Clinical trial of lupatadine combined with azlastine hydrochloride nasal spray in the treatment of allergic rhinitis patients
10.13699/j.cnki.1001-6821.2024.19.013
- VernacularTitle:卢帕他定联合盐酸氮斯汀鼻喷雾剂治疗过敏性鼻炎患者的临床研究
- Author:
Hong-Bin XU
1
,
2
;
Ke-Liang LI
;
Ke LI
;
Mei WANG
;
Lu-Lu HU
;
Ming-Peng SUN
;
Bu-Sheng TONG
Author Information
1. 安徽医科大学第一附属医院耳鼻咽喉头颈外科,安徽合肥 230031
2. 阜阳市人民医院耳鼻咽喉头颈外科,安徽阜阳 236000
- Keywords:
lupatadine tablet;
azelastine hydrochloride nasal spray;
allergic rhinitis;
clinical efficacy;
safety evaluation
- From:
The Chinese Journal of Clinical Pharmacology
2024;40(19):2822-2825
- CountryChina
- Language:Chinese
-
Abstract:
Objective To observe the clinical efficacy and safety of lupatadine tablets combined with azelastine hydrochloride nasal spray in the treatment of allergic rhinitis patients.Methods Patients with allergic rhinitis were randomly divided into control group and treatment group.Both groups received general treatment.On this basis,the control group was given azelastine hydrochloride nasal spray 0.14 mg per nostril each time,bid;on the basis of control group,the treatment group received lupatadine tablets 10 mg each time,orally,qd.Two groups were treated for 4 weeks.The clinical efficacy,rhinoconjunctivitis related quality of life questionnaire(RQLQ),serum indexes[interleukin-6(IL-6),IL-1 β,tumor necrosis factor-α(TNF-α),immunoglobulin E(IgE)]and safety were compared between the two groups.Results Treatment group were enrolled 53 cases,4 cases dropped out,and 49 cases were finally included in the statistical analysis.Control group were enrolled 53 cases,4 cases dropped out,and 49 cases were finally included in the statistical analysis.After treatment,the total effective rates of the treatment and control groups were 95.92％(47 cases/49 cases)and 81.63％(40 cases/49 cases)with significant difference(P＜0.05).After treatment,the RQLQ scores of treatment and control groups were(49.57±6.97)and(58.18±7.78)points,IL-6 levels were(5.12±1.25)and(7.34±1.46)ng·L-1,IL-1 β levels were(12.25±5.64)and(20.05±6.32)pg·mL-1,TNF-α levels were(3.25±0.62)and(4.45±0.49)pg·mL-1,the IgE levels were(114.28±19.63)and(136.84±30.14)μg·L-1,respectively,the differences were statistically significant difference(all P＜0.05).The adverse drug reactions of two groups were dry mouth,fatigue,dizziness and drowsiness.The total incidences of adverse drug reactions in the treatment and control groups were 16.33％and 10.20％without significant difference(P＞0.05).Conclusion Lupatadine tablets combined with azostine hydrochloride nasal spray have a definitive clinical efficacy in the treatment of allergic rhinitis patients,which can effectively reduce the inflammatory reaction,reduce the IgE levels,improve the quality of life,without increasing the incidence of adverse drug reactions.
