Storms W, Bronsky E, Findlay S, Pearlman D, Rosenberg S, Shapiro G, Southern L, Tinkelman D, Weakley S, Welch M
Ann Allergy. 1991 Apr;66(4):329-34.
A randomized, double-blind, placebo-controlled, parallel group study was conducted in 11 centers to evaluate the safety and efficacy of a once-a-day regimen of 110 micrograms, 220 micrograms; and 440 micrograms of triamcinolone acetonide intranasal aerosol versus placebo in relieving the symptoms of rhinitis in 305 adult and older pediatric patients with perennial allergic rhinitis. Nasal stuffiness, nasal discharge, sneezing, nasal itching and the nasal index (the sum of the mean scores of the first three symptoms) averaged over the first 6 weeks and second 6 weeks of the study were significantly reduced in patients who received the 220 micrograms/day and the 440 micrograms/day dosages. The 110 micrograms/day group had a reduction in these nasal symptoms, but only the sneezing and nasal index were significantly (P less than .05) better than placebo. During the last 6 weeks of the study, patients were allowed to take oral back-up medication for their nasal symptoms; all three groups receiving triamcinolone nasal aerosol took less back-up medication than did the placebo group. There were no significant adverse effects or laboratory abnormalities noted during this study. Intranasal triamcinolone acetonide 220 micrograms and 440 micrograms, used once-a-day for 12 weeks is clinically and statistically superior to placebo for the treatment of perennial allergic rhinitis.
一项随机、双盲、安慰剂对照、平行组研究在11个中心开展,以评估每日一次使用110微克、220微克和440微克曲安奈德鼻用气雾剂与安慰剂相比,在305例患有常年性变应性鼻炎的成人和大龄儿童患者中缓解鼻炎症状的安全性和有效性。在研究的前6周和后6周,接受220微克/天和440微克/天剂量的患者,鼻阻塞、流涕、打喷嚏、鼻痒以及鼻指数(前三种症状的平均得分总和)均显著降低。110微克/天组的这些鼻部症状有所减轻,但只有打喷嚏和鼻指数显著(P<0.05)优于安慰剂。在研究的最后6周,允许患者针对鼻部症状服用口服备用药物;所有接受曲安奈德鼻气雾剂的三组患者服用的备用药物均少于安慰剂组。在本研究期间未观察到显著的不良反应或实验室异常。每日一次使用220微克和440微克曲安奈德鼻喷雾剂,持续12周,在治疗常年性变应性鼻炎方面在临床和统计学上优于安慰剂。