BACKGROUND: In this study patients with peripheral vascular disease were treated with PGE1 alpha-ciclodestrina. In the intermittent claudication group (walking distance at inclusion between 200-600 m) we included 55 patients treated with PGE1 alpha-ciclodestrina (15 diabetics) and 22 controls (not treated with PGE1 alpha-ciclodestrina). In the critical ischemia group 46 patients were treated and 47 patients followed up as controls (rest pain or necrotic lesions had been present for more than 2 weeks). METHODS: Patients with intermittent claudication were evaluated by a treadmill test (walking distance was the endpoint) and in those with critical ischemia the number of minor and major amputations in 12 months were considered as endpoints. A dose of PGE1 alpha-ciclodestrina (60-80 micrograms/day for 2 days) was repeated either every 6 or, in alternative, every 10 weeks. In the control group only antiplatelet agents, support treatment (control of risk factors) and exercise were used. RESULTS: All subgroups of patients treated with PGE1 alpha-ciclodestrina with intermittent claudication increased their walking distance (including the subgroup of diabetics). In critical ischemia there were no major amputations (only 2 minor amputations) in the PGE1 alpha-ciclodestrina group vs 10.6% (of major amputations) in the control group. Also an evaluation of laser Doppler flow, volume flow and transcutaneous PO2 indicated in subgroups of patients an improvement of microcirculation and limb perfusion with PGE1 alpha-ciclodestrina. CONCLUSIONS: The cost analysis and the quality of life evaluation indicated a benefit of preserving limbs from amputation.
BACKGROUND: In this study patients with peripheral vascular disease were treated with PGE1 alpha-ciclodestrina. In the intermittent claudication group (walking distance at inclusion between 200-600 m) we included 55 patients treated with PGE1 alpha-ciclodestrina (15 diabetics) and 22 controls (not treated with PGE1 alpha-ciclodestrina). In the critical ischemia group 46 patients were treated and 47 patients followed up as controls (rest pain or necrotic lesions had been present for more than 2 weeks). METHODS:Patients with intermittent claudication were evaluated by a treadmill test (walking distance was the endpoint) and in those with critical ischemia the number of minor and major amputations in 12 months were considered as endpoints. A dose of PGE1 alpha-ciclodestrina (60-80 micrograms/day for 2 days) was repeated either every 6 or, in alternative, every 10 weeks. In the control group only antiplatelet agents, support treatment (control of risk factors) and exercise were used. RESULTS: All subgroups of patients treated with PGE1 alpha-ciclodestrina with intermittent claudication increased their walking distance (including the subgroup of diabetics). In critical ischemia there were no major amputations (only 2 minor amputations) in the PGE1 alpha-ciclodestrina group vs 10.6% (of major amputations) in the control group. Also an evaluation of laser Doppler flow, volume flow and transcutaneous PO2 indicated in subgroups of patients an improvement of microcirculation and limb perfusion with PGE1 alpha-ciclodestrina. CONCLUSIONS: The cost analysis and the quality of life evaluation indicated a benefit of preserving limbs from amputation.