RESUMEN
BACKGROUND: The aim of our study was to evaluate any correlation between symptoms of the upper digestive tract, endoscopic findings and the clinical stage of disease. METHODS: Thirty-four anti-HIV positive patients were enrolled and subdivided, according to CDC classification, as follows: 28 CDC II/III (asymptomatics) and 6 CDC IV (AIDS). The past medical history of all patients was investigated and oesophagogastroduodenoscopy (OGDS) was carried out. RESULTS: All anti-HIV positive patients complained of gastrointestinal symptoms (100%), while endoscopic lesions were observed in 11/34 (32.3%). CONCLUSIONS: The data did not show any correlation between symptoms and endoscopic alterations; we showed more frequent endoscopic alteration in CDC IV patients, even if being treated, compared with CDC II/III.
RESUMEN
Thirty-six patients with hepatitis C virus-RNA positive chronic hepatitis were studied to evaluate whether recombinant alpha-2b interferon, in medium-high doses, (6-9 MU 3 times/week) over a long period (12-18 months), was more effective in reducing or normalizing alanine aminotransferase values, and in reducing the relapsing percentage than the historical trials. At the end of the 12th and 18th month of treatment, mean alanine aminotransferase values were significantly reduced; the level of complete responses was 36.1%, at the end of the 12th month, and 19.4% at the end of the 18th month (intention to treat). These results were no better than comparable findings in the literature. At the end of the first follow-up (12th month), percent complete responses fell to 15.5%, with a relapse rate of 14.3%. At the end of the second follow-up (24th month), percent complete responses fell further to 11.1% (all 4 patients with a 24 months sustained response showed absence of viraemia), with a relapse rate of 42.9%; even these percentages were judged unsatisfactory. In conclusion, no significant advantage was obtained by prolonging interferon treatment and/or using higher dosages. However, the possible virus clearance in all the long-term responders seems to justify further investigation in terms of cost-benefit analysis.
Asunto(s)
Antivirales/administración & dosificación , Hepatitis C/terapia , Hepatitis Crónica/terapia , Interferón-alfa/efectos adversos , Alanina Transaminasa/sangre , Esquema de Medicación , Femenino , Estudios de Seguimiento , Hepatitis C/diagnóstico , Hepatitis Crónica/diagnóstico , Humanos , Interferón alfa-2 , Hígado/patología , Masculino , Persona de Mediana Edad , Proteínas Recombinantes , Recurrencia , Factores de Tiempo , Resultado del TratamientoRESUMEN
The activity of pidotimod ((R)-3-[(S)-(5-oxo2-pyrrolidinyl) carbonyl]-thiazolidine-4-carboxylic acid, PGT/1A, CAS 121808-62-6) on immunological parameters was evaluated in a double-blind trial, involving two Research Centres. 16 patients with a primary or metastatic neoplasm, 16 elderly patients under immunodeficiency conditions and 11 healthy volunteers were enrolled in the present study. The patients, randomized within each centre, were assigned to one of the following treatments lasting 15 days: one vial i.m. of pidotimod 50 mg, 100 mg, 200 mg twice a day, respectively; one vial i.m. of physiological saline twice a day. The lymphocyte PHA-stimulation test evidenced a significant variability due to the different treatment groups (p = 0.004). The analysis of the stimulation index (SI), computed from the mean c.p.m. before and after PHA-stimulation, showed a significant difference, dose-independent, between saline and active treatment (p = 0.002). The SI analysis, on the basis of the data of the allogenic stimulation test (mixed lymphocyte culture), confirmed the difference between saline and active treatment (p = 0.05) with a significant linear component in the time-effect curve (p = 0.001) but not in the dose-effect curve. A 12% increase in CD 3 lymphocytes compartment was observed with pidotimod 400 mg/day. The drug was well tolerated by all the patients included in the study.
Asunto(s)
Adyuvantes Inmunológicos/farmacología , Inmunidad Celular/efectos de los fármacos , Ácido Pirrolidona Carboxílico/análogos & derivados , Tiazoles/farmacología , Adyuvantes Inmunológicos/efectos adversos , Adulto , Anciano , Anciano de 80 o más Años , Complejo CD3/análisis , Método Doble Ciego , Femenino , Humanos , Recuento de Linfocitos/efectos de los fármacos , Masculino , Persona de Mediana Edad , Neoplasias/inmunología , Fitohemaglutininas/farmacología , Ácido Pirrolidona Carboxílico/efectos adversos , Ácido Pirrolidona Carboxílico/farmacología , Estimulación Química , Linfocitos T/efectos de los fármacos , Linfocitos T/inmunología , Tiazoles/efectos adversos , TiazolidinasRESUMEN
The aim of this study was to evaluate the activity of pidotimod ((R)-3-[(S)-(5-oxo-2-pyrrolidinyl)carbonyl]-thiazolidine-4-carboxylic acid, PGT/1A, CAS 121808-62-6) on 52 patients affected with chronic obstructive pulmonary disease (COPD). The study was carried out in a randomized, parallel, double-blind trial, followed by incomplete blocks design. Pidotimod 800 mg was administered orally twice a day for 30 days. The follow-up period was 5 weeks. Our results show that in patients with COPD pidotimod potentiates T-cell activity. The effects on T-cells appear after 15 days of treatment and last for 5 weeks after the end of therapy. Since other studies demonstrated that pidotimod displays an immunopotentiating activity also on macrophages and granulocytes, the drug is useful to increase the immune defense during infections. The drug has a good compliance and is well tolerated also during long-term treatment.