Clinical Trial
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Medicamentous treatment of chronic venous insufficiency using semisynthetic diosmin--a prospective study.

INTRODUCTION: Chronic venous insufficiency (HVI) is manifested by the progressive signs of venous stasis. This disorder is treated by: compressive bandaging, medicaments, sclerotherapy, surgery, etc.

AIM: Prospective study of the effects of semisynthetic diosmin (clinical signs, quality of life, local biochemical parameters) on patients with HVI to whom no other method of treatment has previously been administered. METHOD APPLIED: This prospective study analysed the presence of risk factors and personal history of 80 patients with HVI. Diagnosis of HVI was based on the clinical apperance and the color duplex scan. Each patient's clinical signs (pain, oedma, feeling of heaviness and tightness in the lower leg), quality of life (physical, social, and psychological), and CEAP stage were assessed prior to and 30 days after the treatment with Phlebodia 600. For 15 patients with unilateral varicose veins, local values of lactates and gass analysis were taken under the conditions before and following the static load, and venous control samples were taken from the healthy leg. The acquired data were processed by means of descriptive statistics, while the significance of nonparametric features was measured by Wilcoxon test.

RESULTS: HVI is somewhat more frequent among females than among mails, on the left than on the right leg, and at the average age of 52.3 +/- 10.5. The patients with HVI are basicly engaged in professions with static load and have positive family history. The patients mainly started medical treatment 12.5 +/- 8.6 years after the first symptoms of the disease. Clinical improvement was recorded on the state of 65/80 patients. After the treatment numerical values of some of the clinical signs were statisticaly lower compared to the values before the administration of semisynthetic diosmin: oedema (0.94:1.50), pain (1.10:1.84), feeling of heaviness (1.20:1.96), and tightness (1.14:1.78). After the administration of the tested medication, parameters of physical, social, and psychological quality-of life were significantly improved (p<0,0001), accompanied with significantly improved (p<0,0001) CEAP stage of HVI (3.00:3.40). Local biochemical parameters had not been significantly changed.

CONCLUSION: Administration of semisynthetic diosmin during 30 days results in significant improvement of clinical signs, quality of life and CEAP stage of HVI.

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