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糠酸莫米松鼻喷雾剂每日一次治疗常年性变应性鼻炎患者的疗效与丙酸倍氯米松每日两次相当。

Once daily mometasone furoate aqueous nasal spray is as effective as twice daily beclomethasone dipropionate for treating perennial allergic rhinitis patients.

作者信息

Drouin M, Yang W H, Bertrand B, Van Cauwenberge P, Clement P, Dalby K, Darnell R, Ernst T M, Hébert J, Karlsson G, Luciuk G, Mazza J, Roovers M, Ruoppi P, Seppey M, Stern M, Suonpää J, Sussman G, Tan K Y, Tse K, Widjaja P, Jensen P, Nolop K, Lutsky B N

机构信息

Allergy and Asthma Research Centre, Ottawa, Ontario, Canada.

出版信息

Ann Allergy Asthma Immunol. 1996 Aug;77(2):153-60. doi: 10.1016/s1081-1206(10)63502-8.

DOI:10.1016/s1081-1206(10)63502-8
PMID:8760782
Abstract

BACKGROUND

Perennial allergic rhinitis is chronic and persistent, may lead to a constellation of secondary complaints including sinusitis, mouth-breathing, and some symptoms resembling a permanent cold, and often requires constant medical intervention. Well-tolerated nasal corticosteroids, alone or in combination with antihistamines, have been found to be very effective in treating this condition.

OBJECTIVE

To compare the effectiveness and tolerability of mometasone furoate aqueous suspension, a new once daily nasal spray, to placebo vehicle and to beclomethasone dipropionate, administered twice daily, in patients with perennial allergic rhinitis.

METHODS

This was a randomized, double-blind, placebo-controlled, double-dummy, parallel group study, in 427 patients age 12 years and older at 24 centers in Canada and Europe. Patients allergic to at least one perennial allergen, confirmed by medical history, skin testing, and adequate symptomatology were eligible to receive one of the following regimens for 3 months: mometasone furoate, 200 micrograms only daily; beclomethasone dipropionate, 200 micrograms twice daily (400 micrograms total dose); or placebo vehicle control. The primary efficacy variable was the change from baseline in total AM plus PM diary nasal symptom score over the first 15 days of treatment.

RESULTS

Three hundred eighty-seven patients were valid for efficacy. For the primary efficacy variable, mometasone furoate was significantly (P < or = .01) more effective than placebo and was indistinguishable from beclomethasone dipropionate. Similar trends were seen among individual symptoms, physician symptom evaluations, and therapeutic response. There was no evidence of tachyphylaxis. All treatments were well tolerated.

CONCLUSIONS

Mometasone furoate nasal spray adequately controls symptoms of perennial allergic rhinitis, offers the advantage of once daily treatment, and is well tolerated.

摘要

背景

常年性变应性鼻炎是慢性且持续存在的,可能导致一系列继发症状,包括鼻窦炎、口呼吸以及一些类似持续性感冒的症状,并且常常需要持续的医学干预。已发现耐受性良好的鼻用皮质类固醇单独使用或与抗组胺药联合使用在治疗这种疾病方面非常有效。

目的

比较糠酸莫米松水混悬液(一种新型每日一次鼻喷雾剂)与安慰剂以及与每日两次给药的二丙酸倍氯米松在常年性变应性鼻炎患者中的有效性和耐受性。

方法

这是一项在加拿大和欧洲24个中心进行的随机、双盲、安慰剂对照、双模拟、平行组研究,纳入了427名12岁及以上的患者。经病史、皮肤试验和充分的症状学确诊对至少一种常年性变应原过敏的患者有资格接受以下治疗方案之一,为期3个月:仅每日一次200微克糠酸莫米松;每日两次200微克二丙酸倍氯米松(总剂量400微克);或安慰剂对照。主要疗效变量是治疗前15天内上午加下午日记中鼻症状总分相对于基线的变化。

结果

387名患者疗效评估有效。对于主要疗效变量,糠酸莫米松比安慰剂显著更有效(P≤0.01),且与二丙酸倍氯米松无差异。在个体症状、医生症状评估和治疗反应方面也观察到类似趋势。没有速发耐受性的证据。所有治疗耐受性良好。

结论

糠酸莫米松鼻喷雾剂能充分控制常年性变应性鼻炎的症状,具有每日一次治疗的优势,且耐受性良好。

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