The Efficacy and Safety of Fexofenadine Hydrochloride at 60mg for the Treatment of Pruritus Cutaneus.
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Accession number;02A0277292
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| Title;The Efficacy and Safety of Fexofenadine Hydrochloride at 60mg for the Treatment of Pruritus Cutaneus. |
| Author;
KAWASHIMA MAKOTO
(Tokyojoidai Hifuka)
NAKAGAWA HIDEMI
(Jichiidai Hifuka)
HARADA SHOTARO
(Ntthigashinihon Kantobyoin Hifuka)
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Journal Title;Journal of Clinical Therapeutics & Medicines
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Journal Code:Y0906A
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ISSN:0910-8211
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VOL.18;NO.2;PAGE.319-334(2002)
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| Figure&Table&Reference;FIG.5, TBL.11, REF.9 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;Fexofenadine hydrochloride at a daily dose of 60mg was given twice daily to patients with pruritus cutaneus, and its efficacy and safety were determined in an open study. 1) Of 40 subjects who had entered the study, 38 were subjected to primary efficacy evaluation excluding one who had not been administered, and one who had used an inhibited drug. 39 were subjected to safety evaluation. Of the 38 analytical subjects for the efficacy, 27 subjects were suffering from general pruritus, and 11 were suffering from local pruritus cutaneus. 2) Average of changes in the itching score, a key efflcacy measure, was -2.85 (-2.97 for general pruritus and -2.56 for local pruritus cutaneus), indicating efficacy of this agent in treating itching. 3) The itching score was greatly reduced on the following day of initial administration by -1.68, and later, decreased gradually. 4) Changes seen in the 1st week (-1.95) was greater than those in the 2nd week (-2.99). 5) There was no major change between the diurnal and night itching scores. 6) Adverse events were seen in 23 (59.0%) of the 39 subjects. Common adverse events include drowsiness in 9 cases, diarrhea in 5 cases, headache in 4 cases, hot flush in 4 cases, and nausea in 3 cases. The severity was mild in all cases other than I case of moderate. 7) Adverse events where the causality could not be ruled out (side effects) were observed in 21 cases (53.8%), including drowsiness in 9 cases, diarrhea in 4 cases, hot flush in 3 cases, and nausea in 3 cases. The severity was mild in all cases other than one case of moderate. 8) There was no death or other serious adverse events in this study. 9) Abnormalitles in laboratory data were seen in 3 cases. The common changes were increased LDH in 2 cases, and an increase in total bilirubin in 1 case. There was no notable change in laboratory data before and after administration.... (author abst.) |
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