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| 每日一次茚达特罗治疗哮喘可以提供持续24小时的支气管扩张：一项为期7天的剂量范围研究 |
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| Indacaterol provides sustained 24h bronchodilation on once-daily dosing in asthma: A 7-day dose-ranging study |
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| LaForce C, Alexander M, Deckelmann R 2009/5/27 10:51:06 |
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| Allergy, 2008, |
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| View at Publisher |
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Abstract
Background:
Indacaterol is a novel, once-daily β2-agonist in development for the treatment of asthma and chronic obstructive pulmonary disease. Studies were required to determine optimal dose(s) for continuing investigation.
Objective:
A dose-ranging study was undertaken to evaluate efficacy and safety of indacaterol.
Methods:
A total of 436 patients with persistent asthma receiving inhaled corticosteroids were randomized to 7 days treatment with once-daily indacaterol 50, 100, 200, or 400μg via multi-dose dry-powder inhaler (MDDPI; Certihaler™), indacaterol 400μg via single-dose dry-powder inhaler (SDDPI), or placebo. Serial 24-h spirometry was performed on days 1 and 7. Vital signs, laboratory evaluations, and adverse events were monitored.
Results:
All doses of indacaterol increased the mean time-standardized area under the curve of forced expiratory volume in 1s (FEV1) from 22 to 24h postdose (P≤0.001 vs placebo) on days 1 and 7, with clinically relevant treatment-placebo differences of 240, 260, 350, 300, and 380ml on day 1 and 230, 220, 320, 250, and 270ml on day 7 for indacaterol 50, 100, 200, and 400μg via MDDPI and 400 μg via SDDPI, respectively. All doses increased mean FEV1 (P<0.05 vs placebo) from 5min to 24h postdose on days 1 and 7. All doses were well tolerated. Most adverse events were mild-to-moderate in severity: most frequently reported were respiratory, thoracic, and mediastinal disorders.
Conclusion:
Once-daily dosing with indacaterol provided sustained 24-h bronchodilation in patients with moderate-to-severe asthma, with a satisfactory overall safety profile. Indacaterol 200μg appears the optimum dose, offering the best efficacy/safety balance.
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 疾病资源中心
病例分析 [栏目介绍]
王燕燕 王曙
上海交通大学附属瑞金医院内分泌科
患者，女，69岁。2009年1月无明显诱因下出现乏力，当时程度较轻，未予以重视。2009年3月患者乏力症状加重，尿色逐渐加深，大便习惯改变，颜色变淡。4月18日入我院感染科治疗，诉轻度头晕、心慌，体重减轻10kg。无肝区疼痛，无发热，无腹痛、腹泻、腹胀、里急后重，无恶性、呕吐等。入院半月前于外院就诊，查肝功能：ALT 601IU/L，AST 785IU/L，TBIL 97.7umol/L，白蛋白 41g/L，甲状腺功能：游离T3 30.6pmol/L，游离T4 51.9pmol/L，心电图示快速房颤。
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