PubMed Health⌕ Search

Biomedical subjects

M R Cesarone

Publications and source records attributed to M R Cesarone.

At least 73 records · Page 4Linked to original sources
PubMed1999

External femoral vein valvuloplasty with limited anterior plication (LAP): a 10-year randomized, follow-up study.

The aim of this study was to evaluate the effects after 10 years of external valvuloplasty of the femoral vein (limited anterior plication or LAP). After informed consent patients with venous hypertension due to deep and superficial venous incompetence were randomized into two treatment groups. Both groups were treated with superficial vein surgery (ligation and section of the major incompetent superficial veins). Group 2 was treated with the same procedure and with LAP. External valvuloplasty of the superficial femoral vein was performed with plication of the anterior vein wall after limited dissection of the vein. Results were evaluated with color-duplex scanning and ambulatory venous pressure (AVP) measurements. Endpoints were AVP, refilling time (RT), presence/absence of reflux at the superficial femoral vein, the variation in the diameter of the vein, and quality of life score (QLS). No complications were observed. All femoral veins treated with LAP were competent after 10 years. Significantly lower AVP and longer RT were observed in the LAP group. Also the average diameter of the vein was smaller in the LAP group. Moreover, QLS was significantly better in the LAP group after 10 years. In conclusion, in selected subjects, with moderate deep venous incompetence, functional cusps, or incompetence mainly due to relative enlargement of the femoral vein, LAP may be an effective alternative to external valvuloplasty.

Adult↗
PubMed1999

Shock waves (SW) noninvasive extracorporeal thrombolysis treatment (NISWT).

A group of 24 patients were considered for noninvasive shock waves thrombolysis (NISWT). Of these, 15 patients gave their informed consent. NISWT was attempted in eight patients (while seven patients were randomized for follow-up only). NISWT was possible in six of seven patients. In one patient randomized for NISWT, local inguinal scarring, due to previous surgery, made impossible the visualization of the femoral vein, and therefore focusing of shock waves (SWs). No side effects were reported in the days after SWs administration during the 4-month follow-up. In patients treated with NISWT it was possible to observe just after the SWs session the presence of echolucent "acoustic holes" and flow (by color and power Doppler) within the "holes." All "echolucent holes" produced at the first session were still present at 4 months, and color flow imaging also detected new flow channels in echogenic areas of thrombi previously not visible. In one patient thrombolysis was achieved after the first treatment, but at 3 and 4 months the thrombus was completely avascular. In conclusion, thrombolysis using SWs was obtained in selected cases and it was still persisting at 4 months in six of the seven treated patients. NISWT appears feasible and promising. These results should be confirmed by larger, prospective trials.

Adult↗
PubMed1999

Comparison of low-molecular-weight heparin, administered primarily at home, with unfractionated heparin, administered in hospital, and subcutaneous heparin, administered at home for deep-vein thrombosis.

In this study, 294 patients with acute proximal DVT (deep venous thrombosis) were randomly assigned to receive intravenous standard heparin in the hospital (98 patients) or low-molecular-weight heparin (LMWH) (nadroparin 0.1 mL [equivalent to 100 AXa IU] per kg of body weight subcutaneously twice daily) administered primarily at home (outpatients) or alternatively in hospital (97 patients) or subcutaneous calcium heparin (SCHep) (99 patients, 0.5 mL bid) administered directly at home. The study design allowed outpatients taking LMWH heparin to go home immediately and hospitalized patients taking LMWH to be discharged early. Patients treated with standard heparin or LMWH received the oral anticoagulant starting on the second day, and heparin was discontinued when the therapeutic range (INR 2-3) had been reached. Anticoagulant treatment was maintained for 3 months. Patients treated with SCHep were injected twice daily for 3 months without oral anticoagulants. Patients were evaluated for inclusion and follow-up with color duplex scanning. Venography was not used. In case of suspected pulmonary embolism (PE) a ventilatory-perfusional lung scan was performed. Endpoints of the study were recurrent or extension of DVT, bleeding, the number of days spent in hospital, and costs of treatments. Of the 325 patients included, 294 completed the study. Dropouts totaled 31 (10.5%); six of the 325 included patients (1.8%) died from the related, neoplastic illness. Recurrence or extension of DVT was observed in 6.1% of patients in the LMWH group, in 6.2% in the standard heparin group, and in 7.1% in the SCHep group. Most recurrences (11/17) were in the first month in all groups. Bleedings were all minor, mostly during hospital stay. Hospital stay in patients treated with LMWH was 1.2+/-1.4 days in comparison with 5.4+/-1.2 in those treated with standard heparin. There was no hospital stay in the SCHep group. Average treatment costs in 3 months in the standard heparin group (US $2,760) were considered to be 100%; in comparison costs in the LMWH group was 28% of the standard heparin and 8% in the SCHep group. This study indicated that LMWH and SCHep can be used safely and effectively to treat patients with proximal DVT at home at a lower cost.

Ambulatory Care↗
PubMed1999

The edema tester in the evaluation of swollen limbs in venous and lymphatic disease.

BACKGROUND: Edema is a common condition in most venous and lymphatic diseases. The ACI edema testers (ET) have been developed to objectively evaluate the presence of edema. Two types of testers have been developed. ET1 is a soft plastic plate (5 x 2 cm) characterised by two parallel protrusions while the ET2 is characterised by two lines of 7 holes. METHODS: The ETs are applied onto the internal perimalleolar region with the protrusions/holes in contact with the skin. A blood pressure cuff is applied over the area (pressure maintained at 50 mmHg for a period between 1-3 minutes). When the cuff is removed, with the ET1 skin marks are usually just visible in normal limbs (they disappear in a few minutes). We studied 22 normal limbs, 19 with varicose veins, 22 with chronic venous insufficiency, 5 with primary lymphedema and 8 with severe chronic lymphedema. RESULTS: In limbs with severe edema the whole length of the protrusions is visible; with moderate edema only a part of the protrusions is visible. With the ET2 skin marks are just visible in normal limbs (only the larger holes). Marks disappear in a few minutes in normal limbs while in limbs with edema the number of visible holes is increased (in severe edema all holes are visible). There were significant differences between normals and patients (considering skin mark length, number of visible holes and disappearance times). CONCLUSIONS: The two testers separated patients with different severity of edema due to chronic venous or lymphatic problems. In severe lymphatic problems all parameters were different (p < 0.02) from those observed in venous disease. A reproducibility study indicated that the ET tests have minimal variations in mark visibility or length or hole numbers (for the ET2).

Adult↗
PubMed1999

A simple test to monitor oxidative stress.

BACKGROUND: The role of oxygen free radicals is considered important in the development of cardiovascular disease. However, until recently determination of free radicals plasma levels and the effect of antioxidant therapy on these levels has been difficult. The aim of the study was to determine the oxidative stress and the effect of the antioxidant compound AR(D) Stenovit on this stress in normal subjects and patients with intermittent claudication after oral administration for one week. METHODS: A portable, free radicals (FRs) determination system (D-Roms test, Diacron, Grosseto, Italy) was used. This test is based on the ability of transition metals to catalyse in the presence of peroxides with formation of FRs which are trapped by an alchilamine. The alchilamine reacts forming a coloured radical detectable at 505 nm. The reagents utilised are the cromogen (R1, an alchilamine) and a pH 4.8 buffer (R2). Ten microl of hemolysis-free serum are to 1 ml of R2 and to 10 microl of R1. The sample is mixed, incubated (1 min; 37 degrees C) and read for optical density. After another minute, the sample is read again. The average delta A/min is multiplied by a K factor and calculated using serum with defined value. RESULTS: In normal subjects the mean (+/-SD) levels of free radicals were 312+/-49 U.CARR (Carratelli units) before treatment and 218+/-33 U.CARR after treatment (p<0.05). A decrease of at least 10% was detected in every subject. In patients with peripheral vascular disease the mean (+/-SD) levels of free radicals were 404+/-42 U.CARR before treatment and 278+/-33 U.CARR after treatment (p<0.02). A decrease of at least 15% was detected in every patient (medium value 31%). CONCLUSIONS: The D-Roms test provides a simple, inexpensive and practical method to identify subjects with a high level of oxidative stress and to demonstrate the effect of treatment. The compound AR(D) Stenovit is effective in reducing circulating free radicals. Its action on the progression of atherosclerotic disease should be assessed in future studies.

Adult↗
PubMed1998

Ocular and orbital blood flow in patients with essential hypertension treated with trandolapril.

PURPOSE: To study the effect of essential hypertension on flow velocity in the central retinal (CRA) and posterior ciliary arteries (PCA). Flow velocity was also evaluated in these arteries in patients with hypertension treated with trandolapril, an oral angiotensin-converting enzyme inhibitor. METHODS: Using the duplex scanner, flow velocity of the CRA and PCA was measured in 12 medication-free patients with hypertension and 10 normal controls. The hypertensive patients were then treated with oral trandolapril, 1 mg/day for 1 week. After 1 week of treatment, flow velocity was again measured in the arteries of the patients with hypertension. RESULTS: There was a significant reduction in systolic and diastolic flow velocity of the vessels tested in the medication-free hypertensive patients when compared with those in the normal controls. In controls, the CRA had a peak systolic flow velocity (PSFV) of 34 cm/sec and an end diastolic flow velocity (EDFV) of 14 cm/sec; the PCA had a PSFV of 38 cm/sec and an EDFV of 16 cm/sec. In the hypertensive patients off medication, the CRA had a PSFV of 16 cm/sec and an EDFV of 6 cm/sec; the PCA had a PSFV of 17 cm/sec and an EDFV of 5 cm/sec. The diastolic component also was significantly decreased in the patients with hypertension. Flow velocity significantly increased in the hypertensive patients treated with trandolapril for 1 week, but did not reach the level of flow measured in normal controls. CONCLUSION: The decreased flow velocity in hypertensive patients may result from a peripheral vasospasm in the vessels of the eye and orbit. This decreased flow velocity may be important in eyes that already have ocular disease. Improvement in flow velocity was noted with oral trandolapril but it did not reach the levels seen in normal controls.

Angiotensin-Converting Enzyme Inhibitors↗
PubMed1998

Shock waves in vascular diseases: an in-vitro study.

UNLABELLED: Three human aortic specimens were used for this in-vitro study on the effects of shock waves on the arterial wall. Specimen one was from a normal (for age) healthy aorta. The full abdominal length was used (including mesenteric and renal arteries and the aortoiliac bifurcation), divided into six pieces (3 cm). The pieces were placed and fixed into degassed water. Shock waves (SW) were focused onto the aortic wall by means of a B-mode ultrasound imager. An SW generator (Minilith SL1, Storz Medical AG, Kreuzlingen, Switzerland) was used for setting of energy flux density between 0.03 and 0.5 mJ/mm2. The six aortic pieces (excluding piece 1, placed in water and left untreated as control) were treated with SW at increasing energy levels. A second aortic specimen of a man with arteriosclerotic plaques was also used and the experiment repeated at energy levels 1, 5, and 8. Another specimen of normal thoracic aorta was exposed at energy levels 1 and 8 only. Energy levels delivered onto the aortic walls were selected from theoretically destructive levels to minimal levels known not to alter vascular tissues. High-resolution ultrasounds of the aortic segments were performed with a 10 MHz high-resolution, broad-band (ATL 3000, USA) probe in water before and after SW application to detect structural changes in the wall after SW. Histology was performed with a standard hematoxylin-eosin staining. RESULTS: The aortic pieces did not show macroscopic damages at visual examination, and at the ultrasound examination no visible changes were observed even at higher levels of SW energy. Also no effects were seen by histology. In conclusion, no damaging effects were observed, visually, by ultrasound, or by histology. At these energy levels SW appear to be safe and do not produce any damage to the aortic wall. Therefore, SW could be considered a safe, nondamaging procedure for potential treatment (ie, thrombolysis) in which vessel walls could be involved. Theoretically it is possible that functional changes could be observed in vivo including cell permeability modifications and other alterations (including changes in the potential of the cells in SW fields to modify themselves and to divide). At the energy levels described in this study SW could, theoretically be, safely used for vascular applications (ie, treating venous and arterial thrombi or in arterial plaques modification) without altering major, structural, arterial wall characteristics. Lesions or alterations that have a different density from the normal wall (thrombi or plaques) could be differently sensitive to the same dosage of SW. These differences in acoustic impedance characteristics could be used for potential treatments with SW without damaging the arterial wall.

Aorta↗
PubMed1998

Treatment of severe intermittent claudication with PGE1--a short-term vs a long-term infusion plan--a 20 week, European randomized trial--analysis of efficacy and costs.

The efficacy, safety, and cost of prostaglandin E1 (PGE1) in the treatment of severe intermittent claudication was studied by comparing a long-term treatment protocol (LTP) with a short-term treatment protocol (STP) in a randomized 20-week study. The study included 109 patients (96 completed the study) with an average total walking distance of 65.5 +/- 8 m (range 20-109). 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 (1st day: morning 20 microg, afternoon 40 microg; 2nd day morning and afternoon 60 microg). The reduced dosage was used only at the first cycle (week 0) to evaluate reduced tolerability or side effects. Full dosage (60 microg b.i.d.) 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 the 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 (101.5% in STP vs 78.3% in LTP), at 8 weeks (260.9% STP vs 107.3% LTP), and at 20 weeks (351% STP vs 242% LTP). Comparable increases in pain-free walking distance were observed in the two groups. No serious drug-related side effects were observed. Local, mild adverse reactions were seen in 7% of the treated subjects in the LTP and 5% in the STP. Average cost of LTP was approximately 6,588 ECU; for STP the average cost was approximately 1,881 ECU. The cost to achieve an improvement in walking distance of 1 m was 35.6 ECU with the LTP and 9.45 ECU with the STP (26% of the LTP cost; p<0.02). For an average 100% increase in walking distance the LTP cost was 1,937 ECU vs 550 ECU with STP (p<0.02). The cost of PGE1 (including infusion and operative costs) was 25% of the total cost for LTP (24.9% for STP). In summary, between-group-analysis favors STP, in terms of walking distance and costs. Results indicate good efficacy and tolerability of PGE1 treatment. With STP less time is spent in infusion and more can be spent in the exercise program. STP reduces costs, speeds up rehabilitation, and may be used in a larger number of nonspecialized units available to follow the protocol.

Alprostadil↗
PubMed1998

[Analysis of costs and results of prostaglandin (PGE1 alpha-cyclodestrin) therapy of peripheral arterial diseases].

BACKGROUND: In this study patients with peripheral vascular disease were treated with PGE1 alpha-ciclodestrina. In the intermittent claudication group (walking distance at inclusion between 200-600 m) we included 55 patients treated with PGE1 alpha-ciclodestrina (15 diabetics) and 22 controls (not treated with PGE1 alpha-ciclodestrina). In the critical ischemia group 46 patients were treated and 47 patients followed up as controls (rest pain or necrotic lesions had been present for more than 2 weeks). METHODS: Patients with intermittent claudication were evaluated by a treadmill test (walking distance was the endpoint) and in those with critical ischemia the number of minor and major amputations in 12 months were considered as endpoints. A dose of PGE1 alpha-ciclodestrina (60-80 micrograms/day for 2 days) was repeated either every 6 or, in alternative, every 10 weeks. In the control group only antiplatelet agents, support treatment (control of risk factors) and exercise were used. RESULTS: All subgroups of patients treated with PGE1 alpha-ciclodestrina with intermittent claudication increased their walking distance (including the subgroup of diabetics). In critical ischemia there were no major amputations (only 2 minor amputations) in the PGE1 alpha-ciclodestrina group vs 10.6% (of major amputations) in the control group. Also an evaluation of laser Doppler flow, volume flow and transcutaneous PO2 indicated in subgroups of patients an improvement of microcirculation and limb perfusion with PGE1 alpha-ciclodestrina. CONCLUSIONS: The cost analysis and the quality of life evaluation indicated a benefit of preserving limbs from amputation.

Alprostadil↗
PubMed1998

[Intra-arterial infusion of PGE1 alpha cyclodextrin].

BACKGROUND: Intra-arterial infusion of PGE1 alpha-ciclodestrina was achieved by intrafemoral catheter in critical limb ischemia. METHODS: The acute infusion of 10 micrograms in 20 minutes, in 50 ml of saline was followed by chronic infusion 20 micrograms/die of PGE1 alpha-ciclodestrina for 5 days. Three male patients (age 65 +/- 12) with severe critical ischemia and rest pain with initial, localised (> 0.5 cm in diameter) necrosis were treated. There was no possibility of revascularisation in these patient. RESULTS: No side effects due to the intra-arterial infusion were observed. After the acute infusion skin flux (measured with laser Doppler at the dorsum of the foot) was increased on average 15.2 times (P < 0.01). The increase in flux was still present 10 days after the initial intra-arterial infusion. Pain was greatly decreased or disappeared in the three following 3 weeks. CONCLUSION: In conclusion, even on the basis of limited clinical data, intra-arterial infusion acutely improves skin perfusion in critical limb ischemia. It could be considered a fast acting treatment in critical ischemia and also a rapid method to evaluate the possibility of improving distal perfusion with PGE1 alpha-ciclodestrina (i.e. patients not responding to intra-arterial infusion could be considered for amputation).

Aged↗
PubMed1998

[European trial of PGE1 alpha cyclodextrin. Short-term vs. long-term therapy in intermittent claudication].

BACKGROUND: The efficacy, safety and cost of prostaglandin E1 (PGE1 alpha-ciclodestrina) 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 randomised, 20-week study. METHODS: The study has selected 120 patients (109 were included and 99 completed the study). The average total walking distance at inclusion was 65.5 +/- 8 m (range 20-109). Phase 1 was a 2-week run-in phase (no treatment) for both protocols. In LTP phase 2 was the main treatment phase. The treatment was performed with 2-hour infusions (60 micrograms PGE1 alpha-ciclodestrina, 5 days each week for 4 weeks. In phase 3 (4-week interval period) PGE1 alpha-ciclodestrina 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 two days with a 2-hour infusion (1st day: morning 20 micrograms, afternoon 40 micrograms; 2nd day 60 micrograms, morning and afternoon). The reduced dosage was used only at the first cycle to evaluate reduced tolerability or side effects. Full dosage (60 micrograms b.i.d.) was used for all other cycles. The same cycle was repeated at the beginning of weeks 4, 8, 12 (phase 3). The observation period was between weeks 12 and 20 (phase 4). For both protocols 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 plan was used in both groups. RESULTS: Intention-to-treat analysis indicated an increase in walking distance which improved at 4 weeks (101.5% in STP vs 78.3% in LTP), at 8 weeks (260.9% in STP vs 107.3% in LTP) and at 20 weeks (351% in STP vs 242% in LTP). Comparable increases in pain-free walking distance were observed in the two groups. No serious drug-related side effects were observed. Local, mild, adverse reactions were seen in 7% of the treated subjects in the LTP and 5% in the STP. The average cost of LTP was approximately 6.588 ECU; for STP the average costs was approximately 1881 ECU. The cost to achieve an improvement in walking distance of 1 m was 35.6 ECU with the LTP and 9.45 ECU with the STP (26% of the LTP cost; P < 0.02). For an average 100% increase in walking distance LTP cost was 1937 ECU vs 550 ECU with STP (P < 0.02). The cost of PGE1 alpha-ciclodestrina (including infusion and operative costs) was 25% of the total cost for LTP (24.9% for STP). CONCLUSION: In summary between-group-analysis favours STP considering walking distance and costs. Results indicate good efficacy and tolerability of PGE1 alpha-ciclodestrina treatment. With STP less time is spent in infusion and more can be spent in the exercise program. STP reduces costs, speeds up rehabilitation and may be used in a larger number of non-specialised units available to follow the protocol.

Alprostadil↗
PubMed1998

[Increasing transcutaneous PO2 in arteriopathies during treatment with PGE1 alpha-cyclodextrin].

BACKGROUND: Transcutaneous PO2 values (at the dorsum of the foot) were evaluated in a group of 8 patients (mean age 66 +/- 11) with critical ischemia including 4 patients (mean age 65 +/- 10) with gangrene[. A group of 5 comparable normal controls was also studied. METHODS: Patients were treated with PGE1 alpha-ciclodestrina (60 mu/die, in two infusions lasting 3 hours; one in the morning and one in the afternoon) for 6 days. RESULTS: Results indicated a maximum increase in PO2 between the second and third day which remains higher than values observed before treatment up to 4 weeks. In another group of patients (6 claudicants with walking distance between 200 and 400 m, 4 with rest pain and 4 with localised gangrene) PO2 foot/chest ratio was studied. The ratio was significantly increased after 6 days of PGE1 alpha-ciclodestrina treatment. The evaluation of PO2 with an exercise test on treadmill (including 6 claudicants, 4 patients with rest pain and 5 normal controls) indicated a large decrease in PO2 with exercise in limbs with critical ischemia; the PO2 decrease on effort was less visible in claudicants. Recovery time to pre-exercise values was also very long in subjects with critical ischemia. The exercise test may be useful to monitor the efficacy of PGE1 alpha-ciclodestrina treatment. However the test is not standardised and commonly used. CONCLUSIONS: In conclusion this study indicated that PO2 increases after PGE1 alpha-ciclodestrina treatment may last for at least 4 weeks and also that transcutaneous PO2 could be an effective method to follow up changes in perfusion. However tests based on PO2 measurements should be standardised to constitute a common evaluation method.

Aged↗
PubMed1998

[Reduction of cardiovascular morbidity/mortality in arteriopathies treated ith PGE1 alpha-cyclodextrin].

BACKGROUND: Cardiovascular morbidity and mortality were evaluated in two groups of vascular patients (one treated with PGE1 alpha-ciclodestrina according to the short term protocol and one reference group) with a follow up of at least 24 month. METHODS: The former group included patients who had been treated with at least four PGE1 alpha-ciclodestrina, short-term treatment cycles per year while the latter was a historical reference group managed without prostaglandins. The two groups were comparable for sex and age distribution. RESULTS: In the PGE1 alpha-ciclodestrina group 142 patients (mean age 64 +/- 17; M:F = 84:58) had been treated (47 for intermittent claudication and 95 for critical ischemia: 43 for rest pain, and 52 for localised gangrene). The historical reference group included 157 patients (mean age 65 +/- 18: M:F = 91:66); 53 with intermittent claudication and 104 with critical ischemia (49 rest pain, 55 gangrene). In claudicants yearly cardiovascular morbidity was reduced from the 15% observed in the reference group to 10% in patients treated with PGE1 alpha-ciclodestrina. Yearly mortality decreased from 11% in the reference group to 6% in the treated group. In rest pain patients morbidity decreased from 24% in the reference group to 19% in the treated group. Mortality also decreased (from 16% to 11%). In patients with gangrene the difference in morbidity between the reference group (35%) and the PGE1 alpha-ciclodestrina group (27%) was even more evident (P < 0.025). In this group the mortality per year was reduced from 26% in the reference group to 17% in the PGE1 alpha-ciclodestrina treated group. CONCLUSION: It appears that cyclic treatment with PGE1 alpha-ciclodestrina produces not only an improvement in signs and symptoms related to vascular disease but also an important decrease in cardiovascular morbidity and mortality which has not been previously reported.

Age Distribution↗
PubMed1998

[Cardiovascular morbidity/mortality modified by the use of FGE1 alpha-cyclodextran and calcium heparin in patients with severe vascular diseases].

BACKGROUND: Morbidity and mortality were evaluated in three groups of vascular patients: one group was treated with PGE1 alpha-ciclodestrina according to the short term protocol; the second group was treated with PGE1 alpha-ciclodestrina and subcutaneous calcium heparin (SCH; 0.5 ml once daily, in the evening) while a third group was a historical reference group. METHODS: All included patients had a follow up of at least 12 months. The historical reference group had been managed without PGE1 alpha-ciclodestrina or SCH while in the two PGE1 alpha-ciclodestrina groups included patients who had been treated with at least four PGE1 alpha-ciclodestrina short-term treatment cycles per year. The 3 groups were comparable for sex and age distribution. In the PGE1 alpha-ciclodestrina group 142 patients (64 +/- 17; M:F = 84:58) had been treated (47 for intermittent claudication and 95 for critical ischemia). The historical reference group included 157 patients (65 +/- 18: M:F = 91:66); 53 with intermittent claudication and 104 with critical ischemia). The group treated with PGE1 alpha-ciclodestrina and SCH included 74 patients (27 with claudication and 47 with critical ischemia). RESULTS: In claudicants yearly cardiovascular morbidity was reduced from 15.5% in the reference group to 10.2% in patients treated with PGE1 alpha-ciclodestrina and to 7.9% in those treated with PGE1 alpha-ciclodestrina and SCH. Mortality decreased from 11.3% in the reference group to 6% in the PGE1 alpha-ciclodestrina group and to 5.1% in the PGE1 alpha-ciclodestrina + SCH group. In patients with critical limb ischemia morbidity decreased from 28.6% in the reference group to 23.2% in PGE1 alpha-ciclodestrina-group and to 19.4% in the PGE1 alpha-ciclodestrina + SCH group. Mortality also decreased from 16% (reference group) to 13% in the PGE1 alpha-ciclodestrinagroup, to 10.3% in the PGE1 alpha-ciclodestrina + SCH group. CONCLUSION: Cyclic treatment with PGE1 alpha-ciclodestrina produces an important decrease in cardiovascular morbidity and mortality which could be further reduced by the chronic use of subcutaneous calcium heparin.

Aged↗
PubMed1998

[Intramuscular injections of PGE1 in patients with severe claudication].

BACKGROUND: In this pilot study we selected 12 patients with short range claudication and treated, after informed consent, 6 patients (mean age 63 +/- 5; range 55-65) with severe claudication (walking distance < 100 m). Selection criteria were patent common and deep femoral artery, occluded superficial femoral artery with patent popliteal artery, with posterior tibial Doppler pressure > 50 mmHg and anterior tibial > 40 mmHg. METHODS: Patients were evaluated with a treadmill test performed to their walking limit. PGE1 was used by intramuscular injections (for a total of 80 micrograms, divided in 4 injections). The injections were about 2 cm deep in the posterior calf muscles. An exercise program was associated. Patients were required to walk 20 minutes just after the injections and to follow an exercise program (walking slowly at least 30 minutes, 3 times daily, in the following 4 weeks). RESULTS: Both the PGE1 group and a comparable control group (12 patients mean age 62 +/- 4; range 56-65) were treated with ASA and pentoxyfillin (400 mg t.i.d.). In the PGE1 group the average total walking distance at inclusion was 25 +/- 16 (range 0-52); it increased to 113 +/- 55 (range 50-289) (after 1 week) and to 117 +/- 27 (range 30-1020) at 4 weeks. No important changes were observed in the control group (54 +/- 6 m at inclusion, 58 +/- 8 after one week and 63 +/- 7 after 4 weeks). There were no important side effects. One patient experienced important injection pain which disappeared in a few hours. No significant changes in tibial pressures were observed. CONCLUSIONS: Intramuscular injection of PGE1 may be an interesting treatment option in patients with severe intermittent claudication but these preliminary findings should be verified in larger randomised studies.

Alprostadil↗
PubMed1998

[Global analysis of data from studies with PDE1 alpha-cyslodextrin].

BACKGROUND: A group of patients with severe peripheral vascular disease has been treated with PGE1 alpha-ciclodestrina (as reported in the previous 9 articles) including 595 patients (mean age 64.52 +/- 12; 307 with intermittent claudication and 237 with critical limb ischemia, rest pain and gangrene). Also 51 diabetics were studied and treated (25% with claudication and the remaining group with critical ischemia and/or neuropathy). The mean dosage administered in most patients (83% were treated with the short-term protocol) had been 20 + 40 micrograms on the first day and 60 + 40 micrograms on the second day. METHODS: Subjects had been treated on average 2.6 times (cycles of short term treatment); 37% of patients had received at least 3 cycles of short term treatment. Clinically relevant side effects have been observed in 30 patients (5% of the 595 treated patients). Temporary suspension of treatment has reduced/abolished side effects in 18 out of 30 patients and only in 5 patients (0.8%) therapy had to be suspended. Clinical improvement was evaluated according to subjective improvement, objective improvement (as defined by the treating physician/surgeon) and one or more physiological parameters (flux, flow, treadmill test). Among patients with intermittent claudication (only considered endpoint was walking distance) 78% was significantly improved. In patients with critical ischemia (endpoints were pain control, decrease of ischemic areas and perfusion improvement, objectively measured) 66% of patients improved. In diabetics (including both claudicants and subjects with critical ischemia) 58% improved. CONCLUSIONS: Global analysis of the previous 9 studies indicates that PGE1 alpha-ciclodestrina treatment is effective, there are few and controllable (in most patients) side effects and the treatment (particularly the short term protocol) is very cost effective.

Alprostadil↗
PubMed1998

[Control of the progress of arteriosclerosis in high risk subjects treated with mesoglycan. Measuring the intima media].

BACKGROUND: Noninvasive ultrasonic biopsy (UB) can be used to classify arteriosclerotic lesions and their progression in the carotid and femoral bifurcation. Also the evaluation of intima-media thickness (IMT) is useful to quantify the progression of early arteriosclerosis. METHODS: Two randomly selected groups of asymptomatic subjects were included in a 18 month, open study. One group was treated with oral mesoglycan (200 mg/day) and one group was followed-up as control. The two groups were comparable for age and sex distribution. RESULTS: The average UB score was 14.4 +/- 5 in the treatment group and 14.3 +/- 8 in the control group. After 18 months the UB score was 15.7 +/- 4 in the treatment and 16.2 +/- 6 in the control group. The average increase in IMT in 18 months in the treatment group was 0.016 mm equivalent to 0.0106 mm per year. In the control group the average increase was 0.119 equivalent to 0.0793 per year. Therefore the increase in IMT was 7.48 times greater in the control group. These differences were significant (p < 0.05). Two drop-outs were recorded in the treatment group and 1 in the control group. CONCLUSIONS: In conclusion IMT measurements showed a decreased level of IMT progression in subjects under mesoglycan treatment. These results need to be confirmed by a larger randomised study.

Arteriosclerosis↗