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Online ISSN 1827-1766
Colombo F. 1, Farina M. A. 2, Priulla R. 3, Bonadeo P. 4, Romagnoli G. 5, Ballo M. 6, Fossati L. 7, Gasbarro V. 8
1 Servizio Angiologia, Casa di Cura “La Madonnina”, Milano;
2 Unità Operativa di Chirurgia Vascolare ed Endovascolare, Azienda Ospedaliera San Sebastiano, Caserta;
3 Ambulatorio di Angiologia e Diagnostica Vascolare Non Invasiva c/o Ospedale Koelliker, Torino;
4 Istituto Chirurgia Vascolare, Università degli Studi di Milano, Milano;
5 Unità Operativa di Chirurgia, Sede di Luino, Ospedale di Circolo, Varese;
6 Cattedra di Angiologia, Università degli Studi di Palermo, Palermo;
7 Ambulatorio Vascolare, ARS Medica, Monza (MI);
8 U.O. Chirurgia Vascolare, Arcispedale S. Anna, Ferrara
AIM: The chronic course of the post-phlebitic syndrome is characterised by the likely occurence of thrombotic exacerbations which may require a pharmacological prophylaxis.
This was a randomised study comparing the efficacy and tolerability of a periodical treatment with unfractionated calcium heparin (5,000 I.U. , one subcutaneous injection twice daily) and a treatment with the more recent low molecular weight heparin (calcium nadroparin, 3800 I.U. anti-Xa, 1 subcutaneous injection/day) in patients with post-phlebitic syndrome who were considered suited for an antithrombotic prophylaxis with heparin, due to concomitant conditions favouring the onset of deep venous thrombosis (DVT) recurrences or varicophlebitis in a valve-defective saphenous area.
METHODS: A total of 597 patients were treated for an average period of 30 days; 288 of them in the standard heparin group (UFH) and 309 in the nadroparin group (LMWH).
RESULTS: The results of the study proved the efficacy of both test drugs in improving clinical symptoms and healing trophic lesions related to the post-phlebitic syndrome. The treatment with LMWH proved more effective than UFH in improving clinical signs/symptoms (oedema, p<0.001, feeling of heavy limbs, p<0.001 and burning, p=0.004) and in reducing the size of ulcers (p<0.001). DVT recurrences occurred in 5 patients (1.7%) of the UFH group and in no patients of the LMWH group (p=0.02 between treatments), whereas onset of varicophlebitis during the study period was observed in 11 patients (3.8%) of the standard heparin group and in 3 patients (1.0%) of the low molecular weight heparin (p=0.02) group. Both treatments proved well tolerated, with fewer local side effects (injection site) in the LMWH group, mainly thanks to the reduced number of subcutaneous injections required.
CONCLUSION: Evidence from this study show the efficacy and tolerability of calcium nadroparin for the treatment of patients with post-phlebitic syndromes requiring an antithrombotic therapy. Further studies, maybe with different trial designs, are needed to confirm such results.