Biomedical subjects

M R Cesarone

Publications and source records attributed to M R Cesarone.

At least 37 records · Page 2Linked to original sources

PubMed2001

Essaven gel--review of experimental and clinical data.

Essaven gel (EG) has been developed for local treatment of venous and microcirculatory alterations (varicose veins, chronic venous insufficiency, associated signs and symptoms). Sport injuries (bruises, swelling secondary to sprains and contusions) respond favorably to EG, which is also indicated for varices in pregnancy. Active ingredients of EG are aescinate, sodium heparin, and essential phospholipids (EPL). The dose in 100 g of EG are: 1 g of aescinate, 10,000 IU of sodium heparin, and 1 g EPL. EG is applied several times daily in a thin film. Clinical reports on the activity of EG include several vascular applications in which the product is effective without contraindications or side effects. On the basis of this review, EG offers important therapeutic benefits to several types of patients and the product should be available for its usefulness and safety.

Drug Combinations↗

PubMed2001

Microcirculation after standardized application of Essaven gel on normal skin--a placebo-controlled, randomized study.

Essaven gel (EG) is a naturally derived compound indicated for the treatment of impaired venous circulation and, in microcirculatory disorders, hematomas, swelling, sprains, and all minor sport injuries. The aim of this randomized, placebo-controlled, double-blind study was to evaluate the standardized application of EG on normal skin and its effects on the microcirculation. Standardization of gel application (particularly EG) has been recently described (in healthy subjects and in clinical studies) in defined steps. The results of this study indicate that topical treatment with EG is effective in improving or positively altering the microcirculation in normal skin both at the deeper capillary levels (thermoregulatory, whole-thickness capillary bed [as shown by laser Doppler flowmetry] as well as at the nutritional capillary layer (as shown by PO2). The application of EG can be standardized to obtain consistent results with topical treatment.

Administration, Topical↗

PubMed2001

Microvascular changes in venous hypertension due to varicose veins after standardized application of Essaven gel--a placebo-controlled, randomized study.

The involvement of the microvascular structure in chronic venous insufficiency (CVI) causes venous hypertensive microangiopathy (VHM), which leads to venous ulceration. VHM is characterized by enlarged and ramified capillaries, increased flux and capillary permeability, edema, and altered function of microlymphatics. TcPO2 is decreased and CO2 increased. This perfusional paradox is caused by hyperperfusion in the deep skin layers with hypoperfusion of superficial nutritional capillaries. Exchanges in the capillary bed are altered. Nutritional skin alterations eventually lead to venous ulceration. Edema is the consequence of increased capillary pressure, reduced clearance, and by an increased exchange surface of capillaries. The aim of this randomized, placebo-controlled study was to evaluate the effect of local treatment with Essaven gel (EG) in 22 subjects with VHM due to severe varicose veins, treated with a single application. Measurements of flux, PO2 and PCO2 in standardized conditions of application indicated a significant decrease of the abnormally increased flux and CO2; PO2 increased in the treatment group. Essaven gel, in comparison with placebo and controls acutely improves the microcirculation in VHM even with a single application.

Administration, Topical↗

PubMed2001

Microangiopathy and venous ulceration: topical treatment with Essaven gel--a placebo-controlled, randomized study.

The involvement of the microcirculation in chronic venous insufficiency (CVI) due to venous hypertension causes venous hypertensive microangiopathy (VHM) and venous ulceration. VHM is characterized by the presence of enlarged convoluted capillaries; microvascular thrombosis with obliteration of some capillaries; increase in flux, permeability, and edema; and altered function of microlymphatics. PO2 is decreased and CO2 increased. Capillary exchanges are altered, and nutritional alterations eventually lead to venous ulcers. Edema is associated with increased capillary pressure, reduced clearance, and an increased exchange surface of capillaries, which become tortuous and glomerular-like. The aim of this randomized, placebo-controlled study was to evaluate the effect of local treatment with Essaven gel (EG) in 28 subjects with venous microangiopathy due to severe CVI and ulcers treated with a single acute application, Measurements of laser Doppler flux, PO2 and PCO2 in standardized conditions of application showed positive microcirculatory changes (significant decrease of the abnormally increased flux and CO2 while PO2 increased) in the EG treatment group. Changes in the placebo and control group were more limited (changes in the placebo group were mainly associated with skin manipulation when placebo-EG was applied). In conclusion, Essaven gel, in comparison with placebo, acutely improves the microcirculation in VHM even with a single application.

Administration, Topical↗

PubMed2001

Changes in microcirculation in venous ulcers with Essaven gel--a pilot, cross-over, placebo-controlled, randomized study.

Microcirculatory changes in chronic venous insufficiency (CVI) due to venous hypertension produce venous hypertensive microangiopathy (VHM) and lead to ulceration. VHM is characterized by enlarged, convoluted capillaries; increase in flux, permeability, and edema; and altered microlymphatics. PO2 is decreased and CO2 increased. Capillary exchanges are altered and nutritional alterations in association with microtrauma may cause venous ulcers. The aim of this pilot, cross-over, randomized, placebo-controlled study was to evaluate the effect of local treatment with Essaven gel (EG) (single acute application) in 10 subjects with VHM and venous ulcers. The study was structured over 3 days: day 1 was used for the control evaluation for all patients. One group was randomized for the sequence placebo (day 2) and EG the following day; the second group with the sequence EG (day 2) and placebo (day 3). Independently from the sequence, measurements of flux and PO2 in standard conditions showed positive changes (significant decrease of the abnormally increased flux, PO2 increase) in the EG treatment group. Changes in the placebo group were limited and associated with skin manipulation. In conclusion, EG acutely improves microcirculation in limbs with VHM and ulceration even with a single application.

Administration, Topical↗

PubMed2001

Topical treatment of venous microangiopathy in patients with venous ulceration with Essaven gel--a placebo-controlled, randomized study.

The involvement of the microcirculation in chronic venous insufficiency (CVI), due to venous hypertension, causes venous hypertensive microangiopathy (VHM) and ulceration. VHM is characterized by enlarged, convoluted capillaries; microvascular thrombosis; obliteration of some capillaries; increase in flux, permeability, and edema and altered microlymphatics. PO2 is decreased and CO2 increased. Capillary exchanges are altered and nutritional alterations eventually lead to venous ulcers. Edema is associated with increased capillary pressure, reduced clearance, and increased exchange surface of capillaries, which become tortuous and glomerular-like. The aim of this randomized, placebo-controlled study was to evaluate local treatment with Essaven gel (EG) in subjects with venous microangiopathy and ulcers. Measurements of laser Doppler flux, PO2, and PCO2 in standardized conditions showed positive changes (a significant decrease of the abnormally increased flux and CO2 while PO2 increased) in the EG treatment group. Changes in the placebo and control group were more limited (changes in the placebo group were mainly associated with skin manipulation when placebo-EG was applied). In conclusion, Essaven gel, in comparison with placebo, acutely improves the microcirculation in VHM even with a single acute application.

Administration, Topical↗

PubMed2001

Microvascular alterations in diabetic microangiopathy: topical treatment with Essaven gel--a placebo-controlled, randomized study.

The involvement of the microcirculation in diabetic microangiopathy (DM) may be cause of severe invalidity and ulceration. Diabetic microangiopathy (DM) is characterized by a diffuse increase in skin flux, reduction in venoarteriolar response, and increased capillary permeability resulting in edema; skin PO2 is decreased and CO2 increased. In this condition, capillary exchanges are altered and nutritional alterations eventually lead to skin lesions and ulcers. The aim of this randomized, placebo-controlled study was to evaluate the effect of local foot care and treatment with Essaven gel (EG) in 30 subjects with DM and neuropathy and localized, small (<0.5 cm in maximum diameter) ulcers treated with a single acute application of EG. Measurements of laser Doppler (LDF) flux, PO2 and PCO2 in standardized conditions showed positive microcirculatory changes (a significant decrease of the abnormally increased flux and CO2 while PO2 increased) in the active EG group lasting for at least 6 hours after application. Changes in the control group were not significant. In the placebo group variations were limited, mainly associated with skin manipulation and gel application. In conclusion, local treatment with one single standardized application of Essaven gel, in comparison with placebo, acutely improves the microcirculation in subjects with DM and small ulceration even with a single acute application. The microcirculatory changes are detectable even 10 hours after application.

Administration, Topical↗

PubMed2001

Two-week topical treatment with Essaven gel in patients with diabetic microangiopathy--a placebo-controlled, randomized study.

The involvement of the microcirculation in diabetic microangiopathy (DM) causes of severe incapacitation and ulceration. DM is characterized by a diffuse increase in flux, reduction in venoarteriolar response, associated with increased permeability resulting in edema and altered function of microlymphatics. In DM, skin PO2 is decreased and CO2 increased. In this condition capillary exchanges are altered and nutritional alterations eventually lead to skin lesions and ulcers. The aim of this randomized, placebo-controlled study was to evaluate the effect of local (foot) treatment with Essaven gel (EG) in 35 subjects with DM and neuropathy and localized, small (< 0.5 cm in maximum diameter) ulcers treated for 2 weeks. Measurements of laser Doppler (LDF) flux, PO2, and PCO2 in standardized conditions showed positive microcirculatory changes (a significant decrease of the abnormally increased flux and CO2 while PO2 increased) in the active EG group. Changes in the control group were not significant. In the placebo group variations were limited (mainly associated with skin manipulation and gel application). In conclusion, local treatment for 2 weeks with standardized application of EG acutely improves the microcirculation in subjects with DM and small ulceration.

Administration, Topical↗

PubMed2001

Four-week treatment with Essaven gel in diabetic microangiopathy--a placebo-controlled, randomized study.

The involvement of the microcirculation in diabetic microangiopathy (DM) may be the cause of severe incapacitation and ulceration. DM is characterized by a diffuse increase in skin flux, reduction in venoarteriolar response, and increased permeability, resulting in edema. In this condition capillary exchanges are altered and nutritional alterations eventually lead to skin lesions and ulcers. The aim of this randomized, placebo-controlled study was to evaluate the effect of local (foot) treatment with Essaven gel (EG) in 15 subjects with DM and neuropathy and treated with local application of EG for 4 weeks. Measurements of composite, average laser Doppler (LDF) flux (ten measurements points), in standardized conditions showed a significant decrease in flux in the EG group. The flux decrease was present even after 1 week after the suspension of treatment. Changes in the control group were not significant. In the placebo group, variations were limited (associated with skin manipulation and gel application). In conclusion local treatment for 4 weeks with standardized application of EG improves the microcirculation in subjects with DM. The changes are detectable even 1 week after the end of the treatment period.

Administration, Topical↗

PubMed2001

Treatment of superficial vein thrombosis with standardized application of Essaven gel--a placebo-controlled, randomized study.

The aim of this randomized, placebo-controlled study was to evaluate the effect of local treatment with Essaven gel (EG) in comparison with placebo in 30 patients with superficial vein thrombosis (SVT). The 4-week study evaluated the average skin temperature and an analogue symptomatic score. Below-knee SVT was associated with large varicose veins. In patients treated with active EG the decrease in score and in the average, composite skin temperature was significantly larger than in the placebo and control groups. No intolerance was observed. The decrease in score and temperature in the placebo group was mainly due to skin manipulation and massage. In conclusion, treatment with EG in SVT improves symptoms and decreases skin temperature faster. This study confirms earlier observations on the effective use of EG in SVT.

Administration, Topical↗

PubMed2001

Treatment of superficial vein thrombophlebitis of the arm with Essaven gel--a placebo-controlled, randomized study.

The aim of this randomized, placebo-controlled study was to evaluate the effect of local treatment with Essaven gel (EG), in comparison with placebo and with a group of controls in 23 patients with superficial vein thrombophlebitis (SVTPH) of the arms. SVTPH was consequent to infusional treatment with an intravenous catheter. The 4-week study evaluated the average skin temperature and an analogue symptomatic score. In patients treated with active EG, the decrease in score and in composite skin temperature was significantly larger than in the placebo and control groups. No intolerance was observed. The decrease in score and temperature in the placebo group was mainly due to skin manipulation and massage and to spontaneous resolution. In conclusion treatment with EG in arm SVTPH improves signs /symptoms and decreases skin temperature faster. This study confirms earlier observations on the effective, local use of EG in SVTPH.

Administration, Topical↗

PubMed2001

Treatment of superficial vein thrombosis: clinical evaluation of Essaven gel--a placebo-controlled, 8-week, randomized study.

The aim of this randomized, placebo-controlled study was to evaluate the effect of local treatment with Essaven gel (EG), in comparison with placebo in 30 patients with superficial vein thrombosis (SVT). The 8-week study evaluated SVT with an analogue clinical/symptomatic score. SVT was associated with varicose veins. In patients treated with active EG the decrease in score was significantly larger (p< 0.02) than in the placebo group. No intolerance was observed. The decrease in score in the placebo group was due to spontaneous resolution and to skin manipulation and massage. In conclusion local treatment with EG in SVT improves signs/symptoms much faster than placebo. This study confirms earlier observation on the effective, local use of EG in SVT.

Drug Combinations↗

PubMed2001

Oxygen-free radical decrease in hypertensive patients treated with lercanidipine.

BACKGROUND: The relationship between oxidative stress, lipoproteins, cardiovascular risk factors and vascular disease progression has recently attracted fresh attention due to the possibility of measuring free radicals (FRs). The aim of this study was to evaluate blood plasma variations in oxygen FRs in hypertensive patients treated with lercanidipine, a drug acting on blood pressure and microcirculation. METHODS: Twenty-two patients with moderate hypertension (M:F=12:10; age=52) and no vascular disease (evaluated by high-resolution ultrasound) were treated for 24 weeks with Lercanidipine (10 mg/day or 20 mg/day if BP values did not decrease at least 15 percent after four weeks of treatment). BP was measured at inclusion and after 4, 8, 12 and 24 weeks of treatment. FRs measurements (using the D-Roms test) were made at inclusion, at the 8th, 12th and 24th week. RESULTS: All patients completed the treatment which was well tolerated and without side effects. Systolic and diastolic BP decreased after 8, 12 (p<0.05) and 24 weeks (at 24 weeks systolic pressure was decreased by 21.1 percent, and diastolic by 11.1 percent; p<0.02). FRs levels progressively decreased from 541 Carr Units (SD 54) at inclusion to 411 (SD 56) at eight weeks (p<0.05), to 401 (SD 35) (p<0.05) at 12 weeks and finally to 398 (SD 33), (p<0.02) at 24 weeks of treatment (72.2 percent of the initial value). CONCLUSIONS: The possibility of measuring FRs in vivo with a simple, inexpensive test allows the identification of subjects with a high level of oxidative stress, and the monitoring of the effects of treatments. Lercanidipine, acting on blood pressure, on the microcirculation and decreasing oxidative stress and Frs plasma levels may effectively decrease the rate of progression of cardiovascular diseases offering the advantage of an increased level of protection in patients with high levels of oxidative stress.

Adult↗

PubMed2001

Effects of the total triterpenic fraction of Centella asiatica in venous hypertensive microangiopathy: a prospective, placebo-controlled, randomized trial.

The aim of this study was to demonstrate whether total triterpenic fraction of Centella asiatica (TTFCA), was effective in improving the microcirculation in venous hypertension and microangiopathy. Forty patients with severe venous hypertension, ankle swelling, lipodermatosclerosis were included. After informed consent, patients were randomized into a treatment and a placebo group: those in the treatment group received TTFCA (tablets, 60 mg, twice daily for 8 weeks). The two groups of subjects were comparable for age and sex distribution. The mean age was 48 years (SD 9; M:F= 11:11) in the treatment group (22 patients) and 47.6 (SD 7; M:F= 10:8) in the placebo group (18 patients). There were no differences between placebo and treatment group at inclusion; there was no change between inclusion and measurements at 8 weeks in the placebo group. A decrease (p < 0.05) in RF (flux at rest) and RAS (rate of ankle swelling) were observed in the treatment group. The decrease in capillary filtration was associated with improvement in signs and symptoms (p < 0.05). The difference in flux, signs and symptoms, and filtration was clinically important at 8 weeks. No side effects were observed. In conclusion venous microangiopathy was improved by TTFCA treatment.

Administration, Oral↗

PubMed2001

Increase in echogenicity of echolucent carotid plaques after treatment with total triterpenic fraction of Centella asiatica: a prospective, placebo-controlled, randomized trial.

The aim of this study was to evaluate whether total triterpenic fraction of Centella asiatica (TTFCA), was effective in modulating collagen production over 12 months, by producing an increase in echogenicity in echolucent carotid plaques. Part I was a pilot study aimed at evaluating the effects of TTFCA on different types of plaques. Part II was a prospective, randomized, placebo-controlled trial aimed at evaluating the effects of TTFCA on hypoechoic-echolucent plaques. The sonographic examination of carotid plaques was made with high-resolution ultrasound. Capturing, digital image processing, and normalization were standardized, interobserver, intrascanner, gain-level variability were standardized using as reference blood (black) for the most echolucent parts of the plaque and the adventitia (white) as the most echogenic part. Normalization of echo texture was obtained and plaque characterization differentiated echo-texture of plaque associated with events and those that did not cause embolization, thrombosis, or cardiovascular events. After identifying plaques at higher risk, patients were treated with TTFCA (oral tablets, 60 mg, thrice daily for 12 months) to evaluate whether this compound, by modulating collagen synthesis, could increase the echogenicity and therefore the stability of echolucent plaques. Part II was aimed at evaluating the effects of TTFCA on hypoechoic-echolucent plaques. Asymptomatic patients with echolucent plaques (GSM<18) were treated with TTFCA (60 mg, oral tablets three times daily for 12 months) or with comparable placebo after informed consent. All patients were also treated with antiplatelet agents. In part 1, at inclusion the GSC in the hypoechoic group was 15 (range, 12-18) while in the hyperechoic group it was 26 (range, 24-31); at 6 months it was increased in the hypoechoic group and at 12 months the increase was significant (19.5; p<0.05). There was a minor increase in GSM in the hyperechoic group (30; ns). In part II in the treatment group there was a significant difference in GSM (increase) at 12 months (p<0.05), improvement in texture (p<0.05) and a nonsignificant decrease in stenosis. No changes were observed in the placebo group. Events were observed in 6.5% of patients in the TTFCA group and in 11% in the control group (p<0.05). In conclusion these observations suggest a positive action of TTFCA on the stabilization of hypoechoic, low-density carotid plaques.

Administration, Oral↗

PubMed2001

Treatment of diabetic microangiopathy and edema with total triterpenic fraction of Centella asiatica: a prospective, placebo-controlled randomized study.

The aim of this study was to demonstrate in a prospective, placebo-controlled, randomized study, whether total triterpenic fraction of Centella asiatica (TTFCA) is effective in improving the microcirculation in diabetic microangiopathy and neuropathy, Patients with severe diabetic microangiopathy, neuropathy, and edema; patients with microangiopathy without neuropathy; and healthy subjects were included. Microangiopathy was defined by laser Doppler and capillary filtration (rate on ankle swelling). Inclusion criteria were increase in resting flux and rate of ankle swelling; decrease in venoarteriolar response (VAR) and alteration in flux increase with temperature. Patients were randomized: the treatment group received TTFCA (tablets, 60 mg twice daily for 12 months); those in the placebo group received similar tablets. Healthy controls were followed up as a reference. Groups were comparable; there were no dropouts. There were no differences in the treatment and placebo groups at inclusion. Treatment was well tolerated; no side effects were reported. No variations were observed in normals at 12 months. In the neuropathy A-group, decreases (p<0.05) in RF and RAS were observed in the two treatment groups. The decrease in RAS was associated with a decrease in edema (p<0.05) in both treatment groups. The differences in flux (38%) and in VAR (38%) were associated with a decrease (28%) in the rate of ankle swelling (p<0.05). In patients without neuropathy (B-group) the decrease in flux was 22%, the VAR increased 22.7%, and the RAS decreased 9.5% at 12 months. The variations in normals and the progressive deterioration observed in untreated patients in both groups indicates the difference between treatment and placebo. In conclusion, the decrease in capillary filtration and edema is associated with symptomatic improvement. The action on edema is beneficial for the evolution of neuropathy. The effects of TTFCA on flux, RAS, and edema are important in early stages of microangiopathy to avoid progression to clinical stages.

Administration, Oral↗

PubMed2001

Methods of evaluation and quantification of microangiopathy in high perfusion microangiopathy (chronic venous insufficiency and diabetic microangiopathy).

Noninvasive tests have been developed to provide qualitative and quantitative information that can offer answers to most questions posed in venous diseases. While duplex scanning is used to assess the macrocirculation, microcirculatory methods assess and quantify venous microangiopathy. Laser Doppler flowmetry is used to assess tissue viability and perfusion. Transcutaneous PO2 and PCO2 measurements are used to study venous hypertension, and strain-gauge plethysmography (SGP) is used to assess capillary filtration. In venous hypertension fluid filtration into the extracapillary compartment is increased. The increase in filtration is associated with a decreased venoarteriolar response. To quantify capillary filtration two methods have been developed: venous occlusion plethysmography and rate of ankle swelling. These methods quantify filtration into the extracapillary compartment and therefore are an indication of the formation of edema, which is the most frequent sign of venous hypertension. Other methods such as the vacuum suction chamber and the edema tester can be used to assess changes due to treatment in chronic venous hypertension. These methods have been used and validated in several experimental and clinical studies. The techniques described in this article were used in controlled environmental conditions. Results were consistent with clinical problems and data from previous studies from our group and from data from other investigators.

Blood Gas Monitoring, Transcutaneous↗

PubMed2001

Flight microangiopathy in medium- to long-distance flights: prevention of edema and microcirculation alterations with total triterpenic fraction of Centella asiatica.

The aim of this study was the evaluation of microcirculatory alterations associated with edema in passengers travelling for more than 3 hours and the study of the effects of TTFCA (total triterpenic fraction of Centella asiatica) on the development of microcirculation alterations and edema, in a prospective, randomized study. Laser Doppler flowmetry (LDF), transcutaneous PO2 and PCO2, rate of ankle swelling (RAS) were used. Subjects were randomized after informed consent into two groups: one control group (no drug or other treatment), and a treatment group (TTFCA 60 mg thrice daily for 2 days before the flight, the day of the flight, and for another day after the flight). Inclusion criteria were age range between 30 and 50, mild-moderate superficial venous disease with varicose veins. Subjects traveled in economy class. In controls there was a progressive increase in CO2, RAS, and edema score and a progressive decrease in flux (RF) and venoarteriolar response with flying time. The variations in all parameters were milder (p>0.05) in the TTFCA group. RAS and edema were significantly lower in the TTFCA-treated group (p<0.025). The progressive increase in RAS, PCO2, and the decrease in VAR and O2 were linearly associated with flight time (up to 10 hours). These results are very interesting and indicate an option for patients prone to edema and microcirculation disturbances during long flights.

Adult↗