The problem with purchasing pools.
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Biomedical subjects
Publications and source records attributed to S Findlay.
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The superheated debate over breast implants awakened a sleeping giant of an issue clouding "medical devices"--the government's clumsy nomenclature for any medical product that is not a drug, from breast implants and artificial hips to X-ray machines and surgical thread. Some 130 categories of high-risk devices are in use with little or no proof of safety, reliability or effectiveness. All appeared before 1976, the year that the Food and Drug Administration got the authority to regulate such products. Under activist chief David Kessler and with added clout from a 1990 law, the FDA plans to scrutinize the entire 130-item list. Five will get special attention starting early next year: saline-filled breast implants, inflatable penile implants, testicular implants, heart-bypass pumps and cranial stimulators. U.S. News has looked at all five devices, using FDA data obtained through the Freedom of Information Act. In-depth computer analysis suggested that penile implants deserve closer examination. Why is clear from the following report.
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A 4-week, double-blind, parallel group study compared the safety and efficacy of once-a-day intranasal administration of triamcinolone acetonide (Nasacort) versus placebo in 304 patients (155 adult and 149 adolescent) with seasonal allergic rhinitis. Patients were randomized to receive triamcinolone acetonide (110, 220, or 440 microgram) or placebo once daily each morning. Daily rhinitis symptoms scores, weekly patient and physician global assessments, and weekly nasal eosinophil smears were obtained. In each triamcinolone acetonide group, significant (P less than .05) improvement over placebo was noted in the nasal index (sum of ratings for stuffiness, discharge, and sneezing) by week 1, the first point of analysis, and maintained throughout the study. Triamcinolone acetonide groups also demonstrated significant (P less than .05) improvement over placebo in all individual rhinitis symptoms evaluated. The greatest improvement in symptoms was observed at the 440 microgram dose. A significant decrease in eosinophil counts paralleled clinical improvement in all triamcinolone acetonide groups. Physicians and patients rated triamcinolone acetonide significantly (P less than .05) more effective than placebo. Responses of adult and adolescent patients were comparable. Adverse experiences, clinical laboratory values, and results of physical examinations were unremarkable and comparable between the triamcinolone acetonide and placebo groups. We conclude that triamcinolone acetonide is safe, well tolerated, and superior to placebo as a once-a-day treatment for seasonal allergic rhinitis.
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