Pioglitazone Randomised Italian Study on Metabolic Syndrome (PRISMA): effect of pioglitazone with metformin on HDL-C levels in Type 2 diabetic patients.

BACKGROUND: Previous evidence indicates that pioglitazone may improve dyslipidemia in patients with Type 2 diabetes mellitus (T2DM). AIM: The primary objective of this study was to evaluate the effect of either pioglitazone or placebo with metformin on levels of serum HDL cholesterol (HDL-C) in patients with T2DM. A secondary objective evaluated changes in metabolic syndrome (MS)-specific parameters. SUBJECTS AND METHODS: This multicenter, double-blind, randomized study was performed in patients with T2DM treated with metformin and hemoglobin A1c (HbA1c) levels between 6-8%, central obesity and reduced HDL-C. MS was evaluated from global changes in parameter values and expressed as a single factorial score following multivariate analysis of each parameter. 213 patients (110 in the pioglitazone group and 103 in the placebo group) were available for intention-to-treat analysis. RESULTS: Pioglitazone-treated patients showed a significant increase in HDL-C compared to placebo group (6.3 mg/dl vs 3.0 mg/dl; p<0.01) in addition to a greater reduction in the extent of MS (-13.2 vs -4.9; p=0.0055). Upon study completion, patients treated with pioglitazone had lower levels of HbA1c (6.41±0.65 vs 6.96±0.74%; p<0.001) and homeostasis model assessment-insulin resistance (HOMA-IR) (2.88±1.95 vs 4.68±3.63; p=0.013) and a reduction of the atherogenic LDL subfraction (pattern B) (-5.7%). CONCLUSIONS: The beneficial effects observed in pioglitazone-treated patients in the present study, (i.e. the increase in HDL-C and the reduction of insulin resistance and atherogenic LDL subfractions), support findings from the PROactive trial, where pioglitazone showed pleiotropic effects and reduced death, fatal myocardial infarction (MI) and non-fatal MI in T2DM patients with MS. Furthermore, medication used in this study showed good tolerability.

Imidazole salicylate in the treatment of osteoarthrosis and musculoskeletal trauma: a postmarketing survey.

A postmarketing survey was conducted by 37 orthopedists and traumatologists among 700 patients of both sexes, aged 7 to 87 years, to evaluate the efficacy and tolerability of imidazole salicylate. The 467 patients with osteoarthrosis received 750-mg tablets (TID) for up to one month and 233 patients with traumatic pathologies received imidazole salicylate gel (BID-TID) for ten days, or tablets (BID-TID), or both gel and tablets combined. The treatment was satisfactory in both patient groups, significantly reducing the intensity of pain and swelling and improving articular function. No adverse experiences that had not been reported previously were recorded; only some gastrointestinal side effects exceeded an incidence of 1%.

Perineal floor efficiency in sexually potent and impotent men.

Given the knowledge that the ischiocavernous and bulbocavernous muscles are involved in the erection of the penis, we studied the voluntary contractile activity of the perineal floor muscles in sexually potent and impotent men to investigate whether or not a different muscular efficiency can be found in these subjects. The activity of perineal floor muscles was studied in 76 sexually potent men and in 97 impotent men matched by age. A further group of 217 older impotent men was also studied to verify the impact of age on the efficiency of perineal floor contraction. The average myoelectrical activity of 24 maximized contractions of the perineum was measured in microV by anal plug electromyography. Perineal floor muscle contraction was significantly higher (P = 0.0007) in potent than in impotent men matched by age. In addition, in older impotent men the less perineal floor efficiency was also negatively correlated to age (r = -0.21, P = 0.002). Our results clearly demonstrated that a reduction of contractile activity of perineal muscles may be related to erectile dysfunction in younger men and an additional influence of age on perineal floor efficiency can be present in older impotent men.

Comparative absorption kinetics of imidazole and salicylic acid in volunteers after administration of ITF 182 tablets and suppositories.

Comparative absorption kinetics in volunteers of a new antiinflammatory drug (Selezen), in the form of 750 mg tablets and suppositories, were studied. The two components of the drug, imidazole and salicylic acid were found in plasma. Pharmacokinetic parameters were calculated according to a first order absorption. Salicylic acid showed a maximum concentration 59.2 +/- 5 min and 75.4 +/- 7.6 min after the administration of the tablet and suppository respectively; and imidazole after 86.3 +/- 10.8 min and 75.2 +/- 5.4 min, respectively.

Anionic glycoproteins and their hexosamine content in neoplastic patients: relationships with the clinical stage and the course of the disease.

In 40 healthy subjects, in 47 non-cancer patients, and in 142 cancer patients, perchloric acid soluble glycoproteins (PASG) and hexosamines were determined to investigate their tumor specificity and correlation with the tumor mass. Cancer patients were divided into three subgroups: CI, no evidence of cancer (after radical surgery); CII, locoregional disease; CIII, widespread metastatic disease. There was no statistically significant difference in PASG among normals, non-cancer and CI patients; hexosamines in non-cancer and in CI patients were higher (P less than 0.002) than in normals; both PASG and hexosamines were significantly higher in CII and CIII patients than in normals (P less than 0.001). In the CI group, 62% of patients who relapsed within 10 months after surgery had high hexosamine values, whereas 69% of patients who did not relapse showed normal levels (P less than 0.05). PASG and hexosamines significantly increased with cancer progression and decreased when objective response to treatment was achieved. They are not tumor specific, but seem to be related to the tumor burden; hexosamines seem to have some prognostic value.

[Altered immunoregulation in chronic viral hepatitis. Deficiency of T-lymphocytes with membrane receptors for histamine]. / Alterata immunoregolazione nella epatite cronica virale. Deficit di linfociti T con recettore di membrana per l'istamina.

To further characterize the defect of immunoregulation in chronic active hepatitis (CAH), we measured circulating T cells with membrane receptors for histamine (H + TLy), cells endowed with cytotoxic and suppressor functions, in a group of patients with viral CAH, in patients with non-immune liver disorders and in healthy individuals. Patients with CAH showed significantly lower mean numbers and percentage of H + TLy (p less than 0,001) than controls, while patients with non-immune liver disorders had H + TLy values which did not differ significantly from those found in healthy individuals. The lymphocyte alterations in CAH patients were independent of serum HBsAg, cirrhosis or steroid therapy, but correlated inversely with an in vivo index of plasma cell activity, i.e., serum gammaglobulin levels, and with the histological parameter of hepatic inflammation, i.e. portal and periportal mononuclear infiltration. The normal values of H + TLy in patients with non-immune liver diseases suggest that in CAH the decrease in circulating H + TLy is not secondary to the liver damage. The alteration of immunoregulation associated with CAH may have pathogenetic implications, although it is unlikely to represent the sole mechanism for the perpetuation and worsening of the disease process.

[Function of the pituitary-thyroid axis after partial resection of the thyroid]. / Funzionalità dell'asse ipofisio-tiroideo dopo asportazione parziale della tiroide.

The TSH, T4 and T3 responses to TRH were measured in 48 patients who underwent selective goitre resection (hemithyroidectomy, ablation of single nodule); moreover 3 groups of healthy, hypothyroid and hyperthyroid persons served as reference groups. The main object was to detect eventual onset of preclinical hypothyroidism. This condition was observed after hemithyroidectomy only in 12.5%, and never after ablation of single nodule. Were detected too, among operated patients, 2 subjects with light and 1 with clear hyperthyroidism. Therapeutic implications of such a finding were taken into consideration.

Osteopenia in Puerto Ricans with Crohn's disease.

BACKGROUND: Osteopenia has been reported in association to Inflammatory Bowel Disease, and in particular Crohn's disease. The use of corticosteroids, resection of the ileum, malabsorption, poor calcium intake, and the effect of inflammatory cytokines have all been considered as contributing factors. As Crohn's disease is more prevalent in young people, when peak bone mass is achieved, the presence of osteopenia is especially significant. OBJECTIVES: The aim of this study was to evaluate the bone density of patients with Crohn's disease in the University of Puerto Rico IBD Clinic; to determine the prevalence of osteopenia in these patients and to correlate bone mineral density with risk factors for osteopenia. METHODS: Sixty-six patients, 30 males and 36 females were included. After informed consent, demographic, clinical and metabolic data was obtained. Serum albumin, calcium, inorganic phosphorus and alkaline phosphatase were measured. Body mass index (BMI) was calculated. Bone density was determined by DEXA of the lumbar spine and femur and expressed as the Z score (standard deviations from normal correlated with sex and age). Severe osteopenia was a Z score > or = -2 and osteopenia was Z < or = -1.99 or > or = 1.01. Results were expressed in means. Pearson correlation coefficient was used for quantitative variables and Pearson chi-square for categorical values. RESULTS: Osteopenia was present in the hip in 69% and in the lumbar spine in 68%. Most patients had received steroids; the difference between treated and not treated patients was not significant. Osteopenia did not correlate with ileal resection, gender, BMI, disease characteristics or biochemical parameters. CONCLUSIONS: Low bone density was frequent in patients with Crohn's disease, but no specific risk factors could be identified. Bone density should be determined in patients with Crohn's disease in order to institute appropriate therapeutic measures.

Infections caused by parvovirus B19.

Parvovirus B19 was discovered in 1974 by Cossart et al; is a single stranded unenveloped DNA virus, which virion is isometric, uniform and has icosagedral symmetry. B19 infection has been found in all countries, it is almost certainly world-wide in distribution. Infections occurs most frequently in late winter, spring and early summer months and are transmitted by respiratory route. Erythema infectiosum is the most common manifestation of human parvovirus B19 infection, is most commonly acquired between 4 and 10 years of age and at least 60% of adults are seropositive. Erythema Infectiosum is characterized by three stages of rash that involves the face and may also involves trunk and extremities. In adult patients, particularly women, arthralgia or arthritis have been associated with up to 80% of Erythema Infectiosum casually starts in the small joints of the hand. Maternal parvovirus B19 infection with or without rash, can affect fetus. Transient aplastic crisis can be caused by HPV B19 in patient who have increased rate of RBC destruction or loss. Others diseases or symptoms complexes may be associated with B19 infection in the coming years as this virus and its infections continues being an interesting field of investigation.

Observational study on the performance of the Narhinel method (nasal aspirator and physiological saline solution) versus physiological saline solution in the prevention of recurrences of viral rhinitis and associated complications of the upper respiratory tract infections (URTI), with a special focus on acute rhinosinusitis and acute otitis of the middle ear.

AIM: The aim of this study was to assess the validity of Narhinel method in the prevention of recurrences of viral rhinitis and of any associated sequelae, in particular acute otitis of the middle ear (AOM) and acute rhinosinusitis (AR). METHODS: This was a prospective observational study, in children aged from two months to two years, observed for five months during the cold season and carried out by family pediatricians (FIMP association) in Friuli Venezia Giulia, Italy. The study enrolled 435 patients. The observed population consisted of two groups: the first one of 238 children treated with Narhinel method and the second one of 197 patients treated only with the physiological saline solution. In compliance with the guidelines of an observational trial, the children were prescribed the therapeutic treatments used as a routine. The patients were recruited for the trial after the responsible parent had signed the informed consent form. The study protocol had been approved by the Ethics Committee of the area of Pordenone. In order to be recruited, patients had to comply with the following criteria: symptoms suggestive of the common cold; age > or =2 months < or =2 years; male and female. Patients presenting one or more of the following characteristics were not included: systemic diseases; congenital nasal obstruction (choanal atresia); infections of the upper and lower respiratory tracts other than common cold; systemic and/or topical use of antibiotics and/or corticosteroids at the moment of recruitment. During the five months of the observation period, all the therapies that the investigators had decided it was necessary to administer had been included and recorded in the CRF. Patients evaluations were carried out for five months. The clinical assessment was performed at baseline (B), in the first week (Fw) and monthly and described as M1 to 5; several clinical parameters were analyzed (anterior and posterior rhinorrhoea, oral respiration, noisy nasal respiration, and nasally transmitted thoracic sounds) and measured by the pediatrician at all examinations from B to M5. Other parameters were derived from the parents' daily observations, recorded in a diary and made note of the quality of sleep, diet and respiration, and the use of any drug during any relapse of acute rhinitis (common cold episode). Recurrence of AOM and AR was assessed by the pediatrician at M1-2-3-4-5. Safety of use was determined using the Italian Health Ministry incident/near incident report sheets for Medical Device and based on diaries where the parents took note of any events which occurred during the observation period. Parental satisfaction and compliance were assessed through a questionnaire given to the parents at the end of the last visit (M5). RESULTS: In the Narhinel group, the mean age was inferior (statistically significant): 8.9 compared to 11.4 months in the physiological saline solution group. The frequency of recurrences from viral rhinitis was very similar in the two groups and a decrease (statistical significant) was observed from M3 through M5 in both groups. Rhinorrhea, oral breathing, and other upper respiratory symptoms, improved in the two groups even if in the Narhinel one the improvement was more prominent during the first two months of observation. There was no difference in the frequency of AR between the groups: at M4 and M5, there was a statistically significant decrease in the frequency of episodes. The frequency of AOM varied in the two groups considering a comparison intra-groups: at M5 the decrease of episodes was statistically significant in the Narhinel group. In Narhinel group, AR and acute AOM seem to be more markedly controlled (frequency) especially for AOM. The frequency of adverse events (AEs) did not vary in the two groups: in the Narhinel one there was a difference (not statistically significant and not clinically relevant) in the number of patients with AEs, especially crying and nasal bleeding. One serious AE was reported in the physiological saline solution group. A 14-month-old child developed laryngospasm which recovered completely after hospital treatment with adrenaline. This event was not related to treatment with saline solution and causality was assessed as "unlikely" by the investigator. In the Narhinel group, one serious event of moderate convulsion febrile in a male patient (age of 0.9) was reported. The causality relationship was assessed by the investigator as improbable. Parents' satisfaction was higher (statistically significant) in the Narhinel group compared to the physiological saline solution alone group. CONCLUSION: In acute rhinites (common cold) both medical devices are effective nevertheless Narhinel method is valid and shows better results in AOM and AR. Moreover Narhinel method was also more appreciated by parents than physiological saline solution. According to authors' experience, the Narhinel method is safe and its performance is valid in the prevention of AOM and AR in children.

Renal effects of imidazole-2-hydroxybenzoate in patients with compensated liver cirrhosis.

A double-blind crossover study versus placebo of the renal effects of the nonsteroidal anti-inflammatory drug imidazole 2-hydroxybenzoate was conducted in 10 patients with compensated liver cirrhosis. The administration of the drug (750 mg, t.i.d., for three days) did not affect renal plasma flow, glomerular filtration rate, free water clearance nor the urinary excretion of sodium or potassium. Values of plasma renin activity also did not change after drug administration. Direct tubular damage from imidazole 2-hydroxybenzoate was also excluded by normal excretion of beta-2-microglobulin and N-acetyl-beta-D-glucosaminidase. Urinary 6-keto-PGF1 alpha output were comparable during imidazole 2-hydroxybenzoate and placebo administration. These data indicate that this nonsteroidal antiinflammatory drug does not affect the renal function in patients with compensated liver cirrhosis.

Is transrectal ultrasonography a reliable diagnostic approach in ejaculatory duct sub-obstruction?

We studied the diagnostic predictive power of transrectal ultrasonography (TRUS) coupled with semen volume in cases of distal seminal tract sub-obstruction. As a gold standard for diagnosis we used seminal tract washout (STW). Non-azoospermic subjects (n = 112) were submitted to transrectal ultrasonography because of suspected excretory infertility or other andrological pathologies, before performing STW. STW indicated ejaculatory duct sub-obstruction in 36.6% of the patients. Seminal vesicle enlargement (anterior-posterior diameter > or = 15 mm) and seminal vesicle roundish anechoic areas (stasis) were the ultrasonographic anomalies more often associated with ejaculatory duct sub-obstruction. Stepwise logistic regression (SLR) analysis revealed that the ultrasonographic evidence of stasis was highly diagnostic only in the presence of a low semen volume (< or = 1.5 ml) and that ejaculatory duct sub-obstructions may be present but with no evidence of ultrasonographic anomalies. Therefore, TRUS is a useful approach for the treatment of suspected ejaculatory duct sub-obstruction, but is not a reliable diagnostic tool and, before performing transurethral surgery, STW should be mandatory.