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To evaluate the efficacy and safety of budesonide inhalation suspension (BIS) in the treatment of infantile bronchial asthma, BIS was given to infants with bronchial asthma aged from 6 months to less than 5 years at a daily dose of 0.5-1.0mg (qd or bid) for 24 weeks using an electric nebuliser. At week 12 (FAS with LOCF), the frequency of asthmatic attacks was significantly decreased by 6.99 times/week as compared with the baseline (p<0.001). At week 12, frequency of asthmatic attacks (times/week), frequency of cough, disturbance of daily activity, and disturbance of nighttime sleep showed a tendency toward improvement as compared with the baseline, which continued until week 24. Once daily (qd) and twice daily (bid) groups showed similar changes. Although all the patients experienced at least one adverse event, a total of 3 patients experienced 4 adverse events in which a causal relationship to BIS could not be ruled out: one case each of cheilitis and stomatitis, and 2 cases of oral candidiasis. One patient discontinued the treatment because of stomatitis and oral candidiasis, and these symptoms disappeared after discontinuation. Twenty-four patients experienced a total of 41 serious adverse events including aggravated asthma attack and respiratory tract infection throughout the study period. However, no causal relationship to this drug was observed in any of these patients. Plasma cortisol significantly decreased at week 12 (8.10μg/dL) and at week 24 (8.81μg/dL) as compared with the baseline level (average 11.1μg/dL). (vs 12W: p<0.001, vs 24W: p=0.0086). Administration of BIS via nebuliser at a daily dose of 0.5-1.0mg is considered effective for infantile bronchial asthma. However, it seems necessary to titrate down to a minimum required dose of each patient while monitoring its efficacy, as significant serum cortisol lowering was seen in the study.
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日本小児アレルギー学会 | 論文

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