Sano Yasuyuki, Adachi Mitsuru, Kiuchi Takahiro, Miyamoto Terumasa
Department of Allergy and Respiratory Medicine, Doai Memorial Hospital, Tokyo, Japan.
Respir Med. 2006 Mar;100(3):420-33. doi: 10.1016/j.rmed.2005.06.014. Epub 2005 Aug 10.
Many patients with severe refractory asthma, which is insufficiently controlled by additional high-dose of inhaled corticosteroids, require oral corticosteroids and/or immunosuppressant. Clinicians should seek for suitable medications, for its' chronic use may induce high risk of side effects. The purpose of this study was to evaluate the efficacy and safety of nebulized sodium cromoglycate (3-4 times/day) in adult severe asthmatic patients with poorly controlled asthmatic symptoms, despite treatments with high-dose inhaled corticosteroids. Adult patients with severe asthma (n=251) were enrolled in a randomized clinical trial at 30 medical centers in Japan. Isotonic saline was used as placebo. The study was conducted for 10 weeks; with initial 2 weeks of observation followed by 8 weeks of treatments. Efficacy was primarily evaluated based on improvements in morning peak expiratory flow after treatment. All patients who applied inhalation of nebulized sodium cromoglycate (SCG group) or saline (Controls) were treated with high-dose of inhaled corticosteroids (median of beclomethasone dipropionate equivalent dose: 1600 microg/days) and second-line control therapy including oral corticosteroids. There was no significant difference in morning peak expiratory flow between SCG group and controls. However, when patients were stratified into atopic and non-atopic groups, morning peak expiratory flow had significantly improved in the atopic SCG group compared to atopic Controls. Additional inhalation of nebulized sodium cromoglycate with inhaled corticosteroids is effective even in patients with severe atopic asthma. This finding shows that nebulized sodium cromoglycate is expected to be new second-line therapeutic option in severe asthma.
许多重度难治性哮喘患者，即使增加高剂量吸入性糖皮质激素也无法得到充分控制，需要口服糖皮质激素和/或免疫抑制剂。临床医生应寻找合适的药物，因为长期使用可能会引发高副作用风险。本研究的目的是评估雾化吸入色甘酸钠（每日3 - 4次）对尽管接受高剂量吸入性糖皮质激素治疗但哮喘症状控制不佳的成年重度哮喘患者的疗效和安全性。日本30个医疗中心纳入了251名成年重度哮喘患者进行一项随机临床试验。使用等渗盐水作为安慰剂。研究进行了10周，最初2周为观察期，随后8周为治疗期。疗效主要根据治疗后早晨呼气峰值流速的改善情况进行评估。所有应用雾化吸入色甘酸钠的患者（SCG组）或盐水的患者（对照组）均接受高剂量吸入性糖皮质激素治疗（丙酸倍氯米松等效剂量中位数：1600微克/天）以及包括口服糖皮质激素在内的二线控制治疗。SCG组和对照组之间早晨呼气峰值流速无显著差异。然而，当将患者分为特应性和非特应性组时，与特应性对照组相比，特应性SCG组的早晨呼气峰值流速有显著改善。在重度特应性哮喘患者中，雾化吸入色甘酸钠联合吸入性糖皮质激素治疗是有效的。这一发现表明，雾化吸入色甘酸钠有望成为重度哮喘新的二线治疗选择。
