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Spósito, Andrei C
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Id: biblio-832403
Autor: Carvalho, Luiz Sergio F. de; Sposito, Andrei C.
Título: Sintomas musculares relacionados ao uso de estatinas / Statin-associated muscle symptoms
Fonte: Rev. Soc. Cardiol. Estado de Säo Paulo;26(3):f:180-l:189, jul.-set. 2016. tab.
Idioma: pt.
Resumo: Nas últimas duas décadas, comprovou-se que a terapia com estatinas é o instrumento isolado mais potente para atenuar o risco cardiovascular, e seu uso frequente foi enfatizado como um dos elementos mais importantes para reduzir a mortalidade cardiovascular nos países desenvolvidos. Uma incidência igualmente frequente de sintomas musculares em usuários de estatinas levanta a possibilidade de um nexo de causalidade, que leva a uma entidade patológica conhecida como sintomas musculares associados a estatinas (SMAS). Estudos e ensaios clínicos mecanicistas destinados a estudar os SMAS levaram a uma definição clara da sua história natural e incidência exata. Essa informação é essencial para evitar riscos desnecessários de formas graves de SMAS. Ao mesmo tempo, essa compreensão concreta dos SMAS evita o diagnóstico exagerado e a suspensão desnecessária de uma das mais poderosas estratégias de prevenção atuais. Nesse contexto, este artigo de revisão reuniu todas as informações disponíveis sobre o assunto, que são apresentadas em detalhe neste documento como a base da identificação e tratamento dos SMAS

In the last 2 decades, statin therapy has proved to be the most potent isolated instrument for attenuating cardiovascular risk, and its frequent use has been highlighted as one of the most important elements for reducing cardiovascular mortality in developed countries. An equally frequent incidence of muscle symptoms in statin users raises the possibility of a causal link, leading to a disease entity known as statin-associated muscle symptoms (SAMS). Mechanistic studies and clinical trials designed to the study of SAMS have led to a clear definition of its natural history and accurate incidence. This information is vital for avoiding unnecessary risk of severe forms of SAMS. At the same time, this concrete understanding of SAMS prevents over-diagnosis and unnecessary suspension of one of the most powerful prevention strategies available today. In this context, this review has gathered all the available information on the issue, which is presented in detail, in this document, as the basis for the identification and management of SAMS
Descritores: Sinais e Sintomas
Terapêutica
Inibidores de Hidroximetilglutaril-CoA Redutases/administração & dosagem
Hipolipemiantes/uso terapêutico
-Lovastatina/efeitos adversos
Fatores de Risco
Sinvastatina/efeitos adversos
Creatina Quinase
Atorvastatina/efeitos adversos
Limites: Humanos
Tipo de Publ: Revisão
Responsável: BR44.1 - Serviço de Biblioteca, Documentação Científica e Didática Prof. Dr. Luiz Venere Décourt


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Id: biblio-1254158
Autor: Campos, Diana; Puga, Luis; Guardado, Joana; Saleiro, Carolina; Lopes, João; Teixeira, Rogério; Gonçalves, Lino.
Título: Síndrome de ALCAPA em uma Mulher Jovem / ALCAPA Syndrome in a Young Woman
Fonte: ABC., imagem cardiovasc;34(1), 2021.
Idioma: pt.
Resumo: Mulher de 18 anos com histórico de síncope, angina e palpitações há um ano. Uma indicação crucial era artéria coronária direita dilatada na ecocardiografia transtorácica. Os achados da tomografia computadorizada resultaram no diagnóstico da origem anômala da artéria coronariana esquerda proveniente da síndrome da artéria pulmonar.(AU)
Descritores: Artéria Pulmonar/fisiopatologia
Doença da Artéria Coronariana/cirurgia
Vasos Coronários/diagnóstico por imagem
Síndrome de Bland-White-Garland/patologia
Síndrome de Bland-White-Garland/diagnóstico por imagem
-Raios X
Ecocardiografia
Espectroscopia de Ressonância Magnética/métodos
Eletrocardiografia Ambulatorial/métodos
Creatina Quinase/sangue
Eletrocardiografia
Angiografia por Tomografia Computadorizada/métodos
Limites: Humanos
Feminino
Adolescente
Tipo de Publ: Relatos de Casos
Responsável: BR44.1 - Serviço de Biblioteca, Documentação Científica e Didática Prof. Dr. Luiz Venere Décourt


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Texto completo SciELO Brasil
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Id: biblio-843475
Autor: Ramani, Jaydip; Malhotra, Amber; Wadhwa, Vivek; Sharma, Pranav; Garg, Pankaj; Tarsaria, Malkesh; Pandya, Himani.
Título: Single-dose lignocaine-based blood cardioplegia in single valve replacement patients
Fonte: Rev. bras. cir. cardiovasc = Braz. j. cardiovasc. surg. (impr.);32(2):90-95, Mar.-Apr. 2017. tab.
Idioma: en.
Resumo: Abstract OBJECTIVE: Myocardial protection is the most important in cardiac surgery. We compared our modified single-dose long-acting lignocaine-based blood cardioplegia with short-acting St Thomas 1 blood cardioplegia in patients undergoing single valve replacement. METHODS: A total of 110 patients who underwent single (aortic or mitral) valve replacement surgery were enrolled. Patients were divided in two groups based on the cardioplegia solution used. In group 1 (56 patients), long-acting lignocaine based-blood cardioplegia solution was administered as a single dose while in group 2 (54 patients), standard St Thomas IB (short-acting blood-based cardioplegia solution) was administered and repeated every 20 minutes. All the patients were compared for preoperative baseline parameters, intraoperative and all the postoperative parameters. RESULTS: We did not find any statistically significant difference in preoperative baseline parameters. Cardiopulmonary bypass time were 73.8±16.5 and 76.4±16.9 minutes (P=0.43) and cross clamp time were 58.9±10.3 and 66.3±11.2 minutes (P=0.23) in group 1 and group 2, respectively. Mean of maximum inotrope score was 6.3±2.52 and 6.1±2.13 (P=0.65) in group 1 and group 2, respectively. We also did not find any statistically significant difference in creatine-phosphokinase-MB (CPK-MB), Troponin-I levels, lactate level and cardiac functions postoperatively. CONCLUSION: This study proves the safety and efficacy of long-acting lignocaine-based single-dose blood cardioplegia compared to the standard short-acting multi-dose blood cardioplegia in patients requiring the single valve replacement. Further studies need to be undertaken to establish this non-inferiority in situations of complex cardiac procedures especially in compromised patients.
Descritores: Soluções Cardioplégicas/administração & dosagem
Implante de Prótese de Valva Cardíaca/métodos
Parada Cardíaca Induzida/métodos
Lidocaína/administração & dosagem
-Valva Aórtica/cirurgia
Período Pós-Operatório
Cloreto de Potássio/administração & dosagem
Bicarbonatos/administração & dosagem
Cloreto de Cálcio/administração & dosagem
Cloreto de Sódio/administração & dosagem
Estudos Prospectivos
Resultado do Tratamento
Ácido Láctico/sangue
Troponina I/sangue
Creatina Quinase/sangue
Magnésio/administração & dosagem
Valva Mitral/cirurgia
Limites: Humanos
Masculino
Feminino
Adolescente
Adulto
Pessoa de Meia-Idade
Adulto Jovem
Tipo de Publ: Ensaio Clínico Controlado Aleatório
Responsável: BR1.1 - BIREME


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Texto completo SciELO Brasil
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Id: biblio-1020439
Autor: Carvalho, Letícia Helena de; Teixeira, Leda Fabiélen; Zaqueo, Kayena Delaix; Bastos, Jéssica Felix; Nery, Neriane Monteiro; Setúbal, Sulamita Silva; Pontes, Adriana Silva; Butzke, Diana; Cavalcante, Walter; Gallacci, Marcia; Fernandes, Carla Freire Celedônio; Stabeli, Rodrigo Guerino; Soares, Andreimar Martins; Zuliani, Juliana Pavan.
Título: Local and systemic effects caused by Crotalus durissus terrificus, Crotalus durissus collilineatus, and Crotalus durissus cascavella snake venoms in swiss mice
Fonte: Rev. Soc. Bras. Med. Trop;52:e20180526, 2019. tab, graf.
Idioma: en.
Projeto: Conselho Nacional de Desenvolvimento Científico e Tecnológico.
Resumo: Abstract INTRODUCTION: Crotalus envenomations cause serious complications and can be fatal without appropriate treatment. Venom isoforms present and inter/intraspecific variations in the venom composition can result in different symptoms presented by bites by snakes from the same species but from different geographical regions. We comparatively evaluated the local and systemic effects caused by Crotalus durissus terrificus (Cdt), C.d. collilineatus (Cdcolli), and C.d. cascavella (Cdcasc) envenomation. METHODS: Venom chromatography was performed. Proteolytic, phospholipase, and LAAO activities were analyzed. Edema, myotoxicity, hepatotoxicity, nephrotoxicity, and coagulation alterations were evaluated. RESULTS: The venom SDS-PAGE analyses found the presence of convulxin, gyroxin, crotoxin, and crotamine in Cdt and Cdcolli venoms. Crotamine was not present in the Cdcasc venom. Cdt, Cdcollli, and Cdcasc venoms had no proteolytic activity. Only Cdcasc and Cdt venoms had phospholipase activity. LAAO activity was observed in Cdcolli and Cdcasc venoms. Cdcolli and Cdcasc venoms caused 36.7% and 13.3% edema increases, respectively. Cdt venom caused a 10% edema induction compared to those by other venoms. All venoms increased TOTAL-CK, MB-CK, and LDH levels (indicating muscle injury) and ALT, AST, GGT, and ALP levels (markers of liver damage) and were able to induce a neuromuscular blockade. Urea and creatinine levels were also altered in both plasma and urine, indicating kidney damage. Only Cdcolli and Cdcasc venoms increased TAPP and TAP. CONCLUSIONS: Together, these results allow us to draw a distinction between local and systemic effects caused by Crotalus subspecies, highlighting the clinical and biochemical effects produced by their respective venoms.
Descritores: Crotalus/classificação
Venenos de Crotalídeos/toxicidade
Edema/induzido quimicamente
Rim/efeitos dos fármacos
Fígado/efeitos dos fármacos
-Ureia/sangue
Creatina Quinase/efeitos dos fármacos
Creatina Quinase/sangue
Creatinina/sangue
Modelos Animais
Edema/patologia
Eletroforese em Gel de Poliacrilamida
Fosfatase Alcalina/efeitos dos fármacos
Fosfatase Alcalina/sangue
Transaminases/efeitos dos fármacos
Transaminases/sangue
Rim/patologia
L-Lactato Desidrogenase/efeitos dos fármacos
L-Lactato Desidrogenase/sangue
Fígado/patologia
Camundongos
Limites: Animais
Responsável: BR1.1 - BIREME


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Id: biblio-1057497
Autor: Wu, Hui; Chang, Weiyu; Deng, Yanglin; Chen, Xinli; Ding, Yongli; Li, Xuesong; Dong, Liang.
Título: Effect of simulated geomagnetic activity on myocardial ischemia/reperfusion injury in rats
Fonte: Rev. bras. cir. cardiovasc = Braz. j. cardiovasc. surg. (impr.);34(6):674-679, Nov.-Dec. 2019. tab, graf.
Idioma: en.
Projeto: Research Institutes in Yunnan Medical and Health Units Project; . The National Natural Science Foundation of China.
Resumo: Abstract Objective: To study the response of myocardial ischemia/reperfusion injury (MI/RI) in rats to simulated geomagnetic activity. Methods: In a simulated strong geomagnetic outbreak, the MI/RI rat models were radiated, and their area of myocardial infarction, hemodynamic parameters, creatine kinase (CK), lactate dehydrogenase (LDH), melatonin, and troponin I values were measured after a 24-hour intervention. Results: Our analysis indicates that the concentrations of troponin I in the geomagnetic shielding+operation group were lower than in the radiation+operation group (P<0.05), the concentrations of melatonin in the shielding+operation group and normal+operation group were higher than in the radiation + operation group (P<0.01), and the concentrations of CK in the shielding + operation group were lower than in the radiation + operation group and normal + operation group (P<0.05). Left ventricular developed pressure (LVDP) and ± dP/dtmax in the radiation+operation group were lower than in the shielding + operation group and normal+operation group (P<0.01). Left ventricular end-diastolic pressure (LEVDP) in the shielding + operation group was higher than in the normal + operation group (P<0.05). There was no significant difference in area of myocardial infarction and LDH between the shielding + operation group and the radiation + operation group. Conclusion: Our data suggest that geomagnetic activity is important in regulating myocardial reperfusion injury. The geomagnetic shielding has a protective effect on myocardial injury, and the geomagnetic radiation is a risk factor for aggravating the cardiovascular and cerebrovascular diseases.
Descritores: Traumatismo por Reperfusão Miocárdica/fisiopatologia
Campos Magnéticos/efeitos adversos
-Ratos Sprague-Dawley
Creatina Quinase
Modelos Animais de Doenças
Hemodinâmica
Limites: Animais
Masculino
Ratos
Responsável: BR1.1 - BIREME


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Id: biblio-907758
Autor: Toro-Escobar, Juan M; Arango-Toro, Clara M; Campuzano-Maya, Germán; Aranzazu-Botero, Diana P; McEwen-Tamayo, Óscar I; Tobón-Ospina, Catalina I.
Título: Consumo de estatinas y asociación con la elevación en los niveles de creatina fosfoquinasa / Statin use and association with elevated levels of creatine phosphokinase
Fonte: Med. lab;21(11/12):539-550, 2015. tab, graf.
Idioma: es.
Resumo: Introducción: las estatinas son medicamentos hipolipemiantes asociados con miotoxicidad como efecto adverso. Objetivo: determinar la asociación entre el uso de estatinas y la elevación de la creatinafosfoquinasa. Materiales y métodos: se realizó un estudio transversal en pacientes consecutivos que asistieron al Laboratorio Clínico Hematológico (Medellín, Colombia) para la determinación del perfil lipídico. Se incluyeron 661 pacientes, 329 en el grupo de estatinas y 332 en el de no estatinas.A todos se les midieron los niveles séricos de creatina fosfoquinasa y se consideraron como elevados los niveles superiores a 170 mg/dL. Se estableció un nivel de significancia menor de 0,05. Resultados: se registró mayor proporción de pacientes con creatina fosfoquinasa elevada en el grupo con consumo de estatinas (64,9% frente a 47% en el grupo de no estatinas; razón de disparidad: 2,01; intervalo de confianza del 95%: 1,21-3,32; p= 0,0085). No se encontró asociación entre la elevación de la creatina fosfoquinasa y la presencia de dolor (razón de disparidad: 0,78; intervalo de confianza del 95%: 0,40-1,50; p= 0,5615), fatiga (razón de disparidad: 0,85; intervalo de confianza del 95%: 0,45-1,61; p= 0,7385) y debilidad muscular (razón de disparidad: 1,46; intervalo de confianzadel 95%: 0,68-3,12; p= 0,4333); aunque el grupo de estatinas presentó mayor frecuencia de dolor (razón de disparidad: 2,96), fatiga (razón de disparidad: 1,98) y debilidad muscular (razón de disparidad: 4,19). Conclusiones: el consumo de estatinas se relaciona con síntomas musculares y elevación de creatina fosfoquinasa, sin relación entre la elevación de creatina fosfoquinasa y la presencia de síntomas musculares.

Introduction: statins are a class of lipid-lowering medications associated with the adverse effect of myotoxicity. Objetive: To determine the association between statin use and creatine phosphokinase elevation. Materials and methods: A cross-sectional study, involving consecutive patients attending in the clinical laboratory Laboratorio Clinico Hematologico (Medellin, Colombia) for a serum lipid profile test was performance. A total of 661 patients were included, 329 belonged to the statin group and 332 to the non-statin group. All patients were tested for serum creatine phosphokinase and were considered elevated the serum levels higher than 170 mg/dL. The threshold for significance was set as p-value less than 0.05. Results: Creatine phosphokinase levels were more elevated in the statin group (64.9% versus 47% in non-statin group; odds ratio: 2.01; 95% confidence interval: 1.21-3.32, p= 0.0085). No association was found between the degree of creatine phosphokinase elevation and the presence of muscular pain (odds ratio: 0.78; 95% confidence interval: 95%, 0.40-1.50, p= 0.5615), fatigue (odds ratio: 0.85; 95% confidence interval: 0.45-1.61, p= 0.7385) or muscle weakness (odds ratio: 1.46; 95% confidence interval: 0.68-3.12, p= 0.4333). However, the statin group exhibited greater frequency of muscle pain (odds ratio: 2.96), fatigue (odds ratio: 1.98) and muscle weakness (odds ratio: 4.19). Conclusions: statin use is associated with a higher frequency of muscular symptoms and higher creatine phosphokinase levels, with no relationship between creatine phosphokinase elevation and the presence of muscle symptoms.
Descritores: Creatina Quinase
Inibidores de Hidroximetilglutaril-CoA Redutases
Hipercolesterolemia
Doenças Musculares
Limites: Humanos
Tipo de Publ: Estudo de Avaliação
Responsável: CO373.9 - EDIMECO - Editora Médica Colombiana S.A.


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Texto completo SciELO Chile
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Id: biblio-991383
Autor: Huidobro E, Juan Pablo; Santander, Jaime; Vicentini, Daniel; Jara, Aquiles.
Título: Hipercalcemia severa en el curso de rabdomiolisis: caso clínico / Rhabdomyolysis and severe hypercalcemia: report of one case
Fonte: Rev. méd. Chile;147(1):125-129, 2019. tab, graf.
Idioma: es.
Resumo: Rhabdomyolysis (RD) is the process that leads to cell destruction of striated muscle. Causes include inherited metabolic defects or acquired disorders. RD is frequently associated with acute kidney injury (AKI) and disorders of calcium metabolism. We report a 33 year old man that after amphetamine consumption and an uninterrupted 3,000 km driving presented vomiting, muscle pain and dark urine. He had elevated creatinkinase levels, severe hypocalcemia and an acute renal failure. He was treated with hemodialysis and calcitriol. He was transferred to our hospital and on admission a serum calcium of 18 mg/dl was detected. He continued on hemodialysis, recovering renal function and with normalization of creatinkinase levels and serum calcium level.
Descritores: Rabdomiólise/complicações
Injúria Renal Aguda/etiologia
Hipercalcemia/etiologia
-Cintilografia/métodos
Cálcio/sangue
Diálise Renal/métodos
Creatina Quinase/sangue
Injúria Renal Aguda/terapia
Hipercalcemia/diagnóstico por imagem
Hipocalcemia/etiologia
Limites: Humanos
Masculino
Adulto
Tipo de Publ: Relatos de Casos
Responsável: CL1.1 - Biblioteca Central


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Id: biblio-827860
Autor: Montazerifar, Farzaneh; Bolouri, Ahmad; Paghalea, Raheleh Sharifian; Mahani, Mahbubeh Khodadadpour; Karajibani, Mansour.
Título: Obesity, Serum Resistin and Leptin Levels Linked to Coronary Artery Disease / Obesidade, Soro Resistina e Níveis de Leptina Ligados à Doença Arterial Coronariana
Fonte: Arq. bras. cardiol;107(4):348-353, Oct. 2016. tab, graf.
Idioma: en.
Resumo: Abstract Background: Clinical studies have demonstrated that adipocytokines play an important role in developing atherosclerotic cardiovascular diseases. Objective: The aim of study was to evaluate the relationship between serum resistin and leptin levels with obesity and coronary artery disease (CAD). Methods: In a cross-sectional study, we assessed the levels of serum resistin and leptin, C-reactive protein (CRP), lipid profile and cardiac enzyme tests (AST, CPK, LDH, CK-MB) in 40 CAD patients compared to 40 healthy controls. Anthropometric measurements including weight and height for calculating of body mass index (BMI), and waist circumference (WC) were performed for evaluation of obesity. Results: CAD patients had increased levels of leptin and CRP, (p < 0.001), cholesterol (p < 0.05), triglyceride (p < 0.01), and WC (p < 0.05) compared to healthy controls. There was no statistical difference between CAD and control subjects for resistin (p = 0.058). In a multiple regression analysis, only an association between serum leptin with BMI (β = 0.480, p < 0.05) and WC (β = 1.386, p < 0.05) was found. Conclusions: The findings suggest that leptin is a better marker of fat mass value than resistin and may be considered an independent risk factor for cardiac disorders that is largely dependent on obesity. However, further prospective studies are needed to confirm these results.

Resumo Fundamento: Estudos clínicos demonstraram que adipocitocinas têm papel importante no desenvolvimento de doenças cardiovasculares ateroscleróticas. Objetivo: Avaliar a relação entre níveis de leptina e resistina em soro com obesidade e doença arterial coronariana (DAC). Métodos: Em estudo transversal, avaliamos os níveis de resistina e leptina em soro, proteína C-reativa (CPR), perfil lipídico e testes de enzimas cardíacas (AST, CPK, LDH, CK-MB) em quarenta pacientes com DAC comparados a 40 controles saudáveis. Para avaliação de obesidade, foram feitas as medições antropométricas, incluindo peso e altura para o cálculo do índice de massa corporal (IMC) e circunferência da cintura (CC). Resultados: Pacientes com DAC apresentaram aumento nos níveis de leptina e CPR, (p < 0,001), colesterol (p < 0,05), triglicérides (p < 0,01) e CC (p < 0,05) em comparação aos controles. Não houve diferença significativa entre DAC e controles com relação à resistina (p = 0,058). Na análise de regressão múltipla, foi encontrada apenas uma associação entre leptina em soro ao IMC (β = 0,480, p < 0,05) e CC (β = 1,386, p < 0,05). Conclusões: Os achados sugerem que a leptina é melhor marcadora de valor de massa gorda do que a resistina, e pode ser considerada um fator de risco, dependente da obesidade, independente para distúrbios cardíacos. Contudo, outros estudos prospectivos serão necessários para a confirmação desses resultados.
Descritores: Doença da Artéria Coronariana/sangue
Leptina/sangue
Resistina/sangue
Obesidade/sangue
-Aspartato Aminotransferases/sangue
Valores de Referência
Triglicerídeos/sangue
Proteína C-Reativa/análise
Estudos de Casos e Controles
Antropometria
Colesterol/sangue
Estudos Transversais
Análise de Regressão
Fatores de Risco
Análise de Variância
Estatísticas não Paramétricas
Creatina Quinase/sangue
L-Lactato Desidrogenase/sangue
Limites: Humanos
Masculino
Feminino
Adulto
Pessoa de Meia-Idade
Idoso
Idoso de 80 Anos ou mais
Responsável: BR1.1 - BIREME


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Id: lil-636740
Autor: Alvarado, Paola Coral; Restrepo, José Félix; Rondón Herrera, Federico; Iglesias-Gamarra, Antonio.
Título: HiperCKemia asintomática benigna. A propósito de dos casos / Benign asymptomatic hyperCKemia. With regard to two cases
Fonte: Rev. colomb. reumatol;13(3):228-232, jul.-sep. 2006. ilus.
Idioma: es.
Resumo: La hiperCKemia asintomática es definida como una elevación persistente de niveles séricos de Creatin Fosfoquinasa (CPK), sin manifestaciones clínicas, electromiográficas o histológicas. Su curso es benigno a largo plazo y en muchos casos no es necesario un seguimiento continuo. Si la hiperCKemia es un hallazgo incidental en unos exámenes de laboratorio de rutina, no se justifican estudios extensivos más aun si los pacientes no presentan alteraciones al exámen físico y si los estudios electromiográficos son normales. En este artículo, presentamos dos casos con hiperCKemia asintomática, que son los primeros informados en Hispanoamérica.

Asymptomatic hyperCKemia is defined as a persistent elevation of serum CPK levels, without clinical manifestation abnormal electrodiagnostic, or histologic findings. It has a long-term benign course and in many cases it is not necessary a continuous follow-up. If hyperCKemia is an incidental finding during a routine laboratory check-up, extensive studies are not justified still more if the patients do not present alterations in the physical exam and if the electrodiagnostic studies are normal. In this paper we present two cases of asymptomatic hyperCKemia, that are the first reported in Hispano-America.
Descritores: Remoção
Creatina Quinase
-Biomarcadores
Hispano-Americanos
Doenças Neuromusculares
Limites: Humanos
Adulto
Tipo de Publ: Relatos de Casos
Revisão
Responsável: CO356.9


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Id: biblio-990955
Autor: Vélez, Patricia; Jaller, Juan J; Otero-Escalante, William J; Garda, Erika G; Rojo, Ricardo; Chapman, Douglass; Persand, Katherine; Matiz, Giovanna A.
Título: Tofacitinib, an oral Janus kinase inhibitor, in patients from Colombia with rheumatoid arthritis: Pooled efficacy and safety analyses of data from phase III studies / Tofacitinib, un inhibidor oral de la janus kinasa, en pacientes colombianos con artritis reumatoide: análisis de eficacia y seguridad de los estudios de fase III
Fonte: Rev. colomb. reumatol;25(4):233-244, oct.-dic. 2018. tab, graf.
Idioma: en.
Resumo: ABSTRACT Introduction: Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). Objective: To conduct a post hoc analysis of tofacitinib efficacy and safety in Colombian patients enrolled in global phase III studies. Methods: Data were pooled from Colombian patients with RA across four phase III tofacitinib studies: ORAL Sync, ORAL Scan, ORAL Solo, and ORAL Start. Patients received tofacitinib 5 or 10 mg twice daily, methotrexate (ORAL Start only), or placebo as single therapy (ORAL Start and ORAL Solo), or in combination with csDMARDs (ORAL Sync and ORAL Scan). Data were pooled from three studies with similar patient populations (Sync, Scan, Solo) for efficacy analyses, and from all studies for safety analyses, up to Month 24. The efficacy analysis excluded ORAL Start due to the methotrexate-naive patient population, and placebo and methotrexate groups, due to low patient numbers. Results: Data pooled included 77 patients for efficacy, and 125 for safety analyses. Tofacitinib-treated patients showed improved American College of Rheumatology 20/50/70 response rates, a mean Disease Activity Score 28-4 (erythrocyte sedimentation rate), and a mean change from baseline in Health Assessment Questionnaire-Disability Index. Improvements were sustained in Months 12-24, although patient numbers were low post-Month 12. The most frequently reported adverse events were anemia, headache, influenza, and increased blood creatine phosphokinase. No tuberculosis cases, serious adverse events, or deaths were reported, and few cases of herpes zoster or malignancies occurred. Conclusions: Tofacitinib reduced RA signs and symptoms, and improved physical function. The efficacy and safety of tofacitinib in this Colombian sub-population were consistent with data from global phase III studies.

RESUMEN Introducción: Tofacitinib es un inhibidor oral de la janus kinasa para el tratamiento de la artritis reumatoide (AR). Objetivo: Análisis post hoc para evaluar la eficacia y seguridad de tofacitinib en los pacientes colombianos que participaron en los estudios globales de fase III. Métodos: La información se obtuvo de los pacientes colombianos con AR que participaron en 4 de los estudios de tofacitinib de fase III: ORAL Sync, ORAL Scan, ORAL Solo y ORAL Start. Los pacientes recibieron tofacitinib 5 o 10 mg 2 veces al día, ya sea en monoterapia (ORAL Start y ORAL Solo) o en combinación con csDMARDs (ORAL Scan y ORAL Sync), metotrexate (ORAL Start) o placebo. Para el análisis de eficacia se utilizaron 3 estudios que incluyeron poblaciones similares (Sync, Scan y Solo) y para el análisis de seguridad se utilizaron todos los estudios, hasta el mes 24. El análisis de eficacia excluyó tanto el estudio ORAL Start debido a población metotrexate naive como a los grupos placebo o metotrexate debido al bajo número de pacientes. Resultados: Se incluyeron 77 pacientes para el análisis de eficacia y 125 para seguridad. Los pacientes tratados con tofacitinib mostraron mejorías en las tasas de respuestas del American College of Rheumatology (ACR) 20/50/70, en el promedio del Disease Activity Score (DAS) 28-4 (velocidad de sedimentación globular) y en el cambio promedio desde la basal en el Health Assessment Questionnaire-Disability Index (HAQ-DI). Las mejorías fueron sostenidas desde el mes 12 al mes 24, aunque el número de pacientes luego del mes 12 fue bajo. Los eventos adversos más frecuentemente reportados fueron anemia, cefalea, influenza e incremento de la creatin-fosfoquinasa sérica. No se reportaron casos de tuberculosis, eventos adversos serios o muertes. Ocurrieron casos poco frecuentes de herpes zoster y malignidades. Conclusiones: Tofacitinib redujo los signos y síntomas de la AR y mejoró la función física. La eficacia y seguridad en esta subpoblación colombiana fue consistente con los resultados de los pacientes que participaron en los estudios globales de fase III.
Descritores: Artrite Reumatoide
-Eficácia
Creatina Quinase
Cefaleia
Anemia
Limites: Humanos
Responsável: CO356.9



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