Yang Hongjing, Zhang Chuantao, Gan Wenfan, Chen Jun, Wu Jianying, Xiao Wei, Yang Yang, Zhao Keni, Sun Zengtao, Xie Xiaohong, Huang Qingsong
Department of Respiratory Medicine.
Department of Critical Care Medicine.
Medicine (Baltimore). 2020 Jan;99(5):e18911. doi: 10.1097/MD.0000000000018911.
People with refractory asthma (RA) often seek help from Chinese medicine due to dissatisfaction with conventional treatments. External cold and internal fluid syndrome is the most common type of asthma and the Chinese herbal medicine formula Xiao-Qing-Long (XQL) decoction is commonly prescribed for patients with asthma with this syndrome. However, there is no direct evidence to support the efficacy and safety of XQL decoction for RA treatment and its potential mechanism is still unclear.
We propose a double-blind, placebo-controlled, randomized superiority trial. After a 2-week run-in period, 112 eligible participants will be recruited and randomly allocated to an experimental group or control group in a 1:1 ratio. Patients in the experimental group will take XQL decoction, while patients in the control group will receive a matched placebo. Symbicort Turbuhaler and Montelukast sodium tablets will be provided as the basic treatment for the 2 groups. All participants will receive 4 weeks of treatment and 12 weeks of follow-up. The primary outcome is the mean change in the asthma control test score from the baseline to 4 weeks posttreatment. The secondary outcomes include quality of life, lung function, curative effect of traditional Chinese medicine, and rescue medication used. This trial will also include analyses of the associations between intestinal microbiota and RA treatment. Any side effects of the treatment will be recorded.
The results of this trial will provide consolidated evidence of the effect of XQL decoction for RA and the potential mechanism by which XQL decoction acts, which will inform treatment options for patients with RA.
难治性哮喘（RA）患者常因对传统治疗不满而寻求中医帮助。外寒内饮证是哮喘最常见的证型，中药方剂小青龙（XQL）汤常用于治疗此证型的哮喘患者。然而，尚无直接证据支持XQL汤治疗RA的疗效和安全性，其潜在机制仍不清楚。
我们提出一项双盲、安慰剂对照、随机优效性试验。在为期2周的导入期后，将招募112名符合条件的参与者，并按1:1的比例随机分配到实验组或对照组。实验组患者将服用XQL汤，而对照组患者将接受匹配的安慰剂。两组均提供信必可都保和孟鲁司特钠片作为基础治疗。所有参与者将接受4周的治疗和12周的随访。主要结局是从基线到治疗后4周哮喘控制测试评分的平均变化。次要结局包括生活质量、肺功能、中医疗效和使用的急救药物。该试验还将包括对肠道微生物群与RA治疗之间关联的分析。将记录治疗的任何副作用。
本试验结果将为XQL汤治疗RA的效果及其作用的潜在机制提供确凿证据，这将为RA患者的治疗选择提供参考。
