Post-Marketing Surveillance Study of Talion Tablets on Pediatric Allergic Rhinitis
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Accession number;03A0106637
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| Title;Post-Marketing Surveillance Study of Talion Tablets on Pediatric Allergic Rhinitis |
| Author;
BABA SHUNKICHI
(Nagoya City Univ.)
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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.12;PAGE.1371-1387(2002)
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| Figure&Table&Reference;FIG.4, TBL.6, REF.19 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;A retrospective survey was carried out to collect information on the use of Talion in treating pediatric allergic rhinitis and to confirm appropriate dosage in children. 1) From 50 facilities, 1552 cases were collected. Of these, 236 subjects were excluded from the safety analysis. The remaining 1316 subjects were analyzed for safety. Seven subjects were excluded from the efficacy analysis. The remaining 1309 subjects were evaluated for efficacy. 2) Males predominated, accounting for 59.7%, with females comprising 40.3%. Average age was 11.1 years old, and 27 subjects were infants aged under 7 years. Classified by diagnosis (disease type), perennial allergic rhinitis accounted for 50.0%, seasonal allergic rhinitis 41.8%, perennial and seasonal allergic rhinitis 8.2%. Of the subjects, 38.6% had complications, and 76.4% were receiving concomitant drugs. 3) Subjects taking a daily 20mg dose of Talion (the usual dose in adults) accounted for 73.4%, and those taking 10mg/day accounted for 23.8%. Subjects taking a daily dose of 20mg increased beginning at 8years old, and this ratio increased with increasing age. As for body weight, the number of subjects given daily doses of 10mg/day and 20mg/day was similar in the range of 20kg or more to less than 30kg; however, in the range of 30kg or more to less than 40kg, the rate of 20mg/day was predominant. Average administration period was 40.1 days. About half the subjects were given Talion for a period of 4 weeks or longer. 4) Concerning rating of efficacy, "Almost completely satisfied" or better was reported by 89.5%, indicative of Talion's high efficacy in both children and adults. In investigating possible influences on efficacy, differences were found in diagnosis (disease name), severity before administration, presence or absence of the main antigen mite, past history, and average daily dose per body weight;... (author abst.) |
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