RESUMEN
The aim of this study was to compare the bioavailability of an oral formulation of the coumarin derivative-vitamine K antagonist acenocoumarol (Acebron™ 4 mg, Test) with the reference formulation (Neo-Sintrom™ 4 mg). We performed a single-dose, double-blind, fasting, 2-period, 2-sequence, crossover study design. Plasma concentrations of acenocoumarol were determined using a validated UPLC-MS/MS method. 24 healthy Chilean volunteers (11 male, 13 female) were enrolled and all of them completed the study. Adverse events were monitored throughout the study. The values of the pharmacokinetic parameters were (mean ± SD): AUC0-24 =1 364.38±499.26 ngxh/mL for the test and 1 328.39±429.20 ngxh/mL for the reference; AUC0-∞ =1 786.00±732.85 ngxh/mL for the test and 1 706.71±599.66 ngxh/mL for the reference; Cmax =180.69±35.11 ng/mL with a Tmax of 1.83±0.95 h for the test and 186.97±38.21 ng/mL with a Tmax of 2.19±0.83 h for the reference. Regarding half life measurements, the mean ± SD of t1/2 were 11.84±4.54 h for the test and 11.08±3.28 h for the reference. The 90% confidence intervals for the test/reference ratio using logarithmic transformed data were 97.89-100.87%, 98.62-101.99% and 98.64-102.38% for Cmax, AUC0-t(24) and AUC0-∞. There were no significant differences in pharmacokinetic parameters between groups.The results obtained in this study lead us to conclude, based on FDA criteria, that the test acenocoumarol formulation (Acebron™, 4 mg tablets) is bioequivalent to the reference product (Neo-Sintrom™, 4 mg tablets).
Asunto(s)
Acenocumarol/farmacocinética , Anticoagulantes/farmacocinética , Acenocumarol/administración & dosificación , Acenocumarol/química , Administración Oral , Adolescente , Adulto , Anticoagulantes/administración & dosificación , Anticoagulantes/química , Química Farmacéutica , Estudios Cruzados , Método Doble Ciego , Femenino , Humanos , Masculino , Persona de Mediana Edad , Equivalencia TerapéuticaRESUMEN
Changes in bioavailability of anticonvulsant drugs such as topiramate may cause loss of or worsened seizure control. Thus, the purpose of this study was to evaluate, in a double-blind crossover design, the bioavailability between two oral formulations of topiramate in healthy volunteers after a single dose. The protocol, approved by the Institutional Committee of Ethics, consisted of administration of 1 tablet of 100 mg of topiramate of each formulation (Toprel and Topamax), to 20 healthy volunteers after a 12 h overnight fast, using an open, two-period, randomized, crossover and double-blind design. Thus, the plasma concentrations (Cp) of topiramate were measured at predetermined intervals of time, from 0 to 24 h, using a validated UPLC-MS/MS method. Based on plasma concentration-time profiles we obtained the following pharmacokinetic parameters: AUC(0-inf) 63,418.31 +/- 22,141.69 and 67,094.70 +/- 22,487.2 ngh/ml; AUC0-24: 30,421.02 +/- 9,964.0 and 30,489.35 +/- 9,407.17, ng x h/ml; tmax: 2.77 +/- 1.76 and 1.95 +/- 1.89 h; C(max): 2,143.33 +/- 724.26 and 2,262.51 +/- 751.12 ng/ml, for A (Toprel) and B (Topamax), respectively. All these differences were not statically significant with 90% confidence interval. The test of bioequivalence showed that Cmax, AUC(0-24) and AUC(0-inf) parameters are found within the range of 0.8 - 1.25 recommended by the FDA with a probability of bioequivalence of 100%. In accordance with these results, we can conclude that Toprel 100 mg, A (Test), is a bioequivalent generic and interchangeable with Topamax 100 mg, B (Reference).
Asunto(s)
Anticonvulsivantes/farmacocinética , Cromatografía Liquida/métodos , Fructosa/análogos & derivados , Espectrometría de Masas en Tándem/métodos , Adulto , Anticonvulsivantes/administración & dosificación , Área Bajo la Curva , Disponibilidad Biológica , Estudios Cruzados , Método Doble Ciego , Medicamentos Genéricos/administración & dosificación , Medicamentos Genéricos/farmacocinética , Femenino , Fructosa/administración & dosificación , Fructosa/farmacocinética , Humanos , Masculino , Comprimidos , Equivalencia Terapéutica , Topiramato , Adulto JovenRESUMEN
AIM: To identify the clinical-epidemiological features and the factors related to the presence of disability in patients with migraine. SUBJECTS AND METHODS: A cross-sectional study was conducted in a rural population at the Policlinica Mabay in the province of Granma, Cuba. The second International Headache Society classification was used. Sample size, which was calculated using the program EpiInfo 2002, was 360 adult workers over 18 years of age, who were selected by simple random sampling. RESULTS: Sixty-one respondents were diagnosed with migraine (prevalence: 16.9%; 95% CI = 13.3-21.31). Prevalence among females was 24.3% (CI 95% = 18.7-30.82) and 7.1% (CI 95% = 3.8-12.73) among males. Chronic migraine was the most frequent, with 25 cases (prevalence: 6.9%; CI 95% = 4.63-10.21), followed by migraine without aura, with 18 diagnoses (prevalence: 5%; CI 95% = 3.08-7.93). Frequency of headaches was greater in females (30.17 Y 12 days versus 23.45 Y 10 days; p = 0.041), as was their duration (19.87 Y 6.95 h versus 15.73 Y 5.58 h in males; p = 0.027). Minimal disability affected 24.6% of patients with migraine and 39.3% suffered moderate disability. Higher degrees of disability were associated to being female, the time elapsed since onset of the disease (21.04 Y 10.1 years versus 15.33 Y 7.5 years; p = 0.017), the frequency of headaches in the last three months (30.28 Y 10.1 days with headache versus 25.25 Y 8.5; p = 0.042), the duration of the headache (23.3 Y 15.24 h versus 12.38 Y 10.9 h; p = 0.002) and chronic migraine (p = 0.016). CONCLUSIONS: There is a great social and occupational burden of disability in patients with migraine in the geographical area under study, and females are affected by this condition to a greater extent.
Asunto(s)
Evaluación de la Discapacidad , Trastornos Migrañosos/epidemiología , Trastornos Migrañosos/fisiopatología , Adolescente , Adulto , Niño , Estudios Transversales , Cuba/epidemiología , Femenino , Encuestas Epidemiológicas , Humanos , Masculino , Persona de Mediana Edad , Trastornos Migrañosos/clasificación , Trastornos Migrañosos/diagnóstico , Salud Rural , Índice de Severidad de la Enfermedad , Adulto JovenRESUMEN
AIM: To determine the prevalence and the clinical-epidemiological and therapeutic characteristics of primary headaches in a rural population in Cuba. SUBJECTS AND METHODS: A cross-sectional study was conducted in a rural population of the Policlinica Mabay in the province of Granma, Cuba. The second International Headache Society classification was used. Sample size, which was calculated by means of the program EpiInfo 2002, was 360 adult workers over 18 years of age, who were selected by simple random sampling. RESULTS: The prevalence of primary headaches was 44.72%. There was a predominance of females (71.4%). 31.1% of cases were between 50 and 59 years old. 36.6% had a family history of headaches. Onset of headaches occurred before the age of 15 years in 44.1% of patients. The most frequent location was occipital (45.3% of cases). The most frequent precipitating factors were stress (27.9%) and menstruation (27.3%). The predominant accompanying symptom was dizziness (26.1%). Tension-type headache was the most prevalent, with 92 patients (25.56%), followed by migraine, with 61 diagnoses (16.94%). 78.3% of the patients with tension-type headache and 70.5% of those with migraine tried self-medication with dipyrone and paracetamol. Patients with migraine made more frequent use of prophylactic treatment than those who suffered from tension-type headache (32.8% versus 16.3%; p = 0.01). CONCLUSIONS: The prevalence of primary headaches is high in the rural population under study; the high rate of prescription drug abuse (mainly painkillers and non-steroidal anti-inflammatory drugs) has led to a significant number of headaches becoming chronic. This health problem is also seen to have an important effect on occupational affairs.
Asunto(s)
Cefaleas Primarias/epidemiología , Población Rural/estadística & datos numéricos , Adolescente , Adulto , Amitriptilina/uso terapéutico , Analgésicos/uso terapéutico , Estudios Transversales , Cuba/epidemiología , Utilización de Medicamentos , Ergotamina/uso terapéutico , Femenino , Cefaleas Primarias/tratamiento farmacológico , Humanos , Masculino , Meprobamato/uso terapéutico , Persona de Mediana Edad , Trastornos Migrañosos/tratamiento farmacológico , Trastornos Migrañosos/epidemiología , Trastornos Migrañosos/prevención & control , Prevalencia , Propranolol/uso terapéutico , Muestreo , Cefalea de Tipo Tensional/tratamiento farmacológico , Cefalea de Tipo Tensional/epidemiología , Cefalea de Tipo Tensional/prevención & control , Verapamilo/uso terapéutico , Adulto JovenAsunto(s)
Amebicidas/farmacología , Entamoeba histolytica/efectos de los fármacos , Fenotiazinas/farmacología , Compuestos de Sulfhidrilo/metabolismo , Amebicidas/química , Animales , Cromatografía Líquida de Alta Presión , Entamoeba histolytica/metabolismo , Fenotiazinas/química , Compuestos de Sulfhidrilo/aislamiento & purificaciónRESUMEN
Realizou-se estudo das propriedades gerais da ondansetrona. A estabilidade térmica do sólido é ensaiada mediante determinação do comportamento termogravimétrico e do ponto de fusão. A descrição das características e a interpretação do comportamento térmico são complementadas por meio de estudos espectrométricos: IV, RMH-Hû, RMN-ûüC, UV-VIS e fluorescência
Asunto(s)
Ondansetrón/administración & dosificación , Análisis Espectral , Estabilidad de Medicamentos , Análisis Espectral , TermogravimetríaRESUMEN
OBJECTIVE: To find the nutritional habits, qualitatively speaking, of school-children in our area in order to analyse their possible nutritional deficiencies and establish corrective measures. DESIGN: A crossover study with a randomised sample, stratified by school years. SETTING: A school in a rural area. PATIENTS AND OTHER PARTICIPANTS: A sample of students from this school: 101 out of 247 (41%). MEASUREMENTS AND RESULTS: Using a closed survey without prior notice to the pupils, the food taken the day before at different meals was recorded and placed in each of the 7 groups of the nutritional circle. In addition two food groups considered of high energy content and low nutritional value were included (group 8, cakes and group 9, sweets). 17.82% of pupils had correct nutrition. 99% had milk for breakfast. 37.62% had only milk for breakfast. 46% did not consume vegetables all day. 34% did not consume fruit all day. 34% did not consume pulses all day. 72.28% consumed cakes and/or sweets at some time during the day. CONCLUSIONS: It can be concluded that these school-children eat low-quality food and that this is independent of school cycles or gender. The food of 82% of school-children is incorrect, with insufficient vegetables, fruit and/or pulses. They eat little for breakfast. We propose introducing, jointly with the teachers, measures to correct the problems found.
Asunto(s)
Conducta Alimentaria , Población Rural , Niño , Estudios Transversales , Femenino , Humanos , Masculino , EspañaRESUMEN
La miocardiopatía hipertrófica (MH) es una enfermedad primaria del músculo cardíaco, cuyo majeno quirúrgico es requerido cuando el tratamiento médico no ha sido eficaz. Su asociación y manejo con cardiopatías asociadas ha sido poco estudiada. Reportamos la experiencia del manejo quirúrgico de 23 pacientes con miocardiopatía hipertrófica localizada (HML) en la última década. El grupo I comprende 15 pacientes (65.3 por ciento) con MHL a los que se les realizó miomectomía transaórtica y procedimiento quirúrgico complementario (reemplazo valvular mitral o aórtico, sección y sutura de persistencia de conducto arterioso, etc.). El grupo II presentó mayor morbilidad y mortalidad postoperatoria. La sobrevida global fue de 76.14 por ciento a 5 años
Asunto(s)
Adolescente , Adulto , Persona de Mediana Edad , Humanos , Masculino , Femenino , Prótesis Valvulares Cardíacas , Ventrículos Cardíacos/fisiopatologíaRESUMEN
We report the surgical treatment of 23 patients with local hypertrophic cardiomyopathy (LHM). Fifteen patients, group I (65.3%), with LHM were treated by myotomy-myectomy alone. Eight patients, group II (34.7%), with LHM and other cardiac disease, was treated by myotomy-myectomy and complementary procedure (mitral or aortic replacement, correction of congenital malformation). This group II had the major morbidity and mortality. Five years follow up had a 76.14% survival.