...
  • 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>Clinical and experimental allergy : >Efficacy and safety of birch pollen allergoid subcutaneous immunotherapy: A 2‐year double‐blind, placebo‐controlled, randomized trial plus 1‐year open‐label extension
【24h】

Efficacy and safety of birch pollen allergoid subcutaneous immunotherapy: A 2‐year double‐blind, placebo‐controlled, randomized trial plus 1‐year open‐label extension

机译：桦树花粉的疗效和安全性皮下免疫治疗：2年双盲，安慰剂控制，随机试验加1年开放标签延期

获取原文
获取原文并翻译 | 示例
           
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

Summary Background Previous clinical trials with birch pollen subcutaneous immunotherapy have been conducted over a 1‐ to 2‐year treatment period and involved mostly a single geographic location. Objective This study (EudraCT‐Number: 2005‐000025‐35) intended to evaluate the effect of subcutaneous immunotherapy with high‐dose hypoallergenic birch pollen allergoid in patients with confirmed moderate to severe seasonal allergic rhinitis/rhinoconjunctivitis over a 3‐year course in 19 European centres. Methods Adults with confirmed birch pollen allergy (n?=?253) were randomized to preseasonal placebo (n?=?129) or active treatment (n?=?124). Primary endpoint was change in Symptom Medication Score after 2 years treatment (2007). Results The change in Symptom Medication Score of active‐ vs placebo‐treated patients for the Full Analysis Set (n?=?227, 15.2% reduction, P ?=?0.0710) and Per‐Protocol Set (n?=?216, 16.7% reduction, P ?=?0.0523) showed a positive trend, although significance was not achieved. The primary endpoint, assessed in 2007, coincided with the lowest pollination during the study period. In a subgroup analysis of patients in the north‐eastern region (n?=?102), where birch is the major tree and consequently patients’ exposure is higher, changes in Symptom Medication Score (32.7% reduction, P ?=?0.0034) and median number of well days ( P ?=?0.0232) were highly significant in favour of the active group. During the open‐label third year of treatment, the mean Symptom Medication Score of active‐treated patients was further reduced despite an increased pollen count. Subcutaneous immunotherapy was well tolerated and consistent with the known safety profile. Conclusions and clinical relevance Although the primary endpoint was not reached for the Full Analysis Set, a significant and clinically relevant effect on Symptom Medication Score was clearly demonstrated for the subgroup of patients in the north‐eastern region of Europe, where birch is the predominant tree species. Proving efficacy of birch allergen subcutaneous immunotherapy is challenging due to the numerous factors influencing birch pollen allergen exposure in field studies.
机译：发明内容背景已经在1至2年的治疗期间进行了先前具有桦树花粉皮下免疫疗法的临床试验，并且主要是单一地理位置。目的本研究（Eudract-Number：2005-000025-35）旨在评估皮下免疫治疗与高剂量低过敏性桦木花粉患者的疗效，确认中度至严重季节性鼻炎/ rhinoconjuntivisitis的3年课程欧洲中心。方法具有确认的桦树花粉过敏（Nα=α253）的成虫被随机化为常见安慰剂（n？=Δ129）或主动处理（n？= 124）。初级终点在2年后症状药物评分的变化（2007）。结果全分析组症状治疗患者症状药物评分的变化（n？=Δ227,15.2％，p？= 0.0710）和每协议集（n？=？216,16.7百分比减少，p？= 0.0523）显示出积极的趋势，但没有实现显着性。 2007年评估的主要终点，恰逢研究期间的授粉。在东北地区患者的亚组分析中（n？= 102），其中桦树是主要树，因此患者的暴露更高，症状药物评分的变化（减少32.7％，p？= 0.0034）和中位数的井数（p？= 0.0232）非常显着，有利于活性组。在开放标签的治疗期间，尽管花粉数量增加，所以活性治疗患者的平均症状药物评分进一步降低。皮下免疫疗法耐受良好，与已知的安全型材一致。结论和临床相关性，尽管欧洲东北地区患者的患者亚组明确表明了对症状药物评分的显着和临床相关影响，但桦树是主要的终点物种。桦木过敏原的疗效皮下免疫疗法是挑战，由于影响桦树花粉过敏原暴露在现场研究中的众多因素。

著录项

相似文献

  • 外文文献
  • 专利
获取原文

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号