodos , Dor Musculoesquelética/terapia , Osteoartrite/terapia , Manejo da Dor/métodos , Terapia Combinada , Feminino , Mãos/fisiologia , Humanos , Masculino , Dor Musculoesquelética/etiologia , Dor Musculoesquelética/fisiopatologia , Neurociências/educação , Osteoartrite/complicações , Osteoartrite/diagnóstico , Limiar da Dor , Modalidades de Fisioterapia , Guias de Prática Clínica como Assunto , Índice de Gravidade de DoençaRESUMO
The objective of this prospective study is to investigate possible scapular related risk factors for developing shoulder pain. Therefore, a 2-year follow-up study in a general community sports centre setting was conducted. A sample of convenience of 113 recreational overhead athletes (59 women and 54 men) with a mean age of 34 (17-64; SD 12) years were recruited. At baseline, visual observation for scapular dyskinesis, measured scapular protraction, upward scapular rotation and dynamic scapular control were evaluated. 22% (n=25) of all athletes developed shoulder pain during the 24 months following baseline assessment. The Mean Shoulder Disability Questionnaire (SDQ) score for the painful shoulders was 34.8 (6.3-62.5; SD 17.4). None of the scapular characteristics predicted the development of shoulder pain. However, the athletes that developed shoulder pain demonstrated significantly less upward scapular rotation at 45° (p=0.010) and 90° (p=0.016) of shoulder abduction in the frontal plane at baseline in comparison to the athletes that remained pain-free. In conclusion, although these scapular characteristics are not of predictive value for the development of shoulder pain, this study increases our understanding of the importance of a scapular upward rotation assessment among recreational overhead athletes.
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Escápula/fisiopatologia , Dor de Ombro/etiologia , Esportes/fisiologia , Adolescente , Adulto , Fenômenos Biomecânicos , Avaliação da Deficiência , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Razão de Chances , Estudos Prospectivos , Fatores de Risco , Rotação , Articulação do Ombro/fisiologia , Método Simples-Cego , Inquéritos e Questionários , Adulto JovemRESUMO
BACKGROUND: Many patients with chronic pain, including those with chronic whiplash-associated disorders (WAD), show features of central sensitization. Randomized trials examining whether treatments are able to influence the process of central sensitization in patients with chronic WAD are emerging. Therefore, the present study aimed at examining whether acupuncture results in activation of endogenous analgesia and relief in symptoms in patients with chronic WAD. METHODS: In this randomized crossover pilot trial with blinded assessors, each patient (n = 39) received two treatment sessions of identical duration, with acupuncture and relaxation therapy randomly crossed over in visit 2. Primary outcome measurement included immediate activation of endogenous analgesia i.e., pressure pain sensitivity and conditioned pain modulation. Secondary outcome measurements included pain relief and reduced disability level. RESULTS: Local pressure pain sensitivity at baseline and during conditioned pain modulation decreased significantly more following acupuncture compared with relaxation (time × group interactions: p < 0.001), both in the neck and at a site distinct from the painful region. When comparing the effects of acupuncture versus relaxation, no differences were observed on conditioned pain modulation, temporal summation of pressure pain, neck disability or symptom severity (all p-values >0.05). CONCLUSION: It was shown that one session of acupuncture treatment results in acute improvements in pressure pain sensitivity in the neck and calf of patients with chronic WAD. Acupuncture had no effect on conditioned pain modulation or temporal summation of pressure pain. Both acupuncture and relaxation appear to be well-tolerated treatments for people with chronic WAD. These findings suggest that acupuncture treatment activates endogenous analgesia in patients with chronic WAD.
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Terapia por Acupuntura , Analgesia , Traumatismos em Chicotada/terapia , Pontos de Acupuntura , Adolescente , Adulto , Idoso , Análise de Variância , Estudos Cross-Over , Avaliação da Deficiência , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Dor/etiologia , Dor/fisiopatologia , Manejo da Dor , Medição da Dor , Terapia de Relaxamento , Tamanho da Amostra , Resultado do Tratamento , Adulto JovemRESUMO
BACKGROUND AND OBJECTIVES: It has been suggested that sensitization of the central nervous system plays an important role in the development and maintenance of chronic (pain) complaints experienced by whiplash patients. According to the PRISMA guidelines, a systematic review was performed to screen and evaluate the existing clinical evidence for the presence of central sensitization in chronic whiplash. DATABASES AND DATA TREATMENT: Predefined keywords regarding central sensitization and chronic whiplash were combined in electronic search engines PubMed and Web of Science. Full text clinical reports addressing studies of central sensitization in human adults with chronic complaints due to a whiplash trauma were included and reviewed on methodological quality by two independent reviewers. RESULTS: From the 99 articles that were identified, 24 met the inclusion criteria, and 22 articles achieved sufficient scores on methodological quality and were discussed. These studies evaluated the sensitivity to different types of stimuli (mechanical, thermal, electrical). Findings suggest that although different central mechanisms seem to be involved in sustaining the pain complaints in whiplash patients, hypersensitivity of the central nervous system plays a significant role. Persistent pain complaints, local and widespread hyperalgesia, referred pain and (thoracic) allodynia, decreased spinal reflex thresholds, inefficient diffuse noxious inhibitory controls activation and enhanced temporal summation of pain were established in chronic whiplash patients. CONCLUSIONS: Although the majority of the literature provides evidence for the presence of central sensitization in chronic whiplash, underlying mechanisms are still unclear and future studies with good methodological quality are necessary. In addition, international guidelines for the definition, clinical recognition, assessment and treatment of central sensitization are warranted.
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Sensibilização do Sistema Nervoso Central/fisiologia , Hiperalgesia/fisiopatologia , Traumatismos em Chicotada/fisiopatologia , Anestésicos Locais/uso terapêutico , Estudos de Casos e Controles , Doença Crônica , Ensaios Clínicos como Assunto , Humanos , Hiperalgesia/tratamento farmacológico , Hiperalgesia/etiologia , Dor/etiologia , Dor/fisiopatologia , Medição da Dor , Estimulação Física , Ensaios Clínicos Controlados Aleatórios como Assunto , Reflexo/fisiologia , Projetos de Pesquisa , Traumatismos em Chicotada/complicaçõesRESUMO
OBJECTIVES: Too vigorous exercise or activity increase frequently triggers postexertional malaise in people with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), a primary characteristic evident in up to 95% of people with ME/CFS. The present study aimed at examining whether two different types of exercise results in changes in health status, circulating elastase activity, interleukin (IL)-1beta and complement C4a levels. DESIGN: Comparative experimental design. SETTING: University. SUBJECTS: Twenty-two women with ME/CFS and 22 healthy sedentary controls INTERVENTIONS: participants were subjected to a submaximal exercise (day 8) and a self-paced, physiologically limited exercise (day 16). Each bout of exercise was preceded and followed by blood sampling, actigraphy and assessment of their health status. RESULTS: Both submaximal exercise and self-paced, physiologically limited exercise resulted in postexertional malaise in people with ME/CFS. However, neither exercise bout altered elastase activity, IL-1beta or complement C4a split product levels in people with ME/CFS or healthy sedentary control subjects (P > 0.05). Postexercise complement C4a level was identified as a clinically important biomarker for postexertional malaise in people with ME/CFS. CONCLUSIONS: Submaximal exercise as well as self-paced, physiologically limited exercise triggers postexertional malaise in people with ME/CFS, but neither types of exercise alter acute circulating levels of IL-1beta, complement C4a split product or elastase activity. Further studying of immune alterations in relation to postexertional malaise in people with ME/CFS using multiple measurement points postexercise is required.
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Complemento C4a/metabolismo , Exercício Físico/fisiologia , Síndrome de Fadiga Crônica/metabolismo , Fadiga/metabolismo , Interleucina-1beta/sangue , Elastase Pancreática/sangue , Adulto , Estudos de Casos e Controles , Síndrome de Fadiga Crônica/fisiopatologia , Feminino , Humanos , Inquéritos e QuestionáriosRESUMO
OBJECTIVES: To examine the efficacy of the pain inhibitory systems in patients with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) during two different types of exercise and to examine whether the (mal)functioning of pain inhibitory systems is associated with symptom increases following exercise. DESIGN: A controlled experimental study. SETTING AND SUBJECTS: Twenty-two women with ME/CFS and 22 healthy sedentary controls were studied at the Department of Human Physiology, Vrije Universiteit Brussel. INTERVENTIONS: All subjects performed a submaximal exercise test and a self-paced, physiologically limited exercise test on a cycle ergometer. The exercise tests were undertaken with continuous cardiorespiratory monitoring. Before and after the exercise bouts, subjects filled out questionnaires to assess health status, and underwent pressure pain threshold measurements. Throughout the study, subjects' activity levels were assessed using accelerometry. RESULTS: In patients with ME/CFS, pain thresholds decreased following both types of exercise, whereas they increased in healthy subjects. This was accompanied by a worsening of the ME/CFS symptom complex post-exercise. Decreased pressure thresholds during submaximal exercise were associated with postexertional fatigue in the ME/CFS group (r = 0.454; P = 0.034). CONCLUSIONS: These observations indicate the presence of abnormal central pain processing during exercise in patients with ME/CFS and demonstrate that both submaximal exercise and self-paced, physiologically limited exercise trigger postexertional malaise in these patients. Further study is required to identify specific modes and intensity of exercise that can be performed in people with ME/CFS without exacerbating symptoms.
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Exercício Físico/fisiologia , Síndrome de Fadiga Crônica/psicologia , Atividade Motora/fisiologia , Limiar da Dor/fisiologia , Adulto , Teste de Esforço/métodos , Tolerância ao Exercício/fisiologia , Síndrome de Fadiga Crônica/fisiopatologia , Feminino , Humanos , Pessoa de Meia-Idade , Estimulação Física/métodos , Adulto JovemRESUMO
OBJECTIVES: To assess the effect on cardiac repolarisation of the investigational synaptic vesicle protein 2A (SV2A) ligand brivaracetam. RESEARCH DESIGN AND METHODS: Subjects received double-blind, multiple bid doses of placebo (n = 53), brivaracetam 75 mg (n = 39) or brivaracetam 400 mg (n = 40), or open-label single-dose moxifloxacin 400 mg (positive control, n = 52). Continuous 12-lead ECG recordings were performed at baseline and after last dosing, using a Mortara Holter device. Plasma samples were obtained before and up to 12 h after last dosing for drug determination. Triplicate ECGs were extracted before each sample, and read centrally in a blinded manner. QT was corrected using a centre- and gender-specific correction (QTc(SS) ). MAIN OUTCOME MEASURES: The primary endpoint was the largest time-matched mean difference of QTc(SS) change from baseline between drug and placebo (maximum DeltaDeltaQTc(SS)). The same approach was adopted using the Fridericia's correction (QTc(F)). The relationships between DeltaQTc(SS) and plasma concentration of brivaracetam and moxifloxacin were fitted to a straight line using linear least-squares regression. RESULTS: Mean maximum DeltaDeltaQTc(SS) for brivaracetam 75 and 400 mg bid, and moxifloxacin 400 mg was 0.2 ms, -1.1 ms and 12.4 ms, respectively. The one-sided 95% upper limit for 75 mg and 400 mg brivaracetam was 4.3 ms and 3.0 ms, respectively; the one-sided 95% lower limit for moxifloxacin was 8.6 ms. After brivaracetam no QTc(SS) intervals > 480 ms or changes from baseline of > 60 ms were observed. DeltaQTc(SS) did not increase with plasma concentration of brivaracetam, whereas there was a statistically significant rise with increasing moxifloxacin concentrations. CONCLUSIONS: The study was found to be valid in terms of assay sensitivity and the results demonstrated the absence of effects of brivaracetam on cardiac repolarisation. These results suggest that no intensive cardiac monitoring is required during the subsequent stages of brivaracetam development.
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Coração/efeitos dos fármacos , Pirrolidinonas/farmacologia , Adulto , Relação Dose-Resposta a Droga , Feminino , Frequência Cardíaca/efeitos dos fármacos , Humanos , Masculino , Placebos , Sensibilidade e EspecificidadeRESUMO
The safety and efficacy of the sustained release (SR) mebeverine capsule was compared to the standard plain mebeverine capsule in the treatment of 60 patients suffering from irritable bowel syndrome. Patients, with a score of at least 44 on the Kruis scale, were randomized into a two-period crossover trial. Each treatment period lasted for 6 weeks during which the patients took mebeverine plain 135 mg, two capsules t.i.d., or mebeverine sustained release 200 mg (SR), two capsules b.i.d. After 6 weeks of each treatment, both treatments were regarded 'effective' or 'very effective' by the patient as well as the investigator in more than 80% of the cases. After 3 weeks of the first treatment, the disease score was rated light in 73% of the patients with both medications. After 6 weeks, nine patients (33%) were symptom-free with mebeverine plain, and five (18%) with mebeverine SR. During the second treatment period the number of symptom-free cases reached about 40% with both formulations. Considering the clinical general improvement, more than 70% of all patients had improved after 3 weeks of the first treatment. An additional improvement was reported in 13 patients with mebeverine plain and in 10 patients with mebeverine SR after the next 3 weeks. Abdominal pain was still present in more than 50% of patients but with lower intensity compared with baseline values. Mean scores of efficacy were very similar for both treatments after 3 and 6 weeks (2.0 for mebeverine plain vs. 1.9 for mebeverine SR). The statistical comparison of all scores between the two formulations did not show a significant difference at any time. Very few adverse events were noted and a causal relationship with the study medications was judged as improbable or definitely unrelated. Compliance was close to 100% for most of the patients. The results of the present study indicate that the mebeverine SR capsule provides equivalent efficacy and tolerance to mebeverine plain in the treatment of irritable bowel syndrome (IBS), while reducing the number of daily doses from three to two.
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Doenças Funcionais do Colo/tratamento farmacológico , Parassimpatolíticos/uso terapêutico , Fenetilaminas/uso terapêutico , Dor Abdominal/tratamento farmacológico , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Estudos Cross-Over , Preparações de Ação Retardada , Método Duplo-Cego , Tolerância a Medicamentos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Pacientes Ambulatoriais , Parassimpatolíticos/administração & dosagem , Fenetilaminas/administração & dosagem , Resultado do TratamentoRESUMO
We describe a case of giant congenital melanocytic nevus with placental villous involvement in an otherwise uncomplicated pregnancy. Only four similar cases have been reported in the world literature. Nevomelanocytes were found in both villous stoma and fetal capillaries. No neonatal or maternal adverse effects were observed 5 years after diagnosis in the present case.
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Nevo Pigmentado/congênito , Nevo Pigmentado/patologia , Placenta/patologia , Complicações Neoplásicas na Gravidez/patologia , Neoplasias Cutâneas/congênito , Neoplasias Cutâneas/patologia , Neoplasias Uterinas/complicações , Neoplasias Uterinas/patologia , Adulto , Feminino , Humanos , Recém-Nascido , Masculino , Melanócitos/patologia , Nevo Pigmentado/cirurgia , Gravidez , Neoplasias Cutâneas/cirurgia , Fatores de TempoRESUMO
The authors have studied the toxicity of alkylating agents on the gonads in the light of three cases. The more frequent prescription of these products in chemotherapy when treating cases in Nephrology, Dermatology, Neurology and Ophthalmology as well as general systemic diseases, should make the doctor prescribing them look out for the risks that the reproductive function runs in their use. Although of course there is no valid discussion of the use of these drugs when life is at stake one should all the same, seeing how their efficacy is increasing and survival is becoming more likely, ask oneself about their bad effects on the gonads, and in particular when they are being used for less serious indications. The gonads are often attacked early and insidiously, the the effects on them often starting before the more spectacular secondary effects such as alopecia or neutropenia. A review of the literature brings to light the following : there is a more marked effect on the gonad when it is the testis than when it is the ovary, which seems to be progressively affected; the lesions become worse and increase according to the pubertal state of the male. As far as testicular damage is concerned, it seems debatable whether is is dose-related or related to the length of treatment, and the chances of recovery on stopping chemotherapy with alkylating agents seen to be overall poor. On the practical level the use of sperm banks may resolve some of the worries about later infertility. As far as women are concerned, the greater resistance of the ovary to the effects should make one careful to employ contraceptive measures which are necessary during and after treatment (for fear of teratogenicity).