辛香喷鼻纳米乳剂治疗儿童变应性鼻炎的临床研究

Clinical study on treating allergic rhinitis in children with Pungent Nasal Nanoemulsion

目的:以布地奈德鼻喷剂对照,评价辛香喷鼻纳米乳剂对儿童变应性鼻炎肺气虚寒证的临床疗效。方法:多中心对照研究,分为辛香喷鼻纳米乳剂组59例和阳性药物对照组39例,疗程均为4周。观察治疗前后症状体征积分变化。结果:辛香喷鼻纳米乳剂组显效率为62.71%,总有效率89.83%,阳性药物对照组显效率为64.10%,总有效率89.74%,两组疗效比较,差异无统计学意义;远期疗效评价,辛香喷鼻纳米乳剂组显效率为59.32%,总有效率88.14%,阳性药物对照组显效率为51.28%,总有效率82.05%,经统计学检验,两组远期疗效有显著性差异(P<0.05)。结论:辛香喷鼻纳米乳剂治疗儿童变应性鼻炎肺气虚寒证具有良好的近期疗效和远期疗效,且安全性好。

Objective： To evaluate the clinical efficacy of treating allergic rhinitis in children with syndrome of deficiency and cold of lung qi by using Pungent Nasal Nanoemulsion, and made the Budesonide Nasal Spray as the control agent. Methods： This study was set as a multicenter control study. Ninty-eight cases were selected and divided into Pungent Nasal Nanoemulsion group with 59 cases and positive drug control group with 39 cases, and treated for 4 weeks. Integral changes in symptom and physical sign were observed before and after the treatment. Results： The effective rate of Pungent Nasal Nanoemulsion group was 62.71% and its total efficacy was 89.83%, and the effective rate of positive drug control group was 64.10% and its total efficacy was 89.74%, which showed no statistical significance. For the evaluation of long-term curative effect, the effective rate of Pungent Nasal Nanoemulsion group was 59.32% and its total efficacy was 88.14%, and the effective rate of positive drug control group was 51.28% and its total efficacy was 82.05%. There was a statistical difference of long-term curative effect between the two groups （P〈0.05）. Conclusion： Pungent Nasal Nanoemulsion is safe and has both great short-term and long-term effect in treating pediatric allergic rhinitis in children with syndrome of deficiency and cold of lung qi.