Selner J C, Weber R W, Richmond G W, Stricker W E, Norton J D
Allergy Respiratory Institute of Colorado, Denver, USA.
Clin Ther. 1995 Nov-Dec;17(6):1099-109. doi: 10.1016/0149-2918(95)80088-3.
Beclomethasone dipropionate nasal spray is widely used in the treatment of seasonal allergic rhinitis; however, the time of onset of action has not been determined. This study assessed the onset of action, level of relief, and efficacy of beclomethasone nasal spray in patients with seasonal allergic rhinitis. In a double-blind, randomized, placebo-controlled, parallel-group, multicenter, 7-day study, symptomatic patients were administered two inhalations of beclomethasone dipropionate (n = 80) or placebo (n = 81) into each nostril twice daily. Patients assessed the onset of action and level of relief at 6, 24, and 48 hours and at days 3 and 7. Investigators evaluated symptoms at days 0, 3, and 7 and response to therapy at days 3 and 7. The difference in the cumulative number of patients reporting relief of symptoms was statistically significant in favor of beclomethasone dipropionate by hour 24 (P = 0.05). Patients in the beclomethasone dipropionate group experienced a greater level of relief than patients receiving placebo at hour 24, and improvement increased over the 7-day study compared with a decrease in relief in the placebo group. Beclomethasone dipropionate was significantly more effective than placebo in reducing symptoms (P < or = 0.02), and patients in the beclomethasone dipropionate group showed a more favorable response to treatment than did patients in the placebo group (P < 0.01). Adverse events were minor in both groups. Beclomethasone dipropionate nasal spray produced significant onset of relief of symptoms the first day of treatment; improvement was sustained and increased over the course of the study.
二丙酸倍氯米松鼻喷雾剂广泛用于治疗季节性变应性鼻炎;然而,其起效时间尚未确定。本研究评估了二丙酸倍氯米松鼻喷雾剂对季节性变应性鼻炎患者的起效时间、缓解程度和疗效。在一项双盲、随机、安慰剂对照、平行组、多中心、为期7天的研究中,有症状的患者每天两次向每个鼻孔各喷入两喷二丙酸倍氯米松(n = 80)或安慰剂(n = 81)。患者在6小时、24小时、48小时以及第3天和第7天评估起效时间和缓解程度。研究人员在第0天、第3天和第7天评估症状,并在第3天和第7天评估治疗反应。到24小时时,报告症状缓解的患者累积数量差异具有统计学意义,二丙酸倍氯米松组占优(P = 0.05)。在24小时时,二丙酸倍氯米松组患者的缓解程度高于接受安慰剂的患者,并且在为期7天的研究中,与安慰剂组缓解程度下降相比,二丙酸倍氯米松组的改善情况有所增加。二丙酸倍氯米松在减轻症状方面显著优于安慰剂(P≤0.02),二丙酸倍氯米松组患者对治疗的反应比安慰剂组患者更有利(P < 0.01)。两组的不良事件均较轻微。二丙酸倍氯米松鼻喷雾剂在治疗的第一天即产生显著的症状缓解;在研究过程中改善情况持续且增加。