论文部分内容阅读
【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 evaluate the clinical efficacy and safety of Keke Tablets in the treatment of acute bronchitis-bronchitis syndrome, cold syndrome and phlegm-dampness syndrome. 【Methods】 A total of 240 patients with acute tracheobronchitis were randomly divided into three groups according to the randomized, double-blind, double-dummy, double-blind, The control group of 60 patients were given grams of cough tablets and Tong Xuanfei lung tablets oral treatment for 7 days. The cough symptom score, visual analogue scale (VAS), TCM syndrome score, cough relief and relapse were observed before and after treatment in both groups, and their safety was evaluated. 【Results】 A total of 232 eligible cases were studied, 176 cases in Keke group and 56 cases in control group. After treatment, cough symptom score, VAS score and TCM syndrome score were significantly improved in both groups (P <0.01), but there was no significant difference between the two groups (P> 0.05). The mean cough relief time in Keke group was 3.78 days, and one case developed recurrence. The average cough relief time in control group was 3.84 days without recurrence. There was no significant difference between the two groups in cough relief time and number of recurrence (P> 0.05). Three patients in Keke group had mild adverse events, and no adverse events in control group. [Conclusion] Keke tablets treatment of acute tracheo-bronchitis cold syndrome, cold and phlegm syndrome has a good effect and high security.