芪仙清鸣颗粒治疗支气管哮喘缓解期随机对照双盲多中心临床研究

Randomized controlled double blind multicenter clinical study on treatment of bronchial asthma in remission stage with Qixian Qingming Granules

目的:评价芪仙清鸣颗粒治疗支气管哮喘缓解期的疗效和安全性。方法:采用随机、双盲、对照、多中心的临床研究方法。将200例支气管哮喘缓解期患者按照1∶1的比例随机分为对照组和试验组。在两组均在使用沙美特罗替卡松粉吸入剂(舒利迭)50μg/250μg治疗的基础上,试验组给予芪仙清鸣颗粒,对照组给予模拟颗粒,疗程6个月。评价两组治疗前后疗效及安全性。结果:两组治疗后中医证候疗效评分、呼出气一氧化氮水平及1年内急性发作次数均较治疗前显著下降(P<0.01,P<0.05),一秒率、第1秒用力呼气量、第1秒用力呼气量占预计值百分比、哮喘控制测试评分均显著升高(P<0.01),且试验组治疗前后差值优于对照组(P<0.01,P<0.05)。本研究中不良反应共发生9次(5.1%),均为胃肠道反应。结论:芪仙清鸣颗粒治疗哮喘缓解期的临床疗效显著,安全无严重不良反应,值得临床推广。

Objective: To evaluate the efficacy and safety of Qixian Qingming Granules in the treatment of bronchial asthma in the remission period. Methods: A randomized, double-blind, controlled, multi-center clinical study was conducted. Two hundred patients with bronchial asthma in remission were randomly divided into control group and treatment group according to the ratio of 1∶1. On the basis of the treatment of both groups with Seretide 50μg/250μg, Qixian Qingming Granules were given to the treatment group and simulated granuless to the control group. The treatment course was 6 months. The efficacy and safety indexes of the two groups were evaluated before and after treatment. Results: After treatment, the efficacy score of TCM symptoms, the FeNO level and number of acute attacks in one year in the two groups were significantly lower than those before treatment(P<0.01, P<0.05), one second rate, the forced expiratory volume in the first second and the percentage of the forced expiratory volume in the first second in the predicted value and the ACT score were significantly higher(P<0.01). The difference before and after treatment in treatment group was better than that in control group(P<0.01, P<0.05). In this study, 9 adverse events(5.1%) were found, all of which were gastrointestinal reactions. Conclusion: Qixian Qingming Granules has a significant clinical efficacy in the treatment of asthma in the remission stage and is safe without serious adverse reactions, which is worthy of clinical promotion.