左西替利嗪和布地奈德治疗持续性变应性鼻炎的临床评估：症状严重程度方面

Clinical assessment of levocetirizine and budesonide in treatment of persistent allergic rhinitis regarding to symptom severity.

作者信息

Kulapaditharom Boonchu, Pornprasertsuk Kannika, Boonkitticharoen Vipa

机构信息

Department of Otolaryngology, Faculty of Medicine, Ramathibodi Hospital, Bangkok, Thailand.

出版信息

J Med Assoc Thai. 2010 Feb;93(2):215-23.

PMID:20302004

Abstract

OBJECTIVE

To compare effectiveness of levocetirizine and budesonide in treatment of persistent allergic rhinitis (PER) in patients with high and low total symptom scores (TSS).

MATERIAL AND METHOD

Randomized, parallel-group study. Patients with PER were randomized to receive levocetirizine 5 mg (n = 50) or budesonide 256 microg (n = 50) daily for 4 week and were followed-up for another 4 weeks post-treatment. TSS combining itching, sneezing, rhinorrhea, daytime and nighttime nasal congestion was recorded daily during and after treatment for an entire period of 8 weeks. Efficacy variables included area under curves depicting reduction and increase in TSSs over time relative to baselines and time to response and symptom relapses.

RESULTS

Symptoms were categorized as high and low using a median TSS of 8 as cutoff. Levocetirizine was as effective in control of high and low symptoms except for time to achieve maximum effect (2 days versus 1 week, respectively, p = 0.002) but was more effective in preventing relapses of high symptoms (p = 0.001). Budesonide was more effective against high than low symptoms (p < 0.001) but showed no difference in preventing relapses. Typical response rate of levocetirizine and budesonide were demonstrated in treatment of high symptoms. Levocetirizine achieved its full effectiveness in 2 days while budesonide required 2 weeks. Budesonide at full effect (after 2 weeks) was superior to levocetirizine (p = 0.004) but comparable for the entire treatment of 4 weeks (p =.059) and was inferior to in preventing relapses (p = 0.001). No such difference could be observed between these drugs in control of low symptoms.

CONCLUSION

The effectiveness of the drug treatment in the present study is dependent of symptom severity. Levocetirizine bases on its rate of response and relapse was superior to budesonide in treatment of the high symptom group and is comparable in the low symptom group.

摘要

目的

比较左西替利嗪和布地奈德在治疗总症状评分（TSS）高和低的持续性变应性鼻炎（PER）患者中的疗效。

材料与方法

随机平行组研究。PER患者被随机分为每日接受5mg左西替利嗪（n = 50）或256μg布地奈德（n = 50）治疗4周，并在治疗后再随访4周。在整个8周期间，每天记录合并瘙痒、打喷嚏、流涕、白天和夜间鼻塞的TSS。疗效变量包括描绘TSS相对于基线随时间减少和增加的曲线下面积以及起效时间和症状复发情况。

结果

以TSS中位数8为界值将症状分为高和低两类。左西替利嗪在控制高、低症状方面同样有效，除了达到最大疗效的时间（分别为2天和1周，p = 0.002），但在预防高症状复发方面更有效（p = 0.001）。布地奈德对高症状的疗效优于低症状（p < 0.001），但在预防复发方面无差异。左西替利嗪和布地奈德在治疗高症状方面显示出典型的有效率。左西替利嗪在2天内达到完全疗效，而布地奈德需要2周。布地奈德在充分起效时（2周后）优于左西替利嗪（p = 0.004），但在整个4周治疗期间相当（p = 0.059），且在预防复发方面较差（p = 0.001）。在控制低症状方面，这些药物之间未观察到此类差异。