Nelson H S, Reynolds R, Mason J
National Jewish Medical and Research Center, Denver, Colorado 80206, USA.
Ann Allergy Asthma Immunol. 2000 May;84(5):517-22. doi: 10.1016/S1081-1206(10)62515-X.
Fexofenadine is a nonsedating antihistamine approved for treatment of seasonal allergic rhinitis.
This dose-finding study assessed the safety and efficacy of fexofenadine in chronic idiopathic urticaria.
The 4-week, double-blind, randomized, placebo-controlled study included patients diagnosed with chronic urticaria who had moderate to severe pruritus. Patients received twice daily oral doses of placebo or fexofenadine HCl (20, 60, 120, or 240 mg) at 7 AM and 7 PM. Patients recorded scores for pruritus severity and number of wheals (over the previous 12 hours) in a daily diary. Efficacy variables included mean daily changes from baseline in pruritus severity, number of wheals, and interference with sleep and daily activities due to urticaria.
Patients (N = 418) from 37 investigative sites were included. All four fexofenadine HCl doses were statistically superior to placebo (P < or = .0115) for reducing pruritus and number of wheals scores over the 4-week treatment period. There were greater reductions in urticaria symptoms in the 60 mg fexofenadine HCl group than in the 20 mg group, while similar reductions were observed in the 60, 120, and 240 mg dose groups. Additionally, patients receiving fexofenadine experienced significantly less interference with sleep and daily activities than patients receiving placebo (P < or = .0014). Adverse events occurred with similar incidence in all treatment groups, with no dose-related increases in any event.
Fexofenadine HCl significantly reduced pruritus severity, number of wheals, and interference with sleep and normal daily activities in patients with chronic urticaria compared with placebo. Twice-daily doses of 60 mg or greater were most effective.
非索非那定是一种非镇静性抗组胺药，已被批准用于治疗季节性变应性鼻炎。
本剂量探索性研究评估了非索非那定治疗慢性特发性荨麻疹的安全性和有效性。
这项为期4周的双盲、随机、安慰剂对照研究纳入了诊断为慢性荨麻疹且有中度至重度瘙痒的患者。患者于上午7点和晚上7点每日口服两次安慰剂或盐酸非索非那定（20、60、120或240毫克）。患者在每日日记中记录瘙痒严重程度评分和风团数量（过去12小时内）。疗效变量包括瘙痒严重程度、风团数量以及荨麻疹对睡眠和日常活动的干扰较基线的每日平均变化。
纳入了来自37个研究地点的418例患者。在4周治疗期内，所有四种盐酸非索非那定剂量在减轻瘙痒和风团数量评分方面在统计学上均优于安慰剂（P≤0.0115）。盐酸非索非那定60毫克组的荨麻疹症状减轻程度大于20毫克组，而60、120和240毫克剂量组的减轻程度相似。此外，与接受安慰剂的患者相比，接受非索非那定的患者睡眠和日常活动受到的干扰明显更少（P≤0.0014）。所有治疗组不良事件发生率相似，未观察到任何事件与剂量相关的增加。
与安慰剂相比，盐酸非索非那定显著减轻了慢性荨麻疹患者的瘙痒严重程度、风团数量以及对睡眠和正常日常活动的干扰。每日两次60毫克或更高剂量最为有效。
