治疗过敏性鼻炎,Levoceterizine的效果比Desloratadine好


  Dec. 4, 2002─在12月4日所举行的英国免疫学会与英国过敏及临床免疫年会中所发表的一篇head-to-head trial显示,从Zyrtec衍生而来的Levoceterizine(LCTZ)对于治疗季节性的过敏性鼻炎,比desloratidine(DLOR [Clarinex])具有更好的效果,更快的作用,药效也更持久,但可惜的是,LCTZ尚未通过美国的上市核准。
  
  加拿大安大略省Kingston 综合医院的J.H. Day说,在这个研究中我们发现,LCTZ比DLOR来得更有效,而且LCTZ 的起始作用时间比 DLOR快了2小时。
  
  在这个双盲、平行试验中,524位受试者接受筛检,其中373位被随机分配以LCTZ、DLOR,或安慰剂治疗,共有362位完成2天的试验,所有受试者年龄都在16岁以上,在过去两年间患有季节性的过敏性鼻炎症状,且需以药物治疗,受试前都已先以猪草(ragweed)做过皮肤检测呈阳性反应。
  
  这个研究从头到尾,两种抗组织胺都比安慰剂有效,但LCTZ在降低主要症状复杂分数(MSC)的效果比DLOR好(P=.001),MSC分数是一种混合的分数,它以数量化的方式来呈现患者流鼻水、鼻塞、鼻痒、打喷嚏、流眼泪等症状。与安慰剂组比较,服用LCTZ首次剂量后1小时, MSC分数即有明显改善(P<.001),但服用DLOR首次剂量后需要3小时的时间,MSC分数才有明显改善(P=.005)。
  
  24小时后,就在服用第二剂抗组织胺前,LCTZ组的MSC分数的改变明显大于DLOR组(P=.003)。服用抗组织胺后的第一个五小时,在降低整体症状复杂分数方面,例如:发痒的眼睛、耳朵、喉咙,以及咳嗽、鼻涕倒流等,LCTZ仍然表现得比DLOR优异,而在副作用方面,三组都差不多。
  
  这是第一次利用环境暴露单位(EEU)来比较两种抗组织胺药物的研究。由于环境暴露单位(EEU)能在同时最多有160人的情况下,提供一致的花粉暴露预估值,因此EEU能提供长、短期季节性过敏性鼻炎的药物治疗研究。
  
  
  
  
  
  

Levoceterizine Better Than Des

By Laurie Barclay, MD
Medscape Medical News

Dec. 4, 2002 — Levoceterizine (LCTZ), a modified form of Zyrtec not yet available in the U.S., has greater efficacy, faster onset, and longer duration than desloratidine (DLOR [Clarinex]) in the treatment of seasonal allergic rhinitis, according to the results of a head-to-head trial presented on Dec. 4 at the British Society for Immunology and the British Society for Allergy & Clinical Immunology annual meeting.

"LCTZ was more efficacious than DLOR throughout the study," write J.H. Day and colleagues from Kingston General Hospital in Ontario, Canada. "LCTZ acts one hour post-treatment and two hours earlier than DLOR."

In this double-blind, parallel-group study, 524 subjects were screened, 373 were randomized to treatment with LCTZ, DLOR, or placebo, and 362 completed the two-day study. All subjects were at least 16 years of age, had symptoms of seasonal allergic rhinitis requiring drug therapy for the past two years, and had a positive skin test for ragweed.

Throughout the study, both antihistamines were more effective than placebo, and LCTZ was more effective than DLOR (P=.001) in reducing the Major Symptom Complex (MSC) score, a composite score quantifying runny nose, sniffles, itchy nose, nose blows, sneezes, and watery eyes. Compared with placebo, the improvement in MSC score became significant one hour after the first dose of LCTZ (P<.001) and three hours after the first dose of DLOR (P=.005).

At 24 hours, just before taking the second dose of antihistamine, the change from baseline MSC score was significantly greater with LCTZ than with DLOR (P=.003).

For the first five hours after administration, LCTZ was also superior to DLOR in reducing the Total Symptom Complex score, a composite score measuring MSC symptoms as well as itchy eyes and ears, itchy throat, cough, and postnasal drip. The incidence of adverse events was similar in all three groups.

This was the first study using the Environmental Exposure Unit (EEU) to compare two antihistamines.

"The EEU provides a consistent predetermined level of pollen exposure in a conducive setting involving up to 160 subjects at a time," the authors write, noting that the EEU "enables consistent short- and long-term studies of medications used to treat seasonal allergic rhinitis."

BSI/BSACI Annual Meeting. Presented Dec. 4, 2002.

Reviewed by Gary D.Vogin, MD

    
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