扎鲁司特治疗哮喘的临床疗效和安全性观察

Clinical study of efficacy and safety of zafirlukast on asthma

目的 探讨扎鲁司特对哮喘患者的疗效和安全性。方法 对３９０ 例哮喘患者进行开放性、非对照、多中心研究， 观察病人用药前及用药后肺功能、哮喘自觉症状、不良反应。结果 扎鲁司特使病人的ＦＥＶ１ 由治疗前的２－１１Ｌ 上升至治疗后２－２８Ｌ， 晨间ＰＥＦ（ＰＥＦａｍ） 从３１５－２２Ｌ／ｍｉｎ 升至３５０－２７Ｌ／ｍｉｎ， 上述肺功能及用药后哮喘症状评分、夜间憋醒次数、无症状天数、吸入性β２ 受体激动剂用量与用药前相比， 均明显改善， Ｐ＜ ０－０１。可疑药物不良反应发生率２－１％ ， 主要是消化道不适和头痛。结论 扎鲁司特可提高哮喘患者的肺功能， 改善哮喘症状， 具有良好的安全性。

Objective To investigate the efficacy and safety of zafirlukast on asthmatic patients.Methods The pulmonary function, asthmatic symptoms and adverse effects of 390 asthmatic patients after zafirlukast administration were compared with those of pre-treatment in an open-label, non-comparative, multi-center clinical trial.Results FEV 1 increased from 2 11L(pre-treatment)to 2 28L(post-treatment), morning PEF increased from 315 22L/min to 350 27L/min, and the asthma symptom scores, night-time awakenings, symptom-free days, inhaled β 2-agonist use significantly improved after treatment comparing with baseline(P<0 01) The rate of suspected adverse effects was 2 1% with the common symptoms as gastrointestinal disorder and headache.Conclusion Zafirlukast could improve the pulmonary function and symptoms in asthma patients with good tolerability.