Kemp J P, Bernstein I L, Bierman C W, Li J T, Siegel S C, Spangenberg R D, Tinkelman D G
Allergy and Asthma Medical Group and Research Center, San Diego, CA 92123.
Ann Allergy. 1992 Jun;68(6):488-91.
Pemirolast is a new oral, nonbronchodilator antiallergy medication that is being evaluated for the therapy of asthma. In this multicenter, double-blind, randomized study, 96 patients with mild asthma received pemirolast, 50 mg (n = 34); pemirolast, 25 mg (n = 31); or placebo (n = 31) BID for 6 weeks. Patients were evaluated weekly at the research centers; they maintained daily symptom diaries and measured peak expiratory flow rates twice a day. Methacholine challenge was performed at the start and end of the study. Results with pemirolast, 50 mg BID, showed statistically significant decrease in nocturnal symptoms (P = .02), in composite symptom scores (P = .02) and in bronchodilator use (P = .05) when compared with placebo. There were no statistically significant differences between treatments in pulmonary function tests or in methacholine challenge sensitivity. Pemirolast, 25 mg BID, did not differ from placebo. There were no significant adverse effects. Pemirolast, 50 mg BID, demonstrated sufficient antiasthma activity to warrant further studies in patients with more severe asthma and with higher doses.
吡嘧司特是一种新型口服非支气管扩张剂抗过敏药物，目前正处于哮喘治疗评估阶段。在这项多中心、双盲、随机研究中，96例轻度哮喘患者接受了如下治疗：50毫克吡嘧司特（n = 34）；25毫克吡嘧司特（n = 31）；或安慰剂（n = 31），每日两次，共6周。患者每周在研究中心接受评估；他们每天记录症状日记，并每天测量两次呼气峰值流速。在研究开始和结束时进行了乙酰甲胆碱激发试验。与安慰剂相比，50毫克吡嘧司特每日两次治疗的结果显示，夜间症状（P = .02）、综合症状评分（P = .02）和支气管扩张剂使用（P = .05）在统计学上有显著下降。在肺功能测试或乙酰甲胆碱激发试验敏感性方面，各治疗组之间无统计学显著差异。25毫克吡嘧司特每日两次治疗与安慰剂无差异。无显著不良反应。50毫克吡嘧司特每日两次治疗显示出足够的抗哮喘活性，值得在更严重哮喘患者和更高剂量下进行进一步研究。
