克咳片治疗急性气管—支气管炎多中心随机双盲对照临床研究  

Multiple-center, Randomized, Double-blinded Controlled Trial of Keke Tablets for Treatment of Acute Tracheobronchitis

作　　者：林琳 王奇 李素云[2] 王真[3] 黄河清[4] 毛兵[5] 徐艳玲[6] 成金乐 梁燕玲 

机构地区：[1]广州中医药大学第二附属医院,广东广州510120 [2]河南中医学院第一附属医院,河南郑州450000 [3]浙江省中医院,浙江杭州310006 [4]福建省第二人民医院,福建福州350003 [5]四川大学华西医院,四川成都610041 [6]辽宁中医药大学附属医院,辽宁沈阳110032 [7]中山市中智药业集团有限公司,广东中山528437

出　　处：《广州中医药大学学报》2014年第3期339-342,347,共5页Journal of Guangzhou University of Traditional Chinese Medicine

摘　　要：【目的】评价克咳片治疗急性气管—支气管炎风寒证、风寒兼痰湿证的临床疗效和安全性。【方法】采用多中心、分层区组随机、双盲双模拟、阳性药平行对照临床试验设计,将240例急性气管—支气管炎患者以3∶1的比例随机分为克咳组180例和对照组60例,分别给予克咳片和通宣理肺片口服,疗程7 d。观察2组治疗前后咳嗽症状计分、视觉模拟评分(VAS)、中医证候计分、咳嗽缓解和复发情况,并评价其安全性。【结果】合格的研究病例共232例,克咳组176例,对照组56例。治疗后2组的咳嗽症状计分、VAS评分、中医证候计分均显著改善,与治疗前比较差异均有统计学意义(P<0.01),但组间比较差异无统计学意义(P>0.05)。克咳组平均咳嗽缓解时间为3.78 d,1例出现复发;对照组平均咳嗽缓解时间为3.84 d,未出现复发,2组咳嗽缓解时间和复发次数比较差异无统计学意义(P>0.05)。克咳组有3例患者出现轻度不良事件,对照组未发现不良事件。【结论】克咳片治疗急性气管—支气管炎风寒证、风寒兼痰湿证具有较好的疗效和较高的安全性。Objective To investigate the therapeutic effect and safety of Keke Tablets for acute tracheobronchitis with wind cold syndrome and the syndrome of wind cold complicated with phlegm dampness. Methods A multiple- center stratified block randomization, double-blind, double mimic, positive-medicine parallel-controlled trial was carried out in 240 acute tracheobronchitis patients. The patients were randomized into observation group （N=180） and control group （N=60） in the proportion of 3：1. The observation group was given Keke Tablets and the control group was given Tongxuan Lifei Tablets orally. The treatment lasted 7 days. The scores of cough, visual analogue scale （VAS） and traditional Chinese medical syndrome were compared before and af- ter treatment. The relief and recurrence of cough were observed, and the safety was also monitored. Results The enrolled qualified patients were 232 cases, 176 being in the observation group and 56 being in the control group. After treatment, the scores of cough, VAS and traditional Chinese medical syndrome were improved in both groups （P〈0.01 compared with those before treatment）, but the differences of the scores between the two groups were insignificant （P〉0.05） . The average time for cough relief was 3,78 days in the observation groupand was 3.84 days the control group, in the control group, and cough recurred in one case of the observation group but in none of the difference being insignificant （P〉0.05） . Slight adverse reaction occurred in 3 cases of the observation group, while was not showed in the control group. Conclusion Keke Tablets show certain clinical efficacy and safety for the treatment of acute tracheobronehitis with wind cold syndrome and the syndrome of wind cold complicated with phlegm dampness.

关 键 词：克咳片 咳嗽 急性气管—支气管炎 风寒 风寒兼痰湿 

分 类 号：R255.9[医药卫生—中医内科学]