Bronsky E A, Aaronson D W, Berkowitz R B, Chervinsky P, Graft D, Kaiser H B, Moss B, Nathan R A, Pearlman D S, Ratner P H, Adelglass J M, Southern D L, van Bavel J, Hampel F, Stricker W E, Fourré J A, Cuss F M, Nolop K B
AAAA Medical Research Group, Salt Lake City, UT, USA.
Ann Allergy Asthma Immunol. 1997 Jul;79(1):51-6. doi: 10.1016/S1081-1206(10)63084-0.
Topical nasal corticosteroids are rapidly gaining acceptance as first-line therapy for seasonal allergic rhinitis, but there is a desire for effective corticosteroids with an improved safety profile over existing products.
A multicenter, double-blind dose ranging study was conducted to compare the activity and tolerance of four doses of mometasone furoate nasal spray (tradename Nasonex) and placebo in adult patients with seasonal allergic rhinitis.
Four hundred eighty patients with seasonal allergic rhinitis were enrolled and randomized to receive mometasone furoate nasal spray 50 micrograms (n = 96), 100 micrograms (n = 95), 200 micrograms (n = 98) or 800 micrograms (n = 95), or placebo vehicle (n = 95) once daily for 28 days.
All of the doses of mometasone furoate nasal spray showed activity in reducing the severity of rhinitis. The 200-microgram dose reduced total nasal symptom scores and total symptom scores throughout the study (P < .05 versus placebo vehicle). The 50-microgram dose and the 100-microgram dose showed less consistent activity at early timepoints (days 3 and 7), while the 800 microgram dose did not provide significant additional benefits over the 200-microgram dose. All dose levels were well tolerated
The results of this trial indicate that 200 micrograms once daily is the optimum dose of mometasone furoate nasal spray for the treatment of seasonal allergic rhinitis.
局部用鼻用皮质类固醇作为季节性变应性鼻炎的一线治疗方法正迅速获得认可，但人们希望有比现有产品安全性更高的有效皮质类固醇。
进行一项多中心、双盲剂量范围研究，以比较四剂糠酸莫米松鼻喷雾剂（商品名内舒拿）和安慰剂对成年季节性变应性鼻炎患者的活性和耐受性。
招募480例季节性变应性鼻炎患者，随机分组，分别接受每日一次、为期28天的50微克（n = 96）、100微克（n = 95）、200微克（n = 98）或800微克（n = 95）糠酸莫米松鼻喷雾剂，或安慰剂（n = 95）。
所有剂量的糠酸莫米松鼻喷雾剂在减轻鼻炎严重程度方面均显示出活性。在整个研究过程中，200微克剂量降低了总鼻症状评分和总症状评分（与安慰剂相比，P <.05）。50微克剂量和100微克剂量在早期时间点（第3天和第7天）的活性不太一致，而800微克剂量与200微克剂量相比未提供显著的额外益处。所有剂量水平耐受性良好。
该试验结果表明，每日一次200微克是糠酸莫米松鼻喷雾剂治疗季节性变应性鼻炎的最佳剂量。
