风叶咳喘平合剂治疗急性支气管炎咳嗽(风热犯肺)的随机双盲多中心临床研究

Randomized double-blind multi-center clinical trial to observe therapeutic effect of Fenye Kechuanping Mixture on acute bronchitis cough(wind-heat affecting lung)

目的风叶咳喘平合剂(矮地茶、枇杷叶、麻黄、苦杏仁、薄荷、陈皮、竹茹、鱼腥草和炙甘草)治疗急性支气管炎(风热咳嗽)临床安全性和有效性。方法采用随机双盲多中心临床试验方法,纳入有效病例233例,随机分为高剂量组(风叶咳喘平合剂20 mL)、低剂量组(风叶咳喘平合剂10 mL+安慰剂10 mL)、对照组(安慰剂20 mL)。疗程均为7 d。观察治疗前、后各组患者咳嗽消失率,咳嗽消失时间、咳嗽症状积分,咳嗽视觉量表积分、中医证候积分等变化及不良反应。结果 (1)临床总有效率分别为98.7%(高剂量组)、92.4%(低剂量组)、64.9%(对照组);(2)咳嗽消失率分别为48.7%(高剂量组)、16.5%(低剂量组)、11.7%(对照组)。(3)高剂量组治疗第3、7天时点,咳嗽症状积分和视觉模拟积分改善明显,低剂量组此两项积分改善值优于对照。(4)中医证候疗效总有效率分别为98.7%(高剂量组)、89.9%(低剂量组)、67.5%(对照组),以上差异具有统计学意义(P<0.01和/或P<0.05)。3组不良事件与不良反应比较差异无统计学意义(P>0.05)。结论风叶咳喘平合剂能有效缓解急性支气管炎患者的咳嗽症状,减轻咳嗽严重程度。

AIM To investigate the clinical safety and efficacy of Fenye Kechuanping Mixture （Ardisiae japon- icae Herba, Eriobotryae Folium, Ephedrae Herba, Armeniacae Semen amarum, Methae Herba, Citri reticulatae Pericarpium, bambusae in taenia Caulis, Houttuyniae Herba, Glycyrrhizae Radix et Rhizoma praeparata cum melle. ） in the treatment for acute bronchitis cough （wind-heat affecting lung ）. METHODS Two hundred and thirty-three patients were divided into high-dose group （20 mL Fenye Kechuan Mixture）, low dose group （10 mL Fenye Kechuanping Mixture and 10 mL placebo） and control group （20 mL placebo） adopting random, double blind, double dummy and placebo-controlled clinical tests. One treatment course was seven days and clinical observations were conducted. RESULTS （ 1 ） The overall effective rates of the high-dose group, low dose group and the control group were 98.7% , 92.4% , and 64. 9% in turn. （2） Cough disappearance rate of the high-dose group, low dose group and the control group were 48.7% , 16. 5% , and 11.7% , respectively. （3） The improvement value of the cough symptom score and the visual scale integration in high group was more than that in the low group and the control group on the third and the sventh days of the treatment. （4） The efficacy of TCM syndrome of the high-dose group, the low dose group and the control group were 98.7% , 89.9% , and 7.5% , re- spectively. All the differences were statistically significant （ P 〈 0. 01 and/or P 〈 0.05. The differences of adverse events and adverse reactions among the three groups were not significant （P 〉 0. 05 ）. CONCLUSION Fenye Kechuanping Mixture can effectively relieve symptoms of cough in patients with acute bronchitis and reduce the severity of their cough.