野罂粟总生物碱对单纯型慢性支气管炎止咳效应的药物适应症探索试验  

Phase Ⅱ Clinical Trial to Evaluate the Anti Tussive Effect of Total Alkaloid Agent Extracted from Papaver Somniferum L on Simple Chronic Bronchitis

作　　者：徐丽华[1] 蒋萌[2] 邹建东[2] 朱佳[1] 熊宁宁[2] 

机构地区：[1]南京中医药大学附属医院呼吸科,南京210029 [2]南京中医药大学附属医院临床药理科

出　　处：《中国循证医学杂志》2005年第2期148-151,共4页Chinese Journal of Evidence-based Medicine

基　　金：科技部"临床试验关键技术及平台研究"课题资助 (No .2 0 0 4AA2Z3 766)~~

摘　　要：目的　评价野罂粟总生物碱制剂对单纯型慢性支气管炎肺气上逆证的止咳效应。方法　采用随机、双盲、安慰剂平行组对照、叠加试验 (add ondesign)设计 ,观察单纯型慢性支气管炎肺气上逆证共 4 5例 ,其中试验组2 1例 ,对照组 2 4例。结果　两组服药后咳嗽明显减轻者分别占 6 6 . 6 7%和 70 . 83% (P =0 .76 33) ,首次服药后咳嗽明显减轻的起效时间分别为 14 . 6 4± 16 .30h和 15 .12± 15 .2 8h(P =0 . 795 6 ) ;服药后第 3天两组咳嗽消失率分别为2 8 .5 7%和 16. 6 7% (P =0 .3377) ;咳嗽记分值平均等级分别下降 4 . 2 9和 2 . 88(P =0 . 0 5 4 8)。结论　本临床试验结果提示 ,单纯型慢性支气管炎中度及重度咳嗽少痰者在使用头孢克洛缓释胶囊治疗基础上 ,加用或不加野罂粟总生物碱制剂的疗效差别无统计学意义。经专家讨论 ,在药物运用症的选择上存在问题 ,提前中止试验。Objective To evaluate the anti tussive effect of a total alkaloid agent extracted from Papaver Somniferum L. on simple chronic bronchitis of which the syndrome was counterflow ascent of lung qi according to traditional Chinese medicine (TCM) Methods Randomised, double blind method, placebo control and add on design were applied Forty five patients with counterflow ascent of lung qi of simple chronic bronchitis were randomly divided into two groups: treatment group (n=21) with alkaloid agent and control group (n=24) with placebo Results The incidences of obvious coughing in treatment and control groups were 66 67% and 70 83%(P=0 763 3) respectively The cough alleviation time of patients was 14 64±16 30 h and 15 12±15 28 h(P=0 795 6)respectively The loss of cough rates on the third day was 28 57%, 16 67%(P=0 337 7)respectively The average scores decreased were 4 29 and 2 88(P=0 054 8) respectively Conclusions The study indicates that total alkaloid agent extracted from Papaver somniferum L has no significant anti tussive effect on patients with counterflow ascent of lung qi of simple chronic bronchitis treated with cefaclor sustained release capsules simultaneously The trial was interrupted by the advice from experts who disagreed with the selection of drug indication

关 键 词：总生物碱 野罂粟 单纯型慢性支气管炎 止咳 Ⅱ期临床试验 

分 类 号：R285[医药卫生—中药学]