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目的:观察非索非那定治疗季节性过敏性鼻炎和慢性特发性荨麻疹的疗效和安全性。方法:采用双盲、双模拟、随机、对照的方法,对非索非那定60mg,2次/d治疗季节性过敏性鼻炎和慢性特发性荨麻疹进行Ⅱ期临床试验,疗程分别为14d和28d;对照药为西替利嗪10mg,1次/d。结果:季节性过敏性鼻炎共入组144例,非索非那定组和西替利嗪组纳入符合方案集者分别为64和68例,非索非那定组症状积分下降指数(SSRI)为0.719±0.182,总有效率为85.94%,与西替利嗪组比差异均有统计学意义(P<0.05)。慢性特发性荨麻疹共入组144例,2组纳入符合方案集者分别为67和68例,非索非那定组SSRI为0.771±0.269,总有效率为80.60%,与西替利嗪组比差异均无统计学意义(P>0.05)。非索非那定组和西替利嗪组均无严重不良事件,2组分别有25例(17.6%)和24例(16.9%)发生不良反应,差异无统计学意义(P>0.05)。2组不良反应的表现相似,主要为困倦和口干。2组用药后的心电图均未见有临床意义的改变,用药后的QT间期(QTc)与用药前比无统计学差异(P>0.05)。结论:非索非那定为治疗季节性过敏性鼻炎和慢性特发性荨麻疹的安全有效的药物。
Objective: To observe the efficacy and safety of fexofenadine in the treatment of seasonal allergic rhinitis and chronic idiopathic urticaria. Methods: A double-blind, double-dummy, randomized, controlled trial of fexofenadine 60 mg twice daily for the treatment of seasonal allergic rhinitis and chronic idiopathic urticaria was carried out in phase Ⅱ clinical trials for 14 days And 28d; control drug cetirizine 10mg, 1 time / d. Results: Of the 144 patients with seasonal allergic rhinitis, 64 and 68 patients were enrolled in the fexofenadine group and cetirizine group, respectively, while those in the fexofenadine group (SSRI) (0.719 ± 0.182), the total effective rate was 85.94%, which was significantly different from cetirizine group (P <0.05). A total of 144 patients with chronic idiopathic urticaria were enrolled in this study. The two groups were 67 and 68, respectively. The SSRI of fexofenadine group was 0.771 ± 0.269 and the total effective rate was 80.60% There was no significant difference between the two groups (P> 0.05). There were no serious adverse events in both the fexofenadine group and the cetirizine group, with adverse reactions in 25 (17.6%) and 24 (16.9%) patients in both groups, with no significant difference (P> 0.05). The two groups showed similar adverse reactions, mainly drowsiness and dry mouth. There were no clinically significant changes in the electrocardiogram of the two groups after treatment. The QTc after administration was not significantly different from that before treatment (P> 0.05). Conclusion: Fexofenadine is a safe and effective drug for the treatment of seasonal allergic rhinitis and chronic idiopathic urticaria.