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Biomedical subjects

M R Cesarone

Publications and source records attributed to M R Cesarone.

At least 163 records · Page 9Linked to original sources

Treatment of long-distance intermittent claudication with pentoxifylline: a 12-month, randomized trial.

The efficacy, safety, and cost of pentoxifylline (PXF) in long-range (>400 m interval) intermittent claudication was studied comparing PXF and placebo in a 12-month study. A standardized treadmill test was performed at inclusion and at 6 and 12 months. A training plan based on walking was associated with the control of risk factor levels. Of the 194 included patients, 135 completed the study: 75 in the PXF group and 60 in the placebo group. There were 59 dropouts (due to low compliance). The authors observed a 148% increase in total walking distance (TWD) at 6 months with PXF (vs 110% with placebo; p<0.05); at 12 months, the increase was 170% with PXF (vs 131% with placebo; p<0.02). There was a 38% difference at 6 months and 39% at 12 months in favor of PXF. Treatment was well tolerated. In conclusion, PXF improved walking distance significantly better than placebo.

Aged↗

Treatment of vascular inner ear disease with pentoxifylline: a 4-week, controlled, randomized trial.

The efficacy of pentoxifylline (PXF) in vascular inner ear disease (VIED) was studied comparing PXF and placebo in a 4-week study; 60 patients with unilateral loss of hearing, vertigo, dizziness, tinnitus (analyzed with an analogue scale line), and cochlear flow reduction were included. The aim of the study was to study the effect of PXF (1800 mg/day) in VIED considering clinical outcome and cochlear flow. All patients completed the study. Improvement in cochlear flow (p<0.05) and a decrease in score in both groups were observed. The cochlear flow increase was 287.5% in the PXF group vs 168% in the placebo group (119.5% difference; p<0.02). There was a difference in score decrease (44.1% larger) in the PXF group (p<0.05). PXF was more effective considering flow and symptoms.

Cochlea↗

Treatment of vascular inner ear disease in vascular patients with pentoxifylline: a controlled, randomized trial.

The efficacy of Pentoxifylline in vascular inner ear disease (VIED) was studied comparing PXF and placebo in a 4-week study; 40 patients with vascular disease and monolateral loss of hearing, vertigo, dizziness, tinnitus (analyzed with an analogue scale line), and cochlear flow reduction were included. The aims of the study were to study the effects of PXF (1600 mg daily) in VIED considering clinical outcome and cochlear flow. Of the 20 included patients, 19 completed the study. One dropout in the placebo group was due to low compliance. Intention-to-treat analysis indicated an improvement in cochlear flow (p<0.05) and a decrease in score in both groups. The cochlear flow increase was 287.5% in the PXF group vs 168% in the placebo group (119.5% difference; p<0.02). There was a difference in score decrease (44.1% larger) in the PXF group (p<0.05).Between-group analysis favors PXF considering blood flow and symptoms. Results indicate good efficacy and tolerability of PXF in VIED.

Cochlea↗

Short-range intermittent claudication and rest pain: microcirculatory effects of pentoxifylline in a randomized, controlled trial.

The efficacy of pentoxifylline (PXF) in severe intermittent claudication was studied comparing PXF and placebo. Patients were randomized into two treatment plans: PXF (2400 mg, four 600-mg tablets daily) or equivalent placebo was administered for 10 days. The exercise protocol associated with treatment was conducted under supervision. Skin flux (RF) was measured at rest and after 1 minute of exercise (AEF = after exercise flux; 3 km/hr, 12% inclination) with laser Doppler. PO2 and PCO2 were measured at the dorsum of the foot. All 20 included patients completed the study. The two groups were comparable. In the PXF group there was a significant increase in RF, AEF, and in PO2 (p<0.05); PCO2 was decreased (p<0.05). There were also changes in the placebo group, significantly lower than those observed in the PXF group (p<0.05). In conclusion high-dose PXF treatments improved all microcirculatory parameters in subjects with short-range claudication even with a short period of treatment.

Aged↗

Treatment of vascular retinal disease with pentoxifylline: a controlled, randomized trial.

The aim of this study was to evaluate the effect of PXF (1800 mg daily) in patients with sudden loss of vision (SLV) in a 4-week trial, evaluating clinical outcome and retinal flow parameters. Inclusion criteria were SLV associated with thrombosis of the retinal artery; decrease in retinal blood flow (PSF: peak-systolic flow; EDF: end-diastolic flow velocity) and asymmetry between the two retinal arteries (>40%) documented by duplex scanning. All 10 included patients completed the study. The groups were comparable. No side effects were reported. A significant improvement in flow velocity (p<0.05) and a decrease in analogue score in both groups were observed. PSF increase was 550% in the PXF group vs 288% in the placebo group (262% difference). EDF increase was 400% in the PXF group vs 200% in the placebo group (200% difference). There was a significant difference in the analogue score decrease (33.3% difference larger in the PXF group; p<0.05). In conclusion, PXF treatment improved retinal flow after retinal artery occlusion better than placebo and should be considered as an important option in this condition.

Blood Flow Velocity↗

Treatment of retinal vein thrombosis with pentoxifylline: a controlled, randomized trial.

The aim of this study was to evaluate PXF (pentoxifylline; 1600 mg daily vs placebo) in patients with retinal vein thrombosis (RVT) in a 4-week trial, evaluating clinical outcome and retinal flow. Inclusion criteria were sudden loss of vision (SLV); retinal vein thrombosis (RVT); decrease in retinal vein flow; asymmetry between retinal veins (>40%) documented by duplex scanning (retinal vein thrombosis flow = RVTF). All 18 included patients completed the study. The groups were comparable. No side effect was observed. An improvement in arterial flow (p<0.05) and a decrease in analogue score (p<0.05) were observed in both groups (due to the spontaneous evolution with partial thrombus lysis in 4 weeks). The increase in arterial flow (PSF and EDF) were greater (p<0.05) in the PXF group. The RVFV increase was better in the PXF group (350% increase vs 200% increase in the placebo group; p<0.05). There was a significant difference in the analogue score decrease (4 vs 7) in the PXF group (p<0.05). In conclusion, PXF improved retinal flow after RVT better than placebo. It should be considered as an important treatment option.

Adult↗

Intermittent claudication in diabetics: treatment with exercise and pentoxifylline--a 6-month, controlled, randomized trial.

The aims of this study were to evaluate the effect of PXF (1600 mg daily) in diabetic patients with intermittent claudication. Of the 60 included patients, 53 completed the study (27 in the PXF group). There were seven dropouts. The groups were comparable for age, sex distribution, and total walking distance (TWD), and risk factors. There was an increase in TWD at 3 and 6 months in both groups (p<0.05) possibly due to exercise. However the increase (both absolute and percentage) in TWD was significantly larger in the PXF group. At 6 months, PXF produced a 292% increase in TWD (vs 180% produced by placebo) (p<0.02). The excess increase produced by PXF treatment was 112% at 6 months in comparison with placebo (p<0.02). Treatment was well tolerated. Between-group analysis favors PXF considering TWD, and results indicate good efficacy and tolerability.

Aged↗

Treatment of venous ulcers with pentoxifylline: a 6-month randomized, double-blind, placebo controlled trial.

The aim of this study was the evaluation of treatment with pentoxifylline in patients with venous ulcers in a 6-month, randomized, controlled trial. Treatment with placebo or pentoxifylline (PXF; 400 mg, 3 times daily) lasted 6 months and was associated to elastic bandaging. The endpoints were the number of limbs with complete healing and the variation in the area of ulceration. A group of 172 patients were included: 82 in the PXF group and 88 in the placebo group; 82 completed the study in the PXF group and 78 in the placebo group. Results. The two groups were comparable for age and sex distribution. The treatment was well tolerated. Complete healing was obtained in 67% of patients in the PXF group and 30.7% in the placebo group (p<0.02). The variations in the average area of ulceration were 86.7% (decrease) in the PXF group and 47% in the placebo group. The cost of treatment increased 21% with PXF but the cost due to non-healing of the ulcer was equivalent to a 44% increase (in comparison with the PXF group). In conclusion PXF is effective and cost-effective in improving ulcer healing in patients with chronic venous hypertension.

Aged↗

Treatment of venous ulcers with pentoxifylline: a 12-month, double-blind, placebo controlled trial. Microcirculation and healing.

The aim of this study was the evaluation of the treatment of venous ulcers with pentoxifylline (PXF) in 12 months. This double-blind, placebo-controlled trial was conducted in GCP. Patients were included after consent and randomized for PXF (400 mg three times daily) or placebo. The number of healed ulcers, the variation in the area of ulceration, and the variation in microcirculatory parameters (laser-Doppler flux and skin PO2) were considered as endpoints. Of the 85 patients included, 80 completed the study (41 in the PXF and 39 in the placebo group). The groups were comparable. Healing occurred in 88% of limbs in the PXF and in 44% in the placebo group (44% difference; p<0.02). The average area reduction was 93% in the PXF and 56% in the placebo group. Microcirculation was significantly improved in both groups at 12 months. The decrease in flux and the increase in PO2 were greater in the PXF group (p<0.05). Considering the proportion of healed ulcers a better outcome was observed with PXF (p<0.02; 12% of nonhealed ulcers in the PXF vs 56% in the placebo group). The ulcerated area decreased 93% in the PXF vs 56% in the placebo group (40% difference; p<0.02). Tolerability was comparable (6% in the PXF group and 5% in the placebo group complained for treatment). No important side effects were observed. In conclusion, treatment with PXF in venous ulcers improves healing and microcirculation and should be considered in slow-healing venous ulcers.

Aged↗

Treatment of intermittent claudication with pentoxifylline: a 12-month, randomized trial--walking distance and microcirculation.

The efficacy, safety and cost of pentoxifylline (PXF) in severe intermittent claudication was studied comparing PXF and placebo in a 12-month study. A treadmill test and microcirculatory evaluation with laser Doppler flowmetry were performed at inclusion and at the end of 6 and 12 months. A physical training plan (based on walking) and reduction in risk factor levels plan was used in both groups. Of the 120 included patients, 101 completed the study: 56 in the PXF group and 45 in the placebo group. There were 19 dropouts (due to low compliance). The two groups were comparable for age, sex distribution, walking distance, and the presence of risk factors and smoking. Intention-to-treat analysis indicated a 268% increase in walking distance in the PXF group (vs 198% in the placebo group; p<0.05) at 6 months and an increase of 404% (vs 280% in the placebo group; p<0.02) at 12 months. The absolute and percent increase in pain-free walking distance (PFWD) was greater in the PXF group (p<0.05). Treatment was well tolerated. No serious drug-related side effects were observed. Microcirculatory evaluation indicated an increase in flux (p < 0.05) in the PXF group (not significant in the placebo group); the after-exercise flux (AEF) was increased (p<0.05) in both groups at 6 months but the increase in AEF was greater in the PXF group at 12 month. In conclusion, between-group analysis favors PXF considering walking distance and microcirculatory parameters. Results indicate good efficacy and tolerability.

Aged↗

[The ultrasonographic assessment of carotid plaques in relation to cerebral events and damage over 3 years].

Three hundred carotid plaques (stenosis 45 to 65%) in 300 asymptomatic patients were included into a follow-up study considering three ultrasound types of plaques: type 1, non echogenic; type 2 intermediate, partially echogenic and type 3 highly echogenic. Types 1 and 2 had regular contour/surface while type 3 was irregular and in some patients associated with ultrasonographic signs of ulceration and intra-plaque haemorrhage. Patients were clinically evaluated for 3 years, randomly selected subgroups were studied with cerebral CT or magnetic resonance (MR) scanning to evaluate brain damage. There were no signs of cerebral damage in type 1 plaque patients. The incidence of signs and symptoms were higher in type 2 and 3 plaque patients. This was associated with an increased incidence of CT lesions and an even higher incidence of MR lesions in plaque type 3. In conclusion type 3 plaques are associated both with more clinical problems and evidence of CT/MR brain damage. Furthermore MR reveals more brain lesions than CT.

Aged↗

Non-invasive ultrasonic biopsy in the classification of early arterial lesions and in the evaluation of the rate of progression of arteriosclerosis.

The evaluation of early arterial lesions and the follow-up of the progression of arteriosclerotic wall changes is possible with high resolution ultrasound. While dynamic (duplex scanning) data are suitable for the follow-up of advanced stenosis and plaques, the morphological evaluation performed using the technique of non-invasive ultrasonic biopsy may be used to follow-up early lesions and their progression. The data obtained by ultrasonic biopsy are related to the incidence of occult coronary ischemia and to the occurrence of cardiovascular events in 4 years. The rate of progression (ROP) to the next, more advanced UB class can be also evaluated by ultrasonic biopsy. It has been shown that in diabetic and hyperlipidemic subjects the ROP is higher. Also in interventional studies using lipid lowering agents (with a four-year follow-up) a reduction in ROP in treated asymptomatic hyperlipidemic subjects in comparison with controls has been documented. The combination of dynamic data and morphological data gives us a complete evaluation of the vascular system both for the assessment of single individuals and for large population studies.

Adult↗

Skin blood flux and the venoarteriolar response in the perimalleolar area in patients with venous hypertension.

In patients with venous hypertension due to postphlebitic syndrome or varicose veins skin changes, liposclerosis and ulcerations are associated with increased skin blood flux at rest, a decreased venoarteriolar response and increased capillary filtration. Using laser-Doppler flowmetry we studied skin flux and the venoarteriolar response in the perimalleolar region in 100 normal limbs, 100 limb with varicose veins and 100 postphlebitic limbs with edema, skin changes and liposclerosis. The venoarteriolar response was studied with the leg on dependency, the foot being 50 cm below heart level. Flux at rest and on dependency were increased and the venoarteriolar response decreased in both groups of patients at a significantly greater extent in postphlebitic limbs. In conclusion laser-Doppler flowmetry measurements differentiate between normal limbs and those with venous hypertension and between postphlebitic limbs and limbs with venous hypertension due to varicose veins. The increase in skin flux and decrease in venoarteriolar response may be useful to define and quantify the degree of microangiopathy and the effects of treatments in venous hypertension.

Adult↗

Colour duplex scanning and phlebography in deep vein thrombosis.

Clinical evaluation of deep venous thrombosis is often unreliable. Recently it has been shown that deep venous thrombosis may be detected with colour duplex scanning which is safer than phlebography. However it is not clear how colour duplex correlates with phlebography. One hundred and twenty consecutive patients with suspected deep vein thrombosis were studied by colour duplex scanning and phlebography to compare the two methods. Both tests were positive in 102 limbs and negative in 16 limbs. In two cases of below-knee thrombosis colour duplex was negative while phlebography showed small localised thrombosis. The sensitivity of colour duplex was 98%, its specificity and positive predictive value 100% and its negative predictive value 88.8%. In conclusion colour duplex appears to be as effective as phlebography in detecting deep venous thrombosis above knee.

Adult↗

[Progression of lesions of the arterial wall evaluated by ultrasonic biopsy in asymptomatic subjects and in diabetic and hyperlipidemic patients treated with bezafibrate. A 4-year follow-up].

Non-invasive arterial ultrasonic biopsy (UB) has been used to evaluate and follow-up arterial wall changes in four years in asymptomatic subjects, hyperlipidemics and diabetics. Both groups of patients were randomised in a treatment group (bezafibrate 400 mg daily) and in a control group. The rate of progression (ROP) into the next higher UB class was recorded by UB scans repeated every six months. In diabetics and hyperlipidemics the rate of progression (ROP, namely the percent of patients progressing to the next class) was significantly higher than the ROP in the asymptomatic subjects. However in the bezafibrate group the ROP was significantly lower than that observed in the controls. As each UB class corresponds to different levels of risks of occult coronary ischemia and cardiovascular events in the following four years, the reduction of ROP with bezafibrate was an important and positive achievement.

Adult↗

[Vascular reactivity related to postural changes in diabetics].

Resting skin flow (RF) and the venoarteriolar response (VAR) were studied in 40 patients with diabetic microangiopathy and neuropathy, in 40 diabetes with microangiopathy and in 30 normal subjects using laser-Doppler flowmetry. In patients with microangiopathy and neuropathy RF was increased and the VAR was impaired to a greater extent than in patients without neuropathy. We evaluated the microangiopathy index (VAR/RF) that was lower in diabetics without neuropathy and even lower in those with neuropathy than in normals We also evaluated the VAR with different postural changes.

Adult↗

Laser-Doppler flowmetry in the assessment of "mild" Raynaud's phenomenon and its treatment.

Raynaud's phenomenon is characterised by a reduction in skin temperature and blood flow. Laser-Doppler Flowmetry (LDF) has been used to evaluate LDF recovery time after immersion of hands in water at 20 degrees C for 1 minute before and after treatment. After treatment for 4 weeks with nifedipine 10 mg b.i.d. the recovery time was again measured. The study showed that the treatment is useful for normalising the recovery times and reducing symptoms.

Adult↗

Evaluation of cerebral blood flow in premature newborns by duplex scanning using a high resolution probe.

The evaluation of cerebral blood flow in premature newborns offers interesting information about cerebral circulation and, physiological flow variations. Using a high resolution probe as the Access 10 of the ATL ultramark 4 duplex scanner it was possible to define flow in the anterior cerebral artery and in the middle cerebral artery in newborns without significant pathology. This study was performed in premature babies both to evaluate the best technical solution to study these small arteries and to define a standard of flow to be used in future evaluations. By the 10 MHz focus (on the variable focus probe 5-7.5 and 10 MHz) it was observed that a smaller variation of flow determinations is obtained by the 10 MHz focus (both for the middle and anterior cerebral arteries). In conclusion duplex scanning offers probably the best solution to evaluate cerebral blood flow in premature newborns both in qualitative and quantitative way.

Cerebral Arteries↗