Efficacy and safety of salmeterol in childhood asthma
Efficacy and safety of salmeterol in childhood asthma
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沙美特罗治疗儿童哮喘的疗效和安全性
DOI：
10.1007/bf01958642
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发表时间：
1995
影响因子：
3.6
通讯作者：
behalf of a European Study Group
中科院分区：
文献类型：
--
作者：
W. Lenney;S. Pedersen;A. Boner;A. Ebbutt;M. Jenkins;behalf of a European Study Group
在两项为期3个月、双盲、平行组研究中，比较了沙美特罗25 μg、沙美特罗50 μg和沙丁胺醇200 μg每日两次给药对哮喘儿童的影响，一项研究使用定量吸入器（MDI），另一项研究使用干粉吸入器（DRIhaler，DPI）。两项研究均继续进行了9个月，在此期间监测了急性加重率、诊所肺功能和不良事件。两项研究在设计和方法上的相似性证明了合并分析的合理性。847名哮喘儿童，年龄在4 - 16岁之间（平均10.1岁），需要吸入β 2受体激动剂治疗，随机接受治疗。在2周的导入期后，当所有支气管扩张剂治疗停止时，279例患者接受沙美特罗25 μg bd，290例患者接受沙美特罗50 μg bd，278例患者接受沙丁胺醇200 μg bd。治疗3个月后，沙美特罗50 μg bd组每日早晚呼气峰流速（PEF）较基线的变化显著大于沙丁胺醇200 μg bd组（P<0.001）。沙美特罗50 μg bd在改善平均早晨PEF方面也显著优于沙美特罗25 μg bd（P=0.017），但两种治疗对夜间PEF的影响相似。方差分析显示基线PEF小于100%预测正常值与治疗结果之间存在相互作用。对肺功能较低患者亚组的分析显示，尽管PEF较基线的改善更大，但结果与总人群相似。两项研究的数据显示，在12个月的治疗期间，肺功能的改善得以维持。接受沙美特罗50 μg bd治疗的患者无支气管哮喘的夜晚明显更多（P<0.01），无急救支气管哮喘的天数百分比更高（P=0.01）。哮喘急性发作的发生率在三个治疗组之间均匀分布，没有证据表明12个月期间急性发作的发生率发生任何变化。不良事件在治疗组或年龄组之间没有差异，主要与患者的疾病状态有关。
In children with asthma, twice daily administration of salmeterol 25 μg, salmeterol 50 μg and salbutamol 200 μg were compared in two, 3-month, double-blind, parallel group studies, one using metered dose inhalers (MDIs), the other using dry powder inhalers (Diskhaler, DPIs). Both studies were continued for a further 9 months during which time exacerbation rates, lung function at the clinic and adverse events were monitored. Similarities in design and methodology of the two studies justified a combined analysis. Eight hundred and forty-seven asthmatic children aged between 4 and 16 (mean 10.1) years, requiring inhaled beta2-agonist treatment were randomised to treatment. After a 2 week run-in when all bronchodilator therapy was withdrawn, 279 patients received salmeterol 25 μg bd, 290 patients salmeterol 50 μg bd and 278 patients salbutamol 200 μg bd. After 3 months' treatment the change from baseline in daily morning and evening peak expiratory flow (PEF) was significantly greater with salmeterol 50 μg bd than with salbutamol 200 μg bd (P<0.001). Salmeterol 50 μg bd was also significantly better than salmeterol 25 μg bd at improving mean morning PEF (P=0.017) but both treatments had a similar effect on evening PEF. Analysis of variance showed an interaction between baseline PEF less than 100% predicted normal value and treatment outcome. Analysis of this sub-set of patients with lower lung function revealed similar results to the total population although the improvements in PEF from baseline were greater. Data from both studies, showed that the improvement in lung function was maintained throughout 12 months' treatment. Patients receiving salmeterol 50 μg bd had significantly more symptom-free nights (P<0.01) and a higher percentage of rescue bronchodilator-free days (P=0.01). The incidence of asthma exacerbations was evenly distributed between the three treatment groups and there was no evidence of any change in the rate of occurrence of exacerbations over the 12 month period. Adverse events were no different across treatment groups or across age groups and were primarily related to the patients' disease state.