固定剂量糖皮质激素和长效支气管扩张剂联合治疗作为哮喘患者初期维持治疗的效果
2009/05/18
背景与目的:2006年,澳大利亚国家哮喘委员会(NAC)发布了修订版的哮喘治疗指南。新指南对糖皮质激素和长效支气管扩张剂固定剂量联合(FDC)作为哮喘患者初期维持治疗地位的临床意见和试验数据进行了修改。
方法:系统综述NAC和Tasmania大学提供的相关文献,并提出几个问题,包括:对于未经过激素治疗的患者,是否有证据表明FDC是哮喘患者的一线治疗方案。
结果:共有19篇相关文献,包括20个对照实验。未接受激素治疗定义为之前1个月无ICS治疗或从未接受过ICS治疗。未接受激素治疗患者FDC治疗有效,而且不管是否为激素初始治疗,FDC均较同等剂量ICS更为有效。与ICS单独治疗相比,FDC能增加平均FEV1达140 ml,增加平均早晨PEF值 21 L/min,平均晚间PEF 值20 L/min;无症状天数平均增加9.8%,并使急救用药显著下降(减少0.12喷/24 h)。对于需要全身糖皮质激素治疗的患者,FDC与ICS单独治疗相比,在预防患者中途撤药或症状加重上无优势。无论ICS给予相同剂量或加大剂量,FDC治疗与ICS治疗的副作用相似。
结论:FDC治疗作为未使用糖皮质激素治疗患者的一线治疗方案是有效的,并且不论上次ICS治疗后多长时间,FDC治疗在多数临床转归上都优于单独ICS治疗。
(刘国梁 审校)
Seale JP, et al. Respirology. 2008 Dec 11. [Epub ahead of print]
Benefits of fixed-dose combination therapy with inhaled corticosteroids and long-acting bronchodilators as initial maintenance therapy in the management of asthma.
Background and objective: Revised Australian guidelines for asthma management were released by the National Asthma Council (NAC) in 2006. One area where clinical opinion and trial data have changed recently concerns the place of fixed-dose combination (FDC) therapy with inhaled corticosteroid (ICS) and long-acting beta(2)-agonists as initial maintenance therapy.
Methods: A systematic review of the literature commissioned by the NAC and undertaken by the University of Tasmania addressed several questions, including whether there was evidence for the use of FDC therapy as first-line asthma treatment in steroid-naïve patients.
Results: Nineteen relevant studies were identified, from which 20 comparisons contributed to the analyses. The definition of steroid-naïve ranged from no ICS therapy over the preceding 1 month to no ICS therapy ever. FDC therapy was effective in subjects who were steroid-naïve and was more effective than an equivalent dose of ICS, irrespective of the definition of steroid-naïvety. Compared with ICS alone, FDC therapy increased mean FEV(1) by 140 mL, mean morning PEF by 21 L/min and mean evening PEF by 20 L/min. There was a mean increase of 9.8% in symptom-free days, associated with a greater reduction in rescue medication use of -0.12 puff/24 h. FDC therapy was not superior to ICS alone for prevention of withdrawals or exacerbations requiring systemic corticosteroids. Adverse events were similar for FDC therapy and ICS, whether ICS were administered at the same or an increased dose.
Conclusions: FDC therapy is effective as first-line treatment in steroid-naïve subjects and is superior to ICS alone for most outcomes, irrespective of the period of time since last exposure to ICS.
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长效β激动剂:哮喘临床试验中福莫特罗的安全性资料分析
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