用于缓解鼻塞的盐酸去氧肾上腺素缓释片：一项在变应性鼻炎患者中进行的随机、安慰剂对照试验
Phenylephrine hydrochloride modified-release tablets for nasal congestion: a randomized, placebo-controlled trial in allergic rhinitis patients.
作者信息
Meltzer Eli O, Ratner Paul H, McGraw Thomas
机构信息
Allergy and Asthma Medical Group and Research Center, San Diego, California.
Sylvana Research, San Antonio, Texas.
出版信息
Ann Allergy Asthma Immunol. 2016 Jan;116(1):66-71. doi: 10.1016/j.anai.2015.10.022. Epub 2015 Nov 7.
BACKGROUND
Over-the-counter phenylephrine hydrochloride (PEH) is used for relief of nasal congestion caused by allergic rhinitis; however, data to support its efficacy are lacking. The US Food and Drug Administration recommended clinical trials to evaluate the efficacy and safety of PEH in patients with this condition.
OBJECTIVE
To evaluate the efficacy and safety of PEH 30-mg modified-release (MR) tablets in patients with nasal congestion caused by allergic rhinitis in a multicenter, randomized, double-blinded, placebo-controlled, 2-arm, parallel-group study.
METHODS
Eligible adults at least 18 years old with documented hypersensitivity to fall pollen allergens were randomized to PEH-MR or placebo every 12 hours for 7 days from August 30 to October 12, 2011. The primary end point was mean change from baseline during the entire treatment period in daily reflective nasal congestion score. Secondary end points included changes in other symptom score assessments, time to maximal effect, duration of effect, and quality of life. Safety assessments included adverse events, serious adverse events, vital signs, physical examination, and electrocardiograms.
RESULTS
Of 575 patients, 288 received PEH-MR and 287 received placebo. No significant beneficial difference was detected between PEH-MR and placebo for the primary end point (PEH-MR, mean -0.394, SD 0.4880; placebo, mean -0.412, SD 0.5383; P = .2655). Likewise, no significant differences were observed for most secondary end points or quality of life. Overall, 89 of 575 patients (15.5%), equally distributed between the PEH-MR and placebo groups, experienced at least 1 treatment-emergency adverse event.
CONCLUSION
PEH-MR 30-mg tablets taken orally every 12 hours for 7 days is not more efficacious than placebo in relieving nasal congestion caused by allergic rhinitis.
TRIAL REGISTRATION
clinicaltrials.gov, identifier NCT01413958, protocol CL2011-06.
背景
非处方盐酸去氧肾上腺素（PEH）用于缓解变应性鼻炎引起的鼻充血；然而，缺乏支持其疗效的数据。美国食品药品监督管理局建议进行临床试验，以评估PEH在此类患者中的疗效和安全性。
目的
在一项多中心、随机、双盲、安慰剂对照、双臂、平行组研究中，评估30毫克缓释（MR）片PEH对变应性鼻炎引起鼻充血患者的疗效和安全性。
方法
2011年8月30日至10月12日，符合条件的至少18岁、对秋季花粉过敏原记录有超敏反应的成年人，每12小时随机接受PEH-MR或安慰剂治疗，持续7天。主要终点是整个治疗期间每日反射性鼻充血评分相对于基线的平均变化。次要终点包括其他症状评分评估的变化、达到最大效应的时间、效应持续时间和生活质量。安全性评估包括不良事件、严重不良事件、生命体征、体格检查和心电图。
结果
575例患者中，288例接受PEH-MR，287例接受安慰剂。对于主要终点，PEH-MR与安慰剂之间未检测到显著的有益差异（PEH-MR，均值-0.394，标准差0.4880；安慰剂，均值-0.412，标准差0.5383；P = 0.2655）。同样，大多数次要终点或生活质量方面也未观察到显著差异。总体而言，575例患者中有89例（15.5%），在PEH-MR组和安慰剂组中分布均匀，经历了至少1次治疗中出现的不良事件。
结论
每12小时口服30毫克PEH-MR片，持续7天，在缓解变应性鼻炎引起的鼻充血方面并不比安慰剂更有效。
试验注册
clinicaltrials.gov，标识符NCT01413958，方案CL2011-06。
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