盐酸氮(艹卓)斯汀鼻喷雾剂联合布地奈德治疗变应性鼻炎患者的临床研究OA
Clinical trial of azelastine hydrochloride nasal spray combined with budesonide for the treatment of allergic rhinitis
目的 探究盐酸氮(艹卓)斯汀鼻喷雾剂联合布地奈德鼻喷雾剂治疗变应性鼻炎(AR)患者的临床疗效和安全性.方法 将AR患者根据随机数表法分为对照组和试验组.对照组给予布地奈德鼻喷雾剂,固定剂量为1日256 μg,每次每个鼻孔内喷入64 μg,1日2次,试验组在对照组的基础上给予盐酸氮(艹卓)斯汀鼻喷雾剂,固定剂量为1日400 μg,1日2次,每次每个鼻孔内喷入100μg,2组患者均连续治疗1个月.比较2组的临床疗效、血清嗜酸粒细胞(EOS)、γ-干扰素(IFN-γ)、炎症因子白细胞介素-17(IL-17)、IL-4、、IL-18指标水平、鼻症状总积分量表(TNSS)评分并进行安全性评价.结果 共纳入180例,对照组和试验组各90例.治疗后,试验组和对照组总有效率分别为97.78％(88例/90例)和90.00％(81例/90例),在统计学上差异有统计学意义(P＜0.05);试验组和对照组的 EOS 水平分别为(4.33±0.47)× 109·L-1 和(5.18±0.58)× 109·L-1;IL-4 水平分别为(4.36±0.49)和(5.05±0.55)μg·L-1;IL-17 水平分别为(18.44±1.93)和(23.97±2.91)ng·L-1;IL-18 水平分别为(122.67±12.67)和(149.83±15.84)ng·L-1;TNSS 评分水平分别为(3.76±0.43)和(5.27±0.59)分;IFN-γ 水平水平分别为(83.29±8.49)和(75.12±7.65)mg·L-1,试验组上述指标与对照组比较,在统计学上差异均有统计学意义(均P＜0.001).试验组和对照组的药物不良反应总发生率分别为6.67％(6例/90例)和4.44％(4例/90例),在统计学上差异无统计学意义(P＞0.05).结论 盐酸氮(艹卓)斯汀鼻喷雾剂与布地奈德喷雾剂联合治疗AR,其疗效突出,不仅能够有效调节血清EOS和IFN-γ水平,缓解患者临床症状,减轻炎症反应,且安全性良好.
Objective To explore the clinical efficacy of nasal spray of azelastine hydrochloride combined with budesonide in the treatment of allergic rhinitis(AR).Methods The AR patients were divided into the control group and the treatment group according to the random number table method.The control group was given budesonide nasal spray at a fixed dose of 256 μg per day,with 64 μg sprayed into each nostril per time,twice a day.The treatment group was given azelastine hydrochloride nasal spray on the basis of the control group,with a fixed dose of 400 μg per day,twice a day,with 100 μg sprayed into each nostril per time.Both groups of patients received continuous treatment for one month.Compare the clinical efficacy,serum(EOS)and(IFN-γ),inflammatory factor interleukin-17(IL-17),IL-4,IL-18 index levels,total nasal symptom score scale(TNSS)score of the two groups,and conduct a safety evaluation.Results A total of 180 cases were included,with 90 cases in the control group and 90 cases in the treatment group.After the treatment,the total effective rates of the treatment group and the control group were 97.78％(88 cases/90 cases)and 90.00％(81 cases/90 cases),respectively.The difference was statistically significant(P＜0.05).After treatment,the eosinophil(EOS)levels of the treatment group and the control group were(4.33±0.47)× 109·L-1 and(5.18±0.58)× 109·L-1 respectively,the IL-4 levels were(4.36±0.49)and(5.05±0.55)μg·L-1 respectively;the IL-17 levels were(18.44±1.93)ng·L-1 and(23.97±2.91)ng·L-1,respectively;the IL-18 levels were(122.67±12.67)and(149.83±15.84)ng·L-1,respectively,and the TNSS scores were(3.76±0.43)points and(5.27±0.59)points,respectively;the levels of IFN-γ were(83.29±8.49)and(75.12±7.65)mg·L-1,respectively.Compared with the control group,the above indicators in the treatment group showed statistically significant differences in both cases(all P＜0.001).The total incidence rates of adverse drug reactions in the treatment group and the control group were 6.67％(6 cases/90 cases)and 4.44％(4 cases/90 cases),respectively.There was no statistical significance in this regard(P＞0.05).Conclusion The combination of azelastine hydrochloride nasal spray and budesonide nasal spray has a significant therapeutic effect on AR.It can improve serum EOS and IFN-γ levels,alleviate clinical symptoms and inflammatory reactions in patients,and has favorable safety.
李丽莉;薄少军;王岳衡;张晶
北京市和平里医院耳鼻喉科,北京 100018中国民航总医院耳鼻喉科,北京 100123北京市和平里医院耳鼻喉科,北京 100018北京市和平里医院耳鼻喉科,北京 100018
医药卫生
盐酸氮(艹卓)斯汀鼻喷雾剂布地奈德鼻喷雾剂变应性鼻炎血清嗜酸粒细胞γ-干扰素
azelastine hydrochloride nasal spraybudesonide nasal sprayallergic rhinitisserum eosinophilsγ-interferon
《中国临床药理学杂志》 2026 (12)
1692-1696,5
北京市医院管理中心课题基金资助项目(2021031)
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