Wahn Ulrich, Meltzer Eli O, Finn Albert F, Kowalski Marek L, Decosta Paola, Hedlin Gunilla, Scheinmann Pierre, Bachert Claus, Rosado Pinto Jose E, Baena-Cagnani Carlos, Potter Paul, Simons F Estelle R, Ruuth Erik
Department of Pediatric Pneumology and Immunology, University Children's Hospital, Berlin, Germany.
J Allergy Clin Immunol. 2003 Apr;111(4):763-9. doi: 10.1067/mai.2003.1384.
This is the first prospective, randomized, double-blind, placebo-controlled study showing statistical improvement of an H(1)-antihistamine in children with seasonal allergic rhinitis in all symptoms throughout the entire treatment period.
This randomized, placebo-controlled, parallel-group, double-blind study was performed to assess the efficacy and safety of fexofenadine in children with seasonal allergic rhinitis.
This study was conducted at 148 centers in 15 countries. Nine hundred thirty-five children (aged 6-11 years) were randomized and treated with either fexofenadine HCl 30 mg (n = 464) or placebo (n = 471) tablets twice a day for 14 days. Individual symptoms (sneezing; rhinorrhea; itchy nose, mouth, throat, and/or ears; itchy, watery, and/or red eyes; and nasal congestion) were assessed at baseline and then daily at 7:00 AM and 7:00 PM (+/-1 hour) during the double-blind treatment period. Each total symptom score was the sum of all symptoms, excluding nasal congestion. The primary efficacy variable was the change from baseline in the average of the daily 12-hour evening reflective total symptom scores throughout the double-blind treatment. Safety was evaluated from adverse-event reporting, vital signs, physical examinations, and clinical laboratory data at screening and study end point.
Fexofenadine was significantly superior to placebo in the primary efficacy analysis (P </=.0001). Individual symptom scores showed statistically significant superiority compared with placebo (P <.05), including nasal congestion in the evening reflective assessment (P <.05). There was no significant difference in adverse events between fexofenadine and placebo, either overall or by causality.
The efficacy and safety of the H(1)-antihistamine fexofenadine has been confirmed in this multicenter, multinational study of children aged 6 to 11 years with seasonal allergic rhinitis.
这是第一项前瞻性、随机、双盲、安慰剂对照研究，表明在整个治疗期间，一种H(1)抗组胺药可使季节性变应性鼻炎儿童的所有症状在统计学上得到改善。
本随机、安慰剂对照、平行组、双盲研究旨在评估非索非那定治疗季节性变应性鼻炎儿童的疗效和安全性。
本研究在15个国家的148个中心进行。935名儿童（6至11岁）被随机分组，每天两次服用30毫克盐酸非索非那定片（n = 464）或安慰剂片（n = 471），持续14天。在基线时评估个体症状（打喷嚏、流涕、鼻、口、喉和/或耳部瘙痒、眼痒、流泪和/或眼红、鼻塞），然后在双盲治疗期间每天上午7:00和下午7:00（±l小时）进行评估。每个总症状评分是所有症状的总和，但不包括鼻塞。主要疗效变量是双盲治疗期间每日12小时晚间反映性总症状评分平均值相对于基线的变化。通过不良事件报告、生命体征、体格检查以及筛查和研究终点时的临床实验室数据评估安全性。
在主要疗效分析中，非索非那定显著优于安慰剂（P≤.0001）。个体症状评分与安慰剂相比具有统计学显著优势（P <.05），包括晚间反映性评估中的鼻塞（P <.05）。非索非那定和安慰剂在不良事件方面总体或按因果关系均无显著差异。
在这项针对6至11岁季节性变应性鼻炎儿童的多中心、跨国研究中，H(1)抗组胺药非索非那定的疗效和安全性得到了证实。
