摘要
目的观察固本咳喘颗粒治疗慢性支气管炎(CB)肺气虚弱证的临床疗效和安全性。方法采用多中心、随机对照试验设计,将180例CB肺气虚弱证患者按照2∶1比例随机分为治疗组120例和对照组60例。对照组进行健康教育24周,同时当发生CB急性加重时予常规对症处理。治疗组在对照组治疗方案的基础上口服固本咳喘颗粒每次2 g、每天3次,共24周。两组治疗24周结束后均随访24周。主要疗效指标包括治疗期间、随访期间CB急性加重次数,以及从治疗开始截至随访结束时CB急性加重总次数。次要疗效指标包括CB急性加重情况(即首次急性加重时间、急性加重间隔时间、急性加重持续时间、急性加重症状严重程度评分)和肺功能指标;并比较治疗前,治疗4、8、12、16、20、24周及随访24周时的咳嗽、咳痰、喘息评分及症状总分。记录研究期间不良事件的发生情况并检测安全性指标(包括血常规、肝功能、肾功能、尿常规)。结果最终完成试验179例,包括治疗组119例、对照组60例。与本组治疗前比较,治疗组咳嗽、咳痰、喘息评分及症状总分在治疗4、8、12、16、20、24周及随访24周时均降低;对照组咳嗽评分在治疗16、20、24周时均降低,咳痰、喘息评分在治疗24周及随访24周时均降低,症状总分在治疗20、24周及随访24周时均降低(P<0.05)。与对照组比较,治疗组治疗期间、随访期间CB急性加重次数,从治疗开始截至随访结束时CB急性加重总次数,CB急性加重持续时间、急性加重症状严重程度评分,咳嗽、咳痰、喘息评分及症状总分在治疗8、12、16、20、24周及随访24周时均降低,而CB首次急性加重时间延长(P<0.05或P<0.01)。两组治疗前及治疗24周后肺功能指标比较差异无统计学意义(P>0.05)。两组治疗前后安全性指标均无明显异常,治疗期间两组不良事件发生率比较差异无统计学意义(P>0.05)。结论固本咳喘颗粒可降低CB肺气虚弱证患者急性加重风险,改善咳嗽、咳痰、喘息等临床症状,且安全性好。
Objective This study aimed to evaluate the clinical effectiveness and safety of Guben Kechuan Granules (固本咳喘颗粒) in treating chronic bronchitis(CB) with lung qi weakness pattern. Methods A multicenter, randomized controlled trial was conducted, and 180 patients with CB of lung qi weakness pattern were randomly divided into 120cases in the treatment group and 60 cases in the control group according to a 2∶1 ratio. The control group received health education for 24 weeks, while conventional symptomatic treatment was given when acute exacerbation of CB occurred. Treatment group was treated with the oral administration of Guben Kechuan Granules, 2 g each time, 3times a day, for a total of 24 weeks on the basis of treatment of the control group. Both groups were followed up for 24weeks after 24 weeks of treatment. Primary effectiveness indicators included the number of CB acute exacerbations occurence during the treatment and follow-up period, and the total number of CB acute exacerbations from the start of treatment to the end of follow-up. Secondary effectiveness indicators included the details of CB acute exacerbations, i. e., time to first acute exacerbation, time between acute exacerbations, duration of each time of acute exacerbation, and acute exacerbation symptom severity scores, and lung function indices. The scores of cough, sputum, and wheeze and total symptom scores were compared prior to treatment, at 4, 8, 12, 16, 20, and 24 weeks of treatment, and at 24 weeks of follow-up. The occurrence of adverse events during the study period was recorded and safety indices including blood routine, liver function, kidney function, and urine routine were tested. Results A total of 179 participants completed the trial including 119 in the treatment group and 60 in the control group. Compared to pretreatment scores within the group, the treatment group showed reductions in cough, sputum, and wheeze scores, and total symptom scores at weeks 4, 8, 12, 16, 20, and 24 of treatment, as well as at 24 weeks of follow-up;in the control group, cough scores decreased at weeks 16, 20, and 24, sputum and wheeze scores decreased at week 24 of treatment and at 24 weeks of follow-up, and total symptom scores decreased at weeks 20, 24 of treatment, and at 24 weeks of follow-up(P<0. 05). Compared with the control group, the treatment group showed reductions in the number of CB acute exacerbations occurence during the treatment and follow-up period, and the total number of CB acute exacerbations from the start of treatment to the end of follow-up, the duration of acute exacerbations, the acute exacerbation symptom severity scores, and the scores for cough, sputum, wheeze, and total symptoms at weeks 8, 12, 16, 20, 24of treatment, and at 24 weeks of follow-up;while the time to the first acute exacerbation of CB was significantly prolonged in the treatment group(P<0. 05 or P<0. 01). There were no statistically significant differences in lung function indicators between groups before treatment and at 24 weeks after treatment(P>0. 05). Safety indicators showed no significant abnormalities before or after treatment in either group, and the incidence of adverse events during the treatment period showed no significant differences between the groups(P>0. 05). Conclusion Guben Kechuan Granules can reduce the risk of acute exacerbations in CB patients with lung qi weakness pattern, improve clinical symptoms such as cough, sputum, and wheeze, and show good safety.
作者
杨道文
尚晓凤
洪儿
张洪春
YANG Daowen;SHANG Xiaofeng;HONG Er;ZHANG Hongchun(China-Japan Friendship Hospital,Beijing,100029;Taiyuan Central Hospital,Shanxi Province;Ningbo Hosp ditional Chinese Medicine,Zhejiang Province)
出处
《中医杂志》
北大核心
2025年第3期262-267,共6页
Journal of Traditional Chinese Medicine
基金
中医药传承与创新“百千万”人才工程(岐黄工程)岐黄学者项目(2019-QTL-003)。
关键词
慢性支气管炎
肺气虚弱证
肺功能
固本咳喘颗粒
chronic bronchitis
lung qi weakness pattern
lung function
Guben Kechuan Granules(固本咳喘颗粒)
作者简介
通讯作者:张洪春,zhanghongchun_zry@163.com。
