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曲安奈德水性鼻喷雾剂治疗季节性变应性鼻炎的疗效与安全性

Efficacy and safety of triamcinolone acetonide aqueous nasal spray in patients with seasonal allergic rhinitis.

作者信息

Munk Z M, LaForce C, Furst J A, Simpson B, Feiss G, Smith J A

机构信息

Rhône-Poulenc Rorer, Collegeville, Pennsylvania, USA.

出版信息

Ann Allergy Asthma Immunol. 1996 Oct;77(4):277-81. doi: 10.1016/S1081-1206(10)63320-0.

DOI:10.1016/S1081-1206(10)63320-0
PMID:8885803
Abstract

BACKGROUND

In order to accommodate increasing patient preferences a new aqueous formulation of triamcinolone acetonide nasal spray was developed for the relief of symptoms associated with seasonal and perennial allergic rhinitis.

OBJECTIVE

This multicenter, randomized, double-blind study was designed to compare the efficacy and safety of once-daily triamcinolone acetonide aqueous nasal spray (220 micrograms/day) with placebo in relieving the symptoms of seasonal allergic rhinitis due to ragweed.

METHODS

One hundred forty patients received either a once daily 220-microgram dose of triamcinolone acetonide aqueous nasal spray or placebo for 2 weeks. Patients evaluated the severity of seasonal allergic rhinitis symptoms daily for 2 weeks according to a 4-point scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Physician and patient global evaluations of overall treatment effectiveness were assessed at the end of the treatment period.

RESULTS

Patients receiving triamcinolone acetonide aqueous nasal spray, 220 micrograms/day, had significantly (P < .05) greater improvements in all rhinitis symptoms at weeks 1 and 2 and overall for the 2-week treatment period compared with the placebo group. A significant (P = .006) improvement in the nasal index occurred as early as 12 hours after the first dose of triamcinolone acetonide aqueous nasal spray. Both patients and physicians reported a greater overall improvement in symptoms for the triamcinolone acetonide aqueous nasal spray group. There were no differences between the two treatment groups in the incidence of adverse events.

CONCLUSIONS

This study confirmed that a 220-microgram dose of triamcinolone acetonide aqueous nasal spray, administered once daily for 2 weeks, is well tolerated and reduces effectively the severity of symptoms of seasonal allergic rhinitis due to ragweed.

摘要

背景

为了满足患者日益增长的偏好,研发了一种新的曲安奈德鼻喷雾剂水性制剂,用于缓解季节性和常年性过敏性鼻炎相关症状。

目的

本多中心、随机、双盲研究旨在比较每日一次的曲安奈德水性鼻喷雾剂(220微克/天)与安慰剂在缓解豚草引起的季节性过敏性鼻炎症状方面的疗效和安全性。

方法

140名患者接受每日一次220微克剂量的曲安奈德水性鼻喷雾剂或安慰剂治疗,为期2周。患者在2周内每天根据4分制量表(0 = 无,1 = 轻度,2 = 中度,3 = 重度)评估季节性过敏性鼻炎症状的严重程度。在治疗期结束时评估医生和患者对总体治疗效果的整体评价。

结果

与安慰剂组相比,接受每日220微克曲安奈德水性鼻喷雾剂治疗的患者在第1周和第2周以及整个2周治疗期内,所有鼻炎症状均有显著(P <.05)改善。在首次使用曲安奈德水性鼻喷雾剂后12小时,鼻指数就出现了显著(P =.006)改善。患者和医生均报告曲安奈德水性鼻喷雾剂组的症状总体改善更大。两个治疗组在不良事件发生率方面没有差异。

结论

本研究证实,每日一次给予220微克剂量的曲安奈德水性鼻喷雾剂,持续2周,耐受性良好,并能有效减轻豚草引起的季节性过敏性鼻炎症状的严重程度。

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