Flota-Cervera LF, Nuricumbo-Vázquez A, Santana-Vega D, Guevara-Saldívar MI, Carrizales-Vázquez MG, Cardoso-Villaseñor A, Arizmendi-Nolasco P, González-Villordo D, Cano-Villamil ES, Paz-Janeiro JL, Frati-Munari CA

Language: Spanish
References: 47
Page: 131-137
PDF size: 169.48 Kb.

ABSTRACT

Background. Sulodexide is a glycosaminoglycan useful in chronic venous disease. It was introduced for clinical use in Mexico in 2012. Recently a clinical survey which was conducted in Mexico showed the usefulness of sulodexide in any stage of chronic venous disease.
Objective. To evaluate the time of healing of venous leg ulcers in Mexico.
Material and methods. A sub-analysis of the previous study included the cases with active venous leg ulcers (C-6) with follow-up and information of the time of healing of the ulcer.
Results. 183 cases were analysed, 63% received sulodexide only by oral route, the rest also received intramuscular ampoules. All the ulcers healed. Median time of complete ulcer healing was 60 days. At 60 days 50.8 % of the ulcers healed, at 90 days 66.7% and at 180 days 97.9 %.
Conclusion. Sulodexide is effective to achieve the complete healing of venous leg ulcers, combined with local measures and compressive therapy.

REFERENCES

1. Haremberg J. Review of pharmacodynamics, pharmacokinetics, and therapeutic properties of sulodexide. Med Res Rev 1998; 18: 1-20.

2. Mauro M, Ferraro G, Palmieri GC. Profibrinolytic and antithrombotic effects of sulodexide oral administration: a double-blind, cross-over, placebo-controlled study. Curr Ther Res 1992; 51: 342-50.

3. Babal P, Kristova V, Kriska M. Decreased endothelial loss after sulodexide administration assessed by in vitro vessel perfusion. Res Commun Pharmacol Toxicol 1996; 1: 119-26.

4. Park HY, Kang S, KimGY, et al. Inhibition of neointimal proliferation of rat carotid artery by sulodexide. J Korean Med Sci 1997; 12(3): 210-4.

5. Kristova V, Liskova S, Sotnikova R, et al. Sulodexide improves endothelial dysfunction in streptozotocin-induced diabetes in rats. Physiol Res 2008; 57: 491-4.

6. Broekhuizen LN, Lemkes BA, Mooij HL, Meuwese MC, Verberne H, Holleman F, et al. Effect of sulodexide on endothelial glycocalyx and vascular permeability in patients with type 2 Diabetes Mellitus. Diabetologia 2010; 53: 2646-55.

7. Frati-Munari AC. Glicosaminoglicanos en las enfermedades vasculares. Rev Mex Angiol 2012; 40: 89-99.

8. Mattana P, Mannello F, Ferrari P, Agus GB. Vascular pathologies and inflammation: the anti-inflammatory properties of sulodexide. J Vasc Endovasc Surg 2012; 19(Suppl. 2 to No. 3): 1-7.

9. Mannello F, Ligi D, Canale M, Raffetto J. Pleiotropic properties of glycosaminoglycan Sulodexide in chronic venous disease: in vitro modulation of chemokines and colony stimulating factors. Int Angiol 2013; 32(Suppl. 1 to No. 5): 31.

10. Mannello F, Medda V, Ligi D, Raffetto JD. Glycosaminoglycan Sulodexide inhibition of MMP-9 gelatinase secretion and activity: possible pharmacological role against collagen degradation in vascular chronic diseases. Curr Vasc Pharmacol 2013; 11: 354-65.

11. Frati-Munari AC. Medical significance of endothelial glycocalyx. Arch Cardiol Mex 2013; 83: 303-12.

12. Cospite M, Milio G, Ferrara F, Cospite V. Hemodynamic effects of sulodexide in post-thrombophlebitic syndromes. Acta Ther 1992; 18: 149-61.

13. Allegra C. Rolo attuale dei glicosaminoglicani e prospettive in terapia. Minerva Angiol 1993; 18(Suppl. 3): 45-9.

14. Petruzzellis V, Troccoli T, Florio T, Vadala P. Attività terapeutica del sulodexide per via orale nell’insufficienza venosa cronica. Giorn It Angiol 1991; 11: 139-43.

15. Pecis C, Sgroi G, Giovilli M, et al. Ruolo della terapia medica con sulodexide nel paziente varicoso operato. Flebolinfologia 1990; 1: 51-3.

16. Del Guercio R, Siciliano G, Niglio A, Del Guercio M. Valutazioni sull’impiego del sulodexide in un gruppo di pazienti con IVC. Minerva Angiol 1991; 16: 141-2.

17. Luttichau U, Palazzini E. Pharmacological treatment of post-phlebitic syndromes with sulodexide. Med Praxis 1992; 13: 1-8.

18. Pecis C, Giovilli M, Mezzanotte C, et al. Complementarity of medical therapy in the surgical treatment of varicose disease. Flebolinfologia 1991; 3: 4-6.

19. Rovere V, Armerio A, Mauro M, et al. Efficacia d’azione e tollerabilità di una nuova formulazione oral di sulodexide nel trattamento della sindrome pstflebitica. Studio controllato vs. eparina s.c. Nuova Stampa Med Ital 1992; 12: 25-35.

20. Cospite M, Ferrara F, Cospite V, Palazzini E. Sulodexide and microcirculatory component in microphlebopaties. Curr Med Res Opin 1992; 13: 56-60.

21. Saviano M, Maleti O, Liguori L. Double-blind, doubledummy, randomized, multi-centre assessment of efficacy, tollerability and dose-effect relationship of sulodexide in chronic venous insufficiency. Curr Res Med Opin 1993; 13: 96-108.

22. Flota-Cervera LF, Paz-Janeiro JL, Guevara-Saldivar MI, et al Sulodexida para la enfermedad venosa crónica. Experiencia clínica en México. Rev Mex Angiol 2014; 42: 28-37.

23. Scondotto G, Aloisi D, Ferrari P, Martini L. Treatment of venous leg ulcers with sulodexide. Angiology 1999; 50: 883-9.

24. Coccheri S, Scondotto G, Agnelli G, et al. Randomized, double-blind multicenter, placebo controlled study of sulodexide in the treatment of venous leg ulcers. Thromb Haemost 2002; 87: 947-52.

25. Kucharzewski M, Franec A, Hoziolek H. Treatment of venous leg ulcers with sulodexide. Phlebologie 2003; 32: 115-20.

26. Zou Y, Feng X, Jing Z. Efficacy and safety of sulodexide in the treatment of venous ulcers of leg. Pharm Care & Res 2007; 7: 22-4.

27. Apollonio A, Mosti G, Ricci E. Microcircolo e ulcere venose. Acta Vulnol 2008; 6: 125-32.

28. Deutsche Geselleshaft Für Phlebologie (DGP). Guidelines for the diagnosis and therapy of venous ulcers (versión 8 2008). Phlebologie 2008; 37: 308-32.

29. Kearon C, Kahn SR, Agnelli G, Goldhaber S, Raskob GE, Comerota AJ, et al. Antithrombotic therapy for venous thromboembolic disease: American College of Chest Physicians evidence-based clinical practice guidelines (8th ed). Chest 2008; 133: 454S-545S.

30. Nelson EA. Clinical evidence. Venous leg ulcers. BMJ Clinical evidence 2011; 12: 1901.

31. Jawien A, Szewczyk MT, Kaszuba A, Gaciong Z, Krasinski Z, Wronski J, et al. Guidelines for management of chronic venous ulceration. Recommendation of a multidisciplinary expert group. Leczenie Ran 2011; 8: 59-80.

32. Apollonio A, Antignani PL, Di Salvo M, et al. A large Italian observational multicentre study on vascular ulcers of lower limbs (Studio Ulcere Vascolari). Int Wound J 2014; doi:10.1111/iwj.12216.

33. Jull AB, Arroll B, Parag V, Walters J. Pentoxifylline for treating venous ulcers. The Cochrane Library 2007; (3) http.//www. Thecochranelibrary.com (Consultado 12 de abril 2014).

34. Schürmann W, Eberhardt R. The efficacy of pentoxifylline added to topical and compression therapy in patients with varicose and postthrombotic leg ulcers [Wirksamkeit von Pentoxifyllin als Zusatz zu Kompressions– und Lokaltherapie bei Patienten mit Ulcus crurisvaricosum/postthromboticum]. Therapiewoche 1986; 36: 2343-5.

35. Barbarino C. Pentoxifylline in the treatment of venous leg ulcers. Current Medical Research and Opinion 1992; 12: 547-51.

36. Pizarro I, Aburto EUI, Parra JA, Bianchi V, Ibanez F, Salas S, et al. Venous leg ulcers: in search of the best treatment [Úlceras venosas de las piernas: en busca del mejor tratamiento]. Revista Chilena de Cirugía 1996; 48: 453-60.

37. Colgan MP, Dormandy JA, Jones PW, Schraibman IG, Shanik DG, Young RAL. Oxpentifylline treatment of venous ulcers of the leg. BMJ 1990; 300: 972-5.

38. Falanga V. High doses of pentoxyfylline accelerate the healing of venous ulcers. J Investigative Dermatol 1999; 112: 564.

39. Dale JJ, Ruckley CV, Harper DR, Gibson B, Nelson EA, Prescott RJ. Randomised, double blind placebo controlled trial of pentoxifylline in the treatment of venous leg ulcers. BMJ 1999; 319: 875-8.

40. Nikolovska S, Pavlova L, Petrova N, Gocev G, Ivanovski M. Pentoxifylline-efficient in the treatment of venous ulcers in the absence of compression. Acta Dermatovenerologica Croatia 2002; 10: 9-13.

41. Arenas R, Atoche C. Postthrombotic leg ulcers: safety and efficacy of treatment with pentoxifylline (Doubleblind study in 30 patients). Dermatología Revista Mexicana 1988; 32: 34-8.

42. Belcaro G, Cesarone MR, Nicolaides AN, de Sanctis MT, Incandela L, Geroulakos G. Treatment of venous ulcers with pentoxifylline: a 6-month randomized, double-blind, placebo controlled trial. Angiology 2002; 53 (Suppl. 1): S45-S47.

43. Nicolaides AN, Allegra C, Bergan J, Bradbury M,. Cairols M, Carpentier ac, et al. Consensus statement. Management of chronic venous disorders of the lower limbs. Guidelines according to scientific evidence. Int Angiol 2008; 27: 1-59.

44. Martinez MJ, Bonfil X, Moreno RM, Vargas E, Capellà D. Flebotónicos para la insuficiencia venosa (Revisión Cochrane traducida) Biblioteca Cochrane Plus 2008, (2) Chichester UK, John Wiley & Sons Ltd. Disponible en: http:// www.update-software.com (última modificación 2005).

45. Coleridge-Smith P, Lok C, Ramelet AA. Venous leg ulcer: a meta-analysis of adjunctive therapy with micronized purified flavonoid fraction. Eur J Vasc Endovasc Surg 2005; 38: 198-208.

46. Coleridge-Smith P. Daflon 500 mg and venous leg ulcer: new results from a meta-analysis. Angiology 2005; 56(Suppl. 1): S33-S39.

47. Mannello F, Raffetto JD. Matrix metalloproteinase activity and glicosaminoglycans in chronic venous disease: the linkage among cell biology, pathology and translational research. Am J Transl Res 2011; 3: 149-58.