按需联合吸入二丙酸氯地米松、沙丁胺醇在在轻度持续哮喘中的应用
2007/08/01
支气管哮喘诊治指南建议，对轻度持续哮喘患者应规则使用吸入皮质类固醇治疗。作者的研究目的是观察在哮喘患者中，联合吸入二丙酸氯地米松（beclomethasone dipropionate）、沙丁胺醇（albuterol）是否与单独规则使用吸入beclomethasone具有同样的控制哮喘症状的效果,却又优于按需使用albuterol的疗效。
作者进行了为期6个月的随机、双盲、平行、安慰剂对照的临床试验。在经过4周的筛选期后，轻度持续哮喘患者被随机分配接受下列四个吸入疗法之一:安慰剂 Bid，加用联合beclomethasone 250ug和albuterol 100ug 的吸入装置按需吸入(按需联合吸入治疗组)；安慰剂1天2次，加用 albuterol 100ug按需吸入(按需吸入albuterol治疗组)； beclomethasone 250ug Bid和albuterol 100ug按需吸入(规则beclomethasone治疗组)； 予联合beclomethasone 250ug和albuterol 100ug 的吸入装置吸入Bid ，加用albuterol 100ug按需吸入(规则联合治疗组)。主要观察指标为早晨的呼气峰流量。
455例轻度持续哮喘患者的FEV1为2.96L,(占预计值的88.36%)。按需联合吸入治疗组在6个月治疗期中，其最后2周的PEF较按需吸入albuterol治疗组为高(P=0.04)，而哮喘发作的次数则较按需吸入albuterol治疗组为少(P=0.002)。按需联合治疗组与规则beclomethasone治疗组、规则联合治疗组相比，在PEF及哮喘发作的次数方面，无明显差异。按需联合吸入治疗组吸入beclomethasone的累积剂量较规则beclomethasone治疗组及规则联合治疗组低(P小于0.001)。
研究结果显示轻型持续哮喘患者按需联合吸入beclomethasone 250ug和albuterol 100ug 时，所需用的皮质类固醇剂量较小，而与规则吸入beclomethasone(250微克，Bid)具有相同的疗效。
（张清玲 广州医学院第一附属医院 广州呼吸疾病研究所 510120 摘译）
(N Engl J Med.2007 ;356:2040-2052)
Alberto Papi, Giorgio W.Canonica, Piero Maestrelli. Rescue Use of Beclomethasone and Albuterol in a Single Inhaler for Mild Asthma. N Engl J Med.2007 May 17;356(20):2040-2052
Background：Treatment guidelines recommend the regular use of inhaled corticosteroids for patients with mild persistent asthma. We investigated whether the symptom-driven use of a combination of beclomethasone dipropionate and albuterol (also known as salbutamol) in a single inhaler would be as effective as the regular use of inhaled beclomethasone and superior to the as-needed use of inhaled albuterol.
Methods：We conducted a 6-month, double-blind, double-dummy, randomized, parallel-group trial. After a 4-week run-in, patients with mild asthma were randomly assigned to receive one of four inhaled treatments: placebo twice daily plus 250 μg of beclomethasone and 100 μg of albuterol in a single inhaler as needed (as-needed combination therapy); placebo twice daily plus 100 μg of albuterol as needed (as-needed albuterol therapy); 250 μg of beclomethasone twice daily and 100 μg of albuterol as needed (regular beclomethasone therapy); or 250 μg of beclomethasone and 100 μg of albuterol in a single inhaler twice daily plus 100 μg of albuterol as needed (regular combination therapy). The primary outcome was the morning peak expiratory flow rate.
Results：In 455 patients with mild asthma who had a forced expiratory volume in 1 second of 2.96 liters (88.36% of the predicted value), the morning peak expiratory flow rate during the last 2 weeks of the 6-month treatment was higher (P = 0.04) and the number of exacerbations during the 6-month treatment was lower (P = 0.002) in the as-needed combination therapy group than in the as-needed albuterol therapy group, but the values in the as-needed combination therapy group were not significantly different from those in the groups receiving regular beclomethasone therapy or regular combination therapy. The cumulative dose of inhaled beclomethasone was lower in the as-needed combination therapy group than in the groups receiving regular beclomethasone therapy or regular combination therapy (P<0.001 for both comparisons).
Conclusions：In patients with mild asthma, the symptom-driven use of inhaled beclomethasone (250 μg) and albuterol (100 μg) in a single inhaler is as effective as regular use of inhaled beclomethasone (250 μg twice daily) and is associated with a lower 6-month cumulative dose of the inhaled corticosteroid.
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不同 “降阶梯治疗”战略在轻度持续性哮喘中的应用
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