扎鲁司特可改善中度可逆性气流受限患者的哮喘症状及生活质量。

Zafirlukast improves asthma symptoms and quality of life in patients with moderate reversible airflow obstruction.

作者信息

Nathan R A, Bernstein J A, Bielory L, Bonuccelli C M, Calhoun W J, Galant S P, Hanby L A, Kemp J P, Kylstra J W, Nayak A S, O'Connor J P, Schwartz H J, Southern D L, Spector S L, Williams P V

机构信息

Asthma & Allergy Associates, Colorado Springs, CO, USA.

出版信息

J Allergy Clin Immunol. 1998 Dec;102(6 Pt 1):935-42. doi: 10.1016/s0091-6749(98)70331-8.

DOI:10.1016/s0091-6749(98)70331-8

PMID:9847434

Abstract

BACKGROUND

Previous trials demonstrated the effectiveness of the leukotriene receptor antagonist zafirlukast in patients with mild-to-moderate asthma.

OBJECTIVES

We sought to assess the efficacy and safety of zafirlukast and its effect on patients' quality of life (QOL) during a 13-week, double-blind, placebo-controlled, multicenter trial in adults and adolescents with moderate reversible airflow obstruction.

METHODS

Patients (age range, 12 to 68 years) with total daytime asthma symptoms scores of 10 or greater over 7 consecutive days (maximum, 21/wk), FEV1 45% or greater but less than or equal to 80% of predicted value (>/=6 hours after beta2 -agonist), and reversible airway disease were randomized to 20 mg zafirlukast twice daily (nZ = 231) or placebo twice daily (nP = 223). Efficacy was assessed from changes in daytime and nocturnal symptoms, beta2 -agonist use, nasal congestion score, and pulmonary function. QOL was evaluated with a disease-specific Asthma Quality of Life Questionnaire. Safety was determined from adverse event information and clinical laboratory test results.

RESULTS

Zafirlukast was significantly (P <.001) more effective than placebo, with reductions from baseline in the daytime asthma symptoms score (-23%), nighttime awakenings with asthma (-19%), and beta2 -agonist use (-24%) and improvements from baseline in morning (+25 L/min) and evening (+18 L/min) peak expiratory flow rates. Compared with placebo, zafirlukast significantly (P </=.018) improved scores for QOL domains (activity limitations, symptoms, emotional function, and exposure to environmental stimuli) and overall QOL, with a significantly greater proportion of zafirlukast-treated patients demonstrating clinically meaningful improvements (>/=0.5-unit change from baseline; P </=.037). The safety profile of zafirlukast was clinically indistinguishable from that of placebo.

CONCLUSIONS

Zafirlukast is effective and well tolerated and improves QOL in the long-term treatment of patients with moderate reversible airflow obstruction.

摘要

背景

既往试验证明白三烯受体拮抗剂扎鲁司特对轻至中度哮喘患者有效。

目的

在一项针对患有中度可逆性气流受限的成人和青少年的为期13周的双盲、安慰剂对照、多中心试验中，我们旨在评估扎鲁司特的疗效和安全性及其对患者生活质量（QOL）的影响。

方法

连续7天日间哮喘症状总评分达到10分或更高（最高21分/周）、第一秒用力呼气容积（FEV1）为预测值的45%或更高但小于或等于80%（β2激动剂使用后≥6小时）且患有可逆性气道疾病的患者（年龄范围12至68岁）被随机分为每日两次服用20mg扎鲁司特组（nZ = 231）或每日两次服用安慰剂组（nP = 223）。通过日间和夜间症状、β2激动剂使用情况、鼻塞评分及肺功能的变化评估疗效。使用特定疾病的哮喘生活质量问卷评估生活质量。根据不良事件信息和临床实验室检查结果确定安全性。

结果

扎鲁司特比安慰剂显著更有效（P <.001），日间哮喘症状评分较基线降低（-23%）、哮喘导致的夜间觉醒次数较基线降低（-19%）、β2激动剂使用量较基线降低（-24%），且早晨（+25 L/min）和傍晚（+18 L/min）的呼气峰值流速较基线提高。与安慰剂相比，扎鲁司特显著（P≤.018）改善了生活质量领域（活动受限、症状、情绪功能和暴露于环境刺激）的评分及总体生活质量，接受扎鲁司特治疗的患者中显示出具有临床意义改善（较基线变化≥0.5个单位；P≤.037）的比例显著更高。扎鲁司特的安全性在临床上与安慰剂无差异。