Background: Alprostadil is substance from a group of prostacyclines, recently has been used in a treatment of arterial occlusive disease (AOD) i.e. atherosclerosis obliterans, thromboangiitis obliterans, diabetic angiopathy. Aim: (i) to evaluate results of treatment with alprostadil on several clinical parameters: value of claudication distance (CD), Doppler-pressures (DP), brachiopedal index (BPI), pletismography and local status, (ii) to compare results with the first part of study by formal meta-analysis, on an intention-to-treat basis. Methods: in the first part of study (patients treated on Institute in a period from June 1996 to April 1998) 17 patients were treated: in 7 patients an improvement was achieved, 5 pts. Were without significant changes, 5 patients were with worse clinical status. Second part of study, (a period from May 1998 to April 2001), evaluate 20 patients with arterial occlusive disease (AOD). From a total of 20 patients, 10 (50%) were with obliterating atherosclerotic changes, 7 patients (35%) were with diabetic angiopathy and 3 (15%) pts. were with thromboangiitis obliterans. According to Fontaine classification (staging) of arteriopathies, on the beginning of treatment 12 pts. (60%) were in stage IV, 2 pts. (10%) were in stage III, and 6 pts. (30%) were in stage II. At the end of infusion period, patients were classified as responders or non-responders on the basis of pain relief in the stage III, or signs of ulcer healing in the stage IV. By evaluation of parameters: CD, DP, BPI, pletismography and local status on the end of treatment - 10 pts. (50%) were presented with improved status, 7 pts. (35%) were without changes and worse status was noticed in 3 pts. (15%). We had not any serious interactions
Conclusions: based on results of both part of the study we conclude that alprostadil is an effective substance, especially in patients with stage IV, that cannot undergo reconstructive vascular surgery due to different reasons. On the other hand, these results represent end of the infusion period, and real clinical efficacy needs to be judged in the longer term on the basis of harder end-points.