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接受地氯雷他定治疗的慢性特发性荨麻疹成年患者的生活质量:一项随机、双盲、多中心、安慰剂对照研究。

Quality of life in adults with chronic idiopathic urticaria receiving desloratadine: a randomized, double-blind, multicentre, placebo-controlled study.

作者信息

Grob J J, Auquier P, Dreyfus I, Ortonne J P

机构信息

Service de Dermatologie, Hôpital Ste Marguerite and Faculté de Médicine, Marseille, France.

出版信息

J Eur Acad Dermatol Venereol. 2008 Jan;22(1):87-93. doi: 10.1111/j.1468-3083.2007.02385.x.

Abstract

OBJECTIVE

To assess the effect of desloratadine on quality of life (QoL) in chronic idiopathic urticaria (CIU).

STUDY POPULATION

Patients with a history of CIU (pruritus and weals lasting = 6 weeks) were included in this multicentre, randomized, double-blind placebo-controlled study that took place in dermatology centres throughout France. During the study, patients were randomized to receive desloratadine 5 mg daily or placebo for 42 days.

MAIN OUTCOME MEASURES

Variation of the scores of two QoL dermatology-specific tools between baseline and day 42, the French translation version of the Dermatology Life Quality Index (DLQI) and the VQ-Dermato (a French-language scoring instrument).

RESULTS

The intent-to-treat population comprised 137 patients [desloratadine (n = 65) or placebo (n = 72)]. Desloratadine treatment was associated with significantly greater improvements from baseline to day 42 compared with placebo in DLQI overall score (-6 vs. -2.2 points; P < 0.002) and VQ-Dermato score (18.5 vs. 29.1 points; P = 0.009). Mean scores for sleep disruption and disruption of daily activities were significantly lower in the desloratadine group than in the placebo group from day 1 to the end of the study.

CONCLUSIONS

Desloratadine 5 mg/day was associated with significant improvements in two separate dermatology-specific measures of QoL in patients with CIU. QoL proved to be a relevant primary outcome measure for therapeutic trials in CIU.

摘要

目的

评估地氯雷他定对慢性特发性荨麻疹(CIU)患者生活质量(QoL)的影响。

研究人群

有CIU病史(瘙痒和风团持续≥6周)的患者纳入了这项在法国各地皮肤科中心进行的多中心、随机、双盲、安慰剂对照研究。在研究期间,患者被随机分配接受每日5毫克地氯雷他定或安慰剂治疗42天。

主要观察指标

两种皮肤科专用生活质量工具在基线和第42天之间的评分变化,即皮肤病生活质量指数(DLQI)的法语翻译版本和VQ-Dermato(一种法语评分工具)。

结果

意向性分析人群包括137例患者[地氯雷他定组(n = 65)或安慰剂组(n = 72)]。与安慰剂相比,地氯雷他定治疗从基线到第42天在DLQI总分(-6分对-2.2分;P < 0.002)和VQ-Dermato评分(18.5分对29.1分;P = 0.009)方面有显著更大的改善。从第1天到研究结束,地氯雷他定组睡眠障碍和日常活动干扰的平均评分显著低于安慰剂组。

结论

每日5毫克地氯雷他定可使CIU患者在两种独立的皮肤科专用生活质量测量指标上有显著改善。生活质量被证明是CIU治疗试验的一个相关主要观察指标。

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