フランカルボン酸モメタゾン点鼻液の24週間連続投与試験:通年性アレルギー性鼻炎に対する検討

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<BR>The efficacy and safety of mometasone furoate (MF) nasal spray, a new glucocorticoid developed by Schering-Plough (U. S. ), when administered once daily for a maximum of 24 weeks to patients with perennial allergic rhinitis was examined. Treatment was initiated at the recommended dose of 200 μg/day. After treatment for 4 weeks, the dose could be adjusted to 100 or 400 μg/day depending on nasal symptoms. Of 98 patients who received the study drug,94 were treated for at least 12 weeks, and 85 patients completed 24 weeks of treatment. Twelve patients had their dose increased to 400 luμg/day at least once, and 26 had it reduced to 100 μg/day at least once.<BR>The primary efficacy variable, the mean value ( ± SE) of the score of 4 nasal symptoms, was 8.40 ± 0.20 at the start of treatment,4.55 ± 0.27 after 2 weeks of treatment,3.44 0.24 after 4 weeks,2.76 ± 0.26 after 8 weeks, and 2.25 ± 0.22 at 24 weeks after the start of treatment. The maximum effect was reached after 8 weeks of treatment. The improvement rate reached 89.5% after 8 weeks of treatment and was sustained up to 24 weeks in more than 90% of patients. A clear improvement in the effect was observed in approximately 50% of the 12 patients who required an increase in the dose from 200 to 400 μg/day, and, in almost all of the 26 patients who achieved an adequate response at 200 μg/day and had their dose reduced to 100 μg/day, the effect observed at the time of dose reduction was maintained with the reduced dose.<BR>The incidence of adverse events was 81.6% (80/98) and that of adverse reactions was 40.8% (40/ 98). The severity of adverse events was either mild or moderate, and no serious adverse events were observed. No trend toward an increase in the incidence of adverse events was observed with a longer duration of treatment, and no delayed onset type of adverse event was observed. No withdrawal symptoms or rebound phenomena in nasal symptoms suggestive of adrenocorticoid function suppression were noted.<BR>With the continuous administration of MF nasal spray (200 μg/day) for a maximum of 24 weeks, highlevel efficacy was maintained without an attenuation of effect throughout treatment in about 90% of the patients. A dose increase to 400 μg/day in about 10% of patients with an unsatisfactory response at 200 μg/day resulted in adequate symptom control in 50% of these patients. No adverse events, withdrawal symptoms, nor rebound phenomena which characteristically occur with long-term, continuous administration were observed, and safety was confirmed. Based on the above, the long-term administration of MF nasal spray resulted in satisfactory symptom control in more than 90% of patients with allergic rhinitis.
耳鼻咽喉科臨床学会の論文

フランカルボン酸モメタゾン点鼻液の24週間連続投与試験:通年性アレルギー性鼻炎に対する検討

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