Allergy Diagnostic and Clinical Research Unit, Department of Medicine, University of Cape Town, Cape Town, South Africa.
Pediatr Allergy Immunol. 2013 Mar;24(2):144-50. doi: 10.1111/pai.12036. Epub 2013 Feb 6.
Allergic rhinitis (AR) is one of the most common chronic diseases in childhood. No large, multicentre clinical trials in children with persistent allergic rhinitis (PER) have previously been performed. Rupatadine, a newer second-generation antihistamine, effective and safe in adults, is a promising treatment for children with AR. The aim of the present study was to evaluate the efficacy and safety of a new rupatadine oral solution in children aged 6-11 yr with PER.
A multicenter, randomized, double-blind, placebo-controlled study was carried out worldwide. Patients between 6 and 11 yr with a diagnosis of PER according to ARIA criteria were randomized to receive either rupatadine oral solution (1 mg/ml) or placebo over 6 wk. The primary efficacy end-point was the change from baseline of the total nasal symptoms score (T4SS) after 4 wk of treatment.
A total of 360 patients were randomized to rupatadine (n = 180) or placebo (n = 180) treatment. Rupatadine showed statistically significant differences vs. placebo for the T4SS reduction both at 4 (-2.5 ± 1.9 vs. -3.1 ± 2.1; p = 0.018) and 6 wk (-2.7 ± 1.9 vs. -3.3 ± 2.1; p = 0.048). Rupatadine also showed a statistically better improvement in the children's quality of life compared with placebo. Adverse reactions were rare and non-serious in both treatment groups. No QTc or laboratory test abnormalities were reported.
Rupatadine oral solution (1 mg/ml) was significantly more effective than placebo in reducing nasal symptoms at 4 and 6 wk and was well tolerated overall. This is the first large clinical report on the efficacy of an H1 receptor antagonist in children with PER in both symptoms and quality of life.
过敏性鼻炎（AR）是儿童中最常见的慢性疾病之一。以前没有针对持续性过敏性鼻炎（PER）的大型多中心临床试验。鲁帕他定是一种新型第二代抗组胺药，在成人中有效且安全，是治疗儿童 AR 的有前途的药物。本研究的目的是评估新型鲁帕他定口服溶液在 6-11 岁 PER 儿童中的疗效和安全性。
进行了一项多中心、随机、双盲、安慰剂对照研究。根据 ARIA 标准诊断为 PER 的 6-11 岁患者随机分为鲁帕他定口服溶液（1mg/ml）或安慰剂组，治疗 6 周。主要疗效终点是治疗 4 周后总鼻部症状评分（T4SS）的变化。
共有 360 例患者随机分为鲁帕他定（n=180）或安慰剂（n=180）治疗组。鲁帕他定与安慰剂相比，T4SS 降低在 4 周（-2.5±1.9 对-3.1±2.1；p=0.018）和 6 周时（-2.7±1.9 对-3.3±2.1；p=0.048）均有统计学差异。鲁帕他定还显著改善了儿童的生活质量。两组不良反应均少见且为非严重不良反应。未报告 QTc 或实验室检查异常。
鲁帕他定口服溶液（1mg/ml）在减少 4 周和 6 周时的鼻部症状方面明显优于安慰剂，总体耐受性良好。这是第一项关于 H1 受体拮抗剂在 PER 儿童中在症状和生活质量方面有效性的大型临床报告。
