Stübner P, Zieglmayer R, Horak F
ENT University Clinic Vienna, Austria.
Curr Med Res Opin. 2004 Jun;20(6):891-902. doi: 10.1185/030079904125003700.
The Vienna Challenge Chamber (VCC) is an established method for the controlled exposure of patients to specific allergens, used to make valid comparisons between antihistamines. The aim of the significantly more than loratadine at all time two placebo-controlled, randomised studies reported here was to compare the efficacy and safety of levocetirizine 5 mg od and loratadine 10 mg od in subjects suffering from seasonal allergic rhinitis (SAR) or perennial allergic rhinitis (PAR).
During each study period, SAR and PAR subjects were exposed to grass pollen or house-dust mite allergens, respectively for 6 h on 2 consecutive days in the VCC. Each day, medications were administered 2 h after the start of the challenge; with a washout of at least 5 days between each period. The main criterion for evaluation of efficacy was the major symptom complex (MSC) for SAR and the complex symptom score (CSS) for PAR.
The pattern of patients' response was similar in SAR and PAR. Both levocetirizine and loratadine were superior to placebo in alleviating SAR and PAR symptoms at all time intervals evaluated during the two study days. Levocetirizine decreased the mean MSC score intervals in SAR subjects, with the most marked difference observed on day 2 (p = 0.002). In PAR patients, although with borderline significance (p = 0.08), levocetirizine decreased the mean CSS more than loratadine. Levocetirizine appeared to have a faster onset of action than loratadine in SAR (45 min versus 1 h 15 min) and PAR (1 h versus 1 h 30 min). However, these apparent differences were not tested for statistical significance. Both medications were well tolerated and no treatment-related adverse events were reported. This level of antihistamine efficacy was maintained regardless of whether the subjects' rhinitis was seasonal or perennial.
This study demonstrated that levocetirizine is superior to loratadine in improving symptoms in SAR and that there is a similar trend in PAR.
维也纳激发试验舱（VCC）是一种使患者受控接触特定过敏原的既定方法，用于在抗组胺药之间进行有效比较。本文报道的两项安慰剂对照随机研究的目的是比较5毫克左西替利嗪每日一次和10毫克氯雷他定每日一次在季节性变应性鼻炎（SAR）或常年性变应性鼻炎（PAR）患者中的疗效和安全性。
在每个研究期间，SAR和PAR受试者在VCC中连续2天每天接触草花粉或屋尘螨过敏原6小时。每天在激发开始后2小时给药；每个周期之间至少有5天的洗脱期。评估疗效的主要标准是SAR的主要症状复合体（MSC）和PAR的复合症状评分（CSS）。
SAR和PAR患者的反应模式相似。在两项研究日评估的所有时间间隔内，左西替利嗪和氯雷他定在减轻SAR和PAR症状方面均优于安慰剂。左西替利嗪降低了SAR受试者的平均MSC评分间隔，在第2天观察到最显著差异（p = 0.002）。在PAR患者中，尽管具有临界显著性（p = 0.08），但左西替利嗪比氯雷他定更能降低平均CSS。在SAR（45分钟对1小时15分钟）和PAR（1小时对1小时30分钟）中，左西替利嗪的起效似乎比氯雷他定更快。然而，这些明显差异未进行统计学显著性检验。两种药物耐受性良好，未报告与治疗相关的不良事件。无论受试者的鼻炎是季节性还是常年性，这种抗组胺药疗效水平均得以维持。
本研究表明，左西替利嗪在改善SAR症状方面优于氯雷他定，在PAR中也有类似趋势。
