A method of evaluation of the influence of aspirin formulations on gastrointestinal microbleeding in humans
| Autor: | Barrie M. Phillips, Paul J. Kraus, James L. Allen, Roger M. Buslee |
|---|---|
| Rok vydání: | 1971 |
| Předmět: |
Adult
Male Pharmacology Clinical Trials as Topic Aspirin Adult male Buffered aspirin business.industry Drug Compounding Middle Aged Toxicology Placebo Feces Blood loss Evaluation Studies as Topic Occult Blood Chromium Isotopes Methods Humans Medicine Gastrointestinal Hemorrhage business medicine.drug |
| Zdroj: | Toxicology and Applied Pharmacology. 20:515-521 |
| ISSN: | 0041-008X |
| DOI: | 10.1016/0041-008x(71)90255-9 |
| Popis: | Human (radiochromate) studies of the effects of aspirin on gastrointestinal microbleeding are limited to 4 treatment periods, and since adequate evaluation of the effect of a new formulation requires the use of both positive and negative aspirin-containing reference formulations as well as a placebo, only 1 new formulation can be evaluated in a given complete cross-over study. The use of an incomplete design allowed evaluation of a greater number of experimental formulations in a smaller number of subjects, with a reduction in statistical efficiency of only one-third. Four experimental buffered aspirin formulations were investigated in a total of 21 normal adult male human subjects. It was shown that treatment with aspirin may influence the fecal blood loss observed during the next period of treatment with a different aspirin formulation. Thus, any cross-over study of aspirin-induced gastrointestinal microbleeding should be balanced for residual effects. |
| Databáze: | OpenAIRE |
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