Analysis of montelukast in mild persistent asthmatic patients with near-normal lung function
Analysis of montelukast in mild persistent asthmatic patients with near-normal lung function
复制标题
DOI：
10.1053/rmed.2001.1052
复制
发表时间：
2001-05-01
影响因子：
4.3
通讯作者：
Edelman, JM
中科院分区：
文献类型：
--
作者：
Barnes, N;Wei, LX;Edelman, JM
很少有研究专门评估轻度持续性哮喘患者的控制性治疗。我们使用亚组分析来研究孟鲁司特，一种有效的半胱氨酰白三烯受体拮抗剂，对哮喘严重程度较轻的成人患者的影响。我们已经确定了七个双盲、随机的。对患有轻中度慢性哮喘的成人患者进行的安慰剂对照研究中，对孟鲁司特进行了调查，将基线1秒用力呼气量(FEV1)和80%>；75%的患者亚组纳入四个队列(A、B、C、D)，其中包括FEV1无救援天数的变化。评估了β-激动剂的使用、夜间觉醒和血液中嗜酸性粒细胞计数。A-D组分别占21%、8%、11%。和4%。分别来自这些研究的患者。平均治疗前FEV1在81%到84%之间，每天使用β-激动剂2(.)4到4(.)5天(-1)在四个队列中，综合结果显示在所有队列中，孟鲁司特的治疗效果都好于安慰剂。适用于所有终端。在所有队列中，接受孟鲁司特治疗的患者的FEV1显著改善(比基线高7-8%)，与安慰剂相比(比基线高1-4%，组间差异P小于或等于0(.)02)。类似地，孟鲁司特P小于或等于0.02时，无救援天数的百分比比安慰剂组(8-13%)增加得更多。这一亚组分析表明，孟鲁司特改善了轻度持续性哮喘患者的哮喘控制参数，这一点应该在其他前瞻性试验中得到证实。
Few studies have specifically evaluated controller therapy in patients with mild persistent asthma. We used a subgroup analysis to investigate the effects of montelukast, a potent cysteinyl leukotriene receptor antagonist, on adult patients on the milder end of the asthma severity spectrum. We have identified seven double-blind, randomized. placebo-controlled studies of adult patients with mild-to-moderate chronic asthma in which montelukast was investigated, Subsets of patients with baseline forced expiratory volume in 1 sec (FEV1) > 80% > 75% predicted or further restricted by less than daily rescue beta -agonist use were included as four cohorts (A, B, C, D), and efficacy measures, including change in FEV1 rescue-free days. beta -agonist use, nocturnal awakenings and blood eosinophil counts were evaluated. Cohorts A to D comprised 21%, 8%, 11%. and 4%. respectively, of patients from these studies. Mean pretreatment FEV1 ranged from 81% to 84% predicted and daily beta -agonist use from 2(.)4 to 4(.)5 puffs day(-1) in the four cohorts, pooled results demonstrated a treatment effect for montelukast over placebo in all cohorts. For all endpoints. There was a significant improvement in FEV1 in montelukast-treated patients (7-8% over baseline) compared with placebo(1-4% over baseline, between-group difference P less than or equal to0(.)02) for all cohorts. Similarly, the percentage of rescue-free days increased substantially more with montelukast P less than or equal to0.02) than with placebo (8-13%). This subgroup analysis indicates that montelukast produced improvements in parameters of asthma control in patients with milder persistent asthma that should be confirmed in additional prospective trials.