丹龙口服液治疗支气管哮喘(热哮证)安全性和有效性的临床研究  

Clinical Study of Efficacy and Safety of Danlong Oral Liquid on Bronchial Asthma(Heat Wheezing Syndrome)

作　　者：李得民[1] 吕天宜 雷翔 李文军[4] 王新民[5] 查日田 靳端阳 黄燕 疏欣杨[1] 张洪春[1] LI Demin;LYU Tianyi;LEI Xiang;LI Wenjun;WANG Xinmin;ZHA Ritian;JIN Duanyang;HUANG Yan;SHU Xinyang;ZHANG Hongchun(China-Japan Friendship Hospital,Beijing 100029,China;Beijing University of Chinese Medicine Beijing 100029,China;Beijing Qihuang Technology Co.,Ltd.,Beijing 100006,China;The Third Hospital of Mianyang,Mianyang 621000,China;Shuyang Hospital of Traditional Chinese Medicine,Shuyang 223600,China;The First People′s Hospital of Wuhu,Wuhu 241000,China;Luohe Hospital of Traditional Chinese Medicine,Luohe 462000,China;Inner Mongolia Hospital of Traditional Chinese Medicine,Hohhot 010020,China)

机构地区：[1]中日友好医院,北京100029 [2]北京中医药大学,北京100029 [3]北京岐黄科技有限公司,北京100006 [4]四川绵阳市第三人民医院,绵阳621000 [5]沭阳县中医院,沭阳223600 [6]芜湖市第一人民医院,芜湖241000 [7]漯河市中医院,漯河462000 [8]内蒙古中医医院,呼和浩特010020

出　　处：《世界中医药》2025年第1期125-129,共5页World Chinese Medicine

基　　金：国家重点研发计划“中医药现代化”专项(2022YFC3500800);中日友好医院“菁英计划”人才培育工程资助项目(ZRJY2021-GG06)。

摘　　要：目的:评价丹龙口服液在广泛使用条件下治疗支气管哮喘(热哮证)的安全性和有效性。方法:选择符合入组条件的支气管哮喘热哮证受试者2000例,受试者在接受常规治疗的基础上,口服丹龙口服液,1支(10 mL)/次,3次/d,持续7 d。比较干预前后受试者中医证候积分、肺功能检查、哮喘控制问卷评分(ACQ)等疗效指标的改善情况及不良事件发生率、血常规、尿常规、血生化及十二导联心电图等安全性指标变化情况。结果:受试者基线期中医证候总积分为(11.49±3.37)分,治疗后中医证候总积分相对基线的变化值为(-6.50±3.68)分,差异有统计学意义(P<0.0001)。受试者基线期肺功能指标第1秒用力呼气容积(FEV_(1))、用力肺活量(FVC)、FEV_(1)/用力肺活量(FVC)、最大呼气中期流量(MMEF)、呼气峰值流量(PEF)值分别为(1.69±0.75)L、(2.59±0.90)L、(77.15±16.33)%、(1.37±0.81)L/s、(3.18±2.24)L/s,治疗后相对于基线的变化值分别为(0.30±0.38)L、(0.29±0.40)L、(6.51±12.16)%、(0.37±0.69)L/s、(0.60±1.51)L/s,差异有统计学意义(P<0.0001)。受试者基线期ACQ平均分为(1.61±0.51)分,治疗后相对基线的变化值为(-0.76±0.42)分,差异有统计学意义(P<0.0001)。相关不良事件发生42例55例次,发生率为2.10%。相关不良事件的严重程度为“1级”35例(1.75%),“2级”8例(0.40%)。结论:丹龙口服液具有缓解热哮证症状、改善肺功能、提高哮喘控制水平的作用,且安全性良好。Objective:To evaluate the safety and efficacy of Danlong Oral Liquid in the treatment of bronchial asthma(heat wheezing syndrome)under widespread use conditions.Methods:A total of 2000 bronchial asthma patients with heat wheezing syndrome who met the inclusion criteria were enrolled and administered Danlong Oral Liquid(10 mL per dose,3 times daily)for 7 days in addition to their routine treatment.Changes in efficacy indicators,including traditional Chinese medicine(TCM)syndrome scores,pulmonary function tests,and asthma control questionnaire(ACQ)scores,were compared before and after the intervention,along with safety indicators such as adverse events,blood routine,urinalysis,blood biochemistry,and 12-lead electrocardiogram.Results:The baseline TCM syndrome score was(11.49±3.37)points,and the change from baseline after treatment was(-6.50±3.68)points,with a statistically significant difference(P<0.0001).Pulmonary function indicators,including forced expiratory volume in one second(FEV_(1)),forced vital capacity(FVC),FEV_(1)/FVC,maximum mid-expiratory flow(MMEF),and peak expiratory flow(PEF),were(1.69±0.75)L,(2.59±0.90)L,(77.15±16.33)%,(1.37±0.81)L/s,and(3.18±2.24)L/s,respectively,at baseline.After treatment,the changes from baseline were(0.30±0.38)L,(0.29±0.40)L,(6.51±12.16)%,(0.37±0.69)L/s,and(0.60±1.51)L/s,with statistically significant differences(P<0.0001).The baseline ACQ score was(1.61±0.51)points,and the change from baseline after treatment was(-0.76±0.42)points,with a statistically significant difference(P<0.0001).A total of 42 adverse events were reported in 55 occurrences,with an incidence rate of 2.10%.The severity of adverse events was classified as“Grade 1”in 35 cases(1.75%)and“Grade 2”in 8 cases(0.40%).Conclusion:Danlong Oral Liquid effectively relieves heat wheezing syndrome symptoms,improves pulmonary function,and enhances asthma control,with good safety.

关 键 词：丹龙口服液 支气管哮喘 热哮证 广泛人群 中医证候积分 肺功能 哮喘控制水平 安全性 

分 类 号：R285.6[医药卫生—中药学] R256.12[医药卫生—中医学]