The Efficacy and Safery of Fexofenadine Hydrochloride for the Treatment of Eczema or Dermatitis.
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Accession number;02A0277291
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| Title;The Efficacy and Safery of Fexofenadine Hydrochloride for the Treatment of Eczema or Dermatitis. |
| 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.297-317(2002)
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| Figure&Table&Reference;FIG.5, TBL.13, REF.18 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;The efficacy and safety of fexofenadine hydrochloride at a daily dose of 60mg twice a day to the patients with eczema or dermatitis was determined in an open study. 1) Of 79 subjects who had entered the study, 74 were subjected to primary efficacy evaluation(FAS) excluding 5 ineligible subjects. The safety was analyzed for 80 subjects including I subject who had been given administration of the test drug before entry. 2) Average of changes in the itching score, a key efficacy measure, was -1.89, indicating efficacy in treating itching due to eczema or dermatitis. The changes in the itching score were similar in the group of concomitant use with external preparations (-1.88) and the hydrocortisone acetate group (-1.91). The itching score was greatly reduced on the following day of administration by -1.12 in comparison with that on the administration day, and later, decreased gradually. Changes seen in the 1st week was greater than those in the 2nd week. 3) The greatest change in the itching score was seen in acute eczema (3 cases): -3.33. The smallest change (-1.25) was seen in atopic dermatitis (35 cases) which was the most common disease in this study. 4) There was no major change between the diurnal and night itching scores. 5) Moderate condition of the skin lesion was the most common before administration. After administration, mild was the most common, showing conditions of the skin lesion was overall improved. More than two-step improvement was seen in 17 subjects (23.0%). 6) Adverse events were seen in 37 (46.3%) in the 80 subjects. The most common events were drowsiness in 11 cases, increased LDH in 4 cases, headache in 3 cases, and positive for albuminuria in 3 cases. As for severity, severe was 1 case, moderate was 6 cases, and mild was 30 cases.... (author abst.) |
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