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丙酸倍氯米松鼻用气雾剂治疗成人季节性变应性鼻炎的多中心研究

Multicentric study of beclomethasone dipropionate nasal aerosol in adults with seasonal allergic rhinitis.

作者信息

Siegel S C, Katz R M, Rachelefsky G S, Geller B D, Montag L L, Brandon M L, Cannon S J

出版信息

J Allergy Clin Immunol. 1982 Apr;69(4):345-53. doi: 10.1016/0091-6749(82)90144-0.

Abstract

A double-blind, parallel-design multicentric study, in two phases, was conducted to examine the safety and efficacy of 2-wk treatment with various doses of beclomethasone dipropionate nasal aerosol (BDNA) and placebo in adults with seasonal allergic rhinitis. In phase I, 162 patients received BDNA, 33.5 micrograms/burst (o.d.,b.i.d., t.i.d., q.i.d.), or placebo; in phase II, 189 patients received BNDA 42, micrograms/burst (b.i.d. q.i.d.), or placebo. In both phases, statistically significant (p less than 0.05) differences favoring BDNA over placebo were found for all efficacy measures (global evaluation and total and individual symptom scores). In phase I, response to treatment increased as BDNA dosage increased, with a leveling off at t.i.d. dosage. In both phases, marked improvements were seen by week 1, with maximum improvement during week 2. Eighty-seven patients had adverse reactions-sneezing and nasal burning were most common. No suppression in morning cortisol levels was seen, nor were Candida infections promoted. A 2-wk treatment with BDNA was safe and effective in the treatment of seasonal allergic rhinitis in adults.

摘要

进行了一项双盲、平行设计的多中心两阶段研究,以考察不同剂量的丙酸倍氯米松鼻气雾剂(BDNA)和安慰剂对成年季节性变应性鼻炎患者进行2周治疗的安全性和有效性。在第一阶段,162例患者接受了33.5微克/揿(每日1次、每日2次、每日3次、每日4次)的BDNA或安慰剂治疗;在第二阶段,189例患者接受了42微克/揿(每日2次、每日4次)的BDNA或安慰剂治疗。在两个阶段中,对于所有疗效指标(总体评估以及总症状和各单项症状评分),均发现BDNA相对于安慰剂具有统计学显著差异(p<0.05)。在第一阶段,随着BDNA剂量增加,治疗反应增强,在每日3次剂量时趋于平稳。在两个阶段中,第1周时均出现明显改善,第2周时改善最大。87例患者出现不良反应,最常见的是打喷嚏和鼻内烧灼感。未观察到晨皮质醇水平受到抑制,也未发现促进念珠菌感染。BDNA进行2周治疗对成年季节性变应性鼻炎患者安全有效。

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