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西替利嗪和氯雷他定治疗2至6岁常年性变应性鼻炎儿童的双盲对照研究

Double-blind comparison of cetirizine and loratadine in children ages 2 to 6 years with perennial allergic rhinitis.

作者信息

Sienra-Monge J J, Gazca-Aguilar A, Del Rio-Navarro B

机构信息

Pulmonology and Allergy Department, Hospital Infantil de Mexico Federico Gómez, Mexico.

出版信息

Am J Ther. 1999 May;6(3):149-55. doi: 10.1097/00045391-199905000-00005.

DOI:10.1097/00045391-199905000-00005
PMID:10423657
Abstract

Antihistamines are the pharmacologic cornerstone of treatment for allergic rhinitis. The comparative effects of the newer, more specific H (1) -antagonists cetirizine and loratadine among younger patients are not well characterized. The efficacy and safety of cetirizine and loratadine were compared in a prospective, randomized, double-blind, longitudinal, parallel-group study of 80 children, 2 to 6 years of age, with perennial allergic rhinitis caused by house dust mites or plant pollens (verified by a radioallergosorbent or skin test). Patients received cetirizine or loratadine at 0.2 mg/kg once daily in the morning for 28 days. Histamine skin tests and eosinophil counts from nasal smears were performed at baseline and at the end of treatment. Individual rhinitis symptoms were assessed by the investigator at baseline and on day 28 and by parents at baseline and daily in symptom diaries. Global assessments were made by using a visual analog scale at baseline and at the end of treatment. Cetirizine produced significantly greater inhibition of the wheal response compared with loratadine (P <.0001). Eosinophil counts were improved to a comparable degree with both agents. Cetirizine and loratadine produced comparable improvements in symptoms and according to a global evaluation as assessed by the investigator at the end of treatment. Both agents produced substantial symptomatic relief according to patients' daily diary assessments; however, cetirizine was more effective than loratadine in relieving the symptoms of rhinorrhea, sneezing, nasal obstruction, and nasal pruritus (P <. 0001). Both treatments were well tolerated; two patients receiving cetirizine were dropped from the study because of adverse events. Cetirizine and loratadine provided effective, well-tolerated relief of the symptoms of perennial allergic rhinitis in small children. Cetirizine was more effective than loratadine in inhibiting the wheal response to histamine challenge and afforded greater reductions in most individual symptoms assessed daily by the parent.

摘要

抗组胺药是治疗变应性鼻炎的药理学基石。新型、更具特异性的H(1)拮抗剂西替利嗪和氯雷他定在年轻患者中的比较效果尚未得到充分描述。在一项针对80名2至6岁因屋尘螨或植物花粉引起常年性变应性鼻炎(经放射变应原吸附试验或皮肤试验证实)儿童的前瞻性、随机、双盲、纵向、平行组研究中,比较了西替利嗪和氯雷他定的疗效及安全性。患者每天早晨接受一次0.2 mg/kg的西替利嗪或氯雷他定治疗,持续28天。在基线期和治疗结束时进行组胺皮肤试验和鼻涂片嗜酸性粒细胞计数。研究者在基线期和第28天评估个体鼻炎症状,家长在基线期和每天通过症状日记评估症状。在基线期和治疗结束时使用视觉模拟量表进行总体评估。与氯雷他定相比,西替利嗪对风团反应的抑制作用显著更强(P<.0001)。两种药物使嗜酸性粒细胞计数改善程度相当。根据研究者在治疗结束时的总体评估,西替利嗪和氯雷他定在症状改善方面相当。根据患者的每日日记评估,两种药物均能显著缓解症状;然而,在缓解流涕、打喷嚏、鼻塞和鼻痒症状方面,西替利嗪比氯雷他定更有效(P<.0001)。两种治疗耐受性均良好;两名接受西替利嗪治疗的患者因不良事件退出研究。西替利嗪和氯雷他定能有效、耐受性良好地缓解小儿常年性变应性鼻炎的症状。在抑制组胺激发试验的风团反应方面,西替利嗪比氯雷他定更有效,并且在家长每天评估大多数个体症状时,西替利嗪能使症状减轻得更多。

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