Open-label, uncontrolled, 6-week clinical trial of beraprost in patients with chronic occlusive arterial disease

摘要: Abstract The efficacy and tolerability of beraprost sodium, sodium (±)-(1 R ,2 ,3a S ,8b )-2,3,3a,8b-tetrahydro-2-hydroxy-1-[(E)-(3 ,4 RS )-3-hydroxy-4-methyl-1-octen-6-ynyl]-1H cyclopenta[ b ]benzofuran-5 butyrate, a prostacyclin analogue, were investigated in 23 patients (21 men 2 women; mean age, 49.6 ± 15.4 years; body weight, 59.9 8.0 kg) with chronic occlusive arterial disease its complications, arteriosclerosis obliterans, thromboangiitis obliterans ischemic limb ulceration. In this open-label, uncontrolled study, was administered orally at daily dosage 40 μg (two 20-μg tablets) TID for 6 weeks. subjective symptoms rest pain coldness limbs improved 14 (60.9%), ulcer size the appearance granulation 16 (69.6%) 19 (82.6%), respectively. Ulcer (calculated as square root longest diameter × shortest diameter) baseline (8.8 mm) had decreased significantly after weeks treatment (5.0 mm). One drug-related adverse event several abnormal laboratory values noted; however, all mild transient. These observations suggest that may be useful treating diseases, they support need controlled clinical studies women.