宣肺化浊丸治疗急性气管-支气管炎的单臂临床研究  

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

作　　者：万佳宜 李兴芳[2] 罗向霞[2] 徐倩 赵冰 梁夏丽 张茂福 沈雁云 李蓉蓉 刘叶元 李欣钰 王冠伟 周立文[2] 张新迪 董敏[2] 安玉芬[2] 孟令鑫 张志明 WAN Jiayi;LI Xingfang;LUO Xiangxia;XU Qian;ZHAO Bing;LIANG Xiali;ZHANG Maofu;SHEN Yanyun;LI Rongrong;LIU Yeyuan;LI Xinyu;WANG Guanwei;ZHOU Liwen;ZHANG Xindi;DONG Min;AN Yufen;MENG Lingxin;ZHANG Zhiming(Gansu University of Chinese Medicine,Lanzhou 730000,China;Gansu Provincial Hospital of Traditional Chinese Medicine,Lanzhou 730050,China)

机构地区：[1]甘肃中医药大学,甘肃兰州730000 [2]甘肃省中医院,甘肃兰州730050

出　　处：《西部中医药》2024年第10期98-101,共4页Western Journal of Traditional Chinese Medicine

基　　金：甘肃省科技计划项目(联合科研基金)(23JRRA1530);甘肃省科技计划项目(科技重大专项计划)(21ZDKA0014)。

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。Objective:To evaluate the efficacy and safety of Xuanfei Huazhuo pil in the treatment of acute trachea-bronchitis of dampness,heat and poison invading lung pattern.Methods:Clinical 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.Results:Total 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).Conclusion:The pills could effectively improve the patients'clinical symptoms,and their quality of life,but more high-quality RCTs are needed for further validation.

关 键 词：急性气管-支气管炎 湿热毒邪犯肺证 单臂临床研究 宣肺化浊丸 

分 类 号：R256.11[医药卫生—中医内科学]