日本患者哮喘急性加重时静脉给予孟鲁司特治疗的疗效和耐受性
2012/11/09
摘要
目的:在日本,哮喘预防和治疗指南推荐采用β-受体激动剂雾化剂、静脉(IV)糖皮质激素和静脉氨茶碱治疗急性哮喘。然而,目前针对急性哮喘的治疗对于一些患者无效。本试验在日本哮喘急性加重的患者中,评价标准治疗联合静脉孟鲁司特治疗的疗效和安全性。
方法:本试验为一项多中心、随机、双盲和平行分组研究,比较静脉给予孟鲁司特(7 mg、14 mg)和安慰剂治疗日本的哮喘急性加重患者(N = 242)。在筛查阶段(≤60 min),15-65岁急性哮喘患者采用标准治疗。FEV1≤70%预测值的患者随机分为3组。主要的终点为给药60 min内时间加权的FEV1平均变化[ΔFEV1 (0-60 min)]。次要终点包括20、40和120 min内时间加权的FEV1平均变化[ΔFEV1 (0-T min)]。
结果:与安慰剂相比,静脉7 mg孟鲁司特治疗能更有效的改善时间加权的平均ΔFEV1 (0-60 min)[最小二乘(LS)均数:0.09 L vs. 0.01 L; P<0.0]。与安慰剂相比,静脉14 mg孟鲁司特治疗更为有效(LS均数:0.17 L; p < .001)。其他时间加权的FEV1平均变化改善与前述类似(p < 0.05)。给药10 min内,与安慰剂相比,两种剂量的孟鲁司特静脉治疗能显著增加平均ΔFEV1(P<0.001至<0.01)。静脉孟鲁司特治疗的耐受性与安慰剂类似。
结论:静脉给予孟鲁司特治疗较安慰剂能更有效的改善日本哮喘患者的ΔFEV1,表明孟鲁司特可作为哮喘急性加重时治疗的一个辅助药物,有望加入现有哮喘指南的推荐措施中。
(苏楠 审校)
J Asthma. 2012 Aug;49(6):649-56. Epub 2012 Jun 28.
The efficacy and tolerability of intravenous montelukast in acute asthma exacerbations in Japanese patients.
Adachi M, Taniguchi H, Tohda Y, Sano Y, Ishine T, Smugar SS, Hisada S.
Source
First Department of Internal Medicine, Showa University School of Medicine , Tokyo , Japan.
Abstract
OBJECTIVES:In Japan, the Asthma Prevention and Management Guidelines recommend nebulized β-agonists, IV (intravenous) drip corticosteroids, as well as IV drip aminophylline for acute asthma treatment. However, current treatment for acute asthma provides inadequate benefit for some patients. We evaluated the efficacy and safety of IV montelukast added to standard therapy in Japanese patients with acute asthma exacerbations.
METHODS:This multicenter, randomized, double-blind, parallel-group study compared IV montelukast 7 mg, 14 mg, and placebo in Japanese patients with acute asthma exacerbations (N = 242). Fifteen- to sixty-five-year-old patients with acute asthma were treated with standard care during a screening period that lasted ≤60 minutes. Patients with FEV(1) (forced expiratory volume in 1 second) ≤70 predicted were randomly allocated to one of three treatment groups. The primary end point was the time-weighted average change in FEV(1) from baseline over 60 minutes [ΔFEV(1) (0-60 minutes)] after study drug administration. Secondary end points included the time-weighted average change in FEV(1) over 20, 40, and 120 minutes [ΔFEV(1) (0-T min)].
RESULTS:IV montelukast 7 mg was significantly more effective than placebo for the time-weighted average ΔFEV(1) (0-60 minutes) [least squares (LS) mean 0.09 L vs. 0.01 L; p < .05]. IV montelukast 14 mg was also more effective than placebo (LS mean 0.17 L; p < .001). Similar improvements in time-weighted average [ΔFEV(1) (0-T min)] were seen at all time points (all p < .05). Both doses of IV montelukast demonstrated a significant increase in average ΔFEV(1) compared with placebo within 10 minutes of administration (p < .001 to p < .01). The tolerability of IV montelukast was similar to that of placebo.
CONCLUSION:IV montelukast was significantly more effective than placebo in the improvement of ΔFEV(1) in Japanese patients, suggesting its role as an adjunctive therapy to existing guideline recommendations.
J Asthma. 2012 Aug;49(6):649-56. Epub 2012 Jun 28.
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成人阻塞性睡眠呼吸暂停及其风险与日间哮喘的相关性
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短程普仑司特联合全身糖皮质激素对上呼吸道感染诱发的急性哮喘加重的治疗作用