Bronsky E, Boggs P, Findlay S, Gawchik S, Georgitis J, Mansmann H, Sholler L, Wolfe J, Meltzer E, Morris R
AAAA Medical Research Group, Salt Lake City, Utah, USA.
J Allergy Clin Immunol. 1995 Aug;96(2):139-47. doi: 10.1016/s0091-6749(95)70001-3.
The treatment of symptoms of seasonal allergic rhinitis often requires the use of a decongestant to improve nasal congestion, along with an antihistamine to adequately control other nasal, as well as nonnasal symptoms.
In this double-blind, placebo-controlled, multicenter study, 874 patients with moderate to severe symptoms of seasonal allergic rhinitis were treated with one of the following: SCH 434 QD (a combination of 10 mg of loratadine in the coating and 240 mg of pseudoephedrine sulfate in an extended-release core) once daily, 10 mg of loratadine once daily, 120 mg of pseudoephedrine sulfate every 12 hours, or placebo for 2 weeks.
SCH 434 QD was consistently superior to placebo in controlling the symptoms of seasonal allergic rhinitis. Composite symptom scores (total, total nasal, and total nonnasal) were reduced significantly in patients treated with SCH 434 QD as compared with placebo (p < 0.01). When compared with its individual components, reductions in mean symptom scores were consistently greater, numerically, in patients treated with SCH 434 QD than in patients who were treated with either loratadine or pseudoephedrine alone. SCH 434 QD was superior to pseudoephedrine in reducing nonnasal symptoms at all time points (p < 0.01), and superior to loratadine in relieving nasal stuffiness at end point (p < 0.01). In the physicians' evaluation of therapeutic response, the SCH 434 QD group had the greatest number of patients with a good or excellent response at end point (58%). All treatments were generally well tolerated with no serious or unusual adverse events. Insomnia and nervousness, adverse events commonly associated with pseudoephedrine, were noted in a significantly greater number of patients treated with SCH 434 QD or pseudoephedrine (p < or = 0.04) as compared with those treated with loratadine or placebo.
The results of the study demonstrate that SCH 434 QD is more effective than placebo or either of its components alone in the treatment of seasonal allergic rhinitis.
季节性变应性鼻炎症状的治疗通常需要使用减充血剂来改善鼻充血，同时使用抗组胺药来充分控制其他鼻部及非鼻部症状。
在这项双盲、安慰剂对照、多中心研究中，874例中重度季节性变应性鼻炎症状患者接受以下治疗之一：SCH 434 QD（包衣中含10 mg氯雷他定和缓释核心中含240 mg硫酸伪麻黄碱的复方制剂）每日1次，氯雷他定10 mg每日1次，硫酸伪麻黄碱120 mg每12小时1次，或安慰剂，疗程2周。
在控制季节性变应性鼻炎症状方面，SCH 434 QD始终优于安慰剂。与安慰剂相比，接受SCH 434 QD治疗的患者综合症状评分（总计、鼻部总计和非鼻部总计）显著降低（p < 0.01）。与单一成分相比，接受SCH 434 QD治疗的患者平均症状评分的降低在数值上始终大于单独接受氯雷他定或伪麻黄碱治疗的患者。在所有时间点，SCH 434 QD在减轻非鼻部症状方面优于伪麻黄碱（p < 0.01），在终点时缓解鼻阻塞方面优于氯雷他定（p < 0.01）。在医生对治疗反应的评估中，SCH 434 QD组在终点时有良好或优秀反应的患者数量最多（58%）。所有治疗总体耐受性良好，未出现严重或异常不良事件。与接受氯雷他定或安慰剂治疗的患者相比，接受SCH 434 QD或伪麻黄碱治疗的患者中出现失眠和紧张（通常与伪麻黄碱相关的不良事件）的人数显著更多（p ≤ 0.04）。
研究结果表明，在治疗季节性变应性鼻炎方面，SCH 434 QD比安慰剂或其单一成分更有效。
