哮喘联盟

   摘要
   背景：人们对于罗氟司特作为潜在哮喘治疗药物的作用尚不完全了解。临床已经开展了一系列的安慰剂对照试验以研究罗氟司特用于哮喘治疗的安全性和疗效。
   目的：纳入1997年-2005年间的9个随机概念验证性安慰剂对照的II期和III期临床研究，以评估罗氟司特单药治疗和联合治疗时的疗效。
   方法：这些研究是在欧洲、北美洲、南美洲、非洲、大洋洲及亚洲进行的，研究时间从4周到24周不等。对4873例12-70岁患者的数据进行分析，这些患者有2668例接受了罗氟司特治疗。随机患者的1秒用力呼气容积(FEV1)为45-90%。研究了125、250、500μg罗氟司特的疗效，并与安慰剂进行对比。有2个研究在标准治疗（吸入糖皮质激素(ICS)：250μg氟替卡松丙酸酯/400μg二丙酸倍氯米松(BDP)）的基础上加用500μg罗氟司特治疗。有7个研究将FEV1自基线的改变作为主要终点。主要的次要终点包括哮喘症状评分和距第一次哮喘重度急性发作的时间。
   结果：在这9个试验中，与安慰剂相比，罗氟司特持续改善FEV1；在3个试验中，有统计学意义。当与ICS联合使用时，罗氟司特能够进一步改善FEV1；相对于安慰剂/400μg BDP，500μg罗氟司特/400μgBDP对FEV1的改善具有统计学意义。
   结论：这些研究表明罗氟司特可作为一种有效的抗炎药物，用于哮喘的治疗。当与ICS联合使用时，可有更大的获益，这还需进一步的研究。

 

（苏欣 审校）
PulmPharmacolTher. 2015Oct21.pii:S1094-5539(15)30006-7.doi:10.1016/j.pupt.2015.10.006. [Epub ahead of print]


 

Roflumilast for asthma: Efficacy findings in placebo-controlled studies.
 

Meltzer EO1, Chervinsky P2, Busse W3, Ohta K4, Bardin P5, Bredenbröker D6, Bateman ED7.
 

Abstract
BACKGROUND:The role of roflumilast as a potential asthma treatment is not yet fully understood. A series of placebo-controlled trials were undertaken in order to investigate the safety and efficacy of roflumilast inasthma.
AIM:To evaluate the efficacy of roflumilast in nine randomized proof-of-concept, placebo-controlled monotherapy and combination therapy phase II and III clinical studies performed between 1997 and 2005.
METHODS:The studies were conducted at sites in Europe, North and South America, Africa, Australasia and Asia and study length varied from 4 to 24 weeks. Data were analyzed from 4873 patients, 12-70 years of age, of whom 2668 received roflumilast. At randomization patients had a forced expiratory flow (FEV1) of 45-90%. Roflumilast was investigated at doses of 125, 250 and 500 μg versus placebo. In two studies, 500 μg roflumilast was added on top of standard therapy with inhaled corticosteroids (ICS), 250 μg fluticasone propionate, or 400 μg beclomethasone dipropionate (BDP). Improvement in FEV1 from baseline was the primary endpoint in seven studies. Key secondary endpoints included asthma symptom scores and time to first severe exacerbation.
RESULTS:Roflumilast consistently improved FEV1 across the nine studies compared with placebo, reaching statistical significance in three studies. When given in addition to ICS, roflumilast provided additional improvements in FEV1 which was statistically significant for 500 μg roflumilast/400 μg BDP versus placebo/400 μg BDP.
CONCLUSION:Together these studies show that roflumilast has potential as an effective anti-inflammatory therapy for the treatment of asthma. Additional beneficial effects are observed when given in combination with ICS, which warrant further investigation.
 

PulmPharmacolTher. 2015Oct21.pii:S1094-5539(15)30006-7.doi:10.1016/j.pupt.2015.10.006. [Epub ahead of print]