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滴通鼻炎水喷雾剂治疗变应性鼻炎的临床研究
引用本文:李政海,阮碧芳,刘大新,王仲岩,锡林托娅.滴通鼻炎水喷雾剂治疗变应性鼻炎的临床研究[J].现代药物与临床,2011,26(4):319-322.
作者姓名:李政海  阮碧芳  刘大新  王仲岩  锡林托娅
作者单位:美国东方生物技术有限公司;广西博科药业有限公司;北京中医药大学东方医院;陕西省人民医院;内蒙古自治区中蒙医医院
摘    要:目的 评价滴通鼻炎水喷雾剂治疗变应性鼻炎(鼻鼽)的临床疗效和安全性.方法采用随机、盲法、安慰剂平行对照、多中心临床研究,88例变应性鼻炎患者分为试验组66例、对照组22例,分别使用滴通鼻炎水喷雾剂和安慰剂,外用喷鼻,每次2揿(0.13 mL/揿),4次/d,疗程14 d.用变应性鼻炎临床疗效、鼻塞缓解时间、鼻塞缓解维持...

关 键 词:滴通鼻炎水喷雾剂  变应性鼻炎  临床疗效  药品安全

Clinical study on Ditong Biyanshui Spray for treatment of allergic rhinitis
LI Zheng-hai,RUAN Bi-fang,LIU Da-xin,WANG Zhong-yan and XILIN Tuo-ya.Clinical study on Ditong Biyanshui Spray for treatment of allergic rhinitis[J].Drugs & Clinic,2011,26(4):319-322.
Authors:LI Zheng-hai  RUAN Bi-fang  LIU Da-xin  WANG Zhong-yan and XILIN Tuo-ya
Institution:LI Zheng-hai1,RUAN Bi-fang2,LIU Da-xin3,WANG Zhong-yan4,XILIN Tuo-ya5 1.American Oriental Bioengineering Co.,Ltd.,Beijing 100176,China 2.Guangxi Boke Pharmaceutical Co.,Ltd.,Nanning 530003,China 3.Beijing University of Traditional Chinese Medicine Subsidiary Dongfang Hospital,Beijing 100078,China 4.Shaanxi Provincial People’s Hospital,Xi’an 710068,China 5.Mongolian Hospital of Inner Mongolia,Hohhot 010020,China
Abstract:Objective To evaluate the clinical efficacy and safety of Ditong Biyanshui Spray for the treatment of allergic rhinitis (Biqiu). Methods A randomized, blinded, placebo controlled, and multicenter trial method was used in this assay. The trial enrolled 88 patients with allergic rhinitis, including 66 cases in experimental group and 22 cases in control group, respectively given Ditong Biyanshui Spray and placebo for external application, pressing 2 once ( 0.13 mL/press ), 4 times/d, using 14 d as a course of treatment. Allergic rhinitis criteria of clinical curative effect, the time for easing stuffy nose and duration, and the number of sneeze were used to assess the efficacy. The general physical examination and adverse events were for assessment in safety. Results The clinical control rate, significant effective rate, effective rate, and ineffective rate were 13.64%, 46.97%, 30.30%, and 9.09% in the experimental group, and 0.00%, 13.64%, 27.27%, and 59.09% in the control group, respectively. Besides nasal congestion relieving duration and the number of sneezes, the overall results showed that the experimental group was superior to the control group with statistical significance (P<0.05). In addition, there were no adverse events in both two groups. Conclusion Ditong Biyanshui Spray is an effective clinical drug for the treatment of allergic rhinitis, as well as a secure drug.
Keywords:Ditong Biyanshui Spray  allergic rhinitis  clinical efficacy  medicine safety
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