The New England journal of medicine
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Randomized Controlled Trial Clinical Trial
Efficacy of ondansetron (GR 38032F) and the role of serotonin in cisplatin-induced nausea and vomiting.
We compared the efficacy and safety of ondansetron (GR 38032F), a selective antagonist of serotonin S3 receptors, with that of placebo in controlling the nausea and vomiting induced by cisplatin treatment in 28 patients with cancer. The patients received either three intravenous doses of ondansetron (0.15 mg per kilogram of body weight) or normal saline (placebo) at four-hour intervals, beginning 30 minutes before the administration of cisplatin. Nausea and vomiting were markedly diminished in the group given ondansetron. ⋯ The urinary excretion of 5-hydroxyindoleacetic acid, the main metabolite of serotonin, was increased in all patients two to six hours after they received cisplatin chemotherapy, and the increases paralleled the episodes of emesis. We conclude that ondansetron is an effective and safe agent for controlling the nausea and vomiting induced by cisplatin treatment. We suggest that cisplatin treatment increases the release of serotonin from enterochromaffin cells, and that ondansetron acts by blocking S3 receptors for serotonin.
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To determine the national origins of high-quality clinical research we looked at research articles published during the past decade in three leading general clinical-research journals, the New England Journal of Medicine, the Journal of Clinical Investigation, and the Lancet, and in a specialty journal, Blood. We found that the proportion of non-U. S. papers published annually in these journals increased between two- and almost threefold, irrespective of whether the total number published per year rose (the Journal of Clinical Investigation and Blood), fell (the Lancet), or remained constant (the New England Journal of Medicine). ⋯ S. papers published reflects an increase in the amount of high-quality research originating abroad as compared with the amount originating in the United States. The explanation for this phenomenon is unclear, but it coincides with the slowed growth of funding from the National Institutes of Health for U. S. clinical research.
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Randomized Controlled Trial Comparative Study Clinical Trial
Immunization of six-month-old infants with different doses of Edmonston-Zagreb and Schwarz measles vaccines.
Because measles causes an estimated 2 million deaths per year among children in developing countries, including a substantial proportion of infants less than nine months old--the age at which vaccination is recommended--there has been interest in using different strains of vaccine and higher doses to achieve immunization of younger infants. We conducted a randomized trial of three different doses of Edmonston-Zagreb and of Schwarz measles vaccines in infants to evaluate the effect of the strain and dose of vaccine on the serologic response and acute adverse reactions to vaccination. Six-month-old infants received a standard, medium, or high dose of one of the vaccines, and nine-month-old infants received a standard dose. ⋯ The seroconversion rates produced by high and medium doses of Edmonston-Zagreb vaccine in six-month-olds were equal to or significantly higher than the rate produced by a standard dose of Schwarz vaccine in nine-month-olds (87 percent). Clinical adverse reactions were not associated with the strain or dose of a vaccine. We conclude that Edmonston-Zagreb vaccine is more immunogenic than Schwarz vaccine in infants and can induce effective immunization against measles at six months of age.
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The prevalence of tuberculosis among blacks is known to be about twice that among whites. When we looked at infection rates among the initially tuberculin-negative residents of 165 racially integrated nursing homes in Arkansas, we were stimulated to investigate whether this difference could be due in part to racial differences in susceptibility to Mycobacterium tuberculosis infection. A new infection was defined by an increase of greater than or equal to 12 mm of induration after a tuberculin skin test (5 tuberculin units) administered at least 60 days after a negative two-step test. ⋯ Data from three outbreaks of tuberculosis in two prisons also showed that blacks have about twice the relative risk of whites of becoming infected with M. tuberculosis. We conclude that blacks are more readily infected by M. tuberculosis than are whites. The data also suggest that susceptibility to M. tuberculosis infection varies independently of the factors governing the progression to clinical disease.