RESUMEN
BACKGROUND: Rectally administered mesalazine (mesalamine; 5-aminosalicylic acid) is the first-line therapy for treatment of distal ulcerative colitis. Recently, a high-volume 5-aminosalicylic acid foam has been shown to be as effective and safe as standard 5-aminosalicylic acid enema. AIM: To study the efficacy and safety of a low-volume vs. a high-volume 5-aminosalicylic acid foam. METHODS: In this investigator-blinded study, patients with active distal ulcerative colitis [Clinical Activity Index (CAI) > 4, Endoscopic Index > or = 4] were randomized to receive 2 x 1 g/30 mL low-volume (n = 163) or 2 x 1 g/60 mL high-volume 5-aminosalicylic acid foam (n = 167) for 42 days. Primary end point was clinical remission (CAI < or = 4) at the final/withdrawal visit (per-protocol). RESULTS: 330 patients were evaluable for efficacy and safety by intention-to-treat, 290 for per-protocol analysis. Clinical remission rates at week 6 (per-protocol) were 77% on low-volume foam vs. 77% on high-volume foam (P = 0.00002 for non-inferiority). The low-volume foam was associated with a lower frequency of severe discomfort, pain and retention problems. CONCLUSIONS: Low-volume 5-aminosalicylic acid foam is as effective and safe as a high-volume 5-aminosalicylic acid foam in the treatment of active distal ulcerative colitis, but offers compliance advantages compared to the high-volume preparation.
Asunto(s)
Antiinflamatorios no Esteroideos/administración & dosificación , Colitis Ulcerosa/tratamiento farmacológico , Mesalamina/administración & dosificación , Administración Rectal , Adolescente , Adulto , Anciano , Antiinflamatorios no Esteroideos/efectos adversos , Antiinflamatorios no Esteroideos/uso terapéutico , Femenino , Humanos , Masculino , Mesalamina/efectos adversos , Mesalamina/uso terapéutico , Persona de Mediana Edad , Método Simple Ciego , Resultado del TratamientoRESUMEN
BACKGROUND: Rectal budesonide is an effective treatment of active ulcerative proctitis or proctosigmoiditis. AIM: To compare the therapeutic efficacy, tolerability and safety, and patient's preference of budesonide foam vs. budesonide enema. METHODS: Patients with active ulcerative proctitis or proctosigmoiditis (clinical activity index > 4 and endoscopic index > or = 4) were eligible for this double-blind, double-dummy, randomized, multicentre study. They received 2 mg/25 mL budesonide foam and placebo enema (n = 265), or 2 mg/100 mL budesonide enema and placebo foam (n = 268) for 4 weeks. Primary endpoint was clinical remission (clinical activity index < or = 4) at the final/withdrawal visit (per protocol). RESULTS: A total of 541 patients were randomized--533 were evaluable for intention-to-treat analysis and 449 for per protocol analysis. Clinical remission rates (per protocol) were 60% for budesonide foam and 66% for budesonide enema (P = 0.02362 for non-inferiority of foam vs. enema within a predefined non-inferiority margin of 15%). Both formulations were safe and no drug-related serious adverse events were observed. Because of better tolerability and easier application most patients preferred foam (84%). CONCLUSION: Budesonide foam is as effective as budesonide enema in the treatment of active ulcerative proctitis or proctosigmoiditis. Both budesonide formulations are safe, and most patients prefer foam.
Asunto(s)
Antiinflamatorios/administración & dosificación , Budesonida/administración & dosificación , Proctitis/tratamiento farmacológico , Administración Rectal , Adolescente , Adulto , Anciano , Antiinflamatorios/efectos adversos , Budesonida/efectos adversos , Colitis Ulcerosa/tratamiento farmacológico , Método Doble Ciego , Enema/métodos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Satisfacción del Paciente , Proctocolitis/tratamiento farmacológico , Resultado del TratamientoRESUMEN
Introduction of turbidimetric homogeneous immunoassays made the determination of plasma ferritin concentration wide-ranging available. However, high-dose hook effect or prozone effect occurring at samples with high ferritin concentration can lead to false-negative results. According to the authors, this phenomenon has considerable clinical significance, in patients with iron-overload disorders false-negative laboratory values may result in inaccurate diagnosis. The prozone effect can be eliminated by reaction kinetic analysis of measurements. The authors developed a neural network classification procedure based on artificial intelligence technology for the recognition of the reactions with differing kinetic flow, and made a computer software for helping the application of the classification system. False-negative results can be filtered using this new technology following the laboratory determination, thus sensitivity of plasma ferritin determination may become safe enough even in case of high concentration samples.
Asunto(s)
Reacciones Falso Negativas , Ferritinas/sangre , Enfermedades Hematológicas/sangre , Humanos , Inmunoensayo , Hepatopatías/sangre , Nefelometría y Turbidimetría , Diálisis RenalRESUMEN
The authors examined the effect of long acting somatostatin analogue (Sandostatin, Sandoz) on acute experimental pancreatitis and on the subsequent regeneration. Acute injury to the pancreas was produced by an intraductal intervention (ligature of the bile duct and intraductal injection of taurocholic acid) and by a metabolic route (supramaximal dose of caerulein by repeated subcutaneous injections). The effect of the drug on the acute injury was examined at 6 and 24 hours following the intervention and the effect on regeneration was examined on day 3 and 5 in all cases by determination of plasma enzyme levels and examination of the pancreatic tissue. Long acting somatostatin analogue did not prove to be effective in the serious acute pancreatitis produced by the intraductal intervention. However, in the acute phase of the caerulein induced pancreatitis, it had a beneficial effect as seen by it's ability to moderate the serum enzyme levels. During the examination of pancreatic regeneration was found that in caerulein induced pancreatitis the weight of the pancreas decreases due to atrophy and that this was not affected by long acting somatostatin analogue. As a matter of fact, the somatostatin counteracted the caerulein induced DNA increase, and therefore acted against the reactive hyperplasia. Therefore, the favorable effect of long acting somatostatin analogue is witnessed only in the caerulein induced acute injury but it does not accelerate the rate of pancreatic regeneration following injury. Due to this fact, protracted administration of this agent can not be rationalized.