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
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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)


Clinical Study of Efficacy and Safety of Danlong Oral Liquid on Bronchial Asthma(Heat Wheezing Syndrome)
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    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2 000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<0.000 1)。受试者基线期肺功能指标第1秒用力呼气容积(FEV1)、用力肺活量(FVC)、FEV1/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<0.000 1)。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<0.000 1)。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。

    Abstract:

    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 2 000 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<0.000 1).Pulmonary function indicators,including forced expiratory volume in one second(FEV1),forced vital capacity(FVC),FEV1/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<0.000 1).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<0.000 1).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.

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李得民,吕天宜,雷翔,李文军,王新民,查日田,靳端阳,黄燕,疏欣杨,张洪春.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[J].世界中医药,2025,(01).

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  • 收稿日期:2024-01-22
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  • 在线发布日期: 2025-03-30
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