Drugs under experimental and clinical research
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Controlled clinical trials, usually carried out in a multicentre, randomized manner, have become fashionable and popular because they contribute to the general acceptance of the results, particularly when the difference between the treatment arms is small. The present book and the present introduction attempt to discuss when and how this form of trial is appropriate. It is recognized that the discussion may be one-sided in the sense that the undoubted and well-known merits of controlled clinical trials are not reiterated. ⋯ The number of patients subjected to phase II trials can be appreciably reduced if reasonable statistical measures are taken, as proposed here, to optimize and minimize the trial. Phase III trials must improve the relevance of the questions asked, reporting of errors, patient information and statistical interpretation. They must be based on promising phase II studies with historical controls so that their efficacy is increased.
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Prostaglandin E1 (PGE1) was incorporated into soybean oil microspheres 0.2 micron in diameter, using lecithin as surfactant. The pharmacological effects of this new galenic form of PGE1 (lipo PGE1) was evaluated in experimental peripheral arterial occlusive disease in rats and in an ex vivo antithrombosis test in rats. ⋯ Total radioisotope activity of 3H-PGE1 in lipid microspheres in blood was higher and persisted longer than that of PGE1 in rats. These results suggested that the favourable features of lipo PGE1 depended on protection against inactivation in the lung and its targeting effect to tissues injured by arterial occlusion.