特非那丁治疗荨麻疹和过敏性鼻炎的多中心双盲试验384例

对760名患有急、慢性荨麻疹,季节性或常年性过敏性鼻炎患者进行临床试验。分特非那丁组(384例)、扑尔敏组(131例)、安慰剂组(245例)。特非那丁和扑尔敏的剂量分别为60mg或4mg,bid,连用1wk。特非那丁组86.7％患者症状有不同程度的改善,而扑尔敏组为74.8％,安慰剂组为23.7％,特非那丁的效果明显优于安慰剂(P<0.01)。其嗜睡的发生率与安慰剂相似,但扑尔敏嗜睡发生率34.4％,显著高于特非那丁(P<0.01)。

Multicenter, double-blind trial of terfenadine in treatment of urticaria and allergic rhinitis in 384 patients

The 760 patients with acute urticaria, chronic urticaria, seasonal rhinitis or perennial rhinitis were divided into terfenadine (n = 384), chlorpheniramine maleate (n = 131), and placebo group (n = 245). Terfenadine 60mg bid or chlorpheniramine maleate 4mg bid was given for 1 wk. Varing degrees of amelioration of symptoms were seen in 86.7% in the terfenadine group as compared to 74.8% in the chlorpheniramine maleate group and 23.7% in. the placebo group. Terfenadine was much more effective than placebo (P<0.01). Incidences of sedation were similar in terfenadine group and placebo group, whereas that in chlorpheniramine maleate was higher (34.4%, P<0.01).