连花急支片治疗急性气管-支气管炎的随机双盲、安慰剂平行对照、多中心Ⅲ期临床研究  

A randomized,double-blind,placebo parallel controlled,multi-center phase Ⅲ clinical study of Lianhuajizhi Tablet on acute trachitis and bronchitis

作　　者：杨立波[1] 高学东[1] 刘贵颖[2] 史利卿[3] 王檀[4] 曲妮妮[5] 朱文翔[6] 范伏元[7] 龙有余[8] 齐文升[9] 

机构地区：[1]石家庄以岭药业股份有限公司,石家庄050035 [2]天津中医药大学第一附属医院,天津300193 [3]北京中医药大学东方医院,北京100078 [4]长春中医药大学附属医院,长春130117 [5]辽宁中医药大学附属医院,沈阳110033 [6]湖北省中医院,武汉430060 [7]湖南中医药大学第一附属医院,长沙410007 [8]天津中医药大学第二附属医院,天津300151 [9]中国中医科学院广安门医院,北京100053

出　　处：《中药药理与临床》2016年第2期193-196,共4页Pharmacology and Clinics of Chinese Materia Medica

基　　金：石家庄市科学技术研究与发展计划:141200813A

摘　　要：目的:研究连花急支片治疗急性气管-支气管炎的临床疗效和安全性。方法:采用随机双盲、安慰剂对照、多中心临床试验的设计方法,480例患者按3:1比例被随机分配服用连花急支片或者安慰剂,一次4片,一日三次,疗程7天。主要评价指标为咳嗽症状积分曲线下面积和咳嗽消失率。结果:治疗结束时,连花急支片组的咳嗽症状积分曲线下面积明显低于安慰剂组,咳嗽消失率明显高于安慰剂组。此外,连花急支片组在咯痰症状积分曲线下面积及消失率、疾病疗效和中医证候疗效等方面的改善均优于安慰剂组。结论:连花急支片治疗急性气管-支气管炎可明显缓解咳嗽、咯痰等临床症状,且无明显不良反应,具有较好的临床疗效和安全性。Objective： To determine clinical efficacy and safety of Lianhuajizhi on acute trachitis and bronchitis. Methods： A randomized,doubleblind,placebo-controlled,multi-center clinical trial randomly divided the 480 cases into experimental group which was treated with Lianhuajizhi Tablet and placebo group treat with placebo with a 3： 1 ratio. The course of treatment was 7days,4 tablets once,3 times a day. Primary endpoint was symptoms integral area under the curve of cough and cough disappearance rate. Results： After the treatment,symptoms integral area under the curve of Lianhuajizhi group was significantly lower than that of placebo group（ P 〈 0. 01）,cough disappearance rate in Lianhuajizhi group was significantly higher than that of placebo group（ P 〈 0. 01）. In addition,symptoms integral area under curve,disappear rate,curative effect,TCM syndrome and other aspects of Lianhuajizhi group were better than those of placebo group. Conclusion： Lianhuajizhi Tablet can significantly relieve symptoms of cough and expectoration with no obvious adverse reactions and better clinical efficacy and safety in treating acute trachitis and bronchitis.

关 键 词：连花急支片 急性气管-支气管炎 随机双盲 安慰剂对照 多中心临床试验 

分 类 号：R259[医药卫生—中西医结合]