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1.
Ann Card Anaesth ; 2022 Jun; 25(2): 210-213
Artigo | IMSEAR | ID: sea-219212

RESUMO

A diagnosis of congenital long QT interval syndrome based on history and electrocardiogram was made in a child in the absence of readily available genetic testing. A genotype 3 (LQT3) was suspected after exclusion of other variants as the child was non?responsive to beta?blocker and sodium channel blocker medication. As the child continues to show episodic bradycardia, polymorphic ventricular ectopy, and T?wave alternans, a single?chamber automated implantable cardioverter?defibrillator implantation was done successfully. This report highlights how the diagnosis of LQT3 was arrived at as well as the anesthetic challenges in the management of patients with LQTS.

2.
Arq. bras. cardiol ; 119(1): 87-94, abr. 2022. tab, graf
Artigo em Português | LILACS-Express | LILACS | ID: biblio-1383725

RESUMO

Resumo Fundamento A ablação por cateter é uma terapia bem estabelecida para controle do ritmo cardíaco em pacientes refratários ou intolerantes a drogas antiarrítmicas (DAA). Porém, a eficácia desse procedimento comparada à de DAA como estratégia de primeira linha no controle do ritmo cardíaco na fibrilação atrial é menos conhecida. Objetivos Conduzir uma revisão sistemática e metanálise da ablação por cateter vs. DAA em pacientes sem nenhum tratamento prévio para controle do ritmo. Métodos Buscamos, nos bancos de dados do PubMed, EMBASE, e Cochrane, ensaios randomizados controlados que compararam ablação por cateter com DAA para controle do ritmo cardíaco em pacientes com FA sintomática e descreveram os seguintes desfechos: (1) recorrência de taquiarritmia atrial (TA); (2) FA sintomática; (3) internações hospitalares; e (4) bradicardia sintomática. A heterogeneidade foi avaliada por estatística I2. Valores de p menores que 0,05 foram considerados estatisticamente significativos. Resultados Incluímos cinco ensaios com 994 pacientes, dos quais 502 (50,5%) foram submetidos à ablação por cateter. O período médio de acompanhamento foi de um a cinco anos. Recorrências de TA (OR 0,36; IC95% 0,25-0,52; p<0,001) e de FA sintomática (OR 0,32; IC95% 0,18-0,57; p<0,001), e internações hospitalares (OR 0,25; IC95% 0,15-0,42; p<0,001) foram menos frequentes nos pacientes tratados com ablação por cateter que naqueles tratados com DAA. Bradicardia sintomática não foi diferente entre os grupos (OR 0,55; IC95% 0,18-1,65; p=0,28). Derrame ou tamponamento pericárdico significativo ocorreu em oito dos 464 (1,7%) pacientes no grupo submetido à ablação. Conclusão Esses achados sugerem maior eficácia da ablação por cateter que das DAA como estratégia inicial de controle do ritmo cardíaco em pacientes com DA sintomática.


Abstract Background Catheter ablation is a well-established therapy for rhythm control in patients who are refractory or intolerant to anti-arrhythmic drugs (AAD). Less is known about the efficacy of catheter ablation compared with AAD as a first-line strategy for rhythm control in atrial fibrillation (AF). Objectives We aimed to perform a systematic review and meta-analysis of catheter ablation vs. AAD in patients naïve to prior rhythm control therapies. Methods PubMed, EMBASE, and Cochrane databases were searched for randomized controlled trials that compared catheter ablation to AAD for initial rhythm control in symptomatic AF and reported the outcomes of (1) recurrent atrial tachyarrhythmias (ATs); (2) symptomatic AF; (3) hospitalizations; and (4) symptomatic bradycardia. Heterogeneity was examined with I2statistics. P values of < 0.05 were considered statistically significant. Results We included five trials with 994 patients, of whom 502 (50.5%) underwent catheter ablation. Mean follow-up ranged from one to five years. Recurrences of AT (OR 0.36; 95% CI 0.25-0.52; p<0.001) and symptomatic AF (OR 0.32; 95% CI 0.18-0.57; p<0.001), and hospitalizations (OR 0.25; 95% CI 0.15-0.42; p<0.001) were significantly less frequent in patients treated with catheter ablation compared with AAD. Symptomatic bradycardia was not significantly different between groups (OR 0.55; 95% CI 0.18-1.65; p=0.28). Significant pericardial effusions or tamponade occurred in eight of 464 (1.7%) patients in the catheter ablation group. Conclusion These findings suggest that catheter ablation has superior efficacy to AAD as an initial rhythm control strategy in patients with symptomatic AF.

3.
Int. j. cardiovasc. sci. (Impr.) ; 33(5): 550-564, Sept.-Oct. 2020. graf
Artigo em Inglês | LILACS | ID: biblio-1134400

RESUMO

Abstract New translational concepts on cellular and tissue substrate of cardiac arrhythmias have been responsible for the development of non-pharmacological interventions, with important achievements compared to the conventional approach with antiarrhythmic drugs. In addition, the increasing knowledge of anatomical and electrophysiological studies, sophisticated mapping methods, special catheters, and controlled clinical trials have favored the progression of ablation of tachyarrhythmias, particularly of ventricular tachyarrhythmias and atrial fibrillation.


Assuntos
Arritmias Cardíacas/fisiopatologia , Pesquisa Translacional Biomédica/métodos , Intervenção Coronária Percutânea/métodos , Arritmias Cardíacas/cirurgia , Arritmias Cardíacas/tratamento farmacológico , Ablação por Cateter , Antiarrítmicos
4.
Arq. bras. cardiol ; 113(5): 925-932, Nov. 2019. graf
Artigo em Inglês | LILACS | ID: biblio-1055040

RESUMO

Abstract Background: D-limonene (DL) is a monoterpene and is the major component in the essential oil of citrus fruit. It presents antihyperglycemic and vasodilatation activities. Objectives: This study evaluated the cardiovascular effects and potential antiarrhythmic of DL in rats. Methods: Hemodynamic and electrocardiographic (ECG) parameters were measured in male Wistar rats, which under anesthesia had been cannulated in the abdominal aorta and lower vena cava and had electrodes subcutaneously implanted. In the in vitro approach, the heart was removed and perfused using the Langendorff technique. The significance level adopted was 5% (p < 0.05). Results: DL, in doses of 10, 20, and 40 mg/kg (i.v), produced intense and persistent bradycardia associated with hypotension. Bradycardia with prolonged QTc was observed in the ECG in vivo recording. In the in vivo model of arrhythmia induced by Bay K8644, DL (10 mg/kg) decreased the arrhythmia score from 15.33 ± 3.52 to 4.0 ± 2.64 u.a (p < 0.05, n = 4). In isolated perfused hearts, DL (10-3 M) promoted significant reductions in heart rate (from 228.6 ± 8.5 ms to 196.0 ± 9.3 bpm; p < 0.05) and left ventricular development pressure (from 25.2 ± 3.4 to 5.9 ± 1.8 mmHg; n = 5, p < 0.05). Conclusions: DL produces bradycardia and antiarrhythmic activity in rat heart.


Resumo Fundamento: O D-limoneno (DL) é um monoterpeno e o principal componente do óleo essencial de frutas cítricas. Ele apresenta atividades anti-hiperglicêmicas e vasodilatadoras. Objetivos: Este estudo avaliou os efeitos cardiovasculares e antiarrítmicos potenciais do DL em ratos. Métodos: Os parâmetros hemodinâmicos e eletrocardiográficos (ECG) foram mensurados em ratos Wistar machos que, sob anestesia, tiveram a aorta abdominal e a veia cava inferior canuladas e receberam eletrodos implantados subcutaneamente. Na abordagem in vitro, o coração foi removido e perfundido utilizando a técnica de Langendorff. O nível de significância adotado foi de 5% (p < 0,05). Resultados: DL, nas doses de 10, 20 e 40 mg/kg (i.v), produziu bradicardia intensa e persistente associada à hipotensão. A bradicardia com QTc prolongado foi observada no registro in vivo do ECG. No modelo in vivo de arritmia induzida por Bay K8644, DL (10 mg / kg) houve diminuição do escore da arritmia de 15,33 ± 3,52 para 4,0 ± 2,64 u.a (p < 0,05, n = 4). Em corações perfundidos isolados, o DL (10-3 M) promoveu reduções significativas na frequência cardíaca (de 228,6 ± 8,5 ms para 196,0 ± 9,3 bpm; p < 0,05) e na pressão desenvolvida do ventrículo esquerdo (de 25,2 ± 3,4 para 5,9 ± 1,8 mmHg; n = 5, p < 0,05). Conclusões: O DL produz bradicardia e atividade antiarrítmica no coração de ratos.


Assuntos
Animais , Masculino , Arritmias Cardíacas/tratamento farmacológico , Bradicardia/tratamento farmacológico , Limoneno/uso terapêutico , Antiarrítmicos/uso terapêutico , Arritmias Cardíacas/diagnóstico , Arritmias Cardíacas/induzido quimicamente , Pressão Sanguínea/efeitos dos fármacos , Bradicardia/diagnóstico , Ratos Wistar , Pressão Ventricular/efeitos dos fármacos , Modelos Animais , Eletrocardiografia , Preparação de Coração Isolado , Limoneno/farmacologia , Frequência Cardíaca/efeitos dos fármacos , Hemodinâmica/efeitos dos fármacos , Hipotensão , Antiarrítmicos/farmacologia
6.
Chinese Journal of Primary Medicine and Pharmacy ; (12): 1937-1939, 2019.
Artigo em Chinês | WPRIM | ID: wpr-753715

RESUMO

Objective To analyze the relationship between arrhythmias and anxiety , and to evaluate the effect of anti -anxiety treatment in patients with arrhythmias while given conventional treatment .Methods From February 2015 to February 2017,111 patients with arrhythmia in the Fourth Hospital of Handan were selected in the study,and they were divided into treatment group (n=62) and control group (n=49) according to the admission to single and double wards.The control group was treated with conventional anti -arrhythmias drugs,while the treatment group was treated with low -dose of anti -anxiety drugs and conventional anti -arrhythmias drugs.The therapeutic effects,symptoms improvement time and adverse reactions were compared between the two groups .Results The effective rate in the treatment group was 96.8%(60/62), which in the control group was 77.6%(38/49), the difference was statistically significant between the two groups (χ2 =9.78,P<0.05).The time of symptoms improve-ment significantly was (4.7 ±1.1)d in the treatment group ,which in the control group was (6.9 ±1.3)d,there was statistically significant difference between the two groups (t=7.33,P<0.05).There was no statistically significant difference in side effect between the two groups (P>0.05).Conclusion Arrhythmia has a certain relationship with anxiety.Anti-anxiety combined with anti -arrhythmic treatment can improve the curative effect of patients with arrhythmia and shorten the time when symptoms begin to improve.

7.
Chinese Journal of Primary Medicine and Pharmacy ; (12): 556-559, 2019.
Artigo em Chinês | WPRIM | ID: wpr-744405

RESUMO

Objective To analyze the efficacy and safety of amiodarone in the treatment of patients with tachyarrhythmia in emergency department.Methods The clinical data of 112 patients with emergency tachyarrhythmia admitted to the Emergency Department of the First People's Hospital of Jinzhong from March 2017 to March 2018 were analyzed.According to the different treatment plans applied,the patients were divided into two groups,with 56 patients in each group.The control group was given routine emergency treatment,and the observation group was treated with routine emergency treatment and amiodarone.The efficacy,blood pressure,heart rate and safety in the two groups were compared.Results The total effective rate in the observation group was 91.07%,which was higher than that in the control group(69.64%) (x2 =8.145,P < 0.05).The diastolic blood pressure,systolic blood pressure and heart rate in the observation group were (77.40:±:6.21) mmHg,(124.24 ± 6.15) mmHg and (130.18 ± 6.14) beats/min,respectively,which were lower than those in the control group[(93.47 ± 7.40)mmHg,(140.60 ± 7.48)mmHg and (150.35 ± 12.32) bests/main] (x2 =8.145,t =12.448,12.642,10.966,all P < 0.05).The total incidence rate of adverse reactions in the observation group was 3.57%,which was lower than 19.64% in the control group (x2 =7.049,P <0.05).Conclusion For patients with tachyarrhythimia in the emergency department,the application of amiodarone has significant curative effects and high safety,which can help stabilize their blood pressure,heart rate and improve their conditions,and yet incurs less adverse reactions.Therefore,it is of significant value to be popularized in clinical applications.

8.
Chinese Journal of Primary Medicine and Pharmacy ; (12): 1937-1939, 2019.
Artigo em Chinês | WPRIM | ID: wpr-802811

RESUMO

Objective@#To analyze the relationship between arrhythmias and anxiety, and to evaluate the effect of anti-anxiety treatment in patients with arrhythmias while given conventional treatment.@*Methods@#From February 2015 to February 2017, 111 patients with arrhythmia in the Fourth Hospital of Handan were selected in the study, and they were divided into treatment group(n=62) and control group(n=49) according to the admission to single and double wards.The control group was treated with conventional anti-arrhythmias drugs, while the treatment group was treated with low-dose of anti-anxiety drugs and conventional anti-arrhythmias drugs.The therapeutic effects, symptoms improvement time and adverse reactions were compared between the two groups.@*Results@#The effective rate in the treatment group was 96.8%(60/62), which in the control group was 77.6%(38/49), the difference was statistically significant between the two groups (χ2=9.78, P<0.05). The time of symptoms improvement significantly was (4.7±1.1)d in the treatment group, which in the control group was (6.9±1.3)d, there was statistically significant difference between the two groups(t=7.33, P<0.05). There was no statistically significant difference in side effect between the two groups(P>0.05).@*Conclusion@#Arrhythmia has a certain relationship with anxiety.Anti-anxiety combined with anti-arrhythmic treatment can improve the curative effect of patients with arrhythmia and shorten the time when symptoms begin to improve.

10.
Chinese Journal of Geriatric Heart Brain and Vessel Diseases ; (12): 593-595, 2018.
Artigo em Chinês | WPRIM | ID: wpr-709165

RESUMO

Objective To study the efficacy and safety of ibutilide for AF and atrial flutter.Methods Thirty-two AF and atrial flutter patients with arrhythmia ≤3 months were randomly divided into ibutilide treatment group (n=17) and amiodarone treatment group (n=15).The patients in ibutilide treatment group were treated with 10 ml 5% glucose injection containing 1 mg ibutilide,which was repeated after 10 min if it was ineffective and those in amiodarone treatment group were treated with 10 ml 5% glucose injection containing 150 mg amiodarone,which was repeated after 10 min if it was ineffective.Results The total recovery rate of AF and atrial flutter was significantly higher in ibutilide treatment group than in amiodarone treatment group (64.7% vs 40.0%,P<0.05).The mean recovery time of AF and atrial flutter was significantly shorter in ibutilide treatment group than in amiodarone treatment group (29.28±12.57 min vs 70.59±16.83 min,P<0.01).Conclusion Ibutilide can rapidly recover AF and atrial flutter with a high success rate and a reliable safety.The therapeutic effect of ibutilide is better than that of amiodarone for AF and atrial flutter.

11.
Chinese Circulation Journal ; (12): 260-265, 2018.
Artigo em Chinês | WPRIM | ID: wpr-703851

RESUMO

Objective: To investigate the current status of tachyarrhythmia treatment and outcomes in emergency patients. Methods: A total of 250 tachyarrhythmia patients treated in emergency departments from 1 tertiary hospital, 1 secondary hospital and 1 cardiovascular hospital in Beijing were enrolled. The baseline condition, type of tachyarrhythmia such as atrial fibrillation (AF)/atrial flutter, intravenous medication, prognosis and the choice of anticoagulation therapy were collected and statistically analyzed. Results: The mean age of patients was 64 years including 123/250 (49.2%) female. Common previous histories included 135 (54.0%) cases of hypertension, 93 (37.2%) cases of CAD, 29 (11.6%) cases of stroke/TIA, 29 (11.6%) cases of valvular heart disease and 18 (7.2%) cases of cardiomyopathy; 136 (54.4%) cases combined with organic heart disease. 123 (49.2) cases had previous atrial flutter/AF. The most common type of tachyarrhythmia was AF (172 cases, 68.8%) and the rest in turn, were supra-ventricular tachycardia (41 cases, 16.4%), ventricular tachycardia (23 cases, 9.2%), atrial flutter (21 cases, 8.4%), atrial tachycardia (12 cases, 4.6%) and premature ventricular contraction (5 cases, 2%). The most commonly used drug for treating supra-ventricular tachycardia was propafenone (151 cases, 60.4%), commonly used drug for treating supra-ventricular tachycardia and ventricular arrhythmia was amiodarone. With proper treatment, arrhythmia was stopped in 56% (140 cases), improved in 40% (100 cases) and unchanged or died in 10% (25 cases). 107 non-valvular AF/atrial flutter patients received low molecular heparin for anticoagulation therapy and only 25 patients continued oral anticoagulant therapy after discharge.Conclusion: In our research, most emergency patients were treated consistently with current guidelines. The choice of medication and anticoagulation therapy in AF patients should be improved.

12.
Korean Journal of Medicine ; : 140-152, 2018.
Artigo em Coreano | WPRIM | ID: wpr-713911

RESUMO

Rhythm control therapy is the main strategy for restoring and maintaining sinus rhythm in patients with non-valvular atrial fibrillation (NVAF). Sinus rhythm is better restored and maintained with antiarrhythmic drugs than with placebo treatment. In addition, catheter ablation or combination therapy is more effective than antiarrhythmic drugs for treating NVAF. However, in most clinical trials to date, rhythm control therapy has resulted in neutral clinical outcomes compared with rate control therapy. The decision to undergo rhythm control therapy should be based on age, atrial fibrillation (AF)-related symptoms, type of AF, structural heart disease, and underlying comorbidities. For now, rhythm control therapy is indicated to improve symptoms in patients with NVAF who have refractory symptoms after adequate rate control therapy. The Korean Heart Rhythm Society organized the Korean AF Management Guideline Committee and analyzed all available data, including South Korean patients with NVAF. This review article provides general principles and detailed methodology for rhythm control therapy in South Korean patients with NVAF.


Assuntos
Humanos , Antiarrítmicos , Fibrilação Atrial , Ablação por Cateter , Comorbidade , Tratamento Farmacológico , Cardiopatias , Coração
13.
Chinese Traditional and Herbal Drugs ; (24): 2780-2786, 2017.
Artigo em Chinês | WPRIM | ID: wpr-852697

RESUMO

Hypericum attenuatum is a Guttiferae Hypericum Linn. plant, which is a folk commonly used drug.H. attenuatum has great medical development value of detoxicating, diminishing inflammation, stopping bleeding, promoting tissue regeneration, regulating menstruation, activating blood, and so on. It was used for empyrosis, hyperhidrosis, especially heart disease in Northeast area of China from the folk records. Modern research shows that it has flavonoids, volatile oils, and phloroglucinol derivative; And it has anti-arrhythmia, antimyocardial ischemia, antitumor, antidepression, antibacterial, and other pharmacologic actions. The recent progress in the studies of the constituents and their pharmacological activity of this plant is reviewed in this paper in order to provide reference for clinical application, quality control and drug discovery.

14.
Chinese Traditional and Herbal Drugs ; (24): 5270-5275, 2017.
Artigo em Chinês | WPRIM | ID: wpr-852332

RESUMO

Tetrahydroberberine (THB) belongs to the alkaloid of tetrahydroisoquinoline, which is derived from the roots of Corydalis yanhusuo and can also be hydrogenated from berberine. THB has a variety of significant biological activities compared to berberine. It is reported that THB has the effects of anti-hypertension, anti-arrhythmia, anti-fibrillation and against acute myocardial infarction, and also can treat and protect the injury of ischemic and reperfusion. Moreover, other research has found its effects upon anti-oxidant and regulating the functions of gastrointestinal tract. By searching literature of domestic and foreign from Pubmed, CNKI and other databases, pharmacological activities of THB were summarized in this paper, in order to provide reference for the further study of THB.

16.
Rev. urug. cardiol ; 31(1): 128-137, abr. 2016. ilus, graf, tab
Artigo em Espanhol | LILACS-Express | LILACS | ID: lil-789150

RESUMO

Resumen Durante años las drogas antiarrítmicas (DAA) han constituido el tratamiento fundacional para los pacientes con fibrilación auricular paroxística (FAP) en los cuales se desea mantener el ritmo sinusal. Debido a las limitaciones en su eficacia, principalmente a largo plazo, sumado a la gran proporción de pacientes que discontinúan la terapia por efectos adversos, nuevas terapias no farmacológicas han sido desarrolladas con el fin de lograr un adecuado control del ritmo. En la última década la ablación por catéter se ha mostrado como la terapia más efectiva y posiblemente la más segura en aquellos pacientes con falla del tratamiento antiarrítmico. Estudios randomizados y metaanálisis recientemente publicados indican que la ablación podría ser considerada como primera línea de terapia en pacientes seleccionados con FAP en quienes se busca controlar el ritmo. Por lo tanto, en este artículo revisaremos la evidencia actual que avala el uso de DAA o ablación en la FAP.

17.
Chinese Traditional and Herbal Drugs ; (24): 165-174, 2016.
Artigo em Chinês | WPRIM | ID: wpr-853797

RESUMO

Cardiac arrhythmia is one of the most common types of cardiovascular diseases that seriously threaten human health. Presently, ion channel blockers are the main options for the treatment of cardiac arrhythmia. However, limited effectiveness and significant adverse effects severely tarnish their clinical application. Therefore, new anti-arrhythmic strategies and agents are urgently in demand. Post-genome era has paved the way for the accelerated discovery of novel gene mutations, gene polymorphisms and the change of gene expression and epigenetics that are attributable to cardiac arrhythmia. Chinese materia medica (CMM), known for its greater efficacy and less side effects, is a promising resource for novel anti-arrhythmic agents. This review summarizes cardiac arrhythmia-related genes and their pathological mechanisms. CMM formulae and derived compounds as potential multi-targeting anti-cardiac arrhythmia drugs are also discussed.

18.
Chinese Traditional and Herbal Drugs ; (24): 3736-3741, 2016.
Artigo em Chinês | WPRIM | ID: wpr-853232

RESUMO

There are abundant active substances in ginsenoside, which have been used effectually in many fields. Ginseng saponins are the effective components in the treatment of cardiovascular diseases. Many kinds of ginseng saponins have a positive therapeutic effect on inhibiting cardiomyocyte hypertrophy, improving myocardial ischemia, protecting the ischemia-reperfusion myocardium, stimulating angiogenesis, and inhibiting myocardial apoptosis and anti-arrhythmia. This article summarized the research progress in the pharmacological effects of ginsenoside on cardiovascular diseases in the last decade.

19.
Tianjin Medical Journal ; (12): 932-934, 2016.
Artigo em Chinês | WPRIM | ID: wpr-496309

RESUMO

Cardiac arrhythmias are varied and very common. They are usually classified as bradyarrhythmias and tachyarrhythmias, which are treated according to their own common principle separately. There is no long term effective oral drugs that can be used to treat bradyarrhythmias effectively up to now. Pacemaker is still the only effective treatment for it. Now catheter ablation has already applied to almost every kind of tachyarrhythmias, and which is the first choice for treating supraventricular tachycardia and atrial flutter because of the satisfactory result. Most patients with other types of tachyarrhythmias, especially atrial fibrillation and all kinds of premature beats are still given drug therapy. Amiodarone, propafenone, sotalol and mexiletine are common used antiarrhythmic drugs in our country. This article overviewed the principle and the matters need to attention in the drug therapy of cardiac arrhythmias.

20.
Rev. Soc. Bras. Clín. Méd ; 14(4): 212-216, 2016.
Artigo em Português | LILACS | ID: biblio-827215

RESUMO

OBJETIVO: Avaliar a bioequivalência de duas formulações de cloridrato de propafenona 300mg em comprimido revestido.MÉTODOS: Estudo randomizado, cruzado, aberto, com dois tratamentos, duas sequências e quatro períodos com 60 participantes sadios de ambos os sexos. Os voluntários foram internados em quatro oportunidades durante 24 horas; em cada período, os sujeitos receberam a formulação teste ou a formulação referência, em regime pós-prandial. Foram coletadas 23 amostras de sangue após administração da droga para determinação plasmática da propafenona. Para quantificação da droga, foi utilizada técnica de cromatografia líquida acoplada à espectrometria de massas sequencial. RESULTADOS: As formulações foram consideradas clinicamente bem toleradas. A concentração máxima e a área sob a curva de zero a 36 horas foram comparadas: a média geométrica da razão entre as formulações teste e referência para concentração máxima foi de 110,16%, com intervalo de confiança de 99,44% a 122,04% e coeficiente de variação de 33,95%. A média geométrica da razão entre as formulações teste e referência para a área sob a curva de zero a 36 horas foi de 107,92%, com intervalo de confiança de 99,58% a 116,96% e coeficiente de variação de 26,39%. A média geométrica da razão entre o medicamento teste e referência para área sob a curva de zero ao infinito foi de 107,12%, com intervalo de confiança de de 99,11% a 115,78% e coeficiente de variação de 25,48%. CONCLUSÃO: As formulações teste e referência foram estatisticamente bioequivalentes, de acordo com sua taxa e extensão de absorção.


OBJECTIVE: To evaluate the bioequivalence of two 300mg profanone hydrochloride coated tablets. METHODS: Randomized, cross-over, openstudy, with two treatments, two sequences, and four periods with 60 healthy participants of both genders. The volunteers were admitted in four opportunities over 24 hours; on each period, the subjects received a test formulation, or a reference formulation, in a postprandial administration. Twenty-three samples of blood were collected after oral administration of the drug for determining plasma level of propafenone. Liquid chromatography-mass spectrometry was used for quantifying propafenone. RESULTS: The formulations were considered clinically well tolerated. The maximum concentration and the area under the curve from zero to 36 hours were compared: the geometric mean of the ratio between the test and reference formulations for maximum concentration was 110.16%, with confidence interval of 99.44% - 122.04%), coefficient of variation of 33.95%. The geometric mean of the ratio between the test and reference formulations for the area under the curve of zero to 36 hours was 107.92%, with confidence interval of 99.58% - 116.96%, and coefficient of variation of 26.39%. The geometric mean of the ratio between the formulations for area under the curve of zero to infinitum as 107.12% with confidence interval of 99.11% - 115.78%),and coefficient of variation of 25.48%. CONCLUSION: According to the rate and extension of absorption, the test and reference formulations are statistically bioequivalent.


Assuntos
Humanos , Masculino , Feminino , Adolescente , Adulto , Pessoa de Meia-Idade , Antiarrítmicos , Período Pós-Prandial/efeitos dos fármacos , Propafenona/administração & dosagem , Propafenona/farmacocinética , Sangue
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