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P Mondani

Publications and source records attributed to P Mondani.

10 recordsLinked to original sources
PubMed2002

[Treatment of severe intermittent claudication: ORACLE-PGE1 short term study. A randomised 40-week study. Evaluation of efficacy and costs].

BACKGROUND: The efficacy and cost of prostaglandin E1 (PGE1) in severe intermittent claudication was studied comparing a long-term protocol (LTP) with a short-term protocol (STP) in a randomised 40-week study. METHODS: Phase 1 was a 2-week run-in phase (no treatment) for both protocols. In LTP, phase 2 was the main treatment phase. Treatment was performed with 2-hour infusions (60 micro g PGE1, 5 days each week for 4 weeks. In phase 3 (4-week interval period), PGE1 was administered twice a week (same dosage). In phase 4 (40 weeks), no PGE1 were used. In STP, phase 2 treatment was performed in two days by a 2-hour infusion (60 micro g PGE1 twice a day in 2 days). The same cycle was repeated every 4 weeks. A treadmill test was performed at inclusion, at the beginning of each phase and at the end of weeks 12, 16, 20 32 and 40. A progressive training plan (walking) and reduction in risk factors plan was used in both groups. RESULTS: Out of the 1276 included patients 1165 completed the study (606 in LTP group; 559 in the STP). Drop-outs were 111. The two groups were comparable in distribution, risk factors and smoking. Intention-to-treat analysis indicated an increase in pain free walking distance (PFWD). The absolute and percent increase in pain-free walking distance (PFWD) was comparable in both LTP and STP groups with a significative increase in TWD at 4 weeks. At 20 and 40 weeks increase was up to 219% in the LTP and 460% in the STP group (p<0.02). Comparable results concerning PFWD were obtained in the two groups. Both treatments were well tolerated. No side effect was observed. Local effects were observed in 8.5% of the treated subjects in the LTP and 4% in the STP. The average cost of the LTP protocol was 8786 Euro. For STP the costs was 946 (10.8% of LTP). For both protocols the cost of the infusion was 24% of the total for the LTP and 35% in the STP. Therefore 75% of the cost is not drug-related. CONCLUSIONS: In conclusion between-group-analysis favours STP considering walking distance and costs. Results indicate good efficacy and tolerability of PGE1 treatment particularly STP.

Alprostadil↗
PubMed2000

PGE(1) treatment of severe intermittent claudication (short-term versus long-term, associated with exercise)--efficacy and costs in a 20-week, randomized trial.

The efficacy, safety, and cost of prostaglandin E1 (PGE1) in the treatment of severe intermittent claudication was studied comparing a long-term treatment protocol (LTP) with a short-term treatment protocol (STP) in a randomized 20-week study. The study included 980 patients (883 completed the study) with an average total walking distance of 85.5 +/-10 m (range 22-119). Phase 1 was a 2-week run-in phase (no treatment) for both protocols. In LTP, phase 2 was the main treatment phase. In the LTP, treatment was performed with 2-hour infusions (60 microg PGE1, 5 days each week for 4 weeks. In phase 3 (4-week interval period) PGE1 was administered twice a week (same dosage). In phase 4 (monitoring lasting 3 months, from week 9 to 20) no drugs were used. In STP phase 2 treatment was performed in 2 days by a 2-hour infusion (first day: morning 20 microg, afternoon 40 microg; second day morning and afternoon 60 microg). The reduced dosage was used only at the first cycle (week 0) to evaluate tolerability or side effects. Full dosage (60 microg bid) was used for all other cycles. The same cycle was repeated at the beginning of weeks 4, 8, and 12. The observation period was between weeks 12 and 20. A treadmill test was performed at inclusion, at the beginning of each phase, and at the end of 20th week. A similar progressive physical training plan (based on walking) and a reduction in risk factors levels plan was used in both groups. Intention-to-treat analysis indicated an increase in walking distance, which improved at 4 weeks and at 20 weeks in the STP more than in the LTP group. At 4 weeks the variation (increase) in pain-free walking (PFWD) was 167.8% (of the initial value) in the LTP group and 185% in the STP group (p<0.05). At 4 weeks the variation (increase) in total walking distance (TWD) was 227.6% of the initial value in the LTP group and 289% in the STP group (p<0.05). At 20 weeks the increase in PFWD was 496% of the initial value in the LTP group vs 643% in the STP group (147% difference; p<0.02). The increase in TWD was 368% in the LTP group and 529% in the STP group (161% difference; p<0.02). In both groups there was a significant increase in PFWD and TWD at 4 and 20 weeks, but results obtained with STP are better considering both walking distances. No serious drug-related side effects were observed. Local, mild adverse reactions were seen in 6.3% of the treated subjects in the LTP and 3% in the STP. Average cost of LTP was 6,664 Euro; for STP the average costs was approximately 1,820 E. The cost to achieve an improvement in walking distance of 1 m was 45.8 E with the LTP and 8.5 E with the STP (18% of the LTP cost; p<0.02). For an average 100% increase in walking distance the LTP cost was 1,989 E vs. 421 E with STP (p<0.02). Between-group analysis favors STP considering walking distance and costs. Results indicate good efficacy and tolerability of PGE, treatment. With STP less time is spent in infusion and more in the exercise program. STP reduces costs, speeds rehabilitation, and may be easily used in a larger number of nonspecialized units.

Aged↗
PubMed2000

Superficial vein valve repair with a new external valve support (EVS). The IMES (International Multicenter EVS Study).

The aim of this international multicenter trial was to evaluate the effects of a new surgical device (Gore External Valve Support-EVS) and technique for external valvuloplasty of the long saphenous vein (LSV). Patients with superficial venous disease and venous hypertension due to pure superficial venous incompetence were randomized into two treatment groups, the first treated with "conventional treatment" (ligation or stripping) and the second with external valvuloplasty with the EVS. Patients with uncomplicated varicose veins within the age range of 35-65 years were included. Incompetence with presence of functional cusps at the saphenofemoral junction (SFJ), with vein dilatation were the main inclusion criteria. The EVS comprised of a GORE-TEX patch material (including a nitinol frame) that is placed around the vein, producing a reduction in the caliber of the vein. Also the vein section becomes elliptical. These combined actions are aimed to reduce incompetence, allowing a better closure of the cusps. The EVS was placed at the SFJ after limited dissection of the vein and ligation of collaterals. The procedure was randomized as an alternative to simple ligation or stripping (according with the procedure commonly used in the center). The associated ligation of distal incompetent veins was allowed. The main outcome measures of the study were evaluated by color-duplex (morphologic findings and evaluation of reflux) and with ambulatory venous pressure (AVP) or air-plethysmography (APG). Main endpoints of the first year of the study and main subject of this report (mainly concerning safety within the first year of follow-up) were considered presence/absence of reflux; patency of the veins; mobility/function of vein cusps; occurrence of thrombosis; tolerability of the device; and increased complexity and operating time needed for the EVS. At 1 year 30 patients had been randomized (14 EVS implanted, 16 controls). Reflux was absent in all EVS patients, all treated veins were patent, and all cusps were mobile. No thrombosis had been observed and the tolerability of the device was very good. The increased complexity required by placing the EVS was limited (5-12 minutes more). In conclusion results of the first year show efficacy and tolerability of the EVS. In selected patients (superficial LSV incompetence, reflux-dilatation, functional SFJ cusps, incompetence mainly due to enlargement of the vein), the EVS could be an effective alternative to "destructive" ligation and/or stripping of the vein. Prolonged follow-up will indicate the clinical potentials of the EVS.

Adult↗
PubMed1995

Optimal site for proximal and distal anastomoses in AAAs repair.

The replacement of straight graft for vascular aortic reconstruction, in the elective treatment of aortic and aorto-iliac aneurysms, is advisable and requires only two anastomoses and a low surgical risk. In our report we have tried to identify the simplest vascular reconstruction for juxtarenal involvement (15% in our experience), reducing the surgical time and the operative (or postoperative) injuries. The decision to employ the tube or the bifurcated reconstruction depends on the surgeon's assessment of the degree of common iliac dilatation, the presence of an iliac aneurysm or the concomitance of occlusive disease of the iliac-femoral district. Some authors extend the bifurcated repair to prevent the possible future occlusive events or iliac dilatation. We have much information about the natural history of aortic aneurysms but we have also to define the indications for a valuable surgical reconstruction. We have considered a consecutive series of 20 patients who underwent elective aortic and aorto-iliac aneurysm repair in S. Rita private hospital; in 13 patients (65%) the aneurysms were treated with tube grafts, the other patients received bifurcate grafts: 3 (15%) aorto-bisiliac, 2 (10%) aorto-bifemoral and 2 (10%) right aorto-iliac and left aortofemoral bypass procedure. We employed Crawford's inclusion in the juxtarenal involvements, generally without the reimplantation of renal arteries, extending the tube repair in the aorto-iliac dilatation, obtaining a simplification of the surgical procedures. The use of straight graft allows a sensible decrease of surgical operating time, a reduction of hematic loss and a very low incidence of postoperative injuries; this solution became possible also in some selected forms of aneurysmatic involvement of renal arteries.(ABSTRACT TRUNCATED AT 250 WORDS)

Aged↗
PubMed1993

Double-blind comparison of nimesulide and diclofenac in the treatment of superficial thrombophlebitis with telethermographic assessment.

A total of 60 patients with acute varicophlebitis or acute superficial thrombophlebitis of the lower limbs were recruited to this randomised double-blind comparative study, which evaluated the efficacy and tolerability of oral nimesulide (100mg twice daily) with those of diclofenac (50 mg/kg twice daily) over a period of < or = 20 days (average duration 13.6 days for nimesulide and 12.6 days for diclofenac). The analgesic effect of both drugs was rapid. Spontaneous pain disappeared within 3 to 5 days of commencing therapy, and pain on palpation within 7 days. Reduced inflammation was observed after approximately 15 days, and total resolution of redness and swelling was observed by day 20. Telethermographic assessment showed a reduction in local temperature, either in absolute terms or in the extent of inflammation. Indeed, 93% of patients showed complete recovery while 7% of patients showed a partial reduction in hyperthermia. For these latter patients, medical treatment was extended, although the subjective symptoms of the disease were no longer present. The comparison between nimesulide and the reference drug, diclofenac sodium, showed no significant difference for any of the considered parameters. Both drugs were well tolerated and no patient reported an adverse event.

Adolescent↗
PubMed1986

Nesosteine: a new mucoregulatory agent.

A new, original molecule, nesosteine, modified both the rheology and the production of tracheobronchial mucus in rabbits. The drug highly significantly reduced the viscosity of tracheobronchial mucus in animals made bronchitic by H2SO4 aerosol and markedly increased mucoproduction in healthy animals. Nesosteine was more active than the best known mucolytic/mucoregulatory drugs, such as sobrerol, N-acetylcysteine, bromexine, ambroxol, S-carboxymethylcysteine and mercaptopropionylglycine. The fluidifying activity of the drug was also demonstrated in vitro (pig's gastric mucin), although this proved to be less marked than in vivo. Nesosteine reduced the amount of total proteins of the tracheobronchial mucus, acting on albumin, alpha 1, alpha 2, beta and gamma mucoproteins.

Acetylcysteine↗
PubMed1982

[Digital radiography].

The reliability of radiographical information may be improved by a) standardised radiography (exposure-development); b) transformation of the original image into a densitometric image and equalization with a reference wedge made of Ergal. The linear absorption coefficient of Ergal in terms of photon X energy is almost identical to the average coefficient of the bone mineral matrix; c) processing the densitometric image for additional information. An automatic image analyser controlled by a computer is used. The first osteological results showing the correspondence between the densitometric measurements provided by the analyser and the actual bone mineral content revealed by chemical analysis are presented.

Animals↗