A preliminary double-blind cross-over trial of lipo-PGI2, a prostacyclin derivative incorporated in lipid microspheres, in cerebral infarction.
Lipo-PGI2 is a drug preparation of a PGI2 analogue (isocarbacyclin methylester) which is incorporated into lipid microspheres with a diameter of 0.2 mu. Lipo-PGI2 has been shown to accumulate at the vascular wall, particularly those of arteriosclerotic lesions, and it has a much stronger inhibitory activity on platelet aggregation than free isocarbacyclin. In this study, a preliminary double-blind cross over trial of lipo-PGI2 in cerebral infarction was carried out. Seventeen patients with chronic cerebral infarction received 2 micrograms of lipo-PGI2 and placebo daily for one week each in a cross-over double blind test. A significant improvement was noted for lipo-PGI2 compared with placebo in the overall improvement in neurological and mental symptoms (p less than 0.01). The patient's preference also indicated the effectiveness of lipo-PGI2 (p less than 0.05). Adverse reactions were noted in 3 patients receiving placebo, but not in any receiving lipo-PGI2. These results show that lipo-PGI2 at a very low dose would be beneficial as a treatment for relieving the clinical symptoms of chronic cerebral infarction and that lipid microspheres are a useful drug carrier for PGI2 analogue therapy.
Hoshi
K
K
Department of Internal Medicine, St. Marianna University, School of Medicine, Kawasaki, Japan.
Mizushima
Y
Y
D000328:Adult; D000368:Aged; D002544:Cerebral Infarction / Q000188:drug therapy*; D004311:Double-Blind Method; D004337:Drug Carriers; D011464:Epoprostenol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male; D008863:Microspheres; D008875:Middle Aged; D010316:Particle Size
D004337:Drug Carriers; C052840:TEI 9090; D011464:Epoprostenol