左西替利嗪可改善生活质量并降低持续性变应性鼻炎长期管理的成本。
Levocetirizine improves quality of life and reduces costs in long-term management of persistent allergic rhinitis.
作者信息
Bachert Claus, Bousquet Jean, Canonica G Walter, Durham Stephen R, Klimek Ludger, Mullol Joaquim, Van Cauwenberge Paul B, Van Hammée Geneviève
机构信息
Department of Oto-Rhino-Laryngology, University Hospital, Ghent, Belgium.
出版信息
J Allergy Clin Immunol. 2004 Oct;114(4):838-44. doi: 10.1016/j.jaci.2004.05.070.
BACKGROUND
Allergic Rhinitis and its Impact on Asthma in collaboration with the World Health Organization initiative reclassified allergic rhinitis, like asthma, by duration and severity. The Xyzal in Persistent Rhinitis Trial is the first large, long-term clinical trial studying patients with persistent rhinitis as defined by Allergic Rhinitis and its Impact on Asthma.
OBJECTIVES
Two primary objectives were defined: comparison of the Rhinoconjunctivitis Quality of Life Questionnaire overall score and Total 5 Symptoms Score (rhinorrhea, sneezing, nasal congestion, and nasal and ocular pruritus) over a period of 4 weeks between levocetirizine 5 mg and placebo. Secondary endpoints included similar evaluations at 1 week and 3, 4.5, and 6 months, summary scores for a general health status questionnaire (Medical Outcomes Survey Short Form 36), a pharmacoeconomic assessment, comorbidities, and a safety evaluation.
METHODS
The Xyzal in Persistent Rhinitis Trial was a 6-month double-blind, placebo-controlled, multicenter, multinational trial in 551 patients. Adults with persistent rhinitis sensitized to both grass pollen and house dust mite were randomized to receive levocetirizine 5 mg/d or placebo.
RESULTS
A total of 421 patients completed the full study. Levocetirizine significantly improved both the Rhinoconjunctivitis Quality of Life Questionnaire overall score and the Total 5 Symptoms Score from week 1 to 6 months (all P values <.001). Medical Outcomes Survey Short Form 36 summary scores were also improved in the levocetirizine group compared with the placebo group. Treatment cessation because of lack of effect, comorbidities, and overall costs of disease, and comorbidities per working patient per month (160.27 vs 108.18) were lower in the levocetirizine group.
CONCLUSION
Levocetirizine was shown to improve quality of life and symptoms and to decrease the overall costs of the disease over the 6-month treatment period.
背景
与世界卫生组织倡议合作开展的“变应性鼻炎及其对哮喘的影响”项目，根据病程和严重程度对变应性鼻炎进行了重新分类，就像对哮喘的分类一样。“开思亭治疗持续性鼻炎试验”是首个针对“变应性鼻炎及其对哮喘的影响”所定义的持续性鼻炎患者开展的大型长期临床试验。
目的
确定了两个主要目标：比较左西替利嗪5毫克与安慰剂在4周时间内的鼻结膜炎生活质量问卷总分及5项症状总分（鼻漏、打喷嚏、鼻塞以及鼻和眼瘙痒）。次要终点包括在1周、3个月、4.5个月和6个月时的类似评估、一般健康状况问卷（医学结局研究简表36）的汇总评分、药物经济学评估、合并症以及安全性评估。
方法
“开思亭治疗持续性鼻炎试验”是一项为期6个月的双盲、安慰剂对照、多中心、跨国试验，共有551例患者参与。对草花粉和屋尘螨均致敏的持续性鼻炎成年患者被随机分配接受左西替利嗪5毫克/天或安慰剂治疗。
结果
共有421例患者完成了整个研究。从第1周到6个月，左西替利嗪显著改善了鼻结膜炎生活质量问卷总分及5项症状总分（所有P值均<.001）。与安慰剂组相比，左西替利嗪组的医学结局研究简表36汇总评分也有所改善。左西替利嗪组因疗效不佳、合并症以及疾病总体费用而停药的情况较少，每位在职患者每月的合并症（160.27对108.18）也较少。
结论
在6个月的治疗期内，左西替利嗪被证明可改善生活质量和症状，并降低疾病的总体费用。
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