Search

The aim of this registry was to evaluate the management of initial symptoms of benign prostatic hyperthrophy (BPH) in otherwise healthy subjects, using Prostaquil® (Alchem) in a 8-week registry. Prostaquil was used at the dosage of 200 mg/day. The product includes Pygeum extract (100 mg) and Saw palmetto oil (35 mg). The two resulting groups standard management and supplement) were comparable.No side effects or comparability problems were observed and compliance was optimal with more than 95% of the capsules correctly used. Empting, frequency, intermittency, urgency, weak flow, straining, nocturia were all significantly improved with Prostaquil (p0.05) and the improvement - globally and evaluating any single item - was significantly superior to the one observed in controls (p0.05). Quality of life with the supplement was also significantly better in comparison with controls (p0.05). The residual vescical volume was 94.7;5,8 ml in the supplement group at inclusion and decreased to 39.3;5 ml (p0.05) at 8 weeks. This decrease was equivalent to a reduction of 58.5%(vs a decrease of 27.9% in controls)(p0.05; ANOVA). In conclusion, the most common symptoms of BPH are controlled by Prostaquil a new standardized supplement including Pygeum.

The aim of this registry study was to evaluate the efficacy of Pycnogenol® (Horphag Research Ltd.), a standardized extract from the French maritime pine bark, to control signs/symptoms and prevent complications associated with hemorrhoids in the months after delivery in healthy women.Women with hemorrhoids after their second pregnancy were included within the third month after pregnancy. Pycnogenol dosage was 150 mg/day for 6 months. Symptoms for 4th and 3rd degree hemorrhoids were evaluated.The registry groups were comparable. For 4th degree hemorrhoids, main symptoms were reduced after 6 months in all patients, but the group using Pycnogenol in addition to standard best management showed more improvement. In patients with 3rd degree hemorrhoids, symptoms were reduced in both management groups at 6 months; with Pycnogenol the reduction in symptoms scores was significantly better. At 6 months 18/24 subjects (75%) in the Pycnogenol group were symptom-free in comparison with 14/25 (56%) in controls. In the 4th degree hemorrhoid group, 7/10 patients (70%) in the Pycnogenol group were symptom-free at 6 months in comparison with 4/11 subjects (36%) in the best management group. No significant side effects were observed.Pycnogenol appears to positively affect hemorrhoid signs and symptoms in the months after pregnancy.

Intermittent claudication (IC) in peripheral vascular disease is characterized by lower limb pain appearing on effort. Treatment with PGE1 has been successfully used to manage IC patients. This registry has evaluated safety and costs of PGE1 in the management of IC.In this study a long-term treatment protocol (LTP), a short-term protocol (STP) and an outpatient (OP), "on-demand" treatment have been compared. A treadmill effort test has been used to evaluate walking distance. The follow up for these three protocols was 40 weeks. PGE1 treatment was associated to a risk reduction plan and to an exercise program.The final analysis has included 252 LTP patients, 223 STP patients and 284 OP patients (total 659 valid cases). A group of 171 comparable patients not treated with PGE1 was used for a parallel comparison. Cardiovascular mortality and morbidity has been evaluated in 731 PGE1 patients completing 24 months of follow up. All protocols have been well tolerated. No side effects were observed. The lower cost has been observed for OP patients. In the long term, mortality and morbidity were lower in patients treated with PGE1 in comparison with patients not treated with PGE1.Considering costs and results (increase in walking distance) and improvement in Karnofsky scale the STP plan appears to be better than LTP for IC patients. The OP, "on-demand" treatment offers further improvements. This last treatment plan is simpler; the plan allows better timing for exercise. The treatment can be used even in non-specialized centers.

This registry evaluation was conducted in post-thrombotic syndrome (PTS) patients (with a minimum five-year follow up). The study evaluated: 1) variations in peripheral edema with an analogue scoring system; 2) ankle circumference at the PTS limb in comparison with the normal contralateral limb.The difference was expressed in percent increase in circumference measured at the PTS limb; 3) other end-points were observed in a five-year follow-up that created a specific PTS registry. Subjects could follow a management system including: 1) compression; 2) compression and Venoruton® (1 g/day); 3) compression and Venoruton® (2 g/day).The groups of patients with chronic venous insufficiency (CVI) resulted comparable. The occurrence of a new deep venous thrombosis (DVT) episode was considered a drop out. At five years there were four new DVTs (in 90 patients) in the compression group. There was one case (90 patients included) in the compression and HR (1 g) group and no DVT in group 3. The outcome in groups 2 and 3 was significantly better (0.05) than in group 1. The need for surgery or sclerotherapy (for larger varicose veins), the occurrence of lipodermatosclerosis and ulcerations were significantly lower in the HR groups with a better outcome in the higher dose group (P0.05). The number of ulcerations were also significantly reduced in the HR groups. The difference in ulcerations was significantly better in the higher dose group in comparison with the other groups (P0.05). The edema score was significantly reduced at five years in the HR groups (P0.05) in comparison with the compression group. The higher dose resulted more effective in controlling edema. Both edema score and ankle circumference at five years were significantly lower (P0.05) in the HR-treated groups with a significant decrease in edema score and ankle circumference in the higher dosage group.The study confirms the long-term efficacy of HR in PTS, CVI patients. Controlling signs/symptoms and edema in CVI with HR prevents the most severe complications of CVI including lipodermatosclerosis and venous ulcerations. An early therapeutic program including exercise, risk factor controls, compression an edema-controlling treatment with HR is effective in decreasing the classic complications of PTS syndrome. The important restrictions and difficulties to the use of elastic stockings (in regions with warmer climates) are not applicable to HR that is well tolerated and can be used all the time alone or in association with compression.

The simplification of the management of asthma in the different clinical phases of this common chronic inflammatory disorder is the main goal of therapy. Pycnogenol®, a standardized extract of French maritime pine bark, inhibits expression of 5-lipoxygenase and consequently decreases leukotriene levels in asthmatic patients. Pycnogenol® anti-inflammatory activities may be supportive when taken in addition to inhalation corticosteroid (ICS), putatively allowing for a reduction in dosage and frequency of ICS administration.This study evaluated the efficacy of Pycnogenol® during a period of six months for improving allergic (mite in house dust) asthma management in patients with stable, controlled conditions. Pycnogenol® was used at a daily dosage of 100 mg, distributed as 50 mg in the morning at 9 am and again in the evening at 9 pm). An individual patient's asthma condition was graded in five steps based on the daily dosage of inhaled fluticasone propionate with step 1 indicating 0 µg and step 5 the maximum dose of 500 µg ICS twice daily.A total 76 patients were enrolled for this study. The group taking Pycnogenol® in addition to ICS and the group taking only ICS were comparable for age, gender and clinical characteristics including FEV1. The analysis of therapeutic ranking steps showed that 55% of patients taking Pycnogenol® improved as judged by passing to a lower ICS dose step. In comparison, only 6% of patients depending exclusively on ICS progressed to a lower (ICS dose) therapeutic step. No deterioration (passage to a higher ICS therapeutic step) was observed in the Pycnogenol® group, whereas in 18.8% of patients depending exclusively on corticosteroids a deterioration requiring a higher dosage step was observed. The passage to different therapeutic steps was statistical significant between groups (P0.05). Drop-outs were associated entirely to irregularities in follow-up and not due to medical reasons. No serious adverse events were observed in both groups and tolerability of Pycnogenol® was very good. The levels of asthma control in the 6 interventional months as compared to the same period in the previous year were compared. In the Pycnogenol® group, night-awakenings were less frequent, the number of days with PEF80% were decreased, days with asthma score1 were lower, requirement for salbutamol and additional asthma medication less frequent, and consultation of general practitioner and specialist required less commonly. All these parameters were statistical significantly improved in Pycnogenol® + ICS group versus the ICS control group where no considerable changes were observed. Various common signs and symptoms were evaluated by visual analog scale, (dry) cough, severity of chest symptoms, wheezing, dyspnea and daytime symptoms. In the ICS-only group values did not improve while they did improve significantly in the ICS + Pycnogenol® group (P0.05 vs. ICS only group). A decrease by 15.2% of the specific IgE titer was found in the Pycnogenol® + ICS group, whereas the titer increased by 13.4% in the ICS-only group, while IgG1 and IgG4 remained unchanged in both groups.Pycnogenol® administration was effective for better control of signs and symptoms of allergic asthma and reduced the need for medication.

The aim of this study was to test mf Odondovis Calcium® as a food supplement in a 3-month product evaluation study measuring how the low jaw bone density, could be improved. The upper jaw density was tested with an ultrasound method, evaluating the grey scale median of the images (GSM).Seventy nine subjects were enrolled; 22 normal subjects (group A) and 57 with upper jaw osteoporosis (according to DEXA values). Patients were divided into 2 groups (group B and C, respectively 28 and 29 cases). These subjects were treated with what was considered the' best treatment' and in the group B only was added mf Odontovis Calcium®, consisting of calcium salts, Vitamin D and physiological modulators with antioxidant activity. This treatment continued for 3 months.The GSM of osteoporotic patients was significantly lower in comparison with GSM in normal subjects. No changes were observed (between the inclusion and 3 month values) in normal subjects and minimal, non-significant changes were observed in control osteoporosis patients. Before-after treatment values of GSM in treatment patients showed a significant increase (P0.022) at 3 months. The increase in GSM in these patients was significantly higher (P0.05) in comparison with control patient with osteoporosis. The Tolerability of the product was very good and the compliance corresponded to 98%.the jaw density in patients with osteoporosis is increased in only 3 months with supplementation with mf Odontovis Calcium®. Long-term clinical implications should be observed in more prolonged studies.

This long-term (10-year) study evaluated the safety and efficacy of expanded polytetrafluoroethylene (ePTFE) external valve support (EVS) implants used for external valvuloplasty in the treatment of incompetence of the proximal long saphenous veins.During a 10-year follow-up, patients with superficial venous disease and venous hypertension due to pure superficial vein incompetence underwent an external valvuloplasty using an EVS with a PTFE suture. Forty-nine patients were included in the EVS group and 47 in the control group. Patients with superficial venous disease and venous hypertension due to pure superficial venous incompetence were randomised into two treatment groups. The first group was treated with what was considered "conventional treatment" (ligation or stripping) and the second with external valvuloplasty with EVS. This report deals with controls treated with ligation as only 6 cases (not mentioned in this report) were treated with stripping. There were no significant differences in the two groups concerning age, sex, or type of venous insufficiency. The procedures focused on only one single limb per patient.46.9% of limbs treated with EVS developed varices in comparison with 73% in the control group. New surgical procedures (localized ligation) were needed in 32.6% of the EVS patients vs. 55.3% in controls. Sclerotherapy was used in 42% of the EVS patients vs. 72.34% in controls. At 10 years the SFJ was incompetent (reflux) in 2 EVS patients (4%); one after 5 years and one after 7 years. There was no incompetence at the level of the ligated junction in controls. There were 62 incompetent venous sites (1.26 per limb) in the EVS group vs. 96 new incompetent venous sites (2.04 per limb) in controls. In controls 10.63% of the limbs developed minor discolorations and signs due to mild CVI; none was observed in the EVS group. In all ESV implants there was full restoration of competence at 1 year.EVS implants used to correct superficial venous incompetence at 10 years were well tolerated and produced good results on incompetence and on the evolution of varicose veins.

Post-thrombotic syndrome is a common complication following deep vein thrombosis. The aim of this twelve month registry study was to compare the efficacy of compression stockings and per oral administration of Pycnogenol® standardized pine bark extract on the severity and incidence of post thrombotic syndrome signs and symptoms.One hundred fifty-six patients with a single, major episode of proximal deep vein thrombosis (DVT) were assigned to one of three groups receiving treatment with either compression stockings (group 1), Pycnogenol® (group 2) or the combination of both (group 3) over an investigational period of one year. The study evaluated treatment on edema using a scoring system, the ankle circumference, and the limb volume as ratio to the healthy contralateral limb.Two new incidents of DVT occurred in the group of 55 patients wearing compression stockings between the third and sixth months, whereas no DVT cases occurred in the two other groups which took Pycnogenol®. The edema symptom score was gradually decreased in all three groups during the one year treatment period. Pycnogenol® was significantly more effective from six months onwards than compression stockings for relieving edema symptoms (P0.05). Symptoms were more effectively reduced with the combination of Pycnogenol® and compression stockings than with the individual regimen alone (P0.05). Limb volume and ankle circumference were likewise more effectively reduced with Pycnogenol® plus stockings than with compression stockings alone after six months. Ambulatory venous pressure progressively decreased in all three groups after twelve months treatment as compared to baseline. Compression stockings and Pycnogenol® were of comparable efficacy, there were no significant differences of ambulatory venous pressure between groups following twelve months treatment. Laser Doppler flowmetry at the dorsum of feet showed improved micro-circulation which was further demonstrated by increased pO2 and decreased pCO2. Importantly, none of the patients developed ulcerations during the observational period.This study suggests that Pycnogenol® may have significant long-term protective efficacy for individuals following a thrombotic event. Moreover, Pycnogenol® appears to be at least as effective for post-thrombosis management as compression stockings, while the combination of both is superior. An important aspect is the patient compliance which was found to be much better in the Pycnogenol® group with two drop-outs due to non-medical reasons, whereas in the compression stockings group eighteen patients were lost to follow-up because wearing stockings at higher temperatures is bothersome.

The aim of the present study was to evaluate the improvement of diabetic microangiopathy in patients suffering from this condition since at least five years, and whose disease was managed without insulin.Curcumin, the orange pigment of turmeric, has recently received increasing attention because of its antioxidant properties, mediated by both direct oxygen radical quenching and by induction of anti-oxidant responses via Nrf2 activation. This aspect, combined with the beneficial effects on endothelial function and on tissue and plasma inflammatory status, makes curcumin potentially useful for the management of diabetic microangiopathy. To further evaluate this, Meriva, a lecithinized formulation of curcumin, was administered at the dosage of two tablets/day (1 g Meriva/day) to 25 diabetic patients for four weeks. A comparable group of subjects followed the best possible management for this type of patients.All subjects in the treatment and control group completed the follow-up period; there were no dropouts. In the treatment group, at four weeks, microcirculatory and clinical evaluations indicated a decrease in skin flux (P0.05) at the surface of the foot, a finding diagnostic of an improvement in microangiopathy, the flux being generally increased in patients affected by diabetic microangiopathy. Also, a significant decrease in the edema score (P0.05) and a corresponding improvement in the venoarteriolar response (P0.05) were observed. The PO2 increased at four weeks (P0.05), as expected from a better oxygen diffusion into the skin due to the decreased edema. These findings were present in all subjects using Meriva, while no clinical or microcirculatory effects were observed in the control group.Meriva was, in general, well tolerated, and these preliminary findings suggest the usefulness of this curcumin formulation for the management of diabetic microangiopathy, opening a window of opportunities to be evaluated in more prolonged and larger studies. The molecular mechanisms involved in the beneficial effects of curcumin on microcirculation and edema are also worth investigation.

In addition to contemporary compression therapy, one of the therapeutic approaches is the use of a topical wound care agent. The goal of this pilot registry study is to evaluate the efficacy and safety of a uniquely designed ointment containing multivalent silver oxide (Ag4O4) in the healing of difficult diabetic or venous ulcerations.Patients who had ulcers resulting from chronic venous insufficiency or diabetes participated in this open-label, randomized registry study. All patients were evaluated by measuring both the area of the ulceration and microcirculatory parameters. 148 patients were included in the study and categorized into two main groups: venous ulcers and diabetic ulcers. Each main group was then randomized into two sub-groups: topical treatment with silver oxide ointment and the control group (standard cleaning and compression management methods, without silver ointment). All patients were treated with accepted cleaning and compression management. RESULTS. In subjects with venous ulcers: After 4 weeks, the silver treatment was more effective than the control group treatment: Skin PO2 was increased 2.1 times more than the control group (17.4% to 8.2%) and skin flux (RF) was improved 1.6 times more than the control group (-38.7% to -24.2%). The total surface area of the ulcer was significantly reduced in the silver treatment group by 1.9 times the control group (-88.7% to -46.9%). In addition, in the silver treatment group we observed complete closure of the ulceration in 42% of subjects compared to 22% in the control group (P=0.05). In subjects with diabetic ulcers: after 4 weeks, the silver treatment was more effective than the control group treatment: Skin PO2 increased 2.6 times more than the control group (23.3% to 9.1%) and skin flux (RF) was significantly improved 4.3 times more than the control group(-26.7% to -6.2%). The total surface area of the ulcer was significantly reduced in the silver treatment group by 3.7 times the control group (-89.0% to -23.9%). In addition, in the silver treatment group we observed complete closure of the ulceration in 39% of subjects compared to 16% in the control group (P/=0.05).This pilot study provides observational data on the efficacy of local treatment of ulcers with a multivalent silver oxide containing ointment. The silver ointment improved microcirculation and the healing rate of all 78 patients that were treated with multivalent silver ointment and closed twice as many ulcers in 4 weeks compared to the control groups (40.7% silver treatment compared to 19.4% for the control). This study demonstrates the feasibility of this type of treatment and provides evidence of efficacy to plan larger randomized controlled studies. The large number of patients that were helped in this study demonstrates the efficacy of multivalent silver oxide topical ointment and its important role in ulcer therapy.

Vascular access for hemodialysis can be provided by a native arteriovenous fistula (AVF), a synthetic arteriovenous graft (AVG), or a central venous catheter. The mature, native fistula is considered the preferred type of vascular access. This study evaluates the results of a retrospective registry assessing topically applied heparin (added to antiplatelet therapy) efficacy in patients with newly created AVF.To the current "best treatment", a number of patients also added topical heparin spray, a formulation containing a high concentration of heparin sodium for topical administration. At present, the average followup time is 7.9 months (range 3-12).In all patients using topical heparin, AVF remained patent and suitable for dialysis at three months. One fistula occluded at six months, and one more become unsuitable for dialysis. In patients using only antiplatelets, three fistulas occluded at three months and another two at six months of follow-up. In all, after six months of follow-up, there were two patients using heparin for whom the dialysis access was not suitable for dialysis; in the group treated with antiplatelets only, the access could not be used any longer in six patients. Addition of heparin reduced the risk for patency loss by 16.7% at three months and by 22.2% at six months. The risk of reduced dialysis suitability of the fistula was reduced by 27.6% and 22.2%, respectively. The odds for the loss of fistula patency and dialysis suitability at six months follow-up in patients treated with antiplatelet versus combined treatment was 6.5 and 4, respectively. Also, the number of patients needed to treat (NNT) with the addition of heparin spray to achieve AVF patency and suitability at three and/or six months suggests the benefit of combined adjuvant medical treatments for prevention of early AV shunt failure. The safety and tolerability of both treatments were good.Considering these results, it appears that topically applied heparin may sustain AVF patency and suitability for dialysis.

This registry evaluated the result of treatment with Crystacide in 73 patients with chronic venous insufficiency (CVI) and ulcerations. The local application of a hydrogen peroxide cream (Crystacide, Sandoz) onto the skin was evaluated with clinical and microcirculatory parameters. After briefing, one group used Crystacide and standard management for ulcers, including compression. A comparable group that did not use Crystacide was also evaluated.Laser Doppler flowmetry (LDF) was used to measure skin perfusion in association with skin TcP02 and TcPCO2. Crystacide was applied around and on the ulcer area for a period between 6 and 9 weeks (with a target time of observation of 8 weeks).Treatment with Crystacide was more effective. The increased skin flux at inclusion (indicating venus hypertension and microangiopathy) decreased in both groups (improving); TcO2 was increased (P0.05) and TcCO2 was decreased (P0.05) in both groups. However, changes in the microcirculatory parameters were significantly larger in the Crystacide group. The average ulcer area was significantly smaller at the average target time of 8 weeks in the Crystacide group in comparison with controls (P0.05). In the Crystacide group 64.86% of the ulcers were completely healed at 8 weeks versus 38.88% in controls. The difference (+25.98%) in the treatment group is significant (P0.002).Local treatment with Crystacide improves the healing of venous ulcerations by improving skin perfusion.

objective: To evaluate the effect of selective saphenous vein repair (SSVR) in a 5-year follow-up study. Design: Prospective, randomized study of 44 subjects randomized to an SSVR group and a control group. Setting: University Clinic, Chieti, and Angiology and vascular Surgery Clinic, Pescara, Italy. Patients: Twenty-two patients in the SSVR group and 22 in the control group. Inclusion criteria were incompetence of the saphenofemoral junction (SFJ) with presence of valve cusps and two to five venous sites in the long saphenous vein. interventions: SFJ plication and selective interruption of the incompetent sites under general anaesthetic. Main outcome measures: Ambulatory venous pressure measurements (refilling time) and colour duplex scanning to detect the number of incompetent sites. Result: After 5 years, 18 patients in the SSVR group and 19 in the control group completed the study. SSVR increased refilling time ( pConclusion: SSVR is an effective treatment with good 5-year results on incompetence and the development of new incompetent venous sites.

Ankle sprains mainly caused by accidents or strenuous sport activities can often be quite painful and impair motility. If not treated immediately and correctly, sprains may lead to severe complications. The aim of the present study was to compare the efficacy and safety of topically applied ketoprofen versus orally administered ketoprofen in 20 patients with grade I ankle sprain and 34 patients with grade II sprain. The patients were divide into in two treatment groups and received either topically applied ketoprofen treatment (ketoprofen 10% spray-gel; Prontoflex; 360 mg/die) or orally administered ketoprofen treatment (ketoprofen tablets; 3x50 mg/die). Treatment duration was one week. After 3 and 7 days of treatment, reduction of spontaneous pain and pain on active movement in the Prontoflex group was significantly bigger greater in the oral treatment group, irrespective of sprain severity. Regarding secondary parameters as mobility impairment and ankle swelling topically applied ketoprofen treatment turned out to be significantly superior to orally administered ketoprofen treatment. Additionally, Prontoflex was well tolerated, whereas ketoprofen tablets caused gastrointestinal side effects in some patients. The good efficacy in pain reduction and absence of side effects in the present study distinguished the topically applied ketoprofen as a favorable treatment for patients with accidental or sport soft tissue injuries.

The aim of this double-blind, placebo-controlled study was to evaluate the efficacy of 100 mg Pycnogenol daily (oral capsules) in a 3 month study in patients with osteoarthritis (OA). OA symptoms were evaluated by WOMAC scores, mobility by recording their walking performance (treadmill). Treatment (77 patients) and placebo group (79) were comparable for age, sex distribution, WOMAC scores, walking distances and use of antiinflammatory drugs. The global WOMAC score decreased by 56% (p < 0.05) in the treatment group versus 9.6% in the placebo group. Walking distance in the treadmill test was prolonged from 68 m at the start to 198 m after 3 months treatment (p < 0.05), under placebo, from 65 m to 88 m (NS). The use of drugs decreased by 58% in the treatment group (p < 0.05) versus 1% under placebo. Gastrointestinal complications decreased by 63% in the treatment group, but only 3% under placebo. Overall, treatment costs were reduced significantly compared with placebo. Foot edema was present in 76% of the patients of the treatment group at inclusion and in 79% of the controls. After 3 months edema decreased in 79% of Pycnogenol patients (p < 0.05) vs 1% in controls. In conclusion, Pycnogenol offers an option for reduction of treatment costs and side effects by sparing antiinflammatory drugs.

In a previous, double-blind, placebo-controlled study we evaluated the efficacy of a 3-month treatment with Pycnogenol for 156 patients with osteoarthritis of the knee. Pycnogenol significantly decreased joint pain and improved joint function as evaluated using the WOMAC score and walking performance of patients on a treadmill. In this study, we further investigated the anti-inflammatory and antioxidant activity of Pycnogenol in a subset of the osteoarthritis patients presenting with elevated C-reactive protein (CRP) and plasma-free radicals. Elevated CRP levels have been suggested to be associated with disease progression in osteoarthritis. In our study, 29 subjects of the Pycnogenol group and 26 patients in the placebo group showed CRP levels higher than 3 mg/l at baseline. Comparison of blood specimens drawn at baseline and after 3-month treatment showed that Pycnogenol significantly decreased plasma free radicals to 70.1% of baseline values. Plasma CRP levels decreased from baseline 3.9 mg/l to 1.1 mg/l in the Pycnogenol group whereas the control group had initial values of 3.9 mg/l which decreased to 3.6 mg/l. The CRP decrease in the Pycnogenol was statistical significant as compared to the control group (P < 0.05). Fibrinogen levels were found to be lowered to 62.8% of initial values (P < 0.05) in response to Pycnogenol. No significant changes for plasma free radicals, CRP and fibrinogen were found in the placebo-treated group. The decrease of systemic inflammatory markers suggests that Pycnogenol may exert anti-inflammatory activity in osteoarthritic joints and patients did not present with other ailments or infections. The nature of the anti-inflammatory effects of Pycnogenol with regard to CRP warrants further investigation.

The aim of this study was to evaluate the prevention of recurrent deep vein thrombosis (RDVT) with an oral antithrombotic agent (sulodexide) in moderate to high-risk subjects. A group of 405 patients was included into the multicenter registry. Both compression and an exercise program were used as well as a risk-factors control plan. After diagnosis of DVT, patients were treated with oral anticoagulants for 6 months. At the end of this period a coagulation study was made and patients started treatment with oral sulodexide capsules for a period of 24 months. The femoral, popliteal, tibial, and superficial veins were scanned with high-resolution ultrasound at inclusion; scans were repeated at 6, 12, 18, and 24 months. Of the 405 subjects included into the registry 178 in the control group (mean age 52.2; SD 11; M:F = 90:88) and 189 in the treatment group (mean age 53.2; SD 10.3; M:F = 93:96) completed the analysis period of 24 months. At 6 and 12 months the incidence of R-DVT was lower (p

The aim of this study was to evaluate deep venous thrombosis (DVT) prophylaxis with specific elastic stockings in longhaul flights (11-13 hours), in high-risk subjects. A group of 300 subjects was included; 76 were excluded for several problems including concomitant treatments; 224 were randomized into two groups (stockings vs. controls) to evaluate prophylaxis with below-knee stockings. An exercise program was used in both groups. Scholl (UK) Flight Socks (14-17 mmHg of pressure at the ankle) were used. DVT was diagnosed with ultrasound scanning. The femoral, popliteal, and tibial veins were scanned before and within 90 minutes after the flights. Of the 205 included subjects, 102 controls and 103 treated subjects completed the study. Drop-outs were due to flight connection problems. Age, gender, and risk distributions were comparable in the two groups. In the treatment group (103 subjects; mean age, 42; SD 9; M:F, 55:48), one limited, distal DVT was observed (0.97%). In the control group (102 subjects; mean age, 42.1; SD 10.3; M:F, 56:46), six subjects (5.8%) had a DVT. There were no superficial thromboses. The difference in DVT incidence is significant (p

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 (p0.02) 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.

Peritoneal mesothelioma is a rare neoplasm with generic and non-specific symptoms. In some cases it is associated with various and particular clinical syndromes. These findings make it so insidious that the diagnosis is rarely make the preoperative course. Usually, there has been previous exposure to asbestos, during even if other causes are reported. Rarely, a peritoneal mesothelioma appears with signs and symptoms suggestive of acute abdomen, such as the present case. On admission the patient presented clinical features apparently requiring emergency surgery. In fact, at laparotomy, the tumour, arising from the mesenterium, had perforated the peritoneal cavity and communicated with the digiunal lumen, causing a septic hemoperitoneum. A radical resection was performed and the continuity of the intestinal tract was restored through an end-to-end entero-anastomosis. The patient, with a history of exposure to asbestos, was alive four years later. But over the last twelve months diffuse metastasis has occurred in the lung and liver, and there was no response to systemic chemotherapy. This case may be considered singular of the clinical syndrome, the long-term survival and the circumscribed aspect of the tumour. Through a review of the literature, the features of the present diagnostic procedure are underlined and the importance of multidisciplinary treatment as the best approach to peritoneal mesothelioma is emphasized.

A case of non-Hodgkin's lymphoma involving the caecum and the rectum was resected. The disease occurs in 1-4% of gastrointestinal neoplasms and comprises 0.2-0.65% of colorectal tumours. The caecum is frequently involved while primary malignant lymphoma localized to the caecum and the rectum is more uncommon. The most representative histological types are histiocytic or lymphocytic tumours. The disease commonly presents as a painful abdominal mass and is associated with weight loss and diarrhoea. Barium enema and pancolonoscopy are sufficient for diagnosis, but echotomography and Tc scan are useful for staging. Surgery is the treatment of choice and overall 5-years survival is 30-40%. The role of adjuvant therapy has not yet been clearly defined, although data from some studies indicate increased survival in those patients given adjuvant therapy compared with patients treated with surgical resection alone.

Spontaneous perforation of colon is a rare disease and physiopathologic basis are actually unknown. Surgical treatment is standardized and post-operative survival is over 60%, morbidity and mortality rate depends on peritoneal contamination. In 1984 J.A. Berry classified spontaneous perforations into "stercoral" and "idiopathic" perforations on the basis of etiopathogenetical causes of lesions. Anatomopathologically stercoral and idiopathic perforations present different characteristics. Macroscopically stercoral perforation origines from an ulcerative lesion often situated on the sigmoid colon or rectum. Microscopical characteristic is represented by a superficial ischemic necrosis of mucosa (caused by fecalomas) followed by an extension to sub-mucosa and muscular tissues of the colonic wall. On the contrary, "idiopathic perforation", frequently situated on the sigma, is a linear laceration of anti-mesenteric side of the colon without pathologic modifications of the colon. Physiopathologic basis of spontaneous perforations of the colon were also discussed. Stercoral perforation is often a consequence of chronic constipation. Instead, two hypoteses are advanced as regards idiopathic perforations. S.V. Kessing e coll. (1962) hypotized a parietal suffering caused by ischemia of anti-mesenteric side of the colon, depending on ipoperfusion of colonic tissues; they also hypotized a constitutional weakness of colonic wall as a cause of idiopathic perforation. Others hypotized an intraluminal hypertension caused by intestinal hernias (J.W. Eadie, 1955; K. Cronin, 1959), rectal prolapse or abnormal depth of Douglas cavity (D.C. Lyon, 1969). In these cases, lesion is caused by contraction of abdominal muscles during defecation, which presses colonic wall during distension.(ABSTRACT TRUNCATED AT 250 WORDS)

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.

A new system to evaluate capillary permeability, the vacuum suction chamber (VSC) device, was used to assess the effects of Venoruton in patients with venous hypertension. A temporary, superficial skin lesion (wheal) was produced with the VSC device by negative pressure (30 mmHg) applied for 10 minutes on the internal, perimalleolar region. Wheals disappear in less than 60 minutes in normals while in patients with venous hypertension the wheal is more persistent, requiring a significantly longer time to disappear. This new technique was used in association with laser-Doppler flowmetry to evaluate the efficacy of Venoruton (1000 mgs t.i.d.) administered for 2 weeks on venous hypertension. Results indicate a positive effect of Venoruton in reducing the abnormally increased capillary permeability in venous hypertension and are proportional to the changes observed in signs and symptoms after treatment.

The effects of chronic treatment with indobufen, an inhibitor of platelet aggregation, was studied in a group of 1428 patients with vascular problems treated in a period of about 6 years in our Units. Venous problems were the major vascular problem in 313 patients, peripheral vascular diseases in 553 and cerebrovascular problems in 562. In patients with venous problems the range of the treatment period in different groups of patients varied from 2 to 42 months. The range was from 1 to 48 months in the group of patients with peripheral vascular diseases and from 2 to 48 in patients with cerebrovascular diseases. An analogic score was used to evaluate the efficacy of indobufen, which was also compared for the occurrence of side-effects with ASA (acetylsalicylic acid) and dipyridamole. Results obtained in this large, chronic open study confirmed the efficacy of indobufen in preventing (or reducing the occurrence) of vascular problems which was significantly greater than that observed with the other two drugs used for comparison. Indobufen also resulted in a lower incidence of side-effects (particularly gastrointestinal disorders) and it was better tolerated than both dipyridamole and ASA.

Defibrotide is a new compound with antithrombotic and profibrinolytic activity. It increases the endogenous fibrinolytic activity by promoting the cellular activator of plasminogen from endothelial cells and by decreasing the concentration of its inhibitors. In this study we evaluated a total of 223 patients for a mean period of 43 days for the following vascular conditions: (a) superficial venous thrombosis; (b) prophylaxis against deep venous thrombosis; (c) peripheral vascular disease (ischaemic foot and intermittent claudication; (d) prophylaxis against TIAs in patients with carotid plaques determining embolization; (e) treatment of venous ulcerations determined by chronic venous incompetence; (f) patients with Raynaud's phenomenon and disease. The tolerability observed was good. No side effects were observed even in more prolonged treatments. The overall efficacy was good for all groups especially in comparison with other treatment already in use for these vascular conditions. In conclusion defibrotide is a particularly useful drug in these vascular diseases and can be used both for acute and chronic treatments.

One case of S.V.C.S. pas observed during surgery for cancer of lung, resection was performed and dacron graft was used. Possibilities of vascular graft in such cases, as well as peculiar situation of emergency which create the opportunity for insertion of synthetic graft were discussed.

Superficial vein thrombosis (SVT) is a common complication of varicose veins. Treatment may be surgical by removal of the superficial clots under local anesthetic or medical in association with elastic compression and mobilization. In this study 83 patients with SVT were randomised in treatments groups: A--superficial thrombectomy and elastic compression (EC); B--Ca Heparin (0.5 mgs b.i.b.) + EC; C--Venoruton (1 g, t.i.d.) + EC; D--Venoruton (1 g, t.i.d.) after superficial thrombectomy + EC; E--elastic compression. All treatments were applied for 8 weeks. The evolution of SVT was studied by a system, based on thermography, which analyse by a computerized system the variation of the hyperthermic areas (HA) on thermograms. This was associated with subjective and objective clinical evaluation. Results indicate a decrease of HA in all groups but patients treated with superficial thrombectomy show a significantly (p, 0.05) greater and faster reduction of HA. The reduction of HA produced by Venoruton was also significantly greater (p less than 0.05) than that observed in patients treated by Ca Heparin or elastic compression and it determined also a faster and greater (p less than 0.05) decrease of HA after thrombectomy. These results were confirmed by clinical observations. In conclusion results from this study indicate a positive effect of Venoruton in SVT in determining a faster decrease of hyperthermic areas probably by decreasing local inflammation.

Morbid obesity is a disease of modern society. Surgery is indicated when there is no endocrinopathy, medical treatment failed and Body Mass index (W/H2) is more than 40 (III degree obesity of Garrow). Many different methods were suggested in connection with the type of obesity, the associated diseases and the psychical state of the patient. Jejuno-ileal by-pass intend to produce a generic malabsorption syndrome. Personal experience is however good, possibly due to the blind loop jejunostomy that we always prepare as a conclusion of the operation and which gives an excellent support for the early post-operative time.

The authors address the topic of acute acalculous cholecystitis and examine the related aetiopathogenetic and clinical problems, taking as their starting point two cases of the disease observed in their department.