Apperti M, Masella A, Sabia D, Verde I
Dipartimento di Scienze Anestesiologiche, Chirurgiche e dell'Emergenza, Servizio di Emergenze Chirurgiche, Seconda Università degli Studi di Napoli.
Ann Ital Chir. 2003 Jul-Aug;74(4):453-7.
The treatment of patients with Peripheral Arterial Occlusive Disease (P.A.O.D.) is, until now, a therapeutics challenge. The purpose of this study was to confirm the safety of Iloprost infusion, to estimate the results after an Home Exercise Program joined to the therapy and to identify groups of patients with P.A.O.D. that can benefit from Iloprost therapy.
360 patients with and without diabetic with P.A.O.D. (Peripheral Arterial Occlusive Disease) at the stage of II, III, & IV, with Buerger Syndrome, were treated with Iloprost at the maximum dosage: 2 ng/kg/min for 6 hours a day, for a minimum of 1 week and a maximum of 3 weeks with cycles of therapy every 3, 6 or 12 months. At the end of each cycle of therapy there was assigned an Home Exercise Program. Patients with symptoms of pain are observed in the study and monitored for how long the pain lasted or diminished. The clinical benefit was evaluated on the reduction of the pain and analgesics, on the improvement of the trophics lesions and on the increase of gait's distance.
After 5 years of follow up, it was reported 12.2% of major amputations and 3.6% of deads. Over 60% of the patients, that were at risk for amputation at the beginning of the study, were alive. The tolerability of therapy was been very acceptable.
This study, at the end of 5 years, showed that the therapeutic infusion of Iloprost associated with an intensive Home Exercise Program, can, before 12 months, show patient improvement of the gait's distance from 50-200%.