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Biomedical subjects

Marcello Marchetti

Publications and source records attributed to Marcello Marchetti.

3 recordsLinked to original sources

Craniotomy using image-guided oscillating saw: technical note.

OBJECTIVE: To describe a new craniotomic technique that eliminates burr holes and minimizes bone loss along the craniotomic line. PATIENTS AND METHODS: Fifty burr hole free craniotomies were performed in varied locations using an image-guided micro-oscillating saw. Care was taken to avoid cutting the inner cortical layer. Upon completing the micro-oscillating saw cut the inner table could then be gently fractured along the craniotomic line with a thin bladed osteotome. Simple silk sutures were used to resecure the bone flap. RESULTS: The craniotomic time required for this procedure ranged from 7 to 24 minutes (mean: 13 minutes). We observed no dural lacerations or signs of brain damage in any of these procedures. The use of image guidance allows a continuous measure of bone thickness along the craniotomic line. In all of the cases we report the cosmetic result was excellent. CONCLUSION: This alternative technique of craniotomy can be used in selected cases to achieve excellent cosmetic results which avoid the time and cost of complex reconstruction techniques.

Adolescent↗

Penetration of orally administered prulifloxacin into human lung tissue.

OBJECTIVE: To evaluate the distribution in lung tissue of ulifloxacin, the active metabolite of prulifloxacin, a new once-daily fluoroquinolone administered orally in a single 600mg dose. DESIGN: Open-label, randomised study. PATIENTS: Twenty-seven patients (25 males, 2 females; mean age 65.7 years [range 49-79 years]) with a lung neoplasm requiring lobectomy or pneumonectomy. METHODS: Patients were randomly assigned to five treatment groups and received a single oral dose of prulifloxacin 600mg at 2, 4, 6, 12 or 24 hours preoperatively. During surgery, blood and healthy lung (based on macroscopic appearance) samples were collected at the same time. Ulifloxacin concentrations in plasma and lung tissue were determined by a validated reversed-phase high-performance liquid chromatography assay. Lung tissue ulifloxacin concentrations were adjusted for blood contamination, by measuring haemoglobin in the supernatant of each tissue sample and applying a corrective equation. RESULTS: Ulifloxacin concentration in lung tissue exceeded plasma concentration at every timepoint. Following administration of prulifloxacin 600mg, the overall mean corrected lung/plasma ratio over the 24-hour period was 6.9 (range 1.2-14.1). When sampling intervals were assessed, the corrected lung/plasma ratios were 7.5 (2 hours after dosing), 6.3 (4 hours), 4.3 (6 hours), 7.0 (12 hours) and 9.2 (24 hours). The mean corrected lung/plasma area under the concentration-time curve ratio was 6.3, demonstrating the ability of the drug to penetrate lung tissue and confirming the high exposure of this target tissue to ulifloxacin. However, the limitation of the lung tissue sampling method and the high interpatient variability should be considered. Over the 24-hour period, the concentrations of ulifloxacin in lung tissue were higher than the minimum inhibitory concentration (MIC) values for pathogens frequently involved in community-acquired respiratory tract infections. CONCLUSION: Lung tissue penetration data may have a supportive value when considered jointly with MICs and efficacy results. The findings from this lung penetration study could explain the efficacy of once-daily prulifloxacin 600mg observed in clinical trials conducted in patients with exacerbation of chronic bronchitis.

Administration, Oral↗

Pharmacokinetics and tolerability of prulifloxacin after single oral administration.

The pharmacokinetic properties and tolerability of three different strengths of prulifloxacin (CAS 123447-62-1), a new antibacterial agent prodrug of AF3013 (CAS 112984-60-8), have been investigated in a randomized, cross-over study performed in 12 Caucasian male subjects (age range 19-34 years). Prulifloxacin was administered as a single oral dose at the dosages of 300, 450 and 600 mg. Plasma concentrations of the active metabolite AF3013 were determined in blood samples collected before the administration (pre-dose) and at 15, 30, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 h after dosing. Urine samples were also collected. Determination in biological samples was performed using validated and specific HPLC methods. The following parameters were calculated: Cmax, tmax, AUC0-t, AUC0--infinity, t1/2, V/F, Aeut, CLren and fe. The analysis of variance performed on dose-normalized data after logarithmic transformation evidenced no statistically significant differences between the three doses concerning Cmax and AUC. Friedman's test applied to tmax and t1/2 did not show any statistically significant difference between doses. A significant linear relationship between doses and AUC0-infinity was detected (p < 0.05). Very high urinary concentrations and the relatively long terminal half-life (10-12 h) suggest that a once-daily application would show adequate clinical efficacy, especially in urinary infections. The safety profile of the three doses was very good.

Adult↗