Li Yanqing, Cheng Lei, Chen Xiaoning, Yang Beibei, Wang Dehui
Department of Otolaryngology, the ENT Hospital, Fudan University, Shanghai, China.
Am J Rhinol Allergy. 2015 Sep-Oct;29(5):e129-33. doi: 10.2500/ajra.2015.29.4218.
To further evaluate the efficacy and safety of a pollen blocker cream against dust-mite allergy.
A multicenter, randomized, double-blind, placebo-controlled, crossover trial was conducted in a Chinese population. Patients diagnosed with perennial allergic rhinitis, sensitive to dust-mite allergy including Dermatophagoides farinae and Dermatophagoides pteronyssinus were randomly allocated to receive a pollen blocker cream or placebo, which was applied and spread evenly to the lower internal nose region three times daily for a total of 30 days. The primary outcome measurements for efficacy were total nasal symptom score (TNSS) and individual nasal symptom score (iNSS). Adverse events were also monitored.
After application of a pollen blocker, the mean TNSS decreased from 23.1 to 13.8, the decrease of the pollen blocker group (9.3) was highly significant compared with the placebo group (5.2; p < 0.001). Similarly, the decreases in iNSSs (rhinorrhea, congestion, sneezing, and itching) between the pollen blocker group and the placebo group were also significant (p < 0.05). In addition, in adults, the pollen blocker led to a remarkably significant decrease in TNSS (9.5) compared with placebo (5.4; p < 0.001); in children, the pollen blocker led to a significant decrease in TNSS (8.6) compared with placebo (4.8; p < 0.05). No statistical difference was found in the incidence of adverse events between the two groups (p > 0.05), and no severe systematic reactions were observed.
Pollen Blocker is a safe and effective alternative to the drugs for treatment of AR, especially for Chinese people allergic to dust-mite allergy.
进一步评估一种花粉阻隔乳膏治疗尘螨过敏的疗效和安全性。
在中国人群中进行了一项多中心、随机、双盲、安慰剂对照的交叉试验。诊断为常年性变应性鼻炎且对包括粉尘螨和屋尘螨在内的尘螨过敏敏感的患者被随机分配接受花粉阻隔乳膏或安慰剂，每天三次将其涂抹并均匀涂抹于鼻内下部区域，共30天。疗效的主要结局指标为总鼻症状评分（TNSS）和个体鼻症状评分（iNSS）。同时监测不良事件。
使用花粉阻隔乳膏后，平均TNSS从23.1降至13.8，花粉阻隔乳膏组的降低值（9.3）与安慰剂组（5.2；p<0.001）相比具有高度显著性。同样，花粉阻隔乳膏组和安慰剂组之间iNSSs（流涕、鼻塞、打喷嚏和瘙痒）的降低也具有显著性（p<0.05）。此外，在成人中，与安慰剂（5.4；p<0.001）相比，花粉阻隔乳膏导致TNSS显著降低（9.5）；在儿童中，与安慰剂（4.8；p<0.05）相比，花粉阻隔乳膏导致TNSS显著降低（8.6）。两组不良事件发生率无统计学差异（p>0.05），未观察到严重的全身反应。
花粉阻隔乳膏是治疗变应性鼻炎药物的一种安全有效的替代品，尤其适用于对尘螨过敏的中国人。
