Munk Z M, Gross G N, Hampel F C, Ratner P H
Allergy Center, Inc, Houston, Texas, USA.
Ann Allergy Asthma Immunol. 1997 Mar;78(3):325-31. doi: 10.1016/S1081-1206(10)63190-0.
Seasonal allergic rhinitis is a common and distressing illness for which treatment is often inadequate. There is a clinical need for safe and effective therapeutic options, including preseasonal treatment, to manage many of these patients.
The goal of this study was to evaluate the clinical effects of preseasonal administration of triamcinolone acetonide nasal aerosol in the management of this illness.
This multicenter, double-blind, placebo-controlled, randomized, parallel group study involved otherwise healthy subjects with a 2-year consecutive history of ragweed-induced seasonal allergic rhinitis. Patients were asymptomatic when randomized to receive 220 micrograms triamcinolone acetonide or placebo nasal aerosol (n = 56 each) once daily for 6 weeks, beginning at least 1 week before significant ragweed pollen was airborne.
Triamcinolone acetonide was significantly (P < .001) more effective than placebo in preventing nasal symptoms as determined by mean placebo-adjusted nasal index scores. Patients in the triamcinolone acetonide group had significantly (P < or = .0004) lower scores in the severity of individual nasal symptoms and the overall mean nasal index score. Severity of ocular symptoms was reduced more in the triamcinolone acetonide than in the placebo group (not significant). Physicians' and patients' global evaluations of efficacy favored triamcinolone acetonide, with statistically significant between-group differences in moderate or complete prevention of rhinitis symptoms. The incidence of adverse effects was similar in the two groups, with the most common being headache and increased rhinitis.
This study demonstrates that preseasonal administration of triamcinolone acetonide nasal aerosol is safe and effective for managing seasonal allergic rhinitis.
季节性变应性鼻炎是一种常见且令人苦恼的疾病,其治疗往往并不充分。临床上需要安全有效的治疗选择,包括季前治疗,来管理这类患者中的许多人。
本研究的目的是评估曲安奈德鼻气雾剂季前给药在该疾病管理中的临床效果。
这项多中心、双盲、安慰剂对照、随机、平行组研究纳入了其他方面健康且有连续2年豚草诱发的季节性变应性鼻炎病史的受试者。患者在随机分组时无症状,从豚草花粉大量飘散前至少1周开始,每天接受一次220微克曲安奈德或安慰剂鼻气雾剂(每组n = 56),共6周。
根据平均安慰剂校正鼻指数评分确定,曲安奈德在预防鼻部症状方面显著(P <.001)优于安慰剂。曲安奈德组患者在个体鼻部症状严重程度和总体平均鼻指数评分方面显著(P ≤.0004)更低。曲安奈德组眼部症状的严重程度比安慰剂组减轻得更多(无显著性差异)。医生和患者对疗效的总体评价支持曲安奈德,在中度或完全预防鼻炎症状方面组间差异有统计学意义。两组不良反应发生率相似,最常见的是头痛和鼻炎加重。
本研究表明,曲安奈德鼻气雾剂季前给药对季节性变应性鼻炎的管理是安全有效的。