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地氯雷他定可改善过敏性鼻炎患者的生活质量和症状严重程度。

Desloratadine improves quality of life and symptom severity in patients with allergic rhinitis.

作者信息

Pradalier A, Neukirch C, Dreyfus I, Devillier P

机构信息

Department of Internal Medicine, Hôpital Louis Mourier, Colombes Cedex, France.

出版信息

Allergy. 2007 Nov;62(11):1331-4. doi: 10.1111/j.1398-9995.2007.01374.x. Epub 2007 May 23.

Abstract

BACKGROUND

Desloratadine is associated with decreased signs and symptoms and improved nasal airflow in multiple clinical trials in patients with allergic rhinitis (AR). The effect of desloratadine on quality of life (QOL) in AR has not been widely reported to date. We compared the effects of desloratadine and placebo on QOL in seasonal AR using validated, disease-specific measures.

METHODS

This was a multicenter, double-blind, randomized, parallel-group study of desloratadine 5 mg or placebo daily for 2 weeks in patients with symptomatic seasonal AR. QOL was assessed at baseline and at day 14 using the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ). AR signs/symptoms and the global response to therapy were measured at baseline and at day 14; signs/symptoms were also rated AM/PM in patient diaries. Adverse events (AE) were recorded.

RESULTS

Overall 234 patients received desloratadine and 249 received placebo. At day 14 desloratadine was associated with a significantly larger improvement from baseline in the mean total RQLQ score vs placebo (P = 0.0003). Desloratadine also led to significant improvements from baseline in all RQLQ sub-domains (P < or = 0.043). At day 14 significant decreases from baseline were noted in the desloratadine group for total nasal (P = 0.0003), total non-nasal (P = 0.001) and total symptoms scores (P = 0.0001). Morning AR symptoms were significantly decreased in the desloratadine group after 1 day of treatment. Desloratadine was well tolerated, with an AE rate similar to placebo.

CONCLUSION

Significant reductions in signs and symptoms of AR with desloratadine treatment were accompanied by improved disease-specific QOL measures.

摘要

背景

在多项变应性鼻炎(AR)患者的临床试验中,地氯雷他定与体征和症状减轻以及鼻气流改善相关。迄今为止,地氯雷他定对AR患者生活质量(QOL)的影响尚未得到广泛报道。我们使用经过验证的、针对特定疾病的测量方法,比较了地氯雷他定和安慰剂对季节性AR患者QOL的影响。

方法

这是一项多中心、双盲、随机、平行组研究,对有症状的季节性AR患者每日给予5mg地氯雷他定或安慰剂,为期2周。在基线和第14天时,使用鼻结膜炎生活质量问卷(RQLQ)评估QOL。在基线和第14天时测量AR体征/症状以及对治疗的总体反应;体征/症状也在患者日记中按上午/下午进行评分。记录不良事件(AE)。

结果

总体上,234例患者接受了地氯雷他定治疗,249例患者接受了安慰剂治疗。在第14天时,与安慰剂相比,地氯雷他定使平均总RQLQ评分较基线有显著更大的改善(P = 0.0003)。地氯雷他定还使所有RQLQ子域较基线有显著改善(P≤0.043)。在第14天时,地氯雷他定组的总鼻部(P = 0.0003)、总非鼻部(P = 0.001)和总症状评分(P = 0.0001)较基线有显著下降。治疗1天后,地氯雷他定组的早晨AR症状显著减轻。地氯雷他定耐受性良好,AE发生率与安慰剂相似。

结论

地氯雷他定治疗可显著减轻AR的体征和症状,同时改善特定疾病的QOL指标。

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