The New England journal of medicine
-
Randomized Controlled Trial Multicenter Study Clinical Trial
Drotrecogin alfa (activated) for adults with severe sepsis and a low risk of death.
In November 2001, the Food and Drug Administration (FDA) approved drotrecogin alfa (activated) (DrotAA) for adults who had severe sepsis and a high risk of death. The FDA required a study to evaluate the efficacy of DrotAA for adults who had severe sepsis and a low risk of death. ⋯ The absence of a beneficial treatment effect, coupled with an increased incidence of serious bleeding complications, indicates that DrotAA should not be used in patients with severe sepsis who are at low risk for death, such as those with single-organ failure or an APACHE II score less than 25.
-
Multicenter Study Clinical Trial
Passive immunization during pregnancy for congenital cytomegalovirus infection.
Currently, there is no effective intervention for a primary cytomegalovirus (CMV) infection during pregnancy. ⋯ Treatment of pregnant women with CMV-specific hyperimmune globulin is safe, and the findings of this nonrandomized study suggest that it may be effective in the treatment and prevention of congenital CMV infection. A controlled trial of this agent may now be appropriate.
-
Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
Effectiveness of antipsychotic drugs in patients with chronic schizophrenia.
The relative effectiveness of second-generation (atypical) antipsychotic drugs as compared with that of older agents has been incompletely addressed, though newer agents are currently used far more commonly. We compared a first-generation antipsychotic, perphenazine, with several newer drugs in a double-blind study. ⋯ The majority of patients in each group discontinued their assigned treatment owing to inefficacy or intolerable side effects or for other reasons. Olanzapine was the most effective in terms of the rates of discontinuation, and the efficacy of the conventional antipsychotic agent perphenazine appeared similar to that of quetiapine, risperidone, and ziprasidone. Olanzapine was associated with greater weight gain and increases in measures of glucose and lipid metabolism.