Azelastine加Fluticasone鼻噴劑可緩解過敏性鼻炎症狀
作者：Deborah Brauser
出處：WebMD醫學新聞
November 13, 2009 (加州聖地牙哥) — 根據一篇新的隨機安慰劑控制研究，在單一給藥裝置中併用azelastine hydrochloride和fluticasone propionate鼻噴劑，可以顯著改善中度到嚴重季節性過敏性鼻炎(seasonal allergic rhinitis，SAR)患者的鼻腔和眼睛症狀。
德州聖安東尼奧藥物研發研究機構Sylvana Research公司發起人暨主任、過敏/免疫專家Paul Ratner醫師在美國過敏、氣喘與免疫學院(ACAAI)2009年度科學會議中發表前述結果。
Ratner醫師在Medscape Allergy and Immunology的訪問中表示，本研究是重要的，如果你注意統計數據，人們的過敏嚴重度提升了，其中眼睛症狀大幅增加。
他報告指出，SAR最嚴重的病患，約有75%抱怨眼睛癢，約三分之二抱怨眼睛一直淚汪汪的；這是經常與鼻充血及流鼻水和其他過敏現象同時發生的症狀。
【併用治療越來越引起興趣】
Ratner醫師表示，最近，併用鼻噴型抗組織胺與鼻噴型皮質類固醇的用法越來越引人興趣，之前的研究顯示，併用治療比單一用法更有效。在本研究中，我們特別注意此併用療法對於改善眼睛症狀的效果。
他的研究團隊在2007/08年德州西洋杉花粉季期間，納入了610名因為SAR而有眼睛症狀的患者，這些病患被隨機分到以下四組之一：只用azelastine、只用fluticasone、azelastine加fluticasone、安慰劑，每個鼻孔每天噴兩次，每次一噴。
初步終點為其效果，定義為鼻充血、打噴嚏、鼻子癢、流鼻水等，整體鼻腔症狀分數(TNSS)相較於開始時的改變。次級終點為azelastine加fluticasone 對於眼睛癢、流眼淚、紅眼等之整體眼睛症狀分數(TOSS)的效果。
【鼻子和眼睛症狀都有改善】
結果顯示，使用併用治療的病患，其TNSS分數(31.3%)有統計上顯著的改善，單用fluticasone者為20.8%、單用azelastine者為16.3%、安慰劑者為(9.0%) (P< .001)。
併用治療者的TOSS分數也有統計上的顯著改善(26.4%)，單用azelastine者為(19.3%)、單用fluticasone者為(16.6%)、安慰劑者為(8.9%)(P<.001)。
併用治療組超過2%的副作用包括苦味(7.2%)、鼻出血(3.9%)和頭痛(2.6%)。
Ratner醫師表示，本研究有兩個關鍵。第一個是，併用鼻噴型抗組織胺和鼻噴型類固醇治療相當成功，比單用任一種更有效治療。第二，除了預期之可治療的鼻腔症狀以外，還可以有緩解眼睛症狀的好處。
他指出，如果你注意現在過敏專家的實務情況，我敢說，他們在30%到40%的病患併用兩種藥物。如果有產品可在單一個吸入劑中提供併用治療，將可大大促進病患的治療。
【治療眼睛和鼻子】
ACAAI摘要回顧委員會主席、紐澤西醫學院醫學臨床副教授John J. Oppenheimer醫師表示，我認為，從這個研究中，我們要記住的是，鼻子和眼睛的症狀要一起處理。
未參與本研究的Oppenheimer醫師表示，當我們考慮過敏性鼻炎時，我們忘記還有眼睛症狀要處理。有許多相當明確的研究顯示，這些病患的眼睛症狀大幅降低生活品質；因此，本研究強調的是複方用藥，使用抗組織胺阻斷劑與鼻腔類固醇，對於治療病患的眼睛症狀和鼻腔症狀來說，是更有效的方法。
他認為需要更多研究來幫助我們釐清重點，SAR病患飽受疾病之苦且每年都會發病，希望未來可以提供更好的介入方式給他們，這對我們來說，是真正的首要之務。
Meda Pharmaceuticals資助本研究。Ratner醫師宣告沒有相關財務關係。Oppenheimer醫師報告擔任Glaxo、AstraZeneca、Schering、Merck、Novartis與Genentech藥廠的顧問，並執行研究。
美國過敏、氣喘與免疫學院(ACAAI)2009年度科學會議：摘要26。發表於2009年11月8日。
Azelastine Plus Fluticasone Nasal Spray Relieves Symptoms of Allergic Rhinitis
By Deborah Brauser
Medscape Medical News
November 13, 2009 (San Diego, California) — A combination of azelastine hydrochloride and fluticasone propionate nasal sprays administered in a single delivery device can significantly improve both nasal and ocular symptoms in patients with moderate to severe seasonal allergic rhinitis (SAR), according to a new randomized placebo-controlled study.
Results were presented here at the American College of Allergy, Asthma Immunology (ACAAI) 2009 Annual Scientific Meeting in a podium session by Paul Ratner, MD, allergist/immunologist and founder and director of Sylvana Research, of San Antonio, Texas, a research facility for investigational medications.
"This study is important because if you look at statistics and at people with increasing severity of their allergies, you see an increasing amount of ocular symptoms," said Dr. Ratner in an interview with Medscape Allergy and Immunology.
He reported that about 75% of the most severe SAR patients complain of itchy eyes and about two thirds of them complain of watery eyes. "It's a very common symptom complex that you see along with the nasal congestion and runny nose and other things that come with allergies."
Growing Interest in Combination Treatment
"Recently, there's been a lot of interest in looking at combinations of nasal antihistamines and nasal corticosteroids, with previous studies showing that the combination is more effective statistically than the single entities," said Dr. Ratner. "In this study, we wanted to look specifically at the ocular effects from treatment with this combination."
His investigational team enrolled 610 patients with ocular symptoms from SAR during the 2007/08 Texas Mountain Cedar season. The patients were randomized to 1 of 4 groups receiving 1 spray per nostril twice daily: azelastine alone, fluticasone alone, azelastine plus fluticasone, and placebo.
The primary end point was efficacy, defined as a change from baseline in the total nasal symptom score (TNSS) for nasal congestion, sneezing, itchy nose, and runny nose.
The secondary end point was the effect of azelastine plus fluticasone on the total ocular symptom score (TOSS) for itchy eyes, watery eyes, and redness.
Nasal and Ocular Symptoms Improved
Results showed that improvements on TNSS were statistically significant for the patients treated with the combination spray (31.3%), compared with those treated with fluticasone alone (20.8%), azelastine alone (16.3%), or placebo (9.0%; P < .001).
There was also a statistically significant improvement in TOSS for those treated with the combination spray (26.4%), compared with those treated with azelastine alone (19.3%), fluticasone alone (16.6%), or placebo (8.9%; P < .001).
The only adverse events reported by more than 2% of those treated with the combination spray were bitter taste (7.2%), epistaxis (3.9%), and headache (2.6%).
"There are 2 key points to this study," said Dr. Ratner. "The first is that the combination therapy with nasal antihistamines and nasal steroids is definitely panning out to be more effective than treatment with the individual components. Second, in addition to treating the nasal symptoms that you would expect, you're also getting the added benefit of having relief of the ocular symptoms."
He added that "if you look at the way allergists are practicing now, I'd say that they're using both drugs in combination in 30% to 40% of their patients. The advantage and ability to have a product that would reflect that combined therapy in a single inhaler is something I think would definitely enhance the treatment of patients."
Treat the Eyes and the Nose
"I think the take-away from this study is to remember that the nose and the eyes go hand and hand," said ACAAI abstract review committee chair John J. Oppenheimer, MD, associate clinical professor of medicine at New Jersey Medical School in Newark.
"When we think about allergic rhinitis, we forget that the eyes come along. There have been a lot of really elegant studies showing that the ocular complaints in these patients are really quality-of-life diminishing. So what this study reinforces is that polypharmacy, using an antihistamine blocker as well as a nasal steroid, may be a more effective modality in treating this ocular complaint and the nasal symptoms," said Dr. Oppenheimer, who was not involved with this study.
He added: "I think more research is needed to help us try to tease out what the most important parts are. Patients with [SAR] really suffer and every year they know they're going to be doomed by this illness. I think being able to provide better interventions for them is really going to be my hope for the future. It's just really important for us to do a better job."
This study was funded by Meda Pharmaceuticals. Dr. Ratner has disclosed no relevant financial relationships. Dr. Oppenheimer reports being a consultant and doing research for Glaxo, AstraZeneca, Schering, Merck, Novartis, and Genentech.
American College of Allergy, Asthma Immunology (ACAAI) 2009 Annual Scientific Meeting: Abstract 26. Presented November 8, 2009.
