A new clinical bioassay for antipyresis.
Three studies that describe antipyretic bioassay are detailed. Reference Standard Endotoxin (RSE) was used to induce fever in healthy male volunteers under randomized, single-dose, double-blind, parallel, and standard drug-control conditions. Thirty minutes before administering RSE, the subjects were medicated with test drug, and oral temperatures were recorded every 15 minutes for 6 to 8 hours. Two NSAIDs and a centrally acting analgesic were evaluated. Both doses of a propionic derivative, three high doses of tebufelone (a new NSAID), as well as the high dose of flupirtine effectively obtunded the fever response to RSE. Adverse reactions consisting of flu-like symptoms such as myalgia, headache, and chills were also significantly reduced with the standard as well as test drugs. The authors conclude that the RSE model is a quick, safe, and reliable method to evaluate antipyresis and to predict other pharmacologic effects of these types of drugs, such as analgesia.
McMahon
F G
FG
Clinical Research Center, New Orleans, Louisiana 70112.
Vargas
R
R
D000328:Adult; D000480:Alkynes / Q000627:therapeutic use*; D000631:Aminopyridines / Q000627:therapeutic use*; D001681:Biological Assay / Q000379:methods*; D004311:Double-Blind Method; D004731:Endotoxins; D005069:Evaluation Studies as Topic; D005334:Fever / Q000188:drug therapy* / Q000209:etiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D010636:Phenols / Q000627:therapeutic use*; D012015:Reference Standards
D000480:Alkynes; D000631:Aminopyridines; D004731:Endotoxins; D010636:Phenols; C034161:flupirtine; C064268:tebufelone