Search PubMed⌕ Search

Biomedical subjects

F Scaglione

Publications and source records attributed to F Scaglione.

At least 37 records · Page 2Linked to original sources
PubMed1997

Pharmacokinetic study of cefodizime and ceftriaxone in sera and bones of patients undergoing hip arthroplasty.

The study was carried out to determine the concentrations of cefodizime (single 2-g intravenous [i.v.] dose) and ceftriaxone (single 2-g i.v. dose) in the sera and bones of 42 patients (18 women and 24 men) undergoing hip arthroplasty. The concentrations of cefodizime and ceftriaxone in cancellous and cortical bone appear to be related to the free levels in serum but not to the total levels in serum, so the concentrations of cephalosporins in bone must be compared with the free concentrations in serum. Both drugs diffuse well into bone, with concentrations exceeding the MIC at which 90% of the major pathogenic infecting organisms are inhibited.

Aged↗
PubMed1997

Double-blind, multicenter, randomized trial to compare the effect of two doses of adrenocorticotropic hormone versus placebo in controlling delayed emesis after high-dose cisplatin in adult patients with cancer.

PURPOSE: To compare, in a double-blind, placebo-controlled, randomized trial, the efficacy of two different doses of the depot formulation of adrenocorticotropic hormone (ACTH) in controlling delayed emesis after cisplatin. PATIENTS AND METHODS: One hundred fifty-two patients were enrolled onto the study. On day 1, all patients received cisplatin (60 to 120 mg/m2) and a combination of dexamethasone 20 mg plus ondansetron or metoclopramide to prevent acute emesis. On day 2 (24 hours after cisplatin administration), patients were randomized to receive placebo, or ACTH 1 mg intramuscularly (I.M.), or ACTH 2 mg I.M. plus one additional dose of 1 mg on day 4. Details of vomiting, nausea, and adverse effects were recorded daily for every 24-hour period from day 2 to day 6. In a subset of patients, serum cortisol levels were measured between 20 and 72 hours after cisplatin administration. RESULTS: One hundred fifty patients were assessable. Over the 5 days of the study, delayed vomiting occurred less frequently in the patients treated with ACTH 2 mg plus 1 mg than in those treated with ACTH 1 mg or placebo (28%, 38%, and 65%, respectively; P = .001). The greatest observed differences were seen on days 2 (24 to 48 hours; P = .01) and 3 (48 to 72 hours; P = .01). On days 4, 5, and 6 (96 to 144 hours), no significant differences were observed among the three arms. The severity of delayed emesis expressed as the mean number of emetic episodes per day was 0.48, 0.70, and 0.80, respectively (P = .002). Patients treated with the higher dose of ACTH had the least nausea on day 3 (P = .02) and day 4 (P = .03). Adrenal cortisol secretion rapidly increased after ACTH injection, but was suppressed for approximately 44 hours in the placebo group. Toxicity was mild and transient in all groups. CONCLUSION: ACTH reduces the incidence and severity of delayed vomiting and nausea after cisplatin. A dose of 2 mg 24 hours after cisplatin is better than one of 1 mg. Whether the activity of ACTH is mediated only by adrenal corticosteroids needs to be verified.

Adrenocorticotropic Hormone↗
PubMed1997

Optimum treatment of streptococcal pharyngitis.

Streptococcal pharyngitis is a common infection in children and adolescents. The great majority of these infections are caused by group A beta-haemolytic streptococci. Although the use of penicillins for group A beta-haemolytic streptococcal pharyngitis has reduced the incidence of rheumatic fever, in the past decade several studies of pharyngitis treatment have reported penicillin failure. It has also been suggested that in comparison with the penicillins the cephalosporins are associated with a lower rate of clinical failure. Cephalosporins have drawbacks in cost, administration frequency or adverse effect profile. Moreover, there is the theoretical risk of cross-antigenicity to cephalosporins in penicillin-allergic patients. Erythromycin is a traditional alternative to penicillins, especially in penicillin-allergic patients, for the treatment of tonsillopharyngitis. However, increased resistance as well as failure rates as high as 24.7% have been reported for erythromycin in the treatment of pharyngitis. Therefore oral penicillins, and alternatively oral cephalosporins, should be considered first-line agents for the treatment of culture-confirmed group A beta-haemolytic streptococcal tonsillopharyngitis. Cephalosporins are useful especially for the treatment of recurrent streptococcal tonsillopharyngitis.

Cephalosporins↗
PubMed1996

Ceftibuten concentrations in human tonsillar tissue.

In a study designed to determine ceftibuten concentrations in tonsillar tissue, subjects scheduled to undergo tonsillectomy were administered 400 mg of ceftibuten in a single oral dose. Between 2 and 24 h after the dose was given, tonsillar tissue samples were taken during surgery and assayed for ceftibuten. Mean concentrations in tonsillar tissue 4.4 h and 24.6 h after the 400 mg dose were 5.3 +/- 2.7 and 0.3 +/- mg/g, respectively. Concurrent mean serum concentrations were 7.42 +/- 1.66 and 0.15 +/- 0.13 mg/ml, respectively. The apparent half-life of drug in the tissue was 5.3 h. The presence of high ceftibuten concentrations in tonsillar tissue suggests that a once-daily regimen may be effective in treating tonsillitis and pharyngitis.

Adolescent↗
PubMed1996

Letrozole, a new oral non-steroidal aromastase inhibitor in treating postmenopausal patients with advanced breast cancer. A pilot study.

PURPOSE: To evaluate the endocrine effects as well as the pharmacokinetic parameters, efficacy and safety of letrozole, a new fourth-generation non-steroidal aromatase inhibitor. PATIENTS AND METHODS: Fourteen postmenopausal women with progressive metastatic breast cancer, previously treated with endocrine therapy and/or chemotherapy for advanced disease, were treated with 0.5 mg daily doses of letrozole, orally. Endocrine and pharmacokinetic measurements were made before treatment and on days 14, 28, 56, and 84 of therapy. RESULTS: Letrozole induced a >86% decrease in plasma estrone and a approximately 67% reduction in circulating estradiol from day 14 on. There was a statistically significant decrease in plasma cortisol, which appeared clinically irrelevant since all values remained within the normal range. No significant changes in aldosterone concentration were noted. One patient achieved a complete response (CR) and 4 patients a partial response (PR), with an objective response rate of 36% (95% CI 13% to 65%). Median duration of response was 24 months, ranging from 4 to 44 months. No toxic effects attributable to letrozole were noted in any patient. CONCLUSION: Letrozole appears to be a very promising new antiaromatase drug. The characteristics of the patients more likely to respond, taking into account prior systemic treatment, should be defined by future studies. Further phase II and phase III studies comparing letrozole to other available second or even first-line endocrine-therapy agents, are warranted.

Adult↗
PubMed1996

Efficacy and safety of the standardised Ginseng extract G115 for potentiating vaccination against the influenza syndrome and protection against the common cold [corrected].

The aim of the study was to determine the properties of a standardized extract of ginseng root in inducing a higher immune response in vaccination against influenza. Attention was also paid to the common cold in this multicentre, two-arm, randomized, placebo-controlled, double-blind investigation. A total of 227 volunteers who visited 3 private practices in Milan received daily oral capsule doses of either placebo (113) or 100 mg of standardized ginseng extract Ginsana G 115 (114) for a period of 12 weeks within which they received an anti-influenza polyvalent vaccination at week 4. As a result, while the frequency of influenza or common cold between weeks 4 and 12 was 42 cases in the placebo group, it was only 15 cases in the G115 group, the difference being statistically highly significant (p < 0.001). Whereas antibody titres by week 8 rose to an average of 171 units in the placebo group, they rose to an average of 272 units in the G115 group (p < 0.0001). Natural killer (NK) activity levels at weeks 8 and 12 were nearly twice as high in the G115 group as compared to the placebo group (p < 0.0001). In all the volunteers, laboratory values of 24 safety parameters showed no significant differences between the end and the beginning of the 12-week study in either of the groups. There were only 9 adverse events in the study, the principal one being insomnia.

Adult↗
PubMed1995

Comparative activities of pefloxacin and ciprofloxacin in the treatment of chronic respiratory tract infections.

To determine the efficacy in vivo of pefloxacin and ciprofloxacin in the treatment of acute infectious bronchopneumopathies, 90 patients, suffering from acute exacerbation of chronic bronchitis and with no known allergies to quinolones, were admitted to the study. Patients were randomly divided into three groups of 30; the first group was dosed with pefloxacin 800 mg i.v. every 24 hours; the second group with pefloxacin 800 mg per os every 24 hours and the third with 500 mg per os of ciprofloxacin every 12 hours. Blood and bronchial secretion samples were simultaneously collected 2, 4, 8, 12, 14 and 24 hours after the first daily dose of antibiotic. Serum and bronchial secretion concentrations of pefloxacin and ciprofloxacin were determined by using a microbiological agar disk diffusion assay, employing Escherichia coli Kp 712 as test organism. Eradication of responsible microorganisms (Staphylococcus aureus, Haemophilus influenzae, Moraxella catarrhalis) were achieved in 98% of patients around 72 hours post treatment. Generally, both antibiotics expressed similar bactericidal properties when orally administered, while intravenous administration of pefloxacin displays a more rapid antibacterial action in comparison with the oral administration schedules. Maximal concentrations of both drugs in bronchial secretion were recorded at the same time after treatment (4 hours), with concentrations of about 2.5 micrograms/ml. Pefloxacin, having a longer half-life, was found 24 hours post-treatment with plasma concentrations of 1.5 micrograms/ml following a single oral dose of 800 mg. Ciprofloxacin, having a shorter half-life, showed a peak of about 1 microgram/ml, 12 hours after administration (500 mg/12 hours/os).

Adult↗
PubMed1995

Once-a-day cephalosporins: reality or myth?

The factors that may influence the pharmacodynamics of antimicrobial agents against microorganisms at the site of infection must be considered before using once-daily antimicrobial chemotherapy in clinical practice. From a pharmacokinetic point of view, we can establish which antibiotic is suitable for once-daily therapy. For aminoglycosides and quinolones, where the bacterial killing is rapid and dose dependent, and there is a post-antibiotic effect (PAE), the pharmacodynamic objective is to maintain the tissue levels way above the minimum inhibitory concentration (MIC) for a short period. This can be achieved by giving single bolus doses at long time intervals. With beta-lactam antibiotics, however, which have a slow time-dependent antibacterial effect and do not display a PAE, the aim is to keep the antibiotic concentration above the MIC for the duration of therapy.

Cephalosporins↗
PubMed1995

Pharmacokinetics of isepamicin in paediatric patients.

The pharmacokinetics of isepamicin were evaluated in 50 paediatric patients ranging from newborn to 13 years old. Children with subdivided according to age: Group I (6-13 years); Group II (4 months to 6 years); Group III (16 days to 4 months); and Group IV (newborn to 16 days). All patients received isepamicin 7.5 mg/kg every 12 hours except those in Group IV who received 7.5 mg/kg once daily. Isepamicin was administered initially as an intravenous 30-minute infusion and then either intravenously or intramuscularly for between 4 and 12 days. Plasma samples were obtained after the first or second dose on day 1 at 0, 0.5, 1, 4, 6, 8 and 12 hours after the initiation of dosing and at 0.5 and 12 hours on other dosing days. Additional samples were collected in the Group IV patients at 18, 20 and 24 hours. Isepamicin showed a similar plasma concentration-time profile in Groups I, II and III (children from 16 days to 13 years), and in these groups the profile was generally similar to that observed in adults. Neonates up to the age of 16 days (Group IV) showed a distinctly different pharmacokinetic profile: a significantly larger AUC, longer half-life, lower Cmax and lower total body clearance. Isepamicin 7.5 mg/kg administered once daily to children less than 16 days old and twice daily to children aged 16 days to 13 years appears to be pharmacokinetically appropriate. The drug was very well tolerated by children of all age groups.

Adolescent↗
PubMed1995

Efficacy and tolerability of brodimoprim od versus norfloxacin bid in the treatment of bacterial urinary tract infections.

The efficacy and tolerability of brodimoprim OD versus norfloxacin BID were studied in patients affected by bacterial urinary tract infections. The study was performed in 203 patients divided into two parallel randomized groups orally given either brodimoprim 400 mg OD on the first day followed by 200 mg OD for 2 days, or norfloxacin 400 mg BID respectively. The efficacy of treatment was evaluated by the bacterial cultures, tolerability, analysis of signs and symptoms, a complete physical examination and from laboratory data. The results showed that brodimoprim and norfloxacin in the majority of patients resulted in a reduction of fever and symptoms caused by the infective process. Of the 103 patients enrolled in the brodimoprim OD group, 99 had a complete course of therapy with a positive outcome. There was only one case of failed treatment and 3 cases which could not be evaluated because of voluntary interruption of treatment. Of the 100 patients treated with norfloxacin BID, 94 completed therapy with a positive clinical outcome and there were 4 cases of treatment failure. Thus the efficacy of brodimoprim OD appears comparable to that of norfloxacin BID in the treatment of urinary tract infections.

Adult↗
PubMed1994

Fosfomycin distribution in the lower urinary tract after administration of fosfomycin trometamol salt.

Fosfomycin trometamol (FT) is a new fosfomycin salt with pharmacokinetic characteristics allowing hypothesis of its use in the single-dose therapy of lower urinary tract infections. In this study the diffusion of fosfomycin into bladder mucosa and urine after administration of a single oral dose of FT (3 g) was evaluated in patients affected by bladder or prostatic carcinoma having to undergo surgery. The administration of FT was scheduled in order to obtain blood, urine and tissue samples, to be collected during surgical operation at different times post administration. The peak concentrations in serum and bladder mucosa were detected within 3 h and 6 h respectively. Fosfomycin concentrations in bladder mucosa proved to be higher than the MICs of the most common urinary tract pathogens for at least 36 h. In urine, fosfomycin reached concentrations markedly higher than those found in serum and bladder mucosa, antibacterial levels lasting until the 48th hour post dosing. Fosfomycin trometamol, because of its pharmacokinetic and pharmacodynamic properties, appears to be suitable for single-dose therapy of uncomplicated UTIs.

Administration, Oral↗
PubMed1993

Primary pharmaco-toxicological evaluation of 2-iodomelatonin, a potent melatonin agonist.

Series of experiments aimed at a primary pharmaco-toxicological evaluation of 2-iodomelatonin, a high-affinity melatonin analogue, were performed. In the rat ovulation-inhibition model, 2-iodomelatonin was much more potent than either melatonin or 6-chloromelatonin. The acute toxicity was extremely low and close to, though slightly higher than that reported previously for melatonin. In the rat, 2-iodomelatonin was slowly metabolized in vivo; its apparent elimination half-life was about 60 minutes, much longer than that reported for melatonin. The in vitro mutagenesis tests demonstrated clearly that 2-iodomelatonin in concentrations, exceeding the dose range employed in the in vivo studies, was actually devoid of mutagenic effects. The obtained results suggest that 2-iodomelatonin deserves a detailed pharmaco-toxicological evaluation and could be eventually used in pharmacokinetic and pharmacodynamic studies in humans.

Animals↗