AIM The study was aimed at assessing efficacy and safety of micronized purified flavonoid fraction (MPFF, Detralex) in comprehensive treatment of chronic venous oedema induced by lower limb varicose veins. PATIENTS AND METHODS We performed a post hoc analysis of the results of treatment of 708 patients included into the observational programme VAP-PRO-C3 (ClinicalTrials.gov. NCT03722836). These patients, depending on the type of treatment, were divided into 8 subgroups: MPFF (n=32); MPFF + compression (n=145); MPFF + compression + topical treatment (n=158); MPFF + compression + topical treatment + endovasal laser coagulation (n=197); MPFF + endovasal laser coagulation (n=3); MPFF + compression + endovasal laser coagulation (n=152), patients not receiving MPFF (n=16); MPFF + topical treatment (n=2). Due to paucity of the participants, from the subsequent analysis we excluded the groups MPFF + endovasal laser coagulation, patients not receiving MPFF (n=16) and MPFF + topical treatment. All further statistical data are shown for the remaining 687 patients. RESULTS Comparing the groups of patients undergoing conservative treatment alone and those subjected to surgical intervention demonstrated no statistically significant differences in dynamics of crural oedema. In both groups at every subsequent visit there was a statistically significant decrease in the ankle volume (p<0.001). During the whole period of follow up the crural volume in patients from the group of conservative treatment totally decreased by 0.201±0.158 L and in the operated patients by 0.236±0.189 L (p=0.021). The QOL assessed by the CIVIQ-14 global index score statistically significantly improved in the unoperated patients from 31.5±19.2 to 12.0±10.1 (p<0.001). In the operated patients, the baseline and final values of the QOL of the global index score amounted to 33.4±17.8 and 7.7±9.2, respectively (p<0.001). In the groups with and without topical treatment, the baseline values of the QOL assessed by CIVIQ-14 global index score amounted to 28.5±17.4 and 36.2±18.6, respectively. During the follow-up period, we observed statistically significant positive dynamics of all parameters of quality of life. The final visit demonstrated improvement of the CIVIQ-14 global index score to 9.4±9.2 in patients without topical treatment and 10.1±10.4 in those receiving topical treatment (p=0.367), with the mean value of this parameter during treatment in both groups decreased significantly (p<0.001). A statistically significant decrease in the ankle volume in both groups was registered at every visit, finally amounting to 0.223±0.166 L and 0.248±0.174 L (p=0.118) for patients not receiving and receiving topical treatment, respectively. In groups of patients not receiving and those receiving compression therapy, the baseline values of the QOL assessed by CIVIQ-14 global index score amounted to 21.4±14.2 and 33.1±18.5 (p<0.001), respectively. At the final visit, these indices statistically significantly (p<0.001) decreased to 7.3±9.1 and 9.9±9.9 (p=0.106). Compared with the baseline values, the ankle volume at the final visit in groups of patients with and without compression therapy statistically significantly decreased by 0.187±0.14 L and 0.238±0.17 L respectively (p=0.204). During the study, there were no adverse events related to the administration of MPFF and use of Detragel. CONCLUSION MPFF and Detragel appear to be effective and safe components of comprehensive conservative therapy of chronic oedema induced by primary varicose veins of lower extremities.

AIM:The purpose of the study was to assess efficacy and safety of using in real clinical practice micronized purified flavonoid fraction (Detralex) in patients with chronic venous oedema.PATIENTS AND METHODS:The study enrolled a total of 708 patients presenting with chronic venous disease, belonging to C3EpAsPr according to the CEAP classification (chronic venous oedema), who. depending on the accepted clinical practice by expert physicians were prescribed compression and phlebotropic therapy, as well as undergoing surgical interventions. The main criteria for efficacy of the micronized purified flavonoid fraction included the dynamics of chronic venous oedema, vein-specific symptoms, as well as the main parameters of quality of life. Assessment was made using visual analogue scales, the vein-specific questionnaire CIVIQ-14, and the method of discs for measuring the volume of the crus.RESULTS:The obtained findings demonstrated significant positive dynamics of the main vein-specific symptoms assessed by a visual analogue scale. When comparing between the visits of recruitment into the study and its termination the feeling of heaviness in calves decreased form 5.38±2.19 cm to 1.56±1.56 cm (p<0.001), pain in the calf diminished from 4.24±3.39 cm to 1.12±1.37 cm (p<0.001), feeling of oedema dropped from 5.68±2.44 cm to 1.38±1.59 cm (p<0.001), severity of nocturnal cramps fell from 2.46±2.30 cm to 0.43±1.01 cm (p<0.001), and intensity of skin inching from 1.46±2.06 cm to 0.43±1.01 cm (p<0.001). Positive dynamics of venous-specific symptoms appeared to be accompanied by significant improvement of all dimensions of quality of life according to the CIVIQ-14 scale: by the pain scale from 41.0±19.1% to 12.8±11.6% (p<0.001), by the physical condition scale - from 31.6±23.8% to 11.1±15.4% (p<0.001), by the psychological state scale - from 24.5±21.1% to 5.7±9.0% (p<0.001). The global index of quality of life also improved significantly from 32.4±18.5% to 9.9±9.9% (p<0.001). The results of the intervention along all the examined parameters (external appearance, possibility of wearing various clothes and increasing the quality of the self-performed work, to improve both interactions with surrounding people and the social activity and rest) turned out better than expectations form an intervention. The volume of the crus as the main criterion over the period of follow up averagely by the group decreased from 3.07±0.84 to 2.78±0.80 litres (p<0.001). A significant decrease in the calf volume from 3.03±0.87 to 2.77±0.85 litres was observed in 288 patients who during the follow up period were not subjected to surgical interventions, with no significant differences in the dynamics of chronic venous oedema revealed between the operated patients and those having received conservative treatment alone.DISCUSSION:According to a meta-analysis, the micronized purified flavonoid fraction (Detralex) turned out to possess better parameters in relation to therapy of chronic venous oedema as compared with other phlebotropic agents. Therefore, it appears absolutely logical to predominantly use the micronized purified flavonoid fraction in real clinical practice in patients with the CEAP C3 clinical class, which was registered in our study. An important result was also the fact that within the specified terms of follow up surgical intervention demonstrated no significant advantage over conservative therapy alone in treatment of chronic venous oedema. Moreover, conservative treatment in the form of a combination of compression and phlebotropic therapy demonstrated a dynamic decrease in the volume of the affected extremity with a probable transition of the CEAP C3 clinical class to C2.CONCLUSION:The micronized purified flavonoid fraction (Detralex) at a standard daily dose of 1000 mg in a combination with compression therapy irrespective of the surgical intervention performed resulted in a significant dynamic decrease in the volume of the calf in patients with chronic diseases of lower limb veins (C3EpAsPr according to the CEAP classification). An anti-oedematous effect of the micronized purified flavonoid fraction (Detralex) in a combination with compression manifests itself during the entire period of treatment.

Recently collated scientific data on the management of C1 clinical class of chronic venous disorders; wide prevalence of the disease and high variability amongst medical practitioners in relation to managing this category of patients and absence of any regulatory documents has prompted the development of clinical guidelines for the treatment of patients with reticular varicose veins and telangiectasias of the lower extremities and various parts of the body. These guidelines have been developed by a self-regulated organization Association “The National College of Phlebology”. The purpose of the de novo guidelines is to systematize the existing evidence and offer minimal standards of care for chronic venous disorders in C1 patients.

AIM The purpose of the study was to assess efficacy and safety of heparin sodium gel 1000 IU/g and Detragel® in decreasing the incidence and treatment of the most common local adverse reactions in patients after endured sclerotherapy of reticular veins and telangiectasias. PATIENTS AND METHODS Our open prospective observational study included a total of sixty 18-to-35-year-old female patients who after undergoing standardized sclerotherapy of reticular veins and telangiectasias on symmetrical portions of lower limbs were given a tube of heparin sodium gel 1000 IU/g or Detragel® to be applied onto the skin of one (left) lower limb in the projection of the sclerotherapy-exposed vessels 2-3 times daily for 10 days followed by putting on a compression class 2 (RAL standard) stocking. The women were allowed to use only the paired stocking on the contralateral extremity. Efficacy and safety of heparin sodium gel 1000 IU/g and Detragel® were evaluated based on the incidence of typical adverse reactions (ecchymoses, phlebitides, hyperpigmentation and neovasculogenesis), as well as on the patient's subjective perceptions. RESULTS The use of heparin sodium gel 1000 IU/g and Detragel® in addition to compression after sclerotherapy of reticular veins and telangiectasias significantly and comparably decreased the incidence and accelerated the resolution of ecchymoses and phlebitides associated with phlebosclerosing treatment. The Detragel® group patients were found to develop hyperpigmentation or neovasculogenesis significantly less often as compared with the heparin sodium gel 1000 IU/g group women. What is more, using Detragel® was not accompanied by hyperkeratosis, pruritus or formation of a sticky film, the events, however, observed while applying heparin sodium gel 1000 IU/g. CONCLUSION The use of Detragel® or heparin sodium gel 1000 IU/g for 10 days additionally to compression significantly decreased the incidence of typical undesirable reactions associated with sclerotherapy of reticular veins and telangiectasias. The Detragel® group women turned out to have lower incidence of hyperpigmentation and neovasculogenesis. Besides, Detragel® demonstrated better organoleptic properties.

AIMThe study was aimed at assessing efficacy and safety of using a micronized purified flavonoid fraction in the perioperative period in patients scheduled for endovascular surgical intervention for CEAP clinical class C2 lower limb varicose veins.PATIENTS AND METHODSThis study enrolled a total of 1519 patients with CEAP C2a,sEpAs (primary varicose vein with valvular incompetence of the great and/or small saphenous vein) who were subdivided into two groups. Group One included 1039 patients who in the perioperative period were prescribed a micronized purified flavonoid fraction at a daily dose of 1000 mg and who continued therapy, including visit 4. Group Two was composed of 480 patients taking no venoactive agents. The main criterion for assessing efficacy of the micronized purified flavonoid fraction was the incidence rate of typical adverse events in the compared groups of patients after surgical intervention.RESULTSThe patients receiving the micronized purified flavonoid fraction were found to have adverse events significantly less often as compared with those in the control group: ecchymosis 7.1 versus 11.0% (p=0.01), haematoma 0.5 vs 1.3% (p=0.1), paresthesia 0.5 vs 1.7% (p=0.02), thrombophlebitis 0.2 vs 0.6% (p=0.2), pigmentation 0.6 vs 3.3% (p=0.001), heat-induced thrombosis 0.3 vs 1.3% (p=0.02). The total incidence rate of adverse events in patients receiving and those not receiving the micronized purified flavonoid fraction amounted to 7.6 vs 15.0%, respectively (<0.001).DISCUSSIONThe micronized purified flavonoid fraction prescribed in the perioperative period, owing to a pluripotent mechanism, adapts the venous system and microcirculatory bed of the lower extremities to operative stress, decreasing the anti-inflammatory response to endovascular intervention, lowering thereby the incidence of undesirable events.CONCLUSIONPrescription of the micronized purified flavonoid fraction in the perioperative period ensures a significant decrease in the incidence of typical adverse events developing after endovascular surgical treatment for CEAP clinical class C2 varicose veins and may be recommended for real clinical practice.

Compression serves as an important component for carrying out successful and safe phlebosclerosing treatment. At the same time, the necessity of wearing compression hosiery or bandages is associated with known limitations and objections of patients, especially in a hot season. We comparatively assessed efficacy of usual compression stockings and a short-term pneumatic bandage with cryoelements while carrying out sclerosing treatment of dilated intradermal veins. Our open prospective observational study included a total of fifty 18-to-35-year-old women. After performing standardized sclerotherapy of reticular veins and telangiectasias on the symmetrical portions of the lower limbs, a pneumatic cryocompression bandage with a pressure of 50 mmHg was applied onto one of the limbs for 15 minutes, with a class 2 compression (RAL standard) medical stocking put on the other limb to be worn by the patients at daytime for 10 days. We assessed completeness of obliteration of the target veins, frequency of the development of typical undesirable events (ecchymoses, phlebitides, hyperpigmentation and neovasculogenesis), as well as the composite discomfort score according to an 11-point visual analogue scale. It was determined that using the pneumatic bandage with cryoelements as compared with the traditional compression stockings significantly decreased the frequency of the development of typical undesirable events after phlebosclerosing treatment, such as formation of ecchymoses, phlebitides, hyperpigmentation and neovasculogenesis. Significance of differences was revealed as early as 7 days after sclerotherapy, to be increasing during further dynamic follow up. By convenience for the patients, the use of the short-term pneumatic cryobandage was four times better than wearing the compression stockings. A conclusion was drawn that while carrying out sclerotherapy of reticular veins and telangiectasias short-term pneumatic cryocompression by efficacy and safety was not inferior to the traditional medical stockings (RAL standard) and made it possible to significantly decrease the incidence of the known undesirable events after phlebosclerosing treatment.

Presented herein are the results of the observational follow up study programme dedicated to the assessment of appropriate use of adjuvant therapy with Detralex while carrying out phlebosclerosing treatment in patients suffering from dilated intradermal veins (clinical class C1 according to the CEAP classification). A conclusion was drawn that administration of Detralex for 60 days decreased the incidence rate of typical undesirable side events after phlebosclerosing therapy, thus making the use of this drug appropriate in routine clinical practice.

Forecasting the development of implants' narrowing appears to be one of the most important problems encountered in vascular surgery today. The present study was therefore undertaken to work out a comprehensive diagnostic methodology making it possible to reliably predict the development of stenosis of vascular anastomoses during the postoperative period in patients presenting with atherosclerosis obliterans. The work was based upon the findings obtained by examining a total of seventy-nine patients diagnosed with atherosclerosis obliterans of the lower-limbs arteries, also including assessment of a large number of haemodynamic and immunological parameters both before and after reconstructive vascular interventions. The study showed substantial dynamics of a series of immunological and haemodynamic indices on the background of the operation and during the postoperative period. Based on the mathematical processing of the obtained data, the authors managed to reveal the factors playing a leading role in the development of stenosis, having also worked out a prognostic algorithm making it possible with high reliability to predict the development of stenosis of arterial anastomoses.