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

发布时间：2019-03-17 13:43

【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(P0.01),但组间比较差异无统计学意义(P0.05)。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(P0.05)。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。
[Abstract]:[objective] to evaluate the clinical efficacy and safety of Ke tablet in the treatment of acute tracheobronchial syndrome of wind-cold, wind-cold and phlegm-dampness syndrome. [methods] A randomized, double-blind, double-simulated, parallel controlled clinical trial was designed with multi-center, double-blind and double-simulated, positive drugs. 240 patients with acute tracheobroncholitis were randomly divided into Ke group (n = 180) and control group (n = 60) at 3:1. The patients were given Ke tablet and Tongxuan Lifei tablet orally for 7 d. The cough symptom score, visual analogue score (VAS), cough remission and recurrence were observed before and after treatment in two groups. [results] there were 232 qualified cases, 176 cases in Ke group and 56 cases in control group. After treatment, the cough symptom score, VAS score and TCM syndrome score of the two groups were significantly improved (P0.01), but there was no significant difference between the two groups (P0.05). The average cough remission time was 3.78 days in Ke group and 1 case recurred, while the average cough relief time in control group was 3.84 days without recurrence. There was no significant difference in cough remission time and recurrence times between the two groups (P0.05). There were 3 cases of mild adverse events in the Ke group, and no adverse events were found in the control group. [conclusion] KKE tablet has better curative effect and higher safety in treating acute tracheobronchial wind-cold syndrome, wind-cold and phlegm-dampness syndrome.
【作者单位】：广州中医药大学第二附属医院;河南中医学院第一附属医院;浙江省中医院;福建省第二人民医院;四川大学华西医院;辽宁中医药大学附属医院;中山市中智药业集团有限公司;
【分类号】：R562.2

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