The aim of this study was to investigate if PGE1 i.v.-therapy after active physical training further increases the walking distance in PAOD stage IIb according to Fontaine. 48 outpatients with intermittent claudication underwent a standardized active walking training of about 6 months twice weekly. Afterwards patients were randomly given once daily an i.v. infusion of 60 micrograms PGE1 (3 ampoules prostavasin) or 600 mg naftidrofuryl. The therapy lasted for 3 weeks with the exception of Saturdays and Sundays. Besides laboratory and doppler parameters, painfree and maximum walking distance (treadmill, 10% incline, 3.5 km/h) were determined.
Results: Under active physical training the patients' walking distance increased significantly to more than double the baseline levels. Further significant increase of the painfree walking distance was seen after a 3 week treatment with PGE1 from 136 to 270 m (99%) as well as with naftidrofuryl from 117 to 230 m (97%). While this difference was not significant there was a significant difference in favour to PGE1 after the follow-up period (p less than 0.01). In the PGE1-group the painfree walking distance showed a further increase (from 270m to 306m) whereas it decreased in the naftidrofuryl-group (from 230m to 210m). At the same time under PGE1 the ankle/arm index increased significantly in comparison to naftidrofuryl (p less than 0.01). Side effects differed significantly in respect of the frequency and severity. In the PGE1-group in 20.8% of the patients side effects occurred, whereas in 91.6% of the patients in the naftidrofuryl-group side effects were observed. In no case therapy had to be discontinued because of side effects.