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

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

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 ondesign)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 4 5例 ,安慰剂对照组 4 4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 .5 6 %和 77.2 7% (P =0 .84 87) ,咳嗽明显减轻者的减轻时间分别为 19.5 5± 18.5 7和 2 5 .2 7±19 .6 0h (P =0 .1993) ;d 3咳嗽消失率分别为33.33%和 36 .36 % (P =0 .76 42 ) ;咳嗽记分值平均等级分别下降 3.5 3和 4 .16 (P =0 .2 786 )。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。

AIM: To evaluate the antitussive effects of total alkaloid a ge nt extracted from Papaver somniferum L. on acute tracheitis and bronchitis of which the syndrome is counterflow ascent of lung qi according to t raditional Chinese medicine (TCM). METHODS: Random principle, do uble blind method, control group applied with placebo and add-on design were ad opted in all trials. 89 patients with acute tracheitis and bronchitis whose synd rome is counterflow ascent of lung qi according to TCM took part in the trial. A mong them 45 were in the treatment group treated with total alkaloid agent extra cted 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. CONCL USION:The total alkaloid agent extracted from Papaver somniferu m L. has no significant antitussive effect on moderate and severe cough on the ground that the patients with acute tracheitis and bronchitis whose syndr ome is counterflow ascent of lung qi according to TCM has been treated with cefa clor sustained release capsules simultaneously.