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Nasya/Prevalin在减轻过敏性鼻炎症状方面的安全性和有效性。

Safety and efficacy of Nasya/Prevalin in reducing symptoms of allergic rhinitis.

作者信息

Stoelzel Katharina, Bothe Gordana, Chong Pee Win, Lenarz Minoo

机构信息

Klinik für Hals-, Nasen-, Ohrenheilkunde, Kopf- und Halschirurgie, Charité - Universitaetsmedizin Berlin, Berlin, Germany.

出版信息

Clin Respir J. 2014 Oct;8(4):382-90. doi: 10.1111/crj.12080. Epub 2013 Dec 23.

DOI:10.1111/crj.12080
PMID:24279907
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4235399/
Abstract

BACKGROUND

Nasya/Prevalin is a natural, drug-free nasal spray for treatment and prevention of allergic rhinitis. Because of its thixotropic property, it forms a barrier on the nasal mucosa, preventing allergen contact. This study assesses the clinical efficacy and safety of Nasya/Prevalin in a nasal provocation test with house dust mite allergens.

METHODOLOGY/PRINCIPAL: In this randomised, double-blind, placebo-controlled trial, 20 subjects suffering from allergic rhinitis because of house dust mite allergens received a single dose of Nasya/Prevalin or saline spray before allergen challenge. Total nasal symptom score and total ocular symptom score were assessed 15, 30, 60, 75, 90, 120 and 240 min after challenge. Further, the appearance of the mucosa was examined by rhinoscopy.

RESULTS

A single treatment with Nasya/Prevalin led to a significant reduction of TNSS at 60, 75 and 90 min after dust mite allergen challenge as compared with placebo (pVCAS  = 0.021, pVCAS  = 0.035, pVCAS  = 0.036, respectively). Mucosa changes assessed by the rhinoscopic score (on swelling, secretion and colour) were significantly worse in the placebo group compared with the Nasya/Prevalin group (P = 0.033). Nasya/Prevalin was well tolerated, and the safety was comparable with placebo.

CONCLUSIONS

Treatment with Nasya/Prevalin was effective in preventing allergic reactions induced by dust mite allergen challenge.

摘要

背景

Nasya/Prevalin是一种用于治疗和预防过敏性鼻炎的天然、无药物的鼻腔喷雾剂。由于其触变性，它在鼻黏膜上形成一道屏障，防止过敏原接触。本研究评估了Nasya/Prevalin在尘螨过敏原鼻腔激发试验中的临床疗效和安全性。

方法/原理：在这项随机、双盲、安慰剂对照试验中，20名因尘螨过敏原而患有过敏性鼻炎的受试者在过敏原激发前接受了单剂量的Nasya/Prevalin或生理盐水喷雾剂。在激发后15、30、60、75、90、120和240分钟评估总鼻症状评分和总眼症状评分。此外，通过鼻内镜检查黏膜外观。

结果

与安慰剂相比，单次使用Nasya/Prevalin治疗导致在尘螨过敏原激发后60、75和90分钟时总鼻症状评分显著降低（分别为pVCAS = 0.021、pVCAS = 0.035、pVCAS = 0.036）。与Nasya/Prevalin组相比，安慰剂组通过鼻内镜评分（关于肿胀、分泌物和颜色）评估的黏膜变化明显更严重（P = 0.033）。Nasya/Prevalin耐受性良好，安全性与安慰剂相当。

结论

使用Nasya/Prevalin治疗可有效预防尘螨过敏原激发引起的过敏反应。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dd91/4235399/29c3fe146c96/crj0008-0382-f3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dd91/4235399/aa9674e97ca4/crj0008-0382-f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dd91/4235399/f89389af0d4a/crj0008-0382-f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dd91/4235399/29c3fe146c96/crj0008-0382-f3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dd91/4235399/aa9674e97ca4/crj0008-0382-f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dd91/4235399/f89389af0d4a/crj0008-0382-f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dd91/4235399/29c3fe146c96/crj0008-0382-f3.jpg

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