通窍鼻炎颗粒治疗中重度持续性变应性鼻炎的临床观察  

Efficacy and Safety of Tongqiao Biyan Granules in the Treatment of Moderate and Severe Persistent Allergic Rhinitis:A multicenter open-label randomize-controlled clinical study

作　　者：周立[1] 孙永东 孟娟[3] 王中亮 鲜小龙 王巧灵[1] 田理[1] ZHOU Li;SUN Yongdong;MENG Juan;WANG Zhongliang;XIAN Xiaolong;WANG Qiaolin;TIAN Li(Department of Otorhinolaryngology,Hospital of Chengdu University of TCM,Chengdu,Sichuan,610075,China)

机构地区：[1]成都中医药大学附属医院耳鼻咽喉科,四川省成都市610075 [2]西南医科大学附属中医医院耳鼻咽喉科,四川省泸州市 [3]四川大学华西医院耳鼻咽喉-头颈外科,四川省成都市 [4]成都市第一人民医院耳鼻喉科,四川省成都市 [5]四川省第二中医医院耳鼻喉科,四川省成都市

出　　处：《中国中西医结合耳鼻咽喉科杂志》2024年第4期255-260,共6页Chinese Journal of Otorhinolaryngology in Integrative Medicine

摘　　要：目的观察通窍鼻炎颗粒治疗中重度持续性变应性鼻炎的有效性和安全性。方法在5家医院招募251例中重度持续性变应性鼻炎患者,随机平行分配至西药组、中成药组及联合治疗组。西药组为氯雷他定联合糠酸莫米松,中成药组为通窍鼻炎颗粒,联合治疗组为西药方案联合中成药方案。观察治疗前后鼻部症状评分(Total Nasal Symptoms Scores,TNSS),眼部症状评分(Total Ocular Symptom Score,TOSS),鼻结膜炎生活质量(Rhinoconjunctivitis Quality of Life Questionnaire,RQLQ),肝肾功能,血清免疫学,前鼻镜评分变化情况,并访视不良反应发生率及24周后变应性鼻炎复发情况。结果各组患者在治疗后TNSS、前鼻镜评分、TOSS、RQLQ以及IL-4、IL-5、IL-13、TGF-β均下降,且有统计学差异(P<0.05)。治疗后总体有效率为80.9%,且3组间无统计学差异(P=0.5552)。治疗后24周复发率,西药组为61.9%,中成药组为45.8%,西药联合中成药组为21.4%,3组间有统计学差异(P<0.01)。总体不良反应发生率6.0%,各组间无统计学差异(P=0.8267)。结论通窍鼻炎颗粒治疗中重度持续性变应性鼻炎疗效显著,安全性高,可改善患者免疫状况并防止复发,值得推广应用。Objective To evaluate the efficacy and safety of Tongqiao Biyan Granules in the treatment of moderate to severe persistent allergic rhinitis(AR).Methods 251 patients with moderate to severe persistent allergic rhinitis recruited in 5 hospitals were randomly assigned to 3 treatment groups.The patients of the first group were treated with loratadine capsule 10mg qd and mometasone furoate aqueous nasal spray 100μg qd for 2 weeks.The patients of the second group were treated with tongqiao biyan granules 2g tid for 3 weeks.The patients of the third group were treated with loratadine capsules and mometasone furoate nasal spray for 2 weeks,combined with tongqiao biyan granules for 3 weeks.The total nasal symptom scores(TNSS),the total ocular symptom scores(TOSS),the quality of life questionnaire scores(RQLQ),the anterior rhinoscopy scores,and recurrence of AR after treatment of 24 weeks,the serum levels of IL-4、IL-5、IL-13 and TGF-β,were used to evaluate the efficacy of each group.Abnormalities in serum levels of AST、ALT、CTE、BUN at the third week after treatment,and the incidence of adverse events reported by patients were used to evaluate the safety of different treatments.Results TNSS,TOSS,RQLQ,the anterior rhinoscopy scores,the serum levels of IL-4,IL-5,IL-13 and TGF-βall had been shown to decrease in each group with statistical differences after treatment.(P<0.05)。The overall effective(TNSS reduction rate≥50%)rate was 80.9%with no statistical difference among groups(P=0.5552).It was shown that recurrence rate of AR at the 24 weeks after treatment was 61.9%in the first group,45.8%in the second group and 21.4%in the third group,and the differences among the 3 groups were statistically significant(P<0.01).The overall incidence of adverse reactions was 6.0%,with no statistical difference(P=0.8267).Conclusion Tongqiao biyan granule has been shown to achieve a superior Efficacy and Safety on the treatment of moderate and severe persistent AR in patients,and has a good long-term effect in preventing recurre

关 键 词：通窍鼻炎颗粒 肺脾气虚证 中重度持续性 变应性鼻炎 

分 类 号：R765.21[医药卫生—耳鼻咽喉科]