Nathan Robert A, Finn Albert F, LaForce Craig, Ratner Paul, Chapman Douglass, de Guia Emilio C, Hewlett Dial, Kramer Ben
Asthma and Allergy Associates, Colorado Springs 80907, USA.
Ann Allergy Asthma Immunol. 2006 Sep;97(3):389-96. doi: 10.1016/S1081-1206(10)60806-X.
Allergic rhinitis (AR) and asthma are common concurrent conditions.
To evaluate the effects of cetirizine hydrochloride (5 mg)-pseudoephedrine hydrochloride (120 mg) (cetirizine-D) twice daily on AR and asthma symptoms, pulmonary function, and asthma-related quality of life in 274 patients with confirmed seasonal AR and concomitant mild-to-moderate asthma.
In this multicenter, randomized, double-blind, placebo-controlled study, after a 1-week screening period, patients took cetirizine-D or placebo for 4 weeks. The primary efficacy variable, AR total symptom severity complex score, was derived from patient daily diary ratings of sneezing, runny nose, itchy nose, postnasal drip, and nasal congestion. Asthma symptom severity total scores were derived from twice-daily diary ratings of wheezing, coughing, shortness of breath, and chest tightness. Pulmonary function was tested at clinic visits and by patients each morning and evening. Patients completed the Asthma Quality of Life Questionnaire at each visit. All tests were 2-sided, with statistical significance at the .05 level.
Cetirizine-D reduced total symptom severity complex scores by 42.3% overall vs 23.6% with placebo (P < .001). Asthma symptom severity total scores were significantly improved with cetirizine-D at most times vs placebo. Cetirizine-D treatment was also associated with significantly improved Asthma Quality of Life Questionnaire overall scores. Pulmonary function test results were neutral. Cetirizine-D was well tolerated, with discontinuation and adverse event rates similar to placebo. Somnolence occurred in 8 patients (5.8%) taking cetirizine-D and in 1 (0.7%) taking placebo.
Treatment with cetirizine-D twice daily significantly reduced rhinitis and asthma symptoms and improved overall asthma quality of life in patients with seasonal AR and concomitant mild-to-moderate asthma.
过敏性鼻炎（AR）和哮喘是常见的并发疾病。
评估每日两次服用盐酸西替利嗪（5毫克）-盐酸伪麻黄碱（120毫克）（西替利嗪-D）对274例确诊为季节性AR并伴有轻度至中度哮喘患者的AR和哮喘症状、肺功能以及哮喘相关生活质量的影响。
在这项多中心、随机、双盲、安慰剂对照研究中，经过1周的筛查期后，患者服用西替利嗪-D或安慰剂4周。主要疗效变量AR总症状严重程度综合评分来自患者对打喷嚏、流鼻涕、鼻痒、鼻后滴漏和鼻塞的每日日记评分。哮喘症状严重程度总分来自对喘息、咳嗽、呼吸急促和胸闷的每日两次日记评分。在诊所就诊时以及患者每天早晚进行肺功能测试。患者在每次就诊时完成哮喘生活质量问卷。所有测试均为双侧，在0.05水平具有统计学意义。
与安慰剂相比，西替利嗪-D总体上使总症状严重程度综合评分降低了42.3%，而安慰剂为23.6%（P < 0.001）。在大多数时间，与安慰剂相比，西替利嗪-D显著改善了哮喘症状严重程度总分。西替利嗪-D治疗还与哮喘生活质量问卷总体评分的显著改善相关。肺功能测试结果无明显差异。西替利嗪-D耐受性良好，停药率和不良事件发生率与安慰剂相似。服用西替利嗪-D的8例患者（5.8%）和服用安慰剂的1例患者（0.7%）出现嗜睡。
每日两次服用西替利嗪-D可显著减轻季节性AR并伴有轻度至中度哮喘患者的鼻炎和哮喘症状，改善哮喘总体生活质量。
