哮喘管理中布地奈德/福莫特罗维持和缓解治疗与传统最佳实践方法的比较
2009/11/17
目的：在患持续性哮喘的患者中，研究传统最佳治疗实践方法（CBP，使用多种吸入器）和布地奈德/福莫特罗（Symbicort，采用一个吸入器的简化治疗方法）维持和缓解治疗（Symbicort SMART, AstraZeneca, Södertalje, 瑞典）的有效性和安全性。
设计：该研究为开放标记随机对照平行试验，为期6个月。
参与者：共纳入908名年龄≥12岁，采用吸入激素（ICS）单独治疗或联合长效β2受体激动剂治疗的持续性哮喘患者。
主要检测指标：首次哮喘严重恶化间隔时间和哮喘严重恶化次数。
结果：首次哮喘严重恶化间隔时间两组间无显著差异（p = 0.75）。两组恶化率均较低。Symbicort SMART组有12名患者观察期内共发生14次哮喘严重恶化事件，CBP组有19名患者共发生25次哮喘严重恶化事件（年发生率为0.07 vs. 0.13; p = 0.09）。Symbicort SMART组平均每日激素吸入量（包括按需使用，表示为BDP当量）显著低于CBP组（749 mg vs.1059 mg; p < 0.0001）。SMART组哮喘控制问卷调查（5个问题的版本）平均评分较CBP组显著改善（p = 0.0026）。Symbicort SMART 和CBP治疗患者均能耐受。与CBP组相比，SMART组患者平均每月每人药物治疗花费显著下降（51.3欧元 vs. 66.5欧元; p < 0.0001）。
结论：对于比利时人，采用布地奈德/福莫特罗维持和缓解治疗的简化方案，在改善哮喘临床症状上与CBP一样有效，并且吸入激素使用量显著降低，同时伴随药物支出显著下降。
（ 苏楠 审校）
Louis R, et al. Int J Clin Pract. 2009 Oct;63(10):1479-1488.
A comparison of budesonide/formoterol maintenance and reliever therapy vs.
conventional best practice in asthma management.
Pneumology, CHU Sart Tilman, Liège, Belgium. r.louis@chu.ulg.ac.be
OBJECTIVE: To study the effectiveness and safety of budesonide/formoterol (Symbicort) Maintenance And Reliever Therapy (Symbicort SMART, AstraZeneca, Södertalje, Sweden), a simplified management approach with one inhaler compared with conventional best practice (CBP) with multiple inhalers in patients with persistent asthma.
DESIGN: Open-label randomised controlled parallel group trial, 6-month treatment.
PARTICIPANTS: A total of 908 patients > or = 12 years of age, with persistent asthma receiving treatment with inhaled corticosteroids (ICS), either alone or in conjunction with long-acting beta(2)-agonist.
MAIN OUTCOME MEASURES: Time to first severe asthma exacerbation and number of severe asthma exacerbations.
RESULTS: No difference between groups was seen in time to first severe exacerbation (p = 0.75). Exacerbation rates were low in both groups. A total of 12 patients in the Symbicort SMART group experienced a total of 14 severe asthma exacerbations, and 19 patients in the CBP group experienced a total of 25 severe asthma exacerbations (annual rate 0.07 vs. 0.13 p = 0.09). The mean daily dose of ICS expressed in BDP equivalent was significantly lower in the Symbicort SMART group (including as-needed use) vs. in the CBP group (749 microg vs. 1059 microg; p < 0.0001). Mean scores in Asthma Control Questionnaire, 5 question version improved significantly in the SMART group compared with the CBP group (p = 0.0026). Symbicort SMART and CBP were equally well tolerated. The mean drug cost/patient/month was significantly lower for the patients in the Symbicort SMART group compared with patients receiving CBP (51.3 euros vs. 66.5 euros; p < 0.0001).
CONCLUSIONS: In Belgian patients, a simplified regimen using budesonide/formoterol maintenance and reliever therapy was at least as effective at improving clinical control compared with CBP with a significantly lower ICS dose and significantly lower drug costs.
Louis R, et al. Int J Clin Pract. 2009 Oct;63(10):1479-88.
设计：该研究为开放标记随机对照平行试验，为期6个月。
参与者：共纳入908名年龄≥12岁，采用吸入激素（ICS）单独治疗或联合长效β2受体激动剂治疗的持续性哮喘患者。
主要检测指标：首次哮喘严重恶化间隔时间和哮喘严重恶化次数。
结果：首次哮喘严重恶化间隔时间两组间无显著差异（p = 0.75）。两组恶化率均较低。Symbicort SMART组有12名患者观察期内共发生14次哮喘严重恶化事件，CBP组有19名患者共发生25次哮喘严重恶化事件（年发生率为0.07 vs. 0.13; p = 0.09）。Symbicort SMART组平均每日激素吸入量（包括按需使用，表示为BDP当量）显著低于CBP组（749 mg vs.1059 mg; p < 0.0001）。SMART组哮喘控制问卷调查（5个问题的版本）平均评分较CBP组显著改善（p = 0.0026）。Symbicort SMART 和CBP治疗患者均能耐受。与CBP组相比，SMART组患者平均每月每人药物治疗花费显著下降（51.3欧元 vs. 66.5欧元; p < 0.0001）。
结论：对于比利时人，采用布地奈德/福莫特罗维持和缓解治疗的简化方案，在改善哮喘临床症状上与CBP一样有效，并且吸入激素使用量显著降低，同时伴随药物支出显著下降。
（ 苏楠 审校）
Louis R, et al. Int J Clin Pract. 2009 Oct;63(10):1479-1488.
A comparison of budesonide/formoterol maintenance and reliever therapy vs.
conventional best practice in asthma management.
Pneumology, CHU Sart Tilman, Liège, Belgium. r.louis@chu.ulg.ac.be
OBJECTIVE: To study the effectiveness and safety of budesonide/formoterol (Symbicort) Maintenance And Reliever Therapy (Symbicort SMART, AstraZeneca, Södertalje, Sweden), a simplified management approach with one inhaler compared with conventional best practice (CBP) with multiple inhalers in patients with persistent asthma.
DESIGN: Open-label randomised controlled parallel group trial, 6-month treatment.
PARTICIPANTS: A total of 908 patients > or = 12 years of age, with persistent asthma receiving treatment with inhaled corticosteroids (ICS), either alone or in conjunction with long-acting beta(2)-agonist.
MAIN OUTCOME MEASURES: Time to first severe asthma exacerbation and number of severe asthma exacerbations.
RESULTS: No difference between groups was seen in time to first severe exacerbation (p = 0.75). Exacerbation rates were low in both groups. A total of 12 patients in the Symbicort SMART group experienced a total of 14 severe asthma exacerbations, and 19 patients in the CBP group experienced a total of 25 severe asthma exacerbations (annual rate 0.07 vs. 0.13 p = 0.09). The mean daily dose of ICS expressed in BDP equivalent was significantly lower in the Symbicort SMART group (including as-needed use) vs. in the CBP group (749 microg vs. 1059 microg; p < 0.0001). Mean scores in Asthma Control Questionnaire, 5 question version improved significantly in the SMART group compared with the CBP group (p = 0.0026). Symbicort SMART and CBP were equally well tolerated. The mean drug cost/patient/month was significantly lower for the patients in the Symbicort SMART group compared with patients receiving CBP (51.3 euros vs. 66.5 euros; p < 0.0001).
CONCLUSIONS: In Belgian patients, a simplified regimen using budesonide/formoterol maintenance and reliever therapy was at least as effective at improving clinical control compared with CBP with a significantly lower ICS dose and significantly lower drug costs.
Louis R, et al. Int J Clin Pract. 2009 Oct;63(10):1479-88.
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腺甘酸受体作为哮喘和慢性阻塞性肺疾病干预治疗的靶点
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城镇家庭中哮喘治疗的障碍：来自家庭看护者和儿童的观点
