Omalizumab可治疗季节性过敏性鼻炎

可减轻症状和血清的IgE抗体浓度

  2001年12月20日报导─据美国医学协会杂志,12月19日一期中报导的一项研究结果显示,Omalizumab可治疗季节性发作的过敏性鼻炎。

  Omalizumab治疗季节性过敏性鼻炎研究小组的Thomas B.Casale医师和他的同事们写道:「Omalizumab可以降低季节性过敏性鼻炎患者,血清游离的IgE抗体浓度,并可以根据药物剂量的不同,得到不同的临床疗效。」

  Omalizumab是一种重组的人工合成的抗IgE单株抗体,可以与血清中的游离IgE形成复合物,阻断其与肥大细胞,和嗜碱性粒细胞的相互作用,降低血清游离的IgE抗体浓度。

  从1997年6月25日到11月21日,在美国25家门诊中心进行这次随机双盲试验,共召募到536名年龄在12到75岁的患者,分不同剂量给药,对照组给以安慰剂。被研究的患者,必须有两年以上的由草本植物引起的中、重度季节性过敏性鼻炎史,并且血清的IgE抗体的基线浓度,在30到700IU/mL之间。

  在草本植物发育的季节来临之前,这些患者立即接受安慰剂或Omalizumab50、150、300mg的皮下植入治疗。在植物传播花粉的时间内,血清IgE抗体基线浓度在151到700IU/mL之间的患者,每3周被重覆一次治疗(一共有4次治疗),而血清IgE抗体基线浓度,在30到150IU/mL之间的患者,每4周被重覆一次治疗(一共有3次治疗)。

  与对照组的患者相比,接受300mg,Omalizuma治疗的患者,鼻炎症状严重程度得分要显著降低。血清IgE抗体的浓度与鼻炎症状,和抗组胺药物的使用量呈显著的相关。虽然在过敏症好发的季节,接受300mg Omalizuma治疗的患者,的鼻炎特异的生活质量评分要比低剂量组,或对照组的得分要高,但服药后的副作用,在各组之间相似。

  作者写道: 「需要进行类似的试验,以便得到对季节性过敏性鼻炎患者,给予准确的临床用药剂量后治疗效果的全部资料。」

Omalizumab Effective in Seasonal Allergic Rhinitis

Decreases Symptoms, Serum IgE Levels

By Laurie Barclay, MD
WebMD Medical News

Reviewed by Dominique Walton Brooks, MD, MBA

Dec. 20, 2001 -- Omalizumab is effective against seasonal allergic rhinitis, according to a study reported in the Dec. 19 issue of The Journal of the American Medical Association.

"Omalizumab decreased serum free IgE levels and provided clinical benefit in a dose-dependent fashion in patients with seasonal allergic rhinitis," write Thomas B. Casale, MD, and colleagues from the Omalizumab Seasonal Allergic Rhinitis Trial Group.

Omalizumab is a recombinant, humanized, monoclonal anti-IgE antibody that forms complexes with free IgE, blocking its interaction with mast cells and basophils and lowering free-circulating IgE levels.

This randomized, double-blind, dose-ranging, placebo-controlled trial from July 25 through Nov. 21, 1997, involved 536 patients, aged 12 to 75, at 25 U.S. outpatient centers. Subjects had at least a two-year history of moderate to severe ragweed-induced seasonal allergic rhinitis and a baseline IgE level between 30 and 700 IU/mL.

Patients received placebo or omalizumab, 50 mg, 150 mg, or 300 mg subcutaneously immediately before ragweed season. During the pollen season, patients with baseline IgE levels of 151 to 700 IU/mL had treatment repeated every three weeks (four total treatments), and those with baseline IgE levels of 30 to 150 IU/mL had treatment repeated every four weeks (three total treatments).

Relative to patients on placebo, those on 300 mg of omalizumab had significantly lower nasal symptom severity scores. IgE reduction was significantly correlated with nasal symptoms and rescue antihistamine use. Throughout the allergy season, rhinitis-specific quality-of-life scores were better in patients on 300 mg of omalizumab than in those on lower dosages or placebo. Adverse event frequency was similar in all groups.

"Comparative trials will be necessary to define the exact placement of this agent in the therapeutic armamentarium for seasonal allergic rhinitis," the authors write.


© 2001 WebMD Corporation. All rights reserved.

    
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