RESUMO
BACKGROUND: There is currently a lot of concern about the quality and therapeutic effectiveness of Mexican pharmaceutical products, and considerable price differences between alternative products containing the same active principle. OBJECTIVE: To establish whether four Mexican drug products, a high price and three lower-cost branded drug products containing sodium naproxen (550 mg immediate release tablets) have equivalent, and consistent pharmaceutical qualities. METHODS: The four products were acquired in Mexico city. Assay for sodium naproxen, content uniformity, disintegration time and dissolution tests were performed according to USP procedures. Drug dissolution profiles were compared using a similarity factor (f(2)). RESULTS AND DISCUSSION: All of the tested products met pharmacopeial quality standards with respect to their active pharmaceutical content and a released drug percentage >70% in 45 min. Lot-to-lot lack of similarity between drug dissolution profiles was observed for two of the products tested. CONCLUSION: There was no significant differences in the quality of the pharmaceutical products tested when judged by the USP pharmaceutical quality standards. However, some differences were observed in the dissolution profiles of the brands tested. Whether these differences are clinically meaningful requires in vivo bioequivalence studies.
Assuntos
Anti-Inflamatórios não Esteroides/química , Naproxeno/química , Química Farmacêutica , Humanos , Cinética , México , Farmacopeias como Assunto , Controle de Qualidade , ComprimidosRESUMO
We underwent a project aimed to define the clinical and immunological characteristics of type 1 diabetes (T1D) in a Colombian population. This was a multicenter and cross-sectional study. Patients were systematically interviewed and their medical records reviewed, using a questionnaire that sought information about demographic, clinical and immunological characteristics. Glutamic acid decarboxylase antibodies (GADA), tyrosine phosphatase antibodies (IA-2A) and insulin antibodies (IAA) were examined by radioimmunoassay. There were 107 patients with T1D. Male:female ratio was 1:1. Half of the patients developed diabetes ketoacidosis at onset. GADA, IA-2A, and IAA were detected in 45%, 40%, and 69% of the cases, respectively. GADA positive patients were older and had a less duration of disease than patients without these autoantibodies (p<0.01). Association between breast feeding with the presence of antibodies or clinical characteristics was not observed. The results highlight some differences of T1D expression according to geographic location and ethnicity. Differences in age at onset and clinical variables may point to an environmental factor or deficient access to health care system. Genetic studies underway will provide important information in this population. These results might help to define public health policies in our population to improve T1D diagnosis, patients' quality of life and their outcome.
Assuntos
Autoanticorpos/sangue , Diabetes Mellitus Tipo 1/imunologia , Glutamato Descarboxilase/imunologia , Anticorpos Anti-Insulina/sangue , Proteínas Tirosina Fosfatases/imunologia , Adulto , Idade de Início , Colômbia , Estudos Transversais , Diabetes Mellitus Tipo 1/complicações , Cetoacidose Diabética/etiologia , Feminino , Humanos , Masculino , Proteína Tirosina Fosfatase não Receptora Tipo 1RESUMO
La biopsia de próstata guiada por ecografía transrectal ha revolucionado la detección del cáncer de próstata, sin embargo, existen pocos ensayos a nivel nacional del impacto de este procedimiento en la calidad de vida de los pacientes, más aún, si consideramos que estudios recientes han sugerido incrementar el número de muestras para aumentar la sensibilidad de este examen. El objetivo de este trabajo fue determinar el impacto en la calidad de vida de los pacientes sometidos a biopsia de próstata guiada por ecografía transrectal en 6 y 12 muestras y demostrar la utilidad de la sedación durante el examen. Se randomizaron 60 pacientes, del Servicio de Urología del Hospital San José, en dos grupos: 30 pacientes con sedación (Midazolam 2,5 mg endovenoso) y 30 pacientes con placebo. Estos grupos se subdividieron en grupos de 6 y 12 muestras de tejido prostático. Se constató edad, antígeno prostático, tacto rectal, comorbilidad y complicaciones post biopsia. Todos los pacientes contestaron un cuestionario realizado post examen y un segundo cuestionario 4 semanas después. La calidad de vida fue evaluada utilizando 2 escalas (Short form 36 item health survey). La edad promedio de los pacientes fue de 70 años, con valores de antígeno prostático entre 4,6- 281 ng/dl. Al comparar los grupos sometidos a sedación (6 y 12 muestras) versus los grupos sin sedación sometidos a biopsia transrectal guiada por ecografía, se encuentran diferencias estadísticamente significativas (p<0,0005). Las complicaciones de la sedación en el procedimiento fueron 0 por ciento. Se discuten los resultados.
Assuntos
Humanos , Masculino , Próstata , Biópsia , Qualidade de Vida , Sedação Consciente/métodos , UltrassonografiaRESUMO
PIP: In Colombia, health workers obtained a nasopharyngeal wash from 103 infants aged less than 12 months hospitalized for acute lower respiratory infection (ALRI) at the General Hospital of Medellin during April 1994 to April 1995 so researchers could determine the frequency of ALRI caused by respiratory syncytial virus (RSV) in hospitalized children. Immunofluorescence detected RSV infection in 43 (41.7%) patients. The presence of the following signs and symptoms allowed a clinical diagnosis of a viral infection: rhinorrhea, prolonged expiration, expiratory wheezing, interstitial infiltrates, and hyperinflation on chest radiographs as well as negative tests for 3 or 4 acute phase reactants. The physicians initiated antibiotic therapy (for 1-3 days) in 12 cases (27.9%) based on acute phase reactant findings who actually had an RSV infection. When the physicians learned that the laboratory confirmed RSV infection, they stopped antibiotic therapy. Antibiotics were continued in 16 (37.2%) other RSV infected infants, all of whom were less than 2 months old, due to mixed pneumonia (viral and bacterial). 39.4% of RSV-infected children whose clinical findings strongly suggested RSV received no antibiotics. None of these children or other ALRI patients with a viral disease suffered complications. They required less hospitalization time--since no further diagnostic tests were needed--than ALRI patients with a bacterial infection. Admissions for both ALRI and RSV infection peaked during November to January. RSV incidence peaked in January (23.3%). The leading reasons for hospitalization were pneumonia and bronchiolitis. These findings show that RSV diagnosis is useful and it lessens the indiscriminate use of antibiotics.^ieng