ACAAI 2008:鼻腔内类固醇在缓解夜间过敏症状上胜过抗组织胺


  November 12, 2008(西雅图) — 根据美国过敏气喘与免疫学会2008年会中发表的一篇直接比较研究,Fluticasone furoate鼻喷剂(FFNS)缓解季节性过敏性鼻炎的夜间过敏症状效果胜过口服fexofenadine(FEX)。
  
  研究者结论表示,FFNS显著改善季节性过敏患者的夜间鼻子症状;北卡罗来纳三角研究园区中、GlaxoSmithKline的对抗过敏临床发展执行主任Edward Philpot医师向Medscape Allergy & Clinical Immunology表示,它显示对眼睛的效果和抗组织胺一样,甚至更好;FEX是不错的产品,但资料显示鼻腔类固醇更优。
  
  该研究包括两种治疗— 亲合力加强的鼻腔内皮质类固醇FFNS、剂量为110 μg,以及非镇静性抗组织胺FEX、口服剂量180-mg;使用公认的夜间症状问卷(夜间症状分数[NSS])、尖峰鼻腔吸气流速[PNIF])以及鼻子和眼睛的症状来评估病患。总共有680名猪草过敏(ragweed allergy)病患参加这个双盲及双虚性试验:224人被随机指派接受FFNS、227 人接受FEX、229人接受安慰剂。
  
  病患每天接受治疗一次,为期两周;研究的初步终点是治疗期间的NSS与开始时相比的平均改变(MCFB);NSS评估鼻症状对入睡和夜间醒来的影响;次级终点包括PNIF的MCFB,以及清晨和夜间的鼻腔(鼻塞、鼻子痒、打喷嚏和流鼻水)与眼睛(撕裂感/流泪、发痒/灼热、发红)症状。
  
  研究者发现,FFNS和FEX在NSS的MCFB有明显差异(-0.9; P < .001);FFNS组的清晨PNIF比FEX组增加(10.6; P < .001)。FFNS和FEX这两组在12小时夜间反应(-1.3; P < .001) 与瞬间(-1.5; P < .001)总鼻腔分数也有差异;两组的12小时夜间反应(-0.6; P = .002)与瞬间(-0.6; P = .002)总眼睛症状分数也有差异。FFNS和安慰剂之间的终点差异是明显的(P < .034)。FEX 组和安慰剂之间则没有显著差异(P≧.176)。
  
  根据该段会议的主持人、纽泽西医学院气喘与过敏研究中心主任Leonard Bielory医师,本研究确认了一般预期的抗发炎剂在此类病患会胜过抗组织胺剂。他向Medscape Allergy & Clinical Immunology表示,另一个重点是,睡眠困扰、鼻塞、打鼾与咳嗽都是与过敏有关的议题,这些抗发炎药剂对那些症状显然有正面影响。
  
  本研究由FFNS的制造商GlaxoSmithKline所赞助。Bielory医师是GlaxoSmithKline与其竞争对手的有给职顾问。
  
  美国过敏气喘与免疫学会(ACAAI) 2008年会:摘要30。发表于2008年11月9日。

ACAAI 2008: Intranasal Steroid Outperforms Antihistamine in Relieving Nighttime Allergy Symptoms

By Jim Kling
Medscape Medical News

November 12, 2008 (Seattle, Washington) — Fluticasone furoate nasal spray (FFNS) relieves nighttime symptoms of seasonal allergic rhinitis better than oral fexofenadine (FEX), according to a presentation of a direct comparison study here at the American College of Allergy, Asthma & Immunology 2008 Annual Meeting.

The researchers concluded that FFNS significantly improved the nighttime nasal symptoms of seasonal allergy sufferers. "It shows that its ocular effect is as good or better than antihistamines," Edward Philpot, MD, executive director of Allergy NA Clinical Development at GlaxoSmithKline in Research Triangle Park, North Carolina, told Medscape Allergy & Clinical Immunology. "[FEX] is a good product but the [data] that's out there certainly [suggest] that nasal steroids are better."

The study included 2 treatments — the enhanced-affinity intranasal corticosteroid FFNS at a dose of 110 μg, and the nonsedating antihistamine FEX in an oral 180-mg dose. Patients were evaluated using a validated nighttime symptom questionnaire (Nighttime Symptoms Score [NSS]), peak nasal inspiratory flow (PNIF), and nasal and ocular symptoms. A total of 680 subjects with ragweed allergy took part in the double-blind, double-dummy trial: 224 were randomly assigned to receive FFNS, 227 received FEX, and 229 received placebo.

Patients received therapy once a day for 2 weeks. The study's primary endpoint was the mean change from baseline (MCFB) of the NSS during the treatment. The NSS assessed the affect of nasal symptoms on difficulty in going to sleep and nighttime awakenings. Secondary endpoints included MCFB in the PNIF as well as morning and nighttime nasal (congestion, itching, sneezing, and rhinorrhea) and ocular (tearing/watering, itching/burning, redness) symptoms.

The researchers found a significant difference between FFNS and FEX in the MCFB of the NSS (-0.9; P < .001). The FFNS group had increased morning PNIF compared with the FEX group (10.6; P < .001). The FFNS and FEX groups also had differences in 12-hour nighttime reflective (-1.3; P < .001) and instantaneous (-1.5; P < .001) total nasal scores. The 12-hour nighttime reflective (-0.6; P = .002) and instantaneous (-0.6; P = .002) total ocular symptom scores also differed between the 2 groups. Endpoint differences between FFNS and placebo were significant (P < .034). There was no significant difference between the FEX group and placebo (P ? .176).

The study confirms the general expectation that an anti-inflammatory agent would outperform an antihistamine in these patients, according to session moderator Leonard Bielory, MD, director of the Asthma & Allergy Research Center at the New Jersey Medical School in Newark, New Jersey. "Another important feature is that sleep disturbance is an issue associated with allergy, you get congestion, snoring, and coughing — these anti-inflammatory agents clearly have positive impacts on those [symptoms]," he told Medscape Allergy & Clinical Immunology.

The study was funded by GlaxoSmithKline, the manufacturer of FFNS. Dr. Bielory has been a paid consultant to GlaxoSmithKline as well as competing companies.

American College of Allergy, Asthma & Immunology (ACAAI) 2008 Annual Meeting: Abstract 30. Presented November 9, 2008.

    
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