Condemi J, Schulz R, Lim J
University of South Carolina, Columbia, USA.
Ann Allergy Asthma Immunol. 2000 May;84(5):533-8. doi: 10.1016/S1081-1206(10)62518-5.
The new aqueous formulation of triamcinolone acetonide (TAA) was compared with loratadine in patients with seasonal allergic rhinitis.
The primary objective of the study was to compare the safety and efficacy of TAA aqueous with loratadine in relieving the symptoms of seasonal allergic rhinitis.
A total of 351 patients were enrolled into this 4-week, double-blind, double-dummy, randomized, parallel group study. Patients received either TAA aqueous nasal spray (220 microg) or loratadine (10 mg) once daily. Efficacy variables were rhinitis symptom changes from baseline, physician global evaluations, and the patient dropout rate due to insufficient treatment effect. Safety and quality of life also was evaluated.
Both TAA aqueous-treated and loratadine-treated patients had improvement in symptoms as early as day 1. Overall, TAA aqueous was significantly (P < .05) more effective than loratadine in reducing total nasal symptoms and individual symptoms of nasal congestion, nasal itch, and sneezing. Ocular symptoms improved from baseline in both groups. There was no statistically significant difference between groups based on physician global evaluation. A similar number of patients in each group discontinued the study due to ineffective treatment. Triamcinolone acetonide aqueous patients maintained a significantly (P < .05) better quality of life in three of the dimensions (activity, nasal symptoms, and practical problems) and for overall quality of life. There were no differences between the two treatment groups in the incidence of adverse events, none of which were clinically significant.
Both TAA aqueous and loratadine were effective and well-tolerated in the treatment of patients with seasonal allergic rhinitis. Triamcinolone acetonide aqueous was significantly (P < .05) more effective than loratadine in controlling nasal symptoms of seasonal allergic rhinitis and maintaining a better quality of life for the patients.
将曲安奈德（TAA）新的水性制剂与氯雷他定用于季节性变应性鼻炎患者进行比较。
本研究的主要目的是比较TAA水性制剂与氯雷他定在缓解季节性变应性鼻炎症状方面的安全性和有效性。
共有351例患者纳入这项为期4周的双盲、双模拟、随机、平行组研究。患者每日接受一次TAA水性鼻喷雾剂（220微克）或氯雷他定（10毫克）治疗。疗效变量包括鼻炎症状相对于基线的变化、医生整体评估以及因治疗效果不佳导致的患者退出率。还评估了安全性和生活质量。
早在第1天，TAA水性制剂治疗组和氯雷他定治疗组的症状均有改善。总体而言，在减轻总鼻部症状以及鼻塞、鼻痒和打喷嚏等个体症状方面，TAA水性制剂比氯雷他定显著更有效（P <.05）。两组的眼部症状均较基线有所改善。基于医生整体评估，两组之间无统计学显著差异。每组中因治疗无效而停止研究的患者数量相似。曲安奈德水性制剂组患者在三个维度（活动、鼻部症状和实际问题）以及总体生活质量方面维持了显著更好的生活质量（P <.05）。两个治疗组在不良事件发生率方面无差异，且均无临床意义。
TAA水性制剂和氯雷他定在治疗季节性变应性鼻炎患者方面均有效且耐受性良好。在控制季节性变应性鼻炎的鼻部症状和为患者维持更好的生活质量方面，曲安奈德水性制剂比氯雷他定显著更有效（P <.05）。
