Efficacy and tolerability of intra-arterial and intravenous prostaglandin E1 infusions in occlusive arterial disease stage III/IV.
The efficacy and tolerability of intra-arterial and intravenous PGE1 infusions in patients with occlusive arterial disease [OAD] were studied in two independent multicentre therapeutic trials. In the first study 218 patients with OAD stage III/IV were given an i.a. infusion of 1/2 to 1 ampoule of Prostavasin (10-20 micrograms PGE1) in 50 ml physiological saline solution, once a day. 211 patients took part in the second study. Patients in stage III received one i.v. infusion of 3 ampoules Prostavasin (60 micrograms PGE1) once daily, and patients in stage IV received one i.v. infusion of 2 ampoules Prostavasin (40 micrograms PGE1) twice daily, in 100-250 ml physiological saline solution. In both studies the treatment period was 4 weeks. Both i.a. and i.v. administration afforded a significant improvement in the clinical symptoms. Ulcers healed completely in 18.6% of patients under i.a. treatment (i.v.: 10.7%) and partially healed in 38.9% (i.v.: 51.1%). 50% of the patients became pain-free in the course of i.a. treatment (i.v.: 47.7%) and, at the end of the study, 61.5% no longer required analgesics (i.v.: 48.6%). Stratification of the patients into diabetics and non-diabetics showed that in the main the therapeutic response in diabetic patients was as good as in non-diabetics, allowing for the fact that the clinical pictures were usually distinctly more severe in the diabetic patients. The adverse drug reactions were, predominantly, familiar symptoms such as redness, swelling and pain in the infused extremity and phlebitis-like redness along the course of the infused vein, gastro-intestinal symptoms and headache.
Balzer
K
K
Rogatti
W
W
Rüttgerodt
K
K
D000368:Aged; D000527:Alprostadil / Q000008:administration & dosage / Q000627:therapeutic use*; D001157:Arterial Occlusive Diseases / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007261:Infusions, Intra-Arterial; D007262:Infusions, Intravenous; D008297:Male
D000527:Alprostadil