宣肺化浊丸治疗急性气管-支气管炎的单臂临床研究-《西部中医药》

文章信息/Info

Title:: A Single-arm Clinical Study of Xuanfei Huazhuo Pills in the Treatment of Acute Trachea-bronchitis

作者:: 李兴芳¹, 罗向霞¹, 万佳宜², 徐倩², 赵冰², 梁夏丽², 张茂福², 沈雁云², 李蓉蓉², 刘叶元², 李欣钰², 王冠伟², 周立文¹, 张新迪¹, 董敏¹, 安玉芬; 1.甘肃省中医院/甘肃中医药大学第一附属医院，甘肃兰州 730050
2.甘肃中医药大学，甘肃兰州 730000

Author(s):: LI Xingfang¹, LUO Xiangxia¹, WAN Jiayi², XU Qian², ZHAO Bing², LIANG Xiali², ZHANG Maofu², SHEN Yanyun², LI Rongrong², LIU Yeyuan², LI Xinyu; 1.Gansu Provincial Hospital of Traditional Chinese Medicine/The First Affiliated Hospital of Gansu University of Chinese Medicine, Lanzhou 730050, China
2.Gansu University of Chinese Medicine, Lanzhou 730000, China

Keywords:: acute trachea-bronchitis; dampness; heat and poison invading lung pattern; single-arm clinical study; pill

摘要:: 目的观察宣肺化浊丸治疗急性气管-支气管炎湿热毒邪犯肺证的临床疗效及安全性。方法采用前瞻性单臂试验临床研究方法，所有病例来自于2024年2～6月甘肃省中医院肺病科门诊确诊为急性气管-支气管炎的患者，对符合纳入、排除标准的患者予宣肺化浊丸治疗，连续治疗7天。比较患者治疗前后视觉模拟量表（visual analogue scale，VAS）评分、中医证候评分、莱塞斯特咳嗽问卷（leicester cough questionnaire，LCQ）评分。结果总有效率为97.86%（320/327）；治疗前VAS评分（6.18±1.38）分，治疗后为（0.98±1.35）分，差异具有统计学意义（P＜0.01）；治疗后咳嗽缓解率为44.34%（145/327），消失率为54.74%（179/327）；治疗后中医证候各项评分及症状发生均低于治疗前（P＜0.01）；治疗后患者LCQ生理、心理、社会及总评分均高于治疗前（P＜0.01）。结论宣肺化浊丸能有效改善急性气管-支气管炎证属湿热毒邪犯肺证患者咳嗽等临床症状，提高患者生活质量，但需要高质量的临床随机对照试验进行进一步验证。

Abstract:: ObjectiveTo evaluate the efficacy and safety of Xuanfei Huazhuo pill in the treatment of acute trachea-bronchitis of dampness, heat and poison invading lung pattern. MethodsClinical research adopted prospective single-arm trial, and all the medical cases were the patients with confirmed acute trachea-bronchitis from the clinic of pulmonary disease of Gansu provincial hospital of traditional Chinese medicine between February and June, 2024, the patients who met the inclusion and exclusion criteria were treated with the pills, for seven days consecutively. To compare VAS scores, TCM syndrome integrals and LCQ scores before and after the treatment. ResultsTotal effective rate was 97.86% (320/327); VAS scores before the treatment were (6.18±1.38) points, and the scores were (0.98±1.35) points after the treatment, the differences had statistical meaning (P<0.01); after the treatment, cough remission rate was 44.34%(145/327), and disappearance rate was 54.74% (179/327); after the treatment, the scores of TCM syndrome items and symptoms were lower than these before the treatment (P<0.01); after the treatment, total scores of LCQ and the scores of physiology, psychology and society were higher than these before the treatment (P<0.01). ConclusionThe pills could effectively improve the patients' clinical symptoms, and their quality of life, but more high-quality RCTs are needed for further validation.