Biomedical subjects

R Cerutti

Publications and source records attributed to R Cerutti.

At least 19 recordsLinked to original sources

PubMed2004

Health-related quality of life in patients with thyroid disorders.

Limited reports are available on quality of life (HRQL) in thyroid diseases, and no data are available in euthyroid disorders, such as goiter and Hashimoto thyroiditis. Also, asymptomatic patients may suffer a reduction in perceived health status due to distress related to physical appearance and awareness of disease. We measured HRQL by means of Medical Outcome Study Short Form-36 (SF-36) and Nottingham Health Profile (NHP) questionnaires in 368 patients (hypothyroid, 81; hyperthyroid, 45 (for both states including overt and subclinical states); Hashimoto thyroiditis, 51; euthyroid goiter, 191). The final scores of the domains were compared with age- and sex-adjusted Italian normative values, by computing the effect size. All domains of SF-36, except bodily pain, were reduced in thyroid disease; this was mainly the case of role limitation (both physical and emotional), general health and social functioning. The domains of NHP were less severely affected. HRQL was impaired also in the absence of altered hormone levels. Mood/behavior disturbances were present in a large proportion of patients and were significantly associated with poor HRQL. HRQL was significantly reduced in patients with thyroid diseases referred to a secondary level endocrinology unit. Perceived health status may be considered as an additional outcome of management and therapy of thyroid disorders.

Adolescent↗

PubMed2003

Contribution of artificial neural networks to the classification and treatment of patients with uninvestigated dyspepsia.

OBJECTIVES: To verify whether symptoms reported by patients with uninvestigated dyspepsia might be helpful in either classifying functional from organic dyspepsia (1st experiment), or recognising which Helicobacter pylori infected patients may benefit from eradication therapy (2nd experiment). METHODS: We compared the performance of artificial neural networks and linear discriminant analysis in two experiments on a database including socio-demographic features, past medical history, alarming symptoms, and symptoms at presentation of 860 patients with uninvestigated dyspepsia enrolled in a large observational multi-centre Italian study. RESULTS: In the 1st experiment, the best prediction for organic disease was given by the Sine Net model (specificity of 87.6% with 13 patients misclassified) and the best prediction for functional dyspepsia by the FF Bp model (sensitivity of 83.4% with 56 patients misclassified). The highest global accuracy of linear discriminant analysis was 65.1%, with 150 patients misclassified. In the 2nd experiment, the highest predictive performance was provided by the SelfDASn model: all infected patients who became symptom-free after successful eradicating treatment were correctly classified, whereas nine errors were made in forecasting patients who did not benefit from such a therapy. The highest global performance of linear discriminant analysis was 53.2%, with 37 patients misclassified. CONCLUSIONS: In patients with uninvestigated dyspepsia, artificial neural networks might have potential for categorising those affected by either organic or functional dyspepsia, as well as for identifying all Helicobacter pylori infected dyspeptic patients who will benefit from eradication.

Adolescent↗

PubMed2001

Chromosome 6 abnormalities in ovarian surface epithelial tumors of borderline malignancy suggest a genetic continuum in the progression model of ovarian neoplasms.

PURPOSE: We used conventional cytogenetics, molecular cytogenetics, and molecular genetic analyses to study the pattern of allelic loss on chromosome 6q in a cohort of borderline epithelial ovarian tumors. EXPERIMENTAL DESIGN: Fifteen tumor samples were collected from patients undergoing surgery for ovarian tumors. The tumors of borderline malignancy, classified according to the standard criteria, included 4 mucinous and 11 serous tumors. Cytogenetic and molecular cytogenetic (with yeast artificial chromosome clones from 6q26-27) studies were performed on tumor areas contiguous to those used for histological examination ensuring the appropriate sampling. Moreover loss of heterozygosity analysis was performed using PCR amplification of eight microsatellite markers mapping on 6q27 (D6S193, D6S297), 6q26 (D6S305, D6S415, D6S441), 6q21 (D6S287), 6q16 (D6S311), and 6q14 (D6S300). RESULTS: Deletions of this chromosome arm, in particular of 6q24-27, were the most frequent lesions found in this set of tumors. In a tumor with a normal karyotype the only detectable alteration was a deletion of approximately 300 kb within the D6S149-D6S193 interval at band 6q27. This is, to date, the smallest deletion described for borderline tumors. CONCLUSION: Alterations in the above-mentioned interval are a common finding in advanced ovarian carcinomas but also in benign ovarian cysts, implying that some tumors of borderline malignancy may arise from benign tumors and that malignant ones may evolve from tumors of borderline malignancy. Genes located in 6q27 seem to be crucial for this mechanism of early events in ovarian tumorigenesis.

Adenocarcinoma, Mucinous↗

PubMed2000

Psychometric validation of two Italian quality of life questionnaires in menopausal women.

OBJECTIVE: To establish the psychometric properties of the Italian version of two quality of life (QOL) questionnaires in menopausal women: the psychological general well being index (PGWBI) and the women's health questionnaire (WHQ). METHOD: These questionnaires were translated into Italian and then self-administered to out-patient women a first time, 1 week later in stable women to assess reproducibility, and 3 months later to evaluate responsiveness over time. Baseline analyses included: factorial structure, multitrait analysis, internal consistency reliability, and clinical validity. RESULTS: Questionnaires were returned by 155 women (median age: 54 years, median duration of amenorrhoea: 56 months, median Kupperman index 26). Principal component analysis (PCA) of the PGWBI showed an important general factor and then, after rotation, three factors. The PCA of the WHQ showed ten factors. Only five reproduced the dimensions postulated à priori quite well. The item convergent validity was confirmed for all items of the major dimension of the two questionnaires, and the item divergent validity, although acceptable, was less satisfying for the PGWBI than the WHQ. The internal reliability was good (Cronbach's alpha > or = 0.70) for the PGWBI and for nine scales out of ten for the WHQ. The six dimensions of the PGWBI and most of the dimensions of the WHQ were significantly correlated to the Kupperman index, indicating the clinical validity of the instruments. The responsiveness to change in clinical status at 3 months was better in the PGWBI than in the WHQ with moderate effect size (around 0.5). CONCLUSION: The Italian versions of the PGWBI and the WHQ are reliable and useful for HRT clinical trials but the dimensional scores must be calculated bearing in mind the limitations in the structure. Other studies are needed to improve the factorial stability of certain WHQ dimensions. For the Italian version of the PGWBI, the validation process is to be completed by studies of mixed populations suffering from other types of disease.

Adult↗

PubMed2000

A large 6q deletion is a common cytogenetic alteration in fibroadenomas, pre-malignant lesions, and carcinomas of the breast.

To assess whether early breast lesions are the precursors of invasive carcinomas, three classes of breast lesions, namely benign tumors (including fibroadenomas), putative premalignant lesions (including cases of atypical hyperplasia), and invasive carcinomas, were compared at the cytogenetic and molecular cytogenetic levels. Genetic relatedness was clearly demonstrated by the sharing of several anomalies, among which 6q deletions outnumbered all of the other alterations detected. Indeed, deletions of the long arm of chromosome 6, most likely occurring in epithelial cells, were present in 83.9% of benign breast tumors, 64% of putative premalignant lesions, and 77.4% of analyzable carcinomas. Furthermore, the interval between 6q24 and qter appeared to be the common region of deletion in all three classes of breast lesions, whereas the minimal common region of deletion was 6q27-qter. Interestingly, the latter region was reported previously to be deleted in benign ovarian tumors and recently found to harbor a gene (SEN6) that is important for SV40-mediated immortalization of human cells.

Adolescent↗

PubMed2000

"From 0 to 18": what happens to the child and his headache?

Prospective and retrospective studies showed that headaches (migraine and tension-type) with childhood or adolescent onset have age-related characteristics and change over time, with high rate of type changing, remission or improvement. The reasons are unknown. On the other hand, several studies focused on factors that may be precursors of childhood headaches. All these factors may allow a developmental arc to be outlined, defining the natural history of headache from birth to adulthood. Familial (genetic?) influence, hyperreactivity, periodic syndromes and anxiety in childhood are factors that may predict headache onset, against the background of developmental modulation of pain. Biological and psychological factors are probably reciprocally involved, although the link is unclear. The identification of prognostic factors could allow a better framing of headaches and, from an integrated perspective, have important implications as regards clarifying the "nature" of headache.

Adolescent↗

PubMed1999

Bioequivalence of levothyroxine tablets administered to a target population in steady state.

Two parallel trials were carried out with levothyroxine sodium salt in 50 and 100 microg strengths, respectively, giving 100 microg day-1(50x2 microg day-1 or 100x1 microg day-1) in both trials in a repeated dose regimen. Twenty patients suffering from primary hypothyroidism under treatment with 100 microg day-1 of thyroxine sodium salt were enrolled in each trial. They were clinically and chemically euthyroid. Each trial lasted 114 days, with 57 days being devoted to the first treatment (test or reference) and 57 days to the other (reference or test), according to a two-period, two-sequence, two-formulation design in a steady state without wash-out. The test formulation was prepared with a technological improvement and is being produced to replace that at present on the market. Serum concentrations of free and total levothyroxine, and free and total levotriiodothyronine were assayed repeatedly during the treatment and in timed samples after the last dose of each formulation, using radioimmunoassays. Cmax and AUCss,tau were considered to be target parameters for bioequivalence which was assessed through 90% confidence intervals in the 0.80-1.25 range, as required by EU and US FDA operating guidelines. The results have shown that of these hormones, the free and total parent compound thyroxine is that which most clearly showed a peak after dosing, whereas its metabolite, free and total triiodothyronine, fluctuated around pre-dose concentrations. Bioequivalence was fully assessed with Cmax and AUCss,tau, with all four hormones tested and at both strengths administered. The two test formulations in 50 and 100 microg are thus bioequivalent with the two reference preparations. Tolerability was very good in all cases.

Adult↗

PubMed1999

Prevalence of subclinical hypothyroidism in a population living in the Milan metropolitan area.

Subclinical hypothyroidism is a condition characterized by increased levels of thyroid-stimulating hormone (TSH) associated with normal levels of free triiodothyronine (FT3) and free thyroxine (FT4). The exact prevalence of this condition in Italy is not known. The aim of this study was to assess the presence of subclinical hypothyroidism in 1001 subjects living in the Milan area (age 17-89) and apparently free from thyroid pathology. This sample which had applied to a large laboratory centre (Centro Diagnostico Italiano, Milano) for a routine check-up was seen from April to July 1996. A serum TSH assay was performed using a highly sensitive immunoenzymatic method, while an FT3 and FT4 assay was performed by means of a radioimmunologic method using commercial kits. The prevalence of subclinical hypothyroidism in the total population proved to be 4.7% (95% CI-Confidence Interval: 3.4-6.0). Sex stratification showed a prevalence of 6.1% in females and 3.4% in males. Prevalence in patients up to 65 was 4.2%. This value increased up to 8.0% in subjects over 65. By combining these variables, in females >65 prevalence increased to 11.3%. Overall, symptoms typical of overt hypothyroidism were found in 58.3% of patients suffering from subclinical hypothyroidism and in 39.9% of healthy subjects (p<0.02). The results of this study show that there is a significant presence (about 5%) of subclinical hypothyroidism in this population and that its frequency is more than doubled in women over 65. Early treatment might reduce the progression to overt hypothyroidism. The benefits of such a procedure were recently suggested by a decision making modelling approach applied to the Italian environment.

Adolescent↗

PubMed1999

Mesalamine in the treatment of mild to moderate active Crohn's ileitis: results of a randomized, multicenter trial.

BACKGROUND & AIMS: The efficacy of 5-aminosalicylic acid (mesalamine) in the treatment of flare-ups of Crohn's disease is controversial. In previous studies, different locations and pathological behavior of Crohn's disease could have obscured the efficacy of these drugs that deliver their substance in different intestinal sites. The present study tested two different mesalamine formulations with 6-methylprednisolone in mild to moderate active Crohn's ileitis. METHODS: Ninety-four patients with Crohn's ileitis (Crohn's Disease Activity Index [CDAI], 180-350) were randomly assigned to receive for 12 weeks mesalamine tablets, 4 g (35 patients); mesalamine microgranular preparation, 4 g (28 patients); and 6-methylprednisolone, 40 mg (31 patients). Mesalamine microgranular preparation was a gelatin capsule containing 400 mg of mesalamine microgranules coated with Eudragit S, which has been shown to deliver the drug in the terminal ileum. RESULTS: Patients taking mesalamine tablets experienced a decrease of CDAI median score value of 113.5 (95% confidence interval [CI], 33-149) compared with 123 (95% CI, 77-155) in the mesalamine microgranular group and 154 (95% CI, 99-197) in the 6-methylprednisolone group (P = 0.07 [NS]). Remission at the final visit occurred in 19 of 31 (61%) patients taking steroids compared with 21 of 35 (60%) patients taking mesalamine tablets and 22 of 28 (79%) patients taking microgranular mesalamine (NS). Five patients on steroids were withdrawn because of side effects, and a case of pancreatitis was related to microgranular mesalamine. CONCLUSIONS: Mesalamine in microgranular formulation seems to be equally as effective as a standard dosage of steroids in the treatment of the mild to moderate form of Crohn's ileitis.

Adult↗

PubMed1999

Microsatellite instability in gastric MALT lymphomas and other associated neoplasms.

BACKGROUND: Microsatellite instability (MSI), caused by a reduced efficacy of the DNA mismatch repair (MMR) machinery, represents a type of genomic instability frequently detected in HNPCC spectrum cancers and in a subset of sporadic carcinomas. The involvement of MSI in the pathogenesis of gastric lymphoma of mucosa-associated lymphoid tissue (MALT) has never been conclusively investigated. In this study, we tested the presence of MSI in tumor samples of patients harboring both MALT lymphomas and other types of malignancies. MATERIALS AND METHODS: We examined 10 microsatellite loci (D3S11, D3S1261, D3S1265, D6S262, D6S193, BAT-26, BAT-25, D17S250, APC, D2S123) out of a total of 34 primary tumors from 14 patients with MALT lymphomas and one or more additional neoplasms. The patients' MSI results were also tested for an association with a positive family history of cancer. RESULTS: MSI, defined by the presence of microsatellite alterations in more than 40% of the examined loci, was scored negative in all tumors studied, and pedigree analysis failed to identify any condition of familial cancer among the patients examined. CONCLUSIONS: The present study suggests that defects in DNA mismatch repair do not contribute significantly to the molecular pathogenesis of MALT lymphomas and associated neoplasms.

Colorectal Neoplasms, Hereditary Nonpolyposis↗

PubMed1999

Is maintenance therapy always necessary for patients with ulcerative colitis in remission?

BACKGROUND: The efficacy of sulphasalazine and mesalazine in preventing relapse in patients with ulcerative colitis is well known. It is less clear how long such maintenance should be continued, and if the duration of disease remission is a factor that affects the risk of recurrence. AIM: To determine whether the duration of disease remission affects the relapse rate, by comparing the efficacy of a delayed-release mesalazine (Asacol, Bracco S.p.A., Milan, Italy) against placebo in patients with ulcerative colitis with short- and long-duration of disease remission. METHODS: 112 patients (66 male, 46 female, mean age 35 years), with intermittent chronic ulcerative colitis in clinical, endoscopic and histological remission with sulphasalazine or mesalazine for at least 1 year, were included in the study. Assuming that a lower duration of remission might be associated with a higher relapse rate, the patients were stratified according to the length of their disease remission, prior to randomization into Group A (Asacol 26, placebo 35) in remission from 1 to 2 years, or Group B (Asacol 28, placebo 23) in remission for over 2 years, median 4 years. Patients were treated daily with oral Asacol 1.2 g vs. placebo, for a follow-up period of 1 year. RESULTS: We employed an intention-to-treat analysis. In Group A, whilst no difference was found between the two treatments after 6 months, mesalazine was significantly more effective than placebo in preventing relapse at 12 months [Asacol 6/26 (23%), placebo 17/35 (49%), P = 0.035, 95% Cl: 48-2.3%]. In contrast, in Group B no statistically significant difference was observed between the two treatments, either at 6 or 12 months [Asacol 5/28 (18%), placebo 6/23 (26%), P = 0.35, 95% Cl: 31-14%] of follow-up. Patients in group B were older, and had the disease and remission duration for longer, than those in Group A. CONCLUSIONS: Mesalazine prophylaxis is necessary for the prevention of relapse by patients with ulcerative colitis in remission for less than 2 years, but this study casts doubt over whether continuous maintenance treatment is necessary in patients with prolonged clinical, endoscopic and histological remission, who are at very low risk of relapse.

Adolescent↗

PubMed1998

Bioavailability, food effect and tolerability of S-naproxen betainate sodium salt monohydrate in steady state.

S-Naproxen betainate sodium salt monohydrate (naproxen-beta Na, CAS 104124-26-7, Aprenin) in 550 mg capsules (corresponding to 327 mg of naproxen) was administered to 24 healthy volunteers (12 males and 12 females) b.i.d. to steady state in order to check its bioavailability, food interaction and tolerability. Plasma concentrations of naproxen were measured by a well validated HPLC method with fluorimetric detection as a morning pre-dose on days 1 to 6 and in timed samples in three different situations, as follows: a) after the morning dose on day 7 in a fasting status, b) after the evening dose and dinner on day 7 and c) after the morning dose of day 8, taken after a high-fat content breakfast. Pharmacokinetic parameters were evaluated from plasma concentrations by non-compartmental analysis to describe the above three situations. The steady state was reached early, namely by the second day of treatment. The extent of absorption did not differ in the three situations tested, whereas the rate of absorption was fastest in fasting conditions, lowest with the evening dose and intermediate after the high-fat content breakfast. The slow absorption rate of the evening dose was attributed to a circadian rhythm and should allow therapeutically active levels early in the morning, when arthritis pain is particularly tedious. In the three situations explored Cmax, Cmin and AUC were associated with CV % values ranging from 11.7 to 17.2%, which are very low and rare in pharmacokinetic trials. This low variability should allow an accurate estimate of the therapeutic effect expected. Tolerability was checked by objective and subjective symptoms, including vital signs, blood/urine biochemical parameters and occult blood in stools, and proved to be very good. From the comparison of these data with those previously published by other authors who have administered 500 mg of naproxen b.i.d., pre-dose concentrations in a steady state proved to be similar, despite the different doses administered, whereas Cmax and AUC obtained in this study were marginally lower. The kind of food interaction was the same as previously described in literature with naproxen.

Adolescent↗

PubMed1997

Absorption and distribution of naproxen in rats orally treated with naproxen betainate sodium salt monohydrate. Comparison with naproxen.

The S-naproxen betainate sodium salt monohydrate (naproxen-betaNa, CAS 104124-26-7, Aprenin) was synthesized to improve bioavailability and tolerability of naproxen. 24 albino rats were treated with naproxen-betaNa (84 mg/kg) and 24 with S-naproxen (naproxen) (50 mg/kg) by the oral route, the doses being equimolar. The animals were sacrificed and naproxen was assayed in timed plasma samples drawn off over a 24-h period and in tissues excised 1 h after administration. Peak concentrations of naproxen proved to be higher with naproxen-betaNa than with naproxen as such. The area under the curve of naproxen concentrations observed with the two administrations overlapped as did concentrations of the drug in the lungs, myocardium and liver. Naproxen concentrations in the gastric wall after naproxen-betaNa proved to be lower than after administration of naproxen as such, which allowed the authors to assume that naproxen-betaNa has a better gastric tolerability.

Animals↗

PubMed1997

Comparative bioavailability study on naproxen betainate sodium salt monohydrate and naproxen sodium salt in healthy volunteers.

The S-naproxen betainate sodium salt monohydrate (naproxen-betaNa, CAS 104124-26-7, Aprenin, test drug), and the sodium salt of S-naproxen (reference), were administered to twelve healthy volunteers of both sexes according to a crossover design, in a single dose of one 575 mg capsule of test, containing 342 mg of S-naproxen and two 275 mg tablets of reference, containing 502 mg of S-naproxen. Blood samples were drawn off over a 24-h period before (time 0) and after administration at foreseen time intervals. Naproxen was measured in plasma by a validated HPLC assay with UV detection which was able to detect 1 microgram/ml and proved to be linear in the range 1-100 micrograms/ml. The non-compartmental pharmacokinetic parameters obtained were statistically processed according to the EU guidance note on bioavailability and bioequivalence Cmax, AUC0-24h and AUC0-infinity were normalized to the dose of 502 mg of naproxen and log-transformed before statistical analysis to assess bioequivalence. Dose-normalized values of plasma concentrations encountered with the two formulations proved to overlap, with the exception of the first sampling time which showed naproxen concentrations that were higher with test drug than with reference. The specific test for bioequivalence led to 90% confidence intervals within the 80-125% range with target pharmacokinetic parameters, whereas the time to peak (tmax) observed with the test and reference drugs did not differ to any statistically significant degree when analysed with Wilcoxon's non-parametric test. It is concluded that the test drug should be declared bioequivalent with the reference drug in terms of dose-normalized concentrations, despite the more rapid increase in plasma concentrations of naproxen observed at the first sampling time with test drug.

Adult↗

PubMed1993

Reduction in urinary prostaglandin excretion in the premenstrual syndrome.

The purpose of the present work was to study some factors involved in renal handling of salt and water in the premenstrual syndrome (PMS), in which salt and water retention is frequently observed. In 18 women with PMS and in 18 healthy women we studied the levels of cyclic adenosine monophosphate, aldosterone, prostaglandin E2, prostaglandin F2 alpha and kallikrein in urinary samples collected during the luteal phase. There was no difference between the two groups regarding sodium, aldosterone and kallikrein urinary excretion. In the PMS group there was a significant reduction in urinary excretion of cyclic adenosine monophosphate, prostaglandin E2 and prostaglandin F2 alpha with respect to the control group. At multivariate analysis sodium urinary excretion proved not to be the same as the model validated in healthy women. There may be different renal handling of water and electrolytes during the luteal phase of the menstrual cycle in women with PMS.

Adult↗

PubMed1990

Pharmacokinetics of iopamidol in adults with renal failure.

The pharmacokinetics of iopamidol 370 (Iopamiro), a non-ionic water soluble organic iodine compound, were studied in adults with different degrees of chronic renal failure and in healthy volunteers. After 50 ml were administered i.v., plasma and urine levels were determined. The main pharmacokinetic parameters were calculated on the basis of bi-compartimental open model. There were significant differences from healthy volunteers in t1/2 beta, which increased with the degree of renal failure as the clearance values decreased. t1/2 beta was equal to 1.67 h in healthy volunteers, 4.24 h in patients with mild renal failure and 10.03 h in patients with severe renal failure. The clearance decreased as follows: 0.11 (l/h kg) in healthy volunteers, 0.06 (l/h kg) in patients with mild renal failure and 0.02 (l/h kg) in patients with severe renal failure. No significant differences were found in distribution volume values nor in t1/2 alpha.

Adult↗

PubMed1989

Psychomotor dysfunctions in alcoholic and post-necrotic cirrhotic patients without overt encephalopathy.

Psychometric tests, visual reaction time tests and electroencephalograms were performed in 26 cirrhotic patients without overt portal-systemic encephalopathy and in 26 healthy individuals. Cirrhotics performed poorly, compared with controls, on intelligence, learning and memory, perceptual motor and spatial tests. Non-alcoholic scored lower than alcoholic cirrhotics compared with controls in most tests. Visual reaction time ability was lower in cirrhotics than controls, but the etiology of the cirrhosis did not influence the test results. EEG was normal in all subjects. We conclude that psychomotor tests are the most useful tool for the detection of latent encephalopathy and in the discrimination of different cirrhosis.

Adult↗

PubMed1989

Pharmacokinetics of iopamidol 370 in infants and children during ivp.

This research was aimed at evaluating the pharmacokinetic parameters of iopamidol 370 (a nonionic water organic iodine compound) during ivp in infants and children. All children examined in the study had symptomatic recurrent urinary tract infections; they were divided into three groups according to age (0-24 months; 25-72 months; 73-120 months). The contrast medium was injected in a dose of 1 ml/kg + 6 ml. Blood and urine samples were taken at regular time intervals over a 24-hour period in children, whereas in infants only blood samples were collected. Pharmacokinetic parameters were estimated using a bicompartmental open model, as follows: t1/2 alpha (h) = 0.33; t1/2 beta (h) = 1.92; Vc (l/kg) = 0.40; V beta (l/kg) = 0.20; Cl (l/kg) = 0.16. These values were not significantly different, as far as our patients were concerned, from those reported in literature for adults.

Aging↗