Efeito terapêutico do uso da L-carnitina+piracetam na fadiga e na força muscular de pacientes com síndrome pós-poliomielite (spp) : estudo clínico randomizado, duplo-cego, controlado com placebo
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2017-12-21
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Dissertação de mestrado
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Introdução: Uma das características mais importantes na Síndrome Pós Poliomielite (SPP) é o aparecimento de uma nova fraqueza muscular. Está pode ocorrer nos músculos previamente afetados assim como nos não acometidos. A fadiga na SPP pode ser periférica ou central e é considerada um dos sintomas mais debilitantes da SPP. Objetivos: Verificar se pacientes com SPP apresentam modificações na fadiga e na força muscular (FM) quando a L-carnitina associada ao Piracetam são usados como terapia adjuvante ao tratamento convencional. Método: estudo clínico randomizado, duplo-cego, placebo controlado, com taxa de randomização 2:1. Participaram 94 pacientes, ao longo de 180 dias, onde passaram por três consultas( visitas V1, V2 e V3), todos realizaram testes laboratoriais e avaliação da FM através do instrumento Medical Research Council Manual Muscular Test (MMT), e da fadiga através da Escala de Severidade e Fadiga (ESF) e da Escala de Fadiga Revisada de Piper (EFRP). Resultados: tanto na EFRP como na ESF apenas o grupo ativo (GA) apresentou melhora significante do sintoma. Na ESF o GA iniciou com uma fadiga grave (53,1), evoluindo para moderada (49,4) p=0,002. Na Piper na média geral do instrumento o GA apresentou melhora da V3 (4,36) em relação a V1(5,73) p=0,001, demonstrando melhora do sintoma. Quanto a intensidade do sintoma na V1 54,7% dos pacientes do GA demonstravam fadiga intensa, já na V3 esse número cai para 35, 9% p=0,033. Todas as dimensões do instrumento apresentaram melhora estatisticamente significante da V1 em relação a V3. Quanto à FM foi observada melhora estatisticamente significante nas musculaturas proximais dos membros inferiores do GA V1 78,99%; V3 81,10% (p= 0,040). Assim como na força dos músculos proximais do membro inferior direito GA V1 77,86% V3 81,69% (p= 0,008), grupo placebo V1 79,67% V3 78,83% (p= 0,035). Conclusão: o uso da L-carnitina associada ao Piracetam se demonstrou eficiente para a melhora da fadiga dos pacientes, inesperadamente eles também apresentaram melhora da FM, assim como um menor decréscimo de FM.
Introduction: The most important characteristic of Post- Poliomyelitis Syndrome (PPS) is the development of a new muscle weakness. That may occur in muscles that already have some degree of muscle weakness or muscles that were previously committed . The fatigue may be peripheral or central is considered one of the most debilitating symptoms of (PPS). Objective: the aim of this study was to verify if patients with PPS present a modification in the fatigue and muscular strength (MS) symptoms, when L-carnitine associated with Piracetam are used as adjunctive therapy to conventional treatment. Methods: A randomized clynical study, double- blind, placebo-controlled (with a 2: 1 randomization rate) was conducted comparing the use of L-Carnitina 330mg associated with Piracetam 270 mg to the placebo. A total of 94 patients, over a period of 180 days, underwent three visits (V1, V2 and V3); all of them underwent laboratory tests, the MS was evaluated through the Medical Research Council Scale (MRC), the fatigue through the Fatigue Severity Scale (FSS) and with the Revised Piper Fatigue Scale (RPFS). Results: in both RPFS and FSS only the active group (GA) presented significant improvement of the symptom. In FSS the AG started with a severe fatigue (53.1), evolving to a moderate (49.4) p = 0.002. At Piper in the general mean of the instrument, the AG showed improvement of V3 (4.36) in relation to V1 (5.73) p = 0.001, showing improvement of the symptom. As to the intensity of the symptom in the V1 54.7% of the patients of the AG showed intense fatigue, already in V3 this number drops to 35, 9% p = 0.033. All the dimensions of the instrument showed a statistically significant improvement of V1 in relation to V3. Regarding MS, a statistically significant improvement was observed in the proximal (MS) of the lower limbs of AG V1 78.99%; V 3 81.10% (p = 0.040). As in MS of the proximal muscles of the right lower limb AG V1 77.86% V3 81.69% (p = 0.008), placebo group (PG) V1 79.67% V3 78.83% (p = 0.035). Only correlation of MS with fatigue in AG V1 was found for distal musculature of the right upper limb. Conclusion: The use of piracetam-associated L-carnitine was shown to be efficient in improving patients' fatigue, but unexpectedly, they also improved MS, as well as a lesser decrease in MS.
Introduction: The most important characteristic of Post- Poliomyelitis Syndrome (PPS) is the development of a new muscle weakness. That may occur in muscles that already have some degree of muscle weakness or muscles that were previously committed . The fatigue may be peripheral or central is considered one of the most debilitating symptoms of (PPS). Objective: the aim of this study was to verify if patients with PPS present a modification in the fatigue and muscular strength (MS) symptoms, when L-carnitine associated with Piracetam are used as adjunctive therapy to conventional treatment. Methods: A randomized clynical study, double- blind, placebo-controlled (with a 2: 1 randomization rate) was conducted comparing the use of L-Carnitina 330mg associated with Piracetam 270 mg to the placebo. A total of 94 patients, over a period of 180 days, underwent three visits (V1, V2 and V3); all of them underwent laboratory tests, the MS was evaluated through the Medical Research Council Scale (MRC), the fatigue through the Fatigue Severity Scale (FSS) and with the Revised Piper Fatigue Scale (RPFS). Results: in both RPFS and FSS only the active group (GA) presented significant improvement of the symptom. In FSS the AG started with a severe fatigue (53.1), evolving to a moderate (49.4) p = 0.002. At Piper in the general mean of the instrument, the AG showed improvement of V3 (4.36) in relation to V1 (5.73) p = 0.001, showing improvement of the symptom. As to the intensity of the symptom in the V1 54.7% of the patients of the AG showed intense fatigue, already in V3 this number drops to 35, 9% p = 0.033. All the dimensions of the instrument showed a statistically significant improvement of V1 in relation to V3. Regarding MS, a statistically significant improvement was observed in the proximal (MS) of the lower limbs of AG V1 78.99%; V 3 81.10% (p = 0.040). As in MS of the proximal muscles of the right lower limb AG V1 77.86% V3 81.69% (p = 0.008), placebo group (PG) V1 79.67% V3 78.83% (p = 0.035). Only correlation of MS with fatigue in AG V1 was found for distal musculature of the right upper limb. Conclusion: The use of piracetam-associated L-carnitine was shown to be efficient in improving patients' fatigue, but unexpectedly, they also improved MS, as well as a lesser decrease in MS.
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MOTTA, Monalisa Pereira. Efeito terapêutico do uso da L-carnitina+piracetam na fadiga e na força muscular de pacientes com síndrome pós-poliomielite(spp): estudo clínico randomizado, duplo-cego, controlado com placebo. 2017. [218] p. Dissertação (Mestrado em Neurologia/Neurociências) - Escola Paulista de Medicina (EPM), Universidade Federal de São Paulo (UNIFESP), São Paulo, 2017.