Pranlukast dry syrup inhibits symptoms of Japanese cedar pollinosis in children using OHIO Chamber.
Pranlukast dry syrup inhibits symptoms of Japanese cedar pollinosis in children using OHIO Chamber.
复制标题
使用 OHIO Chamber，普仑司特干糖浆可抑制儿童日本雪松花粉病的症状。
DOI：
10.2500/aap.2012.33.3517
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发表时间：
2012
影响因子：
2.8
通讯作者：
K. Okubo
中科院分区：
文献类型：
--
作者：
K. Wakabayashi;K. Hashiguchi;S. Kanzaki;M. Fujioka;Nobuaki Tanaka;K. Kawashima;K. Suematsu;H. Yamamotoya;M. Iwasaki;M. Gotoh;S. Horibe;K. Naito;K. Okubo
普仑司特（PLK）是一种白三烯受体拮抗剂（LTRA），在日本已被批准用于治疗所有年龄段患者的哮喘和成人过敏性鼻炎（AR），但未被批准用于儿童AR。这项随机、双盲、安慰剂对照、交叉研究使用人工暴露室（俄亥俄州Chamber）研究PLK在10至15岁因日本雪松（JC）花粉而患有季节性AR（SAR）的儿童中的疗效和安全性。84例受试者入组并随机分配至治疗组，74例纳入符合方案集中。受试者接受PLK干糖浆（DS）或安慰剂治疗1周。在俄亥俄州室中用JC花粉攻击它们3小时。在暴露期间，每30分钟记录一次总鼻部症状评分（TNSS）。与安慰剂相比，PLK DS治疗显著抑制了TNSS较基线的变化。PLK DS治疗组和安慰剂组之间TNSS的最小二乘均值差异为-0.37（95%CI，-0.54，-0.20），p < 0.0001，表明PLK DS显著抑制鼻部症状。关于特定的鼻部症状，PLK DS显著抑制打喷嚏、鼻涕和鼻塞。PLK DS对鼻塞的影响最为显著，在暴露开始后60分钟开始相对于安慰剂有显著改善。研究期间未报告严重不良事件。在本研究中，PLK DS治疗SAR儿童有效且安全。
Pranlukast (PLK) is a leukotriene receptor antagonist (LTRA) that has been approved for treatment of asthma in patients of all ages and allergic rhinitis (AR) in adults but not for AR in children in Japan. This randomized, double-blind, placebo-controlled, crossover study used an artificial exposure chamber (OHIO Chamber) to investigate the efficacy and safety of PLK in children from 10 to 15 years old with seasonal AR (SAR) due to Japanese cedar (JC) pollen. Eighty-four subjects were enrolled and randomized to the treatment arm and 74 were included in the per protocol set. Subjects received either PLK dry syrup (DS) or placebo for 1 week. They were challenged with JC pollen in the OHIO Chamber for 3 hours. Total nasal symptom scores (TNSSs) were recorded every 30 minutes during the exposure. PLK DS treatment suppressed the TNSS changes from baseline significantly when compared with placebo. The difference in the least square means in TNSS between the PLK DS-treated group and placebo group was -0.37 (95% CI, -0.54, -0.20) with a value of p < 0.0001, showing that PLK DS significantly suppressed the nasal symptoms. Regarding specific nasal symptoms, PLK DS significantly suppressed sneezing, nasal discharge, and nasal obstruction. The effect of PLK DS on nasal obstruction was most prominent, with significant improvement relative to placebo beginning 60 minutes after the start of exposure. No serious adverse events were reported during the study. In this study, PLK DS is effective and safe for treatment in children with SAR.