[Comparison of the effectiveness of physical training with parenteral drug therapy in Fontaine stage IIb peripheral arterial occlusive disease].
In an open, randomized study in patients with peripheral arterial occlusive disease in state IIb according to Fontaine the clinical efficacy and tolerability of Actovegin upon intravenous and intraarterial application was examined compared to vascular training. 30 patients were included in each of the three therapy groups. Over a period of four weeks each patient received daily therapy--except for weekends. Patients of group I received a daily intravenous infusion of 250 ml Actovegin 20% p.i. the patients in group II received this medication by the intraarterial route. The third patient group received standardized vascular training. From a total of 90 patients 73 completed the study according to the study protocol. In all three groups the therapy resulted in the improvement of pain-free and pain-limited walking distances. Upon comparison of relative changes in the intraarterial and intravenous group significant differences turned out: whereas patients in the intravenous group achieved a mean increase in pain-free walking distance of 37.8%, a mean increase in walking distance of 44.9% in the intraarterial group was observed. With respect to maximum walking distances the relative improvements amounted to a mean of 44.0% in the intravenous group, and 64.3% in the intraarterial group. After training over four weeks in the vascular-training group the patients achieved a mean increase in pain-free walking distance of 69.6% and 53.5% in pain-limited walking distance. This meant a significantly greater improvement in pain-free walking distance compared to the intravenous group; the difference compared to the intraarterial group was not significant; however the mean values indicated that the vascular-training group showed greater improvements in pain-free walking distance, and more moderate improvements in maximum walking distance than the intraarterial group. However, these results were significantly modified, if a differentiation was made in the vascular-training group between patients with high and low compliance. In the patients' rating all three therapies were described as throughout beneficial, however, less positive for the intravenous therapy, which is in accordance to the results of changes in walking-distance. The results of the present study are discussed having in mind physical therapy being limited through contraindications and insufficient patient compliance.
Streminski
J A
JA
G.E.M. Gesellschaft für Evaluation und Qualitätssicherung in der Medizin mbH, Kaarst Nycomed Arzneimittel GmbH, München.
de la Haye
R
R
Rettig
K
K
Kuntz
G
G
D000328:Adult; D000368:Aged; D001157:Arterial Occlusive Diseases / Q000145:classification / Q000534:rehabilitation*; D015444:Exercise; D005260:Female; D006418:Heme / Q000008:administration & dosage / Q000031:analogs & derivatives*; D006801:Humans; D007261:Infusions, Intra-Arterial; D007262:Infusions, Intravenous; D007383:Intermittent Claudication / Q000145:classification / Q000534:rehabilitation*; D007511:Ischemia / Q000145:classification / Q000534:rehabilitation*; D007866:Leg / Q000098:blood supply*; D008297:Male; D008875:Middle Aged; D016138:Walking
D006418:Heme; C015646:Actovegin
Vergleich der Effizienz des physikalischen Trainings gegenüber parenteraler medikamentöser Therapie bei peripherer arterieller Verschlusskrankheit im Stadium IIb nach Fontaine.