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International Angiology 2003 March;22(1):24-31


language: English

Efficacy of a 6-month treatment with Daflon 500 mg in patients with venous leg ulcers associated with chronic venous insufficiency

Roztocil K. 1, Stvrtinová V. 2, Strejcek J. 3

1 Institute of Clinical and Experimental Medicine, Department of Cardiology, Prague, Czech Republic 2 2nd Clinic of Internal Medicine, Medical Faculty Comenius University, Bratislava, Slovak Republic 3 Centre for Dermatological Angiology, Prague/Ricany, Czech Republic


Aim. Epi­dem­i­olog­i­cal data show that stan­dard com­pres­sion ther­a­py for leg ulcer­a­tion in chron­ic ­venous insuf­fi­cien­cy (CVI) often fails to effec­tive­ly ­improve ­patients’ con­di­tion. This study assess­es the con­tri­bu­tion of Daf­lon 500 mg added to con­ven­tion­al ther­a­py in the heal­ing of hypo­stat­ic ­ulcers of CVI ­patients.
Meth­ods. ­Patients of about 65 years were includ­ed, with ­ulcers ≥2 and ≥10 cm diam­e­ter on 1 or 2 limbs, Dop­pler ankle/arm pres­sure index >0.9, and no ­recent his­to­ry of skin graft. Con­trols (n=68) ­remained on com­pres­sion alone while the test­ed group (n=82) also ­received Daf­lon 500 mg 2 tablets/day dur­ing 6 months. Treat­ment could be ­stopped as soon as the ref­er­ence ulcer ­appeared fully ­healed. Pri­mary end­points were the rate of ­healed ­ulcers and the time to com­plete heal­ing ­assessed by pla­nim­e­try/pho­tog­ra­phy and clin­i­cal exam­ina­tion. Vari­a­tions of the ulcer sur­face, appear­ance of the skin, and clin­i­cal symp­toms of CVI were the sec­on­dary cri­te­ria.
­Results. Only 7% of Daf­lon 500 mg ­patients neces­si­tat­ed the full 6 month ther­a­py. What­ev­er the ­lesion size, from W8 sig­nif­i­cant­ly more ­healed ­ulcers were ­observed under Daf­lon 500 mg (p=0.004), and the ulcer sur­face was more ­reduced (p=0.012). For large ­ulcers, the rate of heal­ing was approx­i­mate­ly 2-fold high­er with Daf­lon 500 mg, and the per­cent­age of ­ulcers ­healed ­before W24 was sig­nif­i­cant­ly high­er (p=0.008). Heavy leg sen­sa­tion was sig­nif­i­cant­ly ­improved by Daf­lon 500 mg from W4 (p<0.05). No treat­ment-relat­ed side ­effects were report­ed and the accept­abil­ity was con­sid­ered excel­lent by 85% of Daf­lon ­500 mg patients.
Con­clu­sion. Six months of Daf­lon 500 mg in addi­tion to com­pres­sion sig­nif­i­cant­ly ­improve some clin­i­cal symp­toms and accel­er­ate the heal­ing pro­cess in ­patients with ulcer­ous com­pli­ca­tions of CVI, with a good accept­abil­ity.

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