ABSTRACT
JUSTIFICATIVA E OBJETIVOS: O uso de heparina de baixo peso molecular (HBPM) na profilaxia ou terapêutica de diversas doenças ou síndromes é de grande importância na prática clínica. O objetivo deste estudo foi avaliar a segurança e a eficácia da enoxaparina sódica, teste (ENOX-T) comparada ao medicamento de referência (ENOX-R). MÉTODO: Foi realizado estudo prospectivo, aleatório, comparativo, unicêntrico e aberto envolvendo pacientes com indicação de profilaxia ou tratamento antitrombótico. Foram incluídos 100 pacientes divididos em 2 braços: profilático (n = 50) e terapêutico (n = 50) divididos em 2 grupos para cada braço (grupo 1: ENOX-R e grupo 2: ENOX-T). Analisou-se em cada segmento os dados clínicos e laboratoriais. A atividade do anti-fator Xa foi aferida em três momentos: basal (1ª avaliação); 1º ou 2º dia (2ª avaliação) e 5º a 7º dia (3ª avaliação). O ultra-som Doppler dos membros inferiores foi realizado na 2ª ou 3ª avaliação do braço profilático. RESULTADOS: Os resultados demonstraram homogeneidade dos grupos nos 2 braços (profilático e terapêutico) quanto a sexo, idade, índice de massa corpórea, creatinina sérica e Apache II. Os valores do anti-fator Xa nos braços profilático e terapêutico demonstraram eficácia adequada dos medicamentos, sem diferença clínica ou estatística entre ambos. A ocorrência de eventos adversos não mostrou diferença clínica ou estatística entre os medicamentos. No braço profilático o ultra-som de membros inferiores acrescentou informações úteis sobre a eficácia dos fármacos estudados. CONCLUSÕES: A enoxaparina sódica teste (ENOX-T) foi segura e eficaz nos pacientes analisados e equivalente ao medicamento de referência (ENOX-R).
BACKGROUND AND OBJECTIVES: Use of low molecular weight heparins (LMWH), either prophylactic or therapeutic, is of most importance in several syndromes and diseases in daily clinical practice. Our objective in this clinical trial was to evaluate safety and efficacy of test sodium enoxaparin (ENOX-T) compared to the reference drug (ENOX-R). METHODS: We conducted a prospective, randomized, comparative, unicentric and open-labeled trial including patients with either prophylactic or therapeutic anti-thrombotic indications. A total of 100 patients were enrolled in two branches: prophylactic (n=50) and therapeutic (n=50) and two groups for each branch (group 1: ENOX-R and group 2: ENOX-T). We analyzed clinical and laboratory data in each segment. Anti-factor Xa was measured in three different moments: baseline (1st evaluation); 1st or 2nd day (2nd evaluation) and 5th to 7th day (3rd evaluation). Doppler-sonography of inferior limbs was performed on all patients in prophylactic group on 2nd or 3rd evaluation. RESULTS: The data showed that both branches (prophylactic and therapeutic) were homogenous in regard of sex, age, body mass index (BMI), serum creatinine and APACHE II severity score at admission. Anti-factor Xa results, in both prophylactic and therapeutic branches, showed expected efficacy to both drugs, without any clinical or statistical difference between them. Adverse events incurred in both groups in a similar way, without any clinical or statistical difference between them. In prophylactic branch, Doppler-sonography of inferior limbs added useful information on drugs efficacy. CONCLUSIONS: We conclude that test sodium enoxaparin (ENOX-T) was effective and safe in our patient's cohort and equivalent to reference drug (ENOX-R).
Subject(s)
Fibrinolytic Agents/administration & dosage , Fibrinolytic Agents/therapeutic use , Heparin, Low-Molecular-Weight/administration & dosage , Heparin, Low-Molecular-Weight/therapeutic useABSTRACT
A síndrome da insuficiência cardíaca está associada a altas taxas de morbidade e mortalidade, apesar de tratamento adequado. A terapêutica inotrópica aumenta a contratilidade miocárdica, porém não melhora a sobrevida a longo prazo. Seu uso é importante para manutenção da função cardiovascular em pacientes críticos com descompensação aguda ou naqueles que aguardam tratamento definitivo. Novas drogas inotrópicas vêm sendo investigadas com resultados promissores.
Subject(s)
Humans , Middle Aged , Cardiotonic Agents/adverse effects , Cardiotonic Agents/pharmacology , Catecholamines , Heart Failure/economics , Heart Failure/epidemiology , Phosphodiesterase Inhibitors , Dobutamine , Dopamine , Isoproterenol , NorepinephrineABSTRACT
OBJECTIVE: To evaluate elastic properties of conduit arteries in asymptomatic patients who have severe chronic aortic regurgitation. METHODS: Twelve healthy volunteers aged 30Ý1 years (control group) and 14 asymptomatic patients with severe aortic regurgitation aged 29Ý2 years and left ventricular ejection fraction of 0.61Ý0.02 (radioisotope ventriculography) were studied. High-resolution ultrasonography was performed to measure the systolic and diastolic diameters of the common carotid artery. Simultaneous measurement of blood pressure enabled the calculation of arterial compliance and distensibility. RESULTS: No differences were observed between patients with aortic regurgitation and the control group concerning age, sex, body surface, and mean blood pressure. Pulse pressure was significantly higher in the aortic regurgitation group compared with that in the control group (78Ý3 versus 48Ý1mmHg, P<0.01). Arterial compliance and distensibility were significantly greater in the aortic regurgitation group compared with that in the control group (11.0Ý0.8 versus 8.1Ý0.7 10-10 N-1 m4, P=0.01 e and 39.3Ý2.6 versus 31.1Ý2.0 10-6 N-1 m², P=0.02, respectively). CONCLUSION: Patients with chronic aortic regurgitation have increased arterial distensibility. Greater vascular compliance, to lessen the impact of systolic volume ejected into conduit arteries, represents a compensatory mechanism in left ventricular and arterial system coupling
Subject(s)
Humans , Male , Female , Aortic Valve Insufficiency , Arteries/physiology , Ventricular Function, Left/physiology , Arteries , Case-Control Studies , Chronic Disease , ElasticityABSTRACT
A síndrome da insuficiência cardíaca congestiva está associada a altas taxas de morbidade e mortalidade, apesar de tratamento adequado. A terapêutica inotrópica aumenta a contratilidade miocárdica, porém näo está associada à melhora da sobrevida a longo prazo. Seu uso é importante para manutençäo da funcçäo cardiovascular em pacientes críticos com descompensaçäo aguda ou naqueles que aguardam tratamento definitivo. Para melhor manejo de doenças cardiopulmonares, é necessária avaliaçäo acurada do estado hemodinâmico. A monitoraizaçäo hemodinâmica invasiva deve ser considerada em pacientes em pacientes com insuficiência cardíaca grave, nos quais a avaliaçäo clínica frequentemente näo é precisa e dados da monitorizaçäo podem resultar em mudanças na estratégia terapêutica.
Subject(s)
Humans , Cardiotonic Agents , Heart Diseases , Hemodynamics , Heart Failure/therapyABSTRACT
PURPOSE--To evaluate the toxicity of thiocyanate induced by the infusion of sodium nitroprusside in patients with severe congestive failure. METHODS--We studied 23 patients with congestive heart failure, in class IV (NYHA) under continuous infusion of sodium nitroprusside with doses varying between 0.5 and 5.5 micrograms/kg/min. Clinical evaluation, thiocyanate serum dosage and laboratorial evaluation of renal, hepatic and pulmonary functions were done. RESULTS--Seventeen patients (74 per cent) presented toxic levels of thiocyanate (over 10 micrograms/ml), with the average of 29.9 +/- 4.4 micrograms/ml. Only renal function was related to the presence of intoxication. Clinical evaluation was not accurate to diagnose the thiocyanate toxicity in the patients. CONCLUSION--Sodium nitroprusside is potentially toxic, especially when the renal function is abnormal. Thiocyanate dosage is useful in diagnosing nitroprusside induced toxicity and then it contributes to an adequate treatment and prevention of clinical toxicity