Gastrointestinal tolerability of ibuprofen administered in two pharmaceutical formulations.

Ibuprofen (CAS 15687-27-1) is a nonsteroidal antiinflammatory drug endowed with analgesic, antiinflammatory and antipyretic activity. The main side effect of ibuprofen and nonsteroidal antiinflammatory agents is addressed to disturbances of the gastrointestinal tract, like gastric pyrosis, gastric and intestinal damage. A pharmaceutical formulation of ibuprofen in fast melting tablets consisting in gastroprotected microgranules to be ingested without concomitant water intake (Cibalginadue Fast, hereinafter referred to as test) was compared in this trial with a formulation of ibuprofen in tablets (reference) on 18 healthy volunteers in terms of gastrointestinal and general tolerability. Both the formulations are present on the market. The two formulations were administered according to a two-period, two-formulation, two-sequence, cross-over design in repeated dose regimen to steady state with wash-out. The dose was 400 mg (2 strengths) b.i.d. over 7 days. Before, during and after each study period general tolerability was carefully checked from blood/urine biochemical parameters, adverse events experienced and vital signs. The target parameters were the gastric permeability to sucrose and the intestinal permeability to lactulose and mannitol, which were administered orally and assayed in the urine excreted during a 6-h period. Urinary excretion > 0.15% of sucrose and > 0.04 of the lactulose to mannitol ratio are considered expression of increased gastric and intestinal permeability, respectively. Three volunteers treated with the reference showed an increased gastric permeability > 0.15%. Neither other gastric nor intestinal increased permeability was detected. Occult blood in faeces was negative in all the cases. The incidence of adverse effects experienced was higher with the reference (9 volunteers) than with the test (5 volunteers). In details gastric pyrosis was experienced by six volunteers treated with the reference and only by two volunteers treated with the test. The whole tolerability was better with the test formulation than with the reference, even if these differences did not reach any statistically significant degree. The better tolerability of the test was attributed to its gastroprotection.

Renal effects of dietary supplementation with fish oil in cyclosporine-treated liver transplant recipients.

Nephrotoxicity is the main untoward effect of cyclosporine (CsA) treatment. Experimental and clinical data suggest that dietary supplementation with fish oil may lessen cyclosporine nephrotoxicity, possibly by lowering renal thromboxane (Tx) production. We have studied the renal effects of a daily supplementation for 2 months of 12 g fish oil (18% C20:5 n-3 eicosapentaenoic acid [EPA] and 12% C22:6 n-3 docosahexanoic acid [DHA]) in a placebo-controlled (12 g corn oil), prospective, randomized, double-blind study of stable CsA-treated liver transplant recipients. Thirteen patients ingested corn oil capsules and 13 fish oil. Compliance with dietary regimen was confirmed by fatty acid chromatography that showed increased plasma concentrations of EPA (from 0.4 +/- 0.02% to 4.6 +/- 0.5%, P < .0001) and DHA (from 1.8 +/- 0.2% to 3.9 +/- 0.1%, P < .0001) in the fish oil group and increased plasma concentration of linoleic acid (C18:2 n-6) in the corn oil group (from 25 +/- 2% to 28.4 +/- 2%, P < .001). At the end of the 2 months of the study, in the fish oil group the effective renal plasma flow increased by 22% (P = .012), the glomerular filtration rate increased by 33% (P = .057), the renal blood flow increased by 17% (P = .024), and the calculated total renal vascular resistances decreased by 20% (P = .034). In contrast, none of these parameters changed in the corn oil group. The renal functional reserve determined during L-arginine infusion, plasma renin activity (PRA), and plasma aldosterone (PA) remained unchanged during the study in either group.(ABSTRACT TRUNCATED AT 250 WORDS)

[Clinical applications of color-Doppler: the parathyroid glands]. / Applicazioni cliniche del color-Doppler: le ghiandole paratiroidi.

The high-resolution appearance of enlarged parathyroid glands is well known. Thus, real-time gray-scale US alone fails to provide, in ENT surgery, adequate sensitivity and specificity rates to differentiate between parathyroid glands, hypoechoic thyroid adenomas and other hypoechoic neck masses. Since parathyroid tissue, in both normal and enlarged glands, is hypervascular, color-Doppler US is used as a sort of non-invasive angiography to identify parathyroid glands. The combined use of B-mode and color-Doppler US allows the vascular features of thyroid masses to be satisfactorily demonstrated, with easy differentiation between enlarged parathyroid glands, featuring diffuse internal vascularization, and thyroid adenomas characterized by rounded peripheral vessels and also lymph nodes and cysts exhibiting different vascular patterns. We studied 25 patients with clinical and biochemical signs of hyperparathyroidism (19 primary and 6 secondary) submitted to surgery in the last 20 months. Every patient was scanned with both B-mode and color-Doppler US. At surgery, 19 parathyroid adenomas were found--16 of them correctly identified preoperatively with color-Doppler US and 3 false negatives (retrotracheal glands). Moreover, 1 false positive was observed due to a small Plummer's adenoma misdiagnosed as an intrathyroid parathyroid adenoma: both lesions had the same vascular pattern on US images. Sensitivity was 84.5% and specificity 93.7%. In secondary HPT patients, 23 hyperplastic glands were found at surgery--21 of them correctly identified preoperatively by color-Doppler US, with 2 false negatives. No false positive was found. Sensitivity was 87.5% and specificity 100%. Sensitivity does not differ very much from what reported in literature. Specificity is clearly increased by the use of color-Doppler US. The possible source of error represented by Plummer's adenomas lead us to investigate pulsed Doppler capabilities in differentiating Plummer's adenomas from PT glands, since color-Doppler findings were similar in the two conditions. Peak velocities recorded with both color and pulsed Doppler showed velocity to range 6 to 40 cm/s in parathyroid glands (mean +/- SD: 14.6 +/- 11.7) and 38 to 120 cm/s in thyrotoxic nodules (mean +/- SD: 78.4 +/- 23). The statistical analysis of the results showed a highly significant difference between the two groups of velocities. Peak velocities as recorded in the main, vessels of the parathyroid glands with color and pulsed Doppler were correlated with the activity of the parathyroid glands.(ABSTRACT TRUNCATED AT 400 WORDS)

[The calcium salt of folinic acid for the treatment of deficiency anemia]. / L'acido folinico sale calcico nel trattamento delle anemie ad impronta carenziale.

Thirty patients (20 adults and 10 children) suffering from nutritional anaemias were treated with folinic acid for 15 days per os at a dosage of 4-8 mg daily. For each patient routine laboratory tests, folic acid assays in the serum and in the erythrocytes have carried out and the clinical parameters have been recorded at the beginning and at the end of the treatment. The results showed statistically significant increase in the number of red cells per cmm, in folic acid content both in the serum and in the erythrocytes; at the same time a decrease of mean corpuscular haemoglobin concentration (MCHC) and mean corpuscular haemoglobin (MCH) was observed.

[Folinic acid in the treatment of elderly patients with macrocytic anemia]. / L'acido folinico come terapia in pazienti anziani portatori di anemia macrocitica.

Thirty elderly patients suffering from macrocytic anaemia associated with chronic diseases were treated with folinic acid for 25 days at a dosage of 4-8 mg daily. For each patient routine laboratory tests have been carried out, the clinical parameters have been recorded at the beginning and at the end of the trial and after 8 days of treatment a possible reticulocyte crisis has been evaluated. The results showed a significant decrease of medium corpuscular volume (MCV), of mean corpuscular haemoglobin (MCH), of iron as well as an increase of folic acid in the serum. After 8 days of treatment a statistically significant reticulocyte crisis was observed.