Olopatadine鼻噴劑降低兒童季節性過敏症狀

作者：Deborah Brauser  
出處：WebMD醫學新聞

　　November 19, 2009（加州聖地牙哥訊）－ 根據一項發表於美國過敏、氣喘與免疫學會（ACAAI）2009年年會的大型研究，olopatadine hydrochloride鼻噴劑0.6%降低12歲以下罹患季節性過敏性鼻炎（SAR）兒童的鼻子與眼睛的症狀。
　　
　　北卡羅萊納大學醫學院小兒科臨床教授Craig F. La Force醫師在他的壁報發表會上指出，部分過去研究曾報告，估計有超過40%的兒童有SAR問題。
　　
　　他解釋，每個人都著眼於可獲得的兒童過敏性鼻炎治療。鼻噴劑對於鼻塞是有幫助的，而口服藥物則沒有這樣的效果。在兒童病患身上沒有其他太多的選擇，就是鼻腔投予類固醇。因此，有個想法是投予非類固醇藥物來治療鼻塞。這也是為什麼都想要看到這些兒童可以使用的裝置。
　　
　　Olopatadine是一種選擇性抗組織胺與巨大細胞穩定劑，適用於12歲以上病患緩解SAR。在這項研究中，研究者們想要檢驗用於治療年紀較小病患的季節性過敏症狀。
　　
　　總共有2,388位年齡介於6~11歲的兒童接受篩選，其中1,174位被隨機分派接受1（共294位）或2（共293位）劑的olopatadine鼻噴劑，每天2次，為期2週，或相對應載體安慰劑1（共294位）或2（共293位）劑。
　　
　　La Force醫師表示，這基本上是一個針對過敏症狀控制的季節性過敏研究，這些兒童被隨機分派接受olopatadine成人劑量，每個鼻孔2劑，每天2次，或每個鼻孔1劑、或相對應的載體安慰劑。
　　
　　所有病患都接受電話每日記錄2次SAR症狀嚴重度。
　　
　　【口腔與鼻症狀減少】
　　代表性的整體鼻症狀分數顯示，所有接受olopatadine治療的患者，其症狀改善程度顯著比所有接受載體安慰劑病患高；這些症狀包括鼻塞、流鼻水、鼻子癢與打噴嚏。
　　
　　這些分數顯示，olopatadine每個鼻孔1劑組的病患，相較於相對應安慰劑組，症狀顯著降低（24.7%相較於17.9%；P=0.0007）。較高劑量每個鼻孔2劑的病患，也有同樣的結果（26.5%相較於20.8%；P=0.0120）。
　　
　　整體眼睛症狀分數，在癢與流眼淚這部份，接受olopatadine組每個鼻孔1劑組（24.5%相較於6.1%；P=0.0084）、每個鼻孔2劑組（26.3%相較於8.2%；P=0.0010）都是顯著減少的。
　　
　　La Force醫師總結，其研究結果顯示，對這些年輕族群來說，在鼻子與眼睛症狀的改善方面，投予olopatadine每個鼻孔1到2劑顯著地比載體安慰劑好。
　　
　　然而，他附帶表示，每個鼻孔投予2劑olopatadine並未比投予1劑提供更多的好處，換句話說，1劑與2劑的效果是一樣好的，而且比較容易投予。
　　
　　【出乎意料的好處】
　　德州華茲堡市北德洲大學小兒醫學臨床教授、ACAAI Bob Lanier執行醫療主任與前理事長Bob Lanier博士表示，許多研究已經證實，類固醇鼻噴劑可以降低眼睛與鼻子的過敏症狀。這項研究希望專一性地針對抗組織胺鼻噴劑進行研究，而不是類固醇。
　　
　　未參加這項研究的Lanier博士表示，過敏會是永久的問題，且不會因為年紀增長而消退，這與一般大眾的認知不同；因此，長期來說，你可能可以說你使用的藥物不會有任何隨著時間堆積的潛力；但類固醇確實有這樣的潛力，雖然很小，而抗組織胺則沒有這樣的困擾。
　　
　　我想這裡所要傳達的是，使用局部藥物，類固醇或抗組織胺藥物，可能不只是改善投予藥物的器官功能，還會影響到其他器官。這對於非吸收物質來說是個出乎意料的好處。我想這對於降低病患使用藥物數量來說是個好消息，且最終可能降低使用這些藥物的費用。
　　
　　【Olopatadine也有相當的安全性】
　　同樣發表在ACAAI年會上、來自這項研究的另外一篇壁報，評估使用這個藥物的安全性預後。結果顯示沒有一位病患發生任何嚴重不良反應。除此之外，不同組之間，治療相關不良反應的發生率是一樣低的：每個鼻孔1劑olopatadine是5.7%、相對應載體安慰劑為4.0%、每個鼻孔2劑olopatadine是6.1%、相對應載體安慰劑為3.7%。
　　
　　而不論組別，最常報告的不良反應都是苦味，但僅發生在不到1.5%的病患身上。
　　
　　這項研究由Alcon研究公司贊助。La Force醫師擔任Alcon藥廠的講師團且接受講師費。Lanier博士過去接受Alcon公司的諮詢，但最近並未接受該公司諮詢，也未被諮詢有關此項研究的相關事項。


Olopatadine Nasal Spray Reduces Seasonal Allergy Symptoms in Children

By Deborah Brauser
Medscape Medical News

November 19, 2009 (San Diego, California) — Olopatadine hydrochloride nasal spray 0.6% reduces both nasal and ocular symptoms in children younger than 12 years of age with seasonal allergic rhinitis (SAR), according to a large study presented here at the American College of Allergy, Asthma Immunology (ACAAI) 2009 Annual Scientific Meeting.

"Some past studies have reported that there is an estimated incidence of [SAR] of more than 40% in the pediatric population," said Craig F. La?Force, MD, clinical professor of pediatrics at the University of North Carolina School of Medicine in Raleigh, during his poster presentation of the results.

"Everybody is looking at available treatments for rhinitis in kids," he explained. "Nasal sprays tend to have an effect on congestion that oral medications typically don't. Your options in pediatrics are nasal steroids; there aren't many others. So the idea is to give a nonsteroidal option for the treatment of congestion. That's why everybody would like to see this kind of modality for kids."

Olopatadine, which is both a selective antihistamine and a mast cell stabilizer, is indicated for the relief of SAR symptoms in patients 12 years and older. For this study, the investigators sought to examine its effectiveness in treating these symptoms in younger children.

A total of 2388 patients between the ages of 6 and 11 years were screened, and 1174 were randomized to receive 1 (n?= 294) or 2 (n= 293) sprays of olopatadine per nostril twice daily for 2 weeks or 1 (n?= 294) or 2 (n?= 293) sprays per nostril from a matching vehicle placebo.

"It was basically a seasonal allergy study looking at allergy symptom control," said Dr. La?Force. "These kids were randomized to [olopatadine] in the adult dosage, which is 2 sprays in each nostril twice a day, 1 spray in each nostril, or the vehicle."

SAR symptom severity was rated by all patients twice daily by telephone diary.

Oral and Nasal Symptoms Reduced

The reflective total nasal symptom scores showed that all olopatadine-treated patients had a greater symptom reduction than all patients treated with the vehicle in nasal congestion, rhinorrhea, itchy nose, and sneezing.

These scores showed a significantly greater symptom decrease for the olopatadine 1 spray/nostril group than for the matching vehicle group (24.7% vs 17.9%; P?= .0007). Similar efficacy was seen with the higher dose of 2 sprays/nostril (26.5% vs 20.8%; P?= .0120).

The reflective total ocular symptom scores for itchy and watery eyes were also reduced significantly more in the olopatadine group than in the 1 spray/nostril vehicle group (24.5% vs 6.1%; P?= .0084) and in the 2 sprays/nostril vehicle group (26.3% vs 8.2%; P?= .0010).

"Our results showed that [olopatadine] administered as 1 or 2 sprays in each nostril is statistically superior to the vehicle for this younger patient population, based on reducing both nasal and eye symptoms," summarized Dr. La?Force.

However, he noted that the administration of 2 sprays per nostril of olopatadine "offered no significant improvement over 1 spray per nostril. In other words, 1 spray is just as good as 2, which is much easier to administer."

An Unexpected Benefit

"It's been proven in several studies that a steroid nasal spray can reduce allergy symptoms in the eyes along with nasal symptoms," said executive medical director and past president of ACAAI Bob Lanier, MD, clinical professor of pediatrics at North Texas University in Fort Worth. "This study was an attempt to specifically look at this effect in an antihistamine spray instead of a steroid."

"Allergy is a permanent lifelong trait that you don't really outgrow, contrary to popular opinion," said Dr. Lanier, who was not involved with the study. So over the long term, you'd like to be able to say that the drug you're using doesn't have any potential for accumulation over a period of time. Steroids do have that potential, though small, while antihistamines do not."

"I think the take-away message here is that using a topical medication, be it steroid or antihistamine, may improve not only the organ in which the drug is delivered, but also other organs. It's an unexpected benefit of a nonabsorbed material. I think it's good news in that it's reducing the amount of medicines that people have to be given and, ultimately, it's reducing the cost for them."

Olopatadine Also Demonstrates Safety

Another poster from this study, measuring safety outcomes, was presented at the ACAAI meeting. It showed that no serious adverse events were reported by any of the patients. Also, the incidence of therapy-related adverse events was similarly low across the groups: 5.7% for olopatadine 1 spray/nostril vs 4.0% for matching vehicle, and 6.1% for olopatadine 2 sprays/nostril vs 3.7% for matching vehicle.

Although bitter taste was the most commonly reported adverse event, it occurred in less than 1.5% of the patients in any group.

This study was funded by Alcon Research. Dr. La?Force reports being on the speakers bureau and receiving honoraria from Alcon. Dr. Lanier reports consulting with Alcon in the past, but not recently and not on this study.

American College of Allergy, Asthma Immunology (ACAAI) 2009 Annual Scientific Meeting: Abstracts P-365 and P-363. Presented November?9, 2009.