摘要目的：比较肥大细胞膜稳定剂吡嘧司特钾片和曲尼司特片治疗支气管哮喘(简称哮喘)和过敏性鼻炎的临床疗效及其安全性。方法在132例哮喘和144例过敏性鼻炎患者中，以曲尼司特片为对照药，采用随机分组、双模拟双盲、多中心平行对照的方法进行了为期1年的临床研究。结果①6周后两组哮喘患者的 FEV1%pred、FEV1%pred 上升率、峰值呼气流速、喘息症状记分、夜间喘息次数、临控率和有效率之间的差异均无统计学意义(P >0.05)，但治疗后第6周试验组哮喘患者按需使用喘康速次数少于对照组(P <0.05)。②两组过敏性鼻炎患者治疗后第2周末和第4周末的总积分及其下降率、临控率、有效率的差异均无统计学意义(P >0.05)。③试验组和对照组患者不良事件和不良反应发生率之间的差异无统计学意义(P >0.05)。结论吡嘧司特钾片治疗哮喘和过敏性鼻炎的疗效与安全性均与对照药曲尼司特相似。

abstractsObjective To analyze the efficacy and safety of pemirolast potassium in comparison with tranilast for bronchial asthma and allergic rhinitis.Methods A multicenter,randomized,double-blind,double-dummy,parallel-group,one-year treatment study was conducted.A total of 132 patients with asthma and 144 patients with allergic rhinitis were given pemirolast potassium or tranilast.Results ①After treatment for six weeks,there was no statistical significance in FEV1 %pred,the rate of increase of FEV1 %pred,peak expiratory flow,the average wheezing score,nocturnal wheezing,the rate and efficiency of clinical control in the patients treated with either pemirolast potassium or tranilast (P > 0.05 ) However,compared with patients treated with tranilast,volunteers administrated with pemirolast potassium required significantly few terbutaline (P < 0.05 ).② For the patients with allergic rhinitis receiving either pemirolast potassium or tranilast,the total score and the ratio of decline,the ratio and efficiency of clinical control were not significantly different (P >0.05 ).③The ratio of side effects and adverse reactions of pemirolast potassium or tranilast in the treatment of patients with bronchial asthma or allergic rhinitis were not significantly different (P > 0.05 ).Conclusions The clinical efficiency and&nbsp;safety for pemirolast potassium or tranilast in the treatment of patients with bronchial asthma or allergic rhinitis are similar.