辛夷鼻炎丸治疗变应性鼻炎的多中心临床试验  

A multicenter clinical trial on Xinyi Biyan Pill treatment of allergic rhinitis

作　　者：刘珊珊 阮岩[2] 唐旭霞[3] 蒋璐云 周小军[5] 谯凤英[6] 朱镇华[7] 谢景华[8] 洪铭[9] 王仁忠[10] 尹震 LIU Shan-shan;RUAN Yan;TANG Xu-xia;JIANG Lu-yun;ZHOU Xiao-jun;JIAO Feng-ying;ZHU Zhen-hua;XIE Jing-hua;HONG Ming;WANG Ren-zhong;YIN Zhen(Department of Researching and developing,Guangzhou Baiyunshan Zhongyi Pharmaceutical Co.,Ltd,Guangzhou 510530,Guangdong,China;不详)

机构地区：[1]广州白云山中一药业有限公司产品研发部,广东广州510530 [2]广州中医药大学第一附属医院耳鼻喉科,广东广州510405 [3]浙江中医药大学附属第一医院耳鼻咽喉科,浙江杭州310006 [4]成都中医药大学附属医院耳鼻喉科,四川成都610075 [5]中山市中医院耳鼻咽喉科,广东中山528400 [6]天津中医药大学第一附属医院耳鼻喉科,天津300000 [7]湖南中医药大学第一附属医院耳鼻咽喉头颈科,湖南长沙410000 [8]广州市第一人民医院耳鼻咽喉科,广东广州510180 [9]重庆市北碚区中医院耳鼻喉科,重庆400700 [10]山东中医药大学附属医院(山东省中医院)耳鼻喉科,山东济南250011

出　　处：《广东医学》2020年第9期898-901,共4页Guangdong Medical Journal

摘　　要：目的评价辛夷鼻炎丸治疗变应性鼻炎(肺经伏热证)的有效性和安全性。方法符合纳入标准的144例变应性鼻炎患者随机接受辛夷鼻炎丸(观察组)或鼻炎灵片(对照组)治疗。观察组患者口服辛夷鼻炎丸,每次3g(40丸),3次/d,同时服用鼻炎灵片模拟剂每次2片,3次/d。疗程21d。对照组患者口服鼻炎灵片,每次2片,3次/d,同时服用辛夷鼻炎丸模拟剂每次3g(40丸),3次/d,口服。疗程21d。观察用药后各项症状体征的改变情况和不良反应。结果观察组中医证候总有效率达80.56%,愈显率达38.89%,均有高于对照组的趋势,但组间差异无统计学意义(P>0.05);嗅觉减退症状消失率为77.78%,显著高于对照组(P<0.05),其他症状体征消失率均在30%以上,高于对照组但差异无统计学意义(P>0.05);中医证候积分及病情严重程度VAS评分均较用药前显著降低(P<0.05);两组未发现明显不良反应及毒副作用。结论辛夷鼻炎丸能有效改善变应性鼻炎患者的症状体征,疗效确切,安全性较好。Objective Compared with Biyan Ling pill,to observe the efficacy and safety of Xinyi Biyan pill on allergic rhinitis with lung heat syndrome.Methods A total of 144 allergic rhinitis patients were randomized to receive Xinyi Biyan pill(test group)or Biyan Ling pill(control group)for 21 days.The changes of symptoms and signs,and adverse reactions were compared.Results The total effective rate of TCM syndrome in the test group was 80.56%,the recovery rate was 38.89%,which were significantly higher than the control group(P>0.05).The hyposmia recovery rate was 77.78%,significantly higher than the control group(P<0.05).The TCM syndrome score and severity of VAS score were significantly lower than baseline(P<0.05).No significant adverse reactions or side effects were observed.Conclusion Xinyi Biyan Pill could effectively improve the symptoms and signs of allergic rhinitis patients,with definite curative effect and better safety.

关 键 词：变应性鼻炎 辛夷鼻炎丸 随机对照 双盲 

分 类 号：R765.22[医药卫生—耳鼻咽喉科] R276.1[医药卫生—临床医学]