罗氟司特治疗哮喘：在非安慰剂对照比较和剂量研究中的疗效发现
2015/12/03
摘要
背景：罗氟司特，一种磷酸二酯酶-4抑制剂，在慢性阻塞性肺疾病的治疗中已经有了确切的地位。但是其在哮喘治疗中的潜在作用尚不明确。
目的：我们对7项双盲、平行对照、二期或三期临床研究的结果进行报道，研究比较了哮喘患者给予罗氟司特和其他两个抗炎治疗药物倍氯米松(BDP)和孟鲁司特治疗的结果。
方法：一项从1998年到2005年在欧洲、北美、南非和澳大利亚的309个中心进行的为期6-12周的研究。接受罗氟司特100μg, 250μg 或500μg 每日一次, BDP 400μg或 500μg每日两次或10mg孟鲁司特每日一次的3802例12-70岁患者的研究数据进行分析。主要终点为研究期间第一秒钟用力呼气量(FEV1)时间曲线下面积，次要终点包括用力肺活量、呼气流量峰值、哮喘症状以及急救药物伴发使用的改变。
结果：罗氟司特不劣于BDP和孟鲁司特并且可以使FEV1持续增加。哮喘急救药物的使用和哮喘症状总分均有显著降低，但是组间无显著统计学差异。次要的肺功能终点总体上支持主要终点的结论。
结论：罗氟司特可以改善轻中度哮喘患者的FEV1和哮喘症状，并且与BDP和孟鲁司特相比不劣于这两种药物。作为治疗哮喘的潜在有效抗炎药物，值得对罗氟司特进行进一步的研究。
（杨冬 审校）
PulmPharmacolTher. 2015Oct6.pii:S1094-5539(15)30002-X.doi:10.1016/j.pupt.2015.10.002. [Epub ahead of print]
Roflumilast for asthma: Efficacy findings in non-placebo-controlled comparator and dosing studies.
Bateman ED1, Bousquet J2, Aubier M3, Bredenbröker D4, O'Byrne PM5.
Abstract
BACKGROUND:Roflumilast, a phosphodiesterase-4 inhibitor, has an established place in the treatment of chronic obstructive pulmonary disease. Its potential role as a treatment for asthma is unclear.
AIM:We report the results from seven double-blind, parallel group, phase II or III studies designed to compare roflumilast with two anti-inflammatory treatments, beclomethasone dipropionate (BDP) and montelukast, in patients with asthma.
METHODS:The studies of 6 to 12 week duration were conducted at 309 sites in Europe, North America, South Africa and Australia from 1998 to 2005. Data from 3,802 patients, aged 12-70 years who received either roflumilast 100μg, 250μg or 500μg once daily, BDP 400μg or 500μg twice daily, or 10mg montelukast once daily was analyzed. Primary endpoints were mean change and time averaged excess area under the curve in forced expiratory volume in one second (FEV1) over the duration of the study. Secondary endpoints included change in forced vital capacity and peak expiratory flow, asthma symptoms and the concomitant use of rescue medication.
RESULTS:Roflumilast was non-inferior to BDP and montelukast and consistently increased FEV1. Use of rescue medication and all asthma symptom scores decreased significantly with all treatments, but no statistically significant between-group differences were observed. Secondary lung function endpoints generally supported the conclusions of the primary outcome measure.
CONCLUSIONS:Roflumilast improves FEV1 and asthma symptoms in patients with mild to moderate asthma, and is non-inferior compared with both BDP and montelukast. It deserves further study as a potentially effective anti-inflammatory treatment for asthma.
2015Oct6.pii:S1094-5539(15)30002-X.doi:10.1016/j.pupt.2015.10.002. [Epub ahead of print]
