【摘要】 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。更多还原

【Abstract】 Objective: To observe the efficacy and safety of fexofenadine in treating seasonal allergic rhinitis (SAR) and chronic idiopathic urticaria (CIU). Methods: In a double-blind, double-dummy, randomized, controlled, multicenter phase Ⅱ clinical trial, the efficacy and safety of fexofenadine (60 mg twice daily) were compared with cetirizine (10 mg/d) in the treatment of SAR and CIU. The duration of treatment was 14 d for patients with SAR and 28 d for patients with CIU. Results: One hundred and forty-four patients with SAR entered the trial. Of the 144 patients, 64 receiving fexofenadine and 68 receiving cetirizine were included in PPS. The symptom score reducing index and overall effective rate in fexofenadine group were 0.719±0.182 and 85.94%, respectively. There were statistically deferences between the fexofenadine group and cetirizine group (P<0.05). One hundred and forty-four patients with CIU entered the trial. Of the 144 patients, 67 receiving fexofenadine and 68 receiving cetirizine were included in PPS. The symptoms score reducing index and overall effective rate in fexofenadine group were 0.771±0.269 and 80.60%, recpectively. There were no marked differences between the two groups (P>0.05). There were no serious adverse reactions in the two groups. The incidence of adverse reactions in the fexofenadine and cetirizine groups was 17.6% and 16.9%, respectively, and there were no significantstastistically deferences between the two groups (P>0.05). The manifestations of adverse reactions in the two groups were similar, and the main of them was drowsiness and dry mouth. There were no obvious changes of ECG after dosing in the two groups, and no significant differences of QTc before and after dosing between the two groups (P>0.05). Conclusion: Fexofenadine is an effective and safe medication for treating seasonal allergic rhinitis and chronic idiopathic urticaria.更多还原