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  

Clinical trial of lupatadine combined with azlastine hydrochloride nasal spray in the treatment of allergic rhinitis patients

作　　者：徐洪彬 李可亮[2] 李科 王梅 胡璐璐[2] 孙明鹏[2] 童步升 XU Hong-bin;LI Ke-liang;LI Ke;WANG Mei;HU Lu-lu;SUN Ming-peng;TONG Bu-sheng(Department of Otolaryngology-Head and Neck Surgery,The First Affliated Hospital of Anhui Medical University,Hefei 230031,Anhui Province,China;Department of Otolaryngology and Head and Neck Surgery,Fuyang People's Hospital,Fuyang 236000,Anhui Province,China)

机构地区：[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

出　　处：《中国临床药理学杂志》2024年第19期2822-2825,共4页The Chinese Journal of Clinical Pharmacology

基　　金：国家卫生健康委医药卫生科技发展研究中心基金资助项目(WKZX2023CX170008);蚌埠医科大学科技基金资助项目(2023byzd221)。

摘　　要：目的观察卢帕他定片联合盐酸氮?斯汀鼻喷雾剂治疗过敏性鼻炎患者的临床疗效及安全性。方法将过敏性鼻炎患者随机分为对照组与试验组。2组患者均接受一般治疗,对照组在此基础上,给予盐酸氮?斯汀鼻喷雾剂每次每侧鼻孔0.14 mg,bid;试验组在对照组治疗的基础上,给予卢帕他定片每次10 mg,口服,qd。2组患者均治疗4周。比较2组患者的临床疗效、鼻-结膜炎相关生活质量调查问卷(RQLQ)、血清指标[白细胞介素-6(IL-6)、IL-1β、肿瘤坏死因子-α(TNF-α)、免疫球蛋白E(IgE)],以及安全性。结果试验组入组53例,脱落4例,最终有49例纳入统计分析;对照组入组53例,脱落4例,最终有49例纳入统计分析。治疗后,试验组和对照组的总有效率分别为95.92%(47例/49例)和81.63%(40例/49例),在统计学上差异有统计学意义(P<0.05)。治疗后,试验组和对照组的RQLQ评分分别为(49.57±6.97)和(58.18±7.78)分,IL-6水平分别为(5.12±1.25)和(7.34±1.46)ng·L^(-1),IL-1β水平分别为(12.25±5.64)和(20.05±6.32)pg·mL^(-1),TNF-α水平分别为(3.25±0.62)和(4.45±0.49)pg·mL^(-1),IgE水平分别为(114.28±19.63)和(136.84±30.14)μg·L^(-1),在统计学上差异均有统计学意义(均P<0.05)。2组患者的药物不良反应均以口干、疲劳乏力、头晕、嗜睡为主。试验组和对照组的总药物不良反应发生率分别为16.33%和10.20%,在统计学上差异无统计学意义(P>0.05)。结论卢帕他定片联合盐酸氮?斯汀鼻喷雾剂治疗过敏性鼻炎患者的临床疗效确切,其能有效减轻患者的炎症反应,降低IgE水平,改善生活质量,且不增加药物不良反应的发生率。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-1β,tumor necrosis factor-α(TNF-α),immunoglobulin E(IgE)]and safety were compared between the two groups.Results Treatment group were enrolled53 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-1β levels were(12.25±5.64)and(20.05±6.32)pg·mL^(-1),TNH-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 effe

关 键 词：卢帕他定片 盐酸氮?斯汀鼻喷雾剂 间歇性过敏性鼻炎 临床疗效 安全性评价 

分 类 号：R987[医药卫生—药品]