Olopatadine鼻喷剂降低儿童季节性过敏症状


  【24drs.com】November 19, 2009(加州圣地牙哥讯)- 根据一项发表于美国过敏、气喘与免疫学会(ACAAI)2009年年会的大型研究,olopatadine hydrochloride鼻喷剂0.6%降低12岁以下罹患季节性过敏性鼻炎(SAR)儿童的鼻子与眼睛的症状。
  
  北卡罗莱纳大学医学院小儿科临床教授Craig F. La Force医师在他的墙报发表会上指出,部分过去研究曾报告,估计有超过40%的儿童有SAR问题。
  
  他解释,每个人都着眼于可获得的儿童过敏性鼻炎治疗。鼻喷剂对于鼻塞是有帮助的,而口服药物则没有这样的效果。在儿童病患身上没有其它太多的选择,就是鼻腔投予类固醇。因此,有个想法是投予非类固醇药物来治疗鼻塞。这也是为什么都想要看到这些儿童可以使用的装置。
  
  Olopatadine是一种选择性抗组织胺与巨大细胞稳定剂,适用于12岁以上病患缓解SAR。在这项研究中,研究者们想要检验用于治疗年纪较小病患的季节性过敏症状。
  
  总共有2,388位年龄介于6~11岁的儿童接受筛选,其中1,174位被随机分派接受1(共294位)或2(共293位)剂的olopatadine鼻喷剂,每天2次,为期2周,或相对应载体安慰剂1(共294位)或2(共293位)剂。
  
  La Force医师表示,这基本上是一个针对过敏症状控制的季节性过敏研究,这些儿童被随机分派接受olopatadine成人剂量,每个鼻孔2剂,每天2次,或每个鼻孔1剂、或相对应的载体安慰剂。
  
  所有病患都接受电话每日记录2次SAR症状严重度。
  
  【口腔与鼻症状减少】
  代表性的整体鼻症状分数显示,所有接受olopatadine治疗的患者,其症状改善程度显著比所有接受载体安慰剂病患高;这些症状包括鼻塞、流鼻水、鼻子痒与打喷嚏。
  
  这些分数显示,olopatadine每个鼻孔1剂组的病患,相较于相对应安慰剂组,症状显著降低(24.7%相较于17.9%;P=0.0007)。较高剂量每个鼻孔2剂的病患,也有同样的结果(26.5%相较于20.8%;P=0.0120)。
  
  整体眼睛症状分数,在痒与流眼泪这部份,接受olopatadine组每个鼻孔1剂组(24.5%相较于6.1%;P=0.0084)、每个鼻孔2剂组(26.3%相较于8.2%;P=0.0010)都是显著减少的。
  
  La Force医师总结,其研究结果显示,对这些年轻族群来说,在鼻子与眼睛症状的改善方面,投予olopatadine每个鼻孔1到2剂显著地比载体安慰剂好。
  
  然而,他附带表示,每个鼻孔投予2剂olopatadine并未比投予1剂提供更多的好处,换句话说,1剂与2剂的效果是一样好的,而且比较容易投予。
  
  【出乎意料的好处】
  德州华兹堡市北德洲大学小儿医学临床教授、ACAAI Bob Lanier执行医疗主任与前理事长Bob Lanier博士表示,许多研究已经证实,类固醇鼻喷剂可以降低眼睛与鼻子的过敏症状。这项研究希望专一性地针对抗组织胺鼻喷剂进行研究,而不是类固醇。
  
  未参加这项研究的Lanier博士表示,过敏会是永久的问题,且不会因为年纪增长而消退,这与一般大众的认知不同;因此,长期来说,你可能可以说你使用的药物不会有任何随著时间堆积的潜力;但类固醇确实有这样的潜力,虽然很小,而抗组织胺则没有这样的困扰。
  
  我想这里所要传达的是,使用局部药物,类固醇或抗组织胺药物,可能不只是改善投予药物的器官功能,还会影响到其它器官。这对于非吸收物质来说是个出乎意料的好处。我想这对于降低病患使用药物数量来说是个好消息,且最终可能降低使用这些药物的费用。
  
  【Olopatadine也有相当的安全性】
  同样发表在ACAAI年会上、来自这项研究的另外一篇墙报,评估使用这个药物的安全性预后。结果显示没有一位病患发生任何严重不良反应。除此之外,不同组之间,治疗相关不良反应的发生率是一样低的:每个鼻孔1剂olopatadine是5.7%、相对应载体安慰剂为4.0%、每个鼻孔2剂olopatadine是6.1%、相对应载体安慰剂为3.7%。
  
  而不论组别,最常报告的不良反应都是苦味,但仅发生在不到1.5%的病患身上。
  
  这项研究由Alcon研究公司赞助。La Force医师担任Alcon药厂的讲师团且接受讲师费。Lanier博士过去接受Alcon公司的咨询,但最近并未接受该公司咨询,也未被咨询有关此项研究的相关事项。

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.

    
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