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中国临床药理学与治疗学 ›› 2004, Vol. 9 ›› Issue (12): 1365-1368.

• 研究原著 • 上一篇    下一篇

野罂粟总生物碱对急性气管-支气管炎止咳效应的探索性临床研究

朱佳, 蒋萌1, 邹建东1, 徐丽华, 熊宁宁1   

  1. 南京中医药大学附属医院呼吸科, 1临床药理科, 南京 210029, 江苏
  • 收稿日期:2004-10-06 修回日期:2004-11-30 出版日期:2004-12-26 发布日期:2020-11-19
  • 通讯作者: 朱佳, 男, 主任医师, 硕士研究生导师, 主要从事呼吸疾病的临床研究。
  • 作者简介:蒋萌, 女, 主任医师, 主要从事临床药理研究。Tel:025-86608875 E-mail:jsnjzj@163.com
  • 基金资助:
    科技部“临床试验关键技术及平台研究” 课题资助(No2004AA2Z3766)

Exploratory clinical study of antitussive effects of total alkaloid agent extracted from Papaver somniferum L.in patients with acute tracheitis and bronchitis

ZHU Jia, JIANG Meng1, ZOU Jian-Dong, XU Li-Hua, XIONG Ning-Ning1   

  1. Department of Pneumaology, 1Department of Clinical Pharmacology, Affiliated Hospital of Nanjing University of Traditional Chinese Medicine, Nanjing 210029, Jiangsu, China
  • Received:2004-10-06 Revised:2004-11-30 Online:2004-12-26 Published:2020-11-19

摘要: 目的: 评价野罂粟总生物碱制剂对急性气管-支气管炎肺气上逆证的止咳效应。方法: 随机、双盲、安慰剂平行对照、叠加试验(add-on design) 设计。观察急性气管-支气管炎肺气上逆证共89 例, 其中野罂粟总生物碱组45 例, 安慰剂对照组44 例。结果: 试验组和安慰剂组服药后咳嗽明显减轻者分别占75.56 %和77.27 %(P=0.8487), 咳嗽明显减轻者的减轻时间分别为19.55±18.57 和25.27±19.60 h (P=0.1993);d 3 咳嗽消失率分别为33.33 %和36.36 %(P=0.7642);咳嗽记分值平均等级分别下降3.53 和4.16(P=0.2786) 。结论: 急性气管-支气管炎中度及重度咳嗽少痰肺气上逆证患者在使用头孢克洛缓释胶囊治疗的基础上, 野罂粟总生物碱制剂没有明显的止咳、平喘作用。

关键词: 野罂粟总生物碱, 急性气管-支气管炎, 止咳, 探索性临床研究

Abstract: AIM: To evaluate the antitussive effects of total alkaloid agent extracted from Papaver somniferum L.on acute tracheitis and bronchitis of which the syndrome is counterflow ascent of lung qi according to traditional Chinese medicine (TCM).METHODS: Random principle, double blind method, control group applied with placebo and add-on design were adopted in all trials. 89 patients with acute tracheitis and bronchitis whose syndrome is counterflow ascent of lung qi according to TCM took part in the trial.Among them 45 were in the treatment group treated with total alkaloid agent extracted from Papaver somniferum L.and 44 were in the control group treated with placebo.RESULTS: The rate of obvious coughing in treatment group and control group were 75.56 % and 77.27 %(P=0.8487), respectively.The cough alleviation time were 19.55±18.57 h and 25.27±19.60 h(P=0.1993), respectively.The cough disappear rate of the third day were 33.33 % and 36.36 %(P=0.7642) respectively. The average mark value drcreased were 3.53 and 4.16(P=0.2786), respectively.CONCLUSION: The total alkaloid agent extracted from Papaver somniferum L.has no significant antitussive effect on moderate and severe cough on the ground that the patients with acute tracheitis and bronchitis whose syndrome is counterflow ascent of lung qi according to TCM has been treated with cefaclor sustained release capsules simultaneously.

Key words: total alkaloid agent extracted from Papaver somniferum L., acute tracheitis and bronchitis, antitussive, exploratory clinical trial

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