RESUMO
Asthma is an increasing pathology with poor compliance. Achievement of control is possible but under intensive treatment. In this setting, fluticasone/salmeterol association delivered by dry powder inhalers is a valuable and proved option. A prospective, parallel, open-label, phase IV, multicentre non-inferiority study was conducted to determine therapeutic similarity between 2 different inhalers: Generic DPI and Diskus®, which both deliver a fluticasone/salmeterol association (CAS 80474-14-2/CAS 89365-50-4). A 103 uncontrolled asthmatic patients were randomly assigned in 2 groups, Generic (G) and Diskus® (D), and received the association for 18 weeks through the appropriate device. They were evaluated according to Asthma Quality of Life Questionnaire and GINA/NIH guidelines. To demonstrate non-inferiority, the estimation of the Relative Risk between the Global Score Rate per group with its 95% confidence interval was calculated and compared against a non-inferiority margin obtained from a previous study. The Global Score Rate was 82% for G Group and 83% for D Group. The RR was 1.0124 (95% CI: 0.847-1.210). The margin set at 0.832 was not reached by the lower 95% CI (z=-2.097; p=0.018) pointing out non-inferiority. The results have demonstrated non-inferiority between groups. Thus, the 2 products are therapeutically similar.
Assuntos
Albuterol/análogos & derivados , Androstadienos/administração & dosagem , Antiasmáticos/administração & dosagem , Asma/tratamento farmacológico , Inaladores de Pó Seco , Adulto , Albuterol/administração & dosagem , Albuterol/efeitos adversos , Androstadienos/efeitos adversos , Combinação de Medicamentos , Feminino , Combinação Fluticasona-Salmeterol , Humanos , Masculino , Pessoa de Meia-IdadeRESUMO
The international consensus is that guidelines for respiratory endoscopy are inadequate, regarding such issues as institutional requirements, benefits, risks and limitations of the procedure, training programs and accreditation, with the result that the way or performing endoscopy varies according to how an operator was trained. The absence of precise recommendations means that practice is highly diverse and inappropriate use of the procedure has increased. The Argentine Consensus Group for Normalization of Respiratory Endoscopy was created in 1995 to unify criteria for several aspects of endoscopic practice. The official recommendations of the Group and of the Argentine Society of Bronchoesophagology define the indications (diagnostic, therapeutic and investigative) and contraindications (absolute, relative and high risk) for bronchoscopy. Required pre-bronchoscopic studies for routine and special cases are defined, as are indications for premedication, intubation and general anesthesia. Requirements for the setting, support personal and instruments are specified. Guidelines for topical anesthesia and techniques for insertion of the endoscope are suggested. The technique, indications and limitations of bronchoalveolar lavage, bronchial brushing and biopsy and transbronchial needle biopsy are defined. The utility and limitations of the various therapeutic techniques of bronchoscopy (laser, radiotherapy and stents) are defined. Norms to safeguard the patient, instruments and operator are emphasized.
Assuntos
Broncoscopia/normas , Anestesia Geral , Anestesia Local , Biópsia , Lavagem Broncoalveolar , Broncoscópios , Contraindicações , Corpos Estranhos/diagnóstico , Corpos Estranhos/terapia , Humanos , Pré-MedicaçãoRESUMO
The demographic features, treatment, and outcome of 36 rattlesnake envenomation cases are reviewed. Two populations at special risk are identified: (1) young children (12/36) who sustain lower extremity bites, and (2) adults who consume alcohol and handle snakes (10/36) who sustain upper extremity bites. Antivenin was used in 22 cases with only one serious case of serum sickness. Three definite diagnoses of compartment syndrome were made on the basis of elevated compartment pressures. Hand bites accounted for 20 of the 36 cases. The greatest functional disability followed digit bites in that 11 patients developed decreased motion and sensation. The indications for fasciotomy and debridement are discussed, both for digit and non-digit envenomations. General treatment recommendations are given.