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中国临床药理学与治疗学 ›› 2003, Vol. 8 ›› Issue (3): 286-288.

• 研究原著 • 上一篇    下一篇

植物药仙露贝滴剂治疗急性鼻窦炎的非劣效性临床研究

蒋萌, 熊宁宁, 严道南1, 刘玉秀2   

  1. 南京中医药大学附属医院临床药理室, 1耳鼻喉科, 南京 210029, 江苏; 2南京军区南京总医院信息科, 南京 210002, 江苏
  • 收稿日期:2003-02-08 修回日期:2003-02-28 出版日期:2003-06-26 发布日期:2020-11-25
  • 通讯作者: 蒋萌, 女, 硕士, 副主任医师, 硕士生导师, 主要从事临床药理研究。Tel:025-6555033 E-mail:jsszyyjd@msn.com

Non-inferiority clinical trial of imported herb sinupret drops in the treatment of Chinese patients with acute sinusitis

JIANG Meng, XIONG Ning-Ning, YAN Dao-Nan, LIU Yu-Xiu1   

  1. Department of Clinical Pharmacology, Department of Otolaryngology, Affiliated Hospital of Nanjin University of TCM, Nanjing 210029, Jiangsu; 1Department of Information, Nanjing General Hospital of Liberation Army, Nanjing 210002, Jiangsu
  • Received:2003-02-08 Revised:2003-02-28 Online:2003-06-26 Published:2020-11-25

摘要: 目的: 研究植物药仙露贝滴剂治疗急性鼻窦炎的疗效与安全性。方法: 以吉诺通胶囊为对照, 进行随机、平行、对照、多中心临床试验, 研究者盲态评价疗效。结果: 两组综合疗效、症状体征疗效比较均无显著的统计学意义(P >0.05), 未发现明显不良反应。结论: 仙露贝滴剂对急性鼻窦炎具有治疗作用, 且较为安全。

关键词: 药效学, 仙露贝滴剂, 急性鼻窦炎, 疗效性, 安全性, 非劣效性, 临床试验

Abstract: AIM: To evaluate efficacy and safety of the sinupret drops in the treatment of Chinese patients with acute sinusitis. METHODS: A randomized, positive-controlled (the capsules of gelomyrtol), parallelgroup, multi-central trial was carried out to evaluate the performance of the sinupret drops in Chinese patients. The assessment was blind to the investigators. RESULTS: There were no statistical differences in total curative efficacy and the approval of symptoms and signs between two groups (P >0.05).No adverse reactions were found during the trial. CONCLUSION: The sinupret drops is efficacy and safety in treatment of Chinese patients with acute sinusitis.

Key words: pharmacodynamics, sinupret drops, acute sinusitis, efficacy, safety, non-inferiority clinic trial

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