Prenner B M, Chervinsky P, Hampel F C, Howland W C, Lawrence M, Meltzer E O, Munk Z M, Ratner P H, Seltzer J M, Settipane G A, Lorber R R, Harrison J E
Allergy Associates Medical Group. Inc., San Diego, CA, USA.
J Allergy Clin Immunol. 1996 Aug;98(2):302-8. doi: 10.1016/s0091-6749(96)70154-9.
The use of intranasally administered corticosteroid sprays is an established treatment option for seasonal allergic rhinitis.
In this double-blind, placebo-controlled, multicenter study, 438 patients with moderate to severe symptoms of seasonal allergic rhinitis were treated for 4 weeks with double-strength beclomethasone dipropionate (BDP) aqueous nasal spray (84 micrograms/spray: BDP-ds), once daily; regular-strength BDP (42 micrograms/spray: BDP-rs), twice daily; high-strength BDP (336 micrograms/spray: BDP-hs), once daily; or placebo. BDP-hs was included as a safety comparison group. All treatments were given as two sprays per nostril.
Physician-rated nasal symptom scores were significantly improved in all three active treatment groups compared with those of the placebo group within the initial 3 days of treatment. Improvement was maintained throughout the 4-week treatment period. BDP-ds and BDP-rs were equivalent at all time points. The BDP-ds, BDP-rs, and BDP-hs groups had greater numbers of patients with a good or excellent therapeutic response at end point than the placebo group. All treatments were well-tolerated, and no unexpected adverse events were reported. No effects on laboratory evaluations or vital signs were evident for any treatment group.
The results of this study show that BDP-ds given once a day and BDP-rs given twice a day in the same total daily dose are comparably safe and effective in the treatment of patients with seasonal allergic rhinitis.
鼻内使用皮质类固醇喷雾剂是季节性过敏性鼻炎的一种既定治疗选择。
在这项双盲、安慰剂对照、多中心研究中，438例中重度季节性过敏性鼻炎症状患者接受了为期4周的治疗，分别为：双倍剂量丙酸倍氯米松（BDP）水性鼻喷雾剂（84微克/喷：BDP - ds），每日一次；常规剂量BDP（42微克/喷：BDP - rs），每日两次；高剂量BDP（336微克/喷：BDP - hs），每日一次；或安慰剂。BDP - hs作为安全性比较组纳入。所有治疗均为每侧鼻孔喷两下。
与安慰剂组相比，在治疗的最初3天内，所有三个活性治疗组的医生评定的鼻部症状评分均显著改善。在整个4周治疗期间，改善情况得以维持。BDP - ds和BDP - rs在所有时间点均等效。与安慰剂组相比，BDP - ds、BDP - rs和BDP - hs组在终点时具有良好或优异治疗反应的患者数量更多。所有治疗耐受性良好，未报告意外不良事件。任何治疗组对实验室评估或生命体征均无明显影响。
本研究结果表明，每日总剂量相同的情况下，每日一次给予BDP - ds和每日两次给予BDP - rs在治疗季节性过敏性鼻炎患者时具有相当的安全性和有效性。
