肃肺平喘方治疗支气管扩张症合并气流受限痰热蕴肺兼肺脾气虚证患者的随机对照试验  

Sufei Pingchuan Formula(肃肺平喘方)for the Treatment of Bronchiectasis Patients Combined with Airflow Limitation of Phlegm-Heat Obstructing the Lung and Lung-Spleen Qi Deficiency Syndrome:A Randomised Controlled Trial

作　　者：袁沙沙[1] 张海艳 石霞 王冰[1] 丛晓东[1] 苗青[1] YUAN Shasha;ZHANG Haiyan;SHI Xia;WANG Bing;CONG Xiaodong;MIAO Qing(Xiyuan Hospital,China Academy of Chinese Medical Sciences,Beijing,100091;Shenzhen Hospital of Beijing University of Chinese Medicine)

机构地区：[1]中国中医科学院西苑医院,北京市海淀区100091 [2]北京中医药大学深圳医院

出　　处：《中医杂志》2025年第6期581-587,共7页Journal of Traditional Chinese Medicine

基　　金：中国中医科学院名老中医经验传承研究专项(XYZX0101-38)。

摘　　要：目的评价肃肺平喘方治疗支气管扩张症(简称支扩)合并气流受限痰热蕴肺兼肺脾气虚证患者的有效性及安全性。方法采用随机、双盲、安慰剂对照试验方案,将72例稳定期支扩合并气流受限的痰热蕴肺兼肺脾气虚证患者随机分为治疗组和对照组各36例。两组患者在规律使用噻托溴铵吸入喷雾剂的基础上,治疗组给予肃肺平喘方颗粒剂,对照组给予肃肺平喘方颗粒剂模拟剂,两组疗程均为12周。分别观察两组患者治疗前后肺功能第一秒用力呼气容积(FEV1);分别于治疗前及治疗4、8、12周后观察两组患者改良版英国医学研究委员会呼吸困难量表(mMRC)、24小时痰量、慢性阻塞性肺病评估测试(CAT)、中医证候积分;于治疗4、8、12周后统计两组患者急性加重情况;记录两组患者治疗前后血常规、尿常规、肝肾功能等变化及不良事件的发生情况。结果治疗后治疗组脱落4例,对照组脱落6例。治疗12周后两组FEV1均较治疗前升高(P<0.05),但治疗后组间比较差异无统计学意义(P>0.05)。与治疗前比较,治疗组在治疗12周后mMRC评分降低(P<0.05),在治疗4、8、12周后24小时痰量、CAT评分、中医证候积分均降低(P<0.05);对照组在治疗12周后24小时痰量降低(P<0.05),在治疗8、12周后中医证候积分均降低(P<0.05)。与对照组比较,治疗组在治疗12周后mMRC降低(P<0.05),在治疗4、8、12周后24小时痰量、中医证候积分均降低(P<0.05),在治疗8、12周后CAT评分降低(P<0.05)。治疗组的急性加重例次及急性加重次数在治疗12周后均低于对照组(P<0.05)。两组患者均未发生严重不良事件。结论肃肺平喘方可以改善支扩合并气流受限患者的肺功能FEV1、呼吸困难严重程度,减少24小时痰量和频繁急性加重,并改善生活质量,且安全性较好。Objective To evaluate the effectiveness and safety of Sufei Pingchuan Formula(肃肺平喘方)in the treatment of bronchiectasis with airflow limitation,phlegm-heat obstructing the lung,and lung-spleen qi deficiency syndrome.Methods A randomized,double-blind,placebo-controlled trial was conducted.A total of 72 patients with stable bronchiectasis with airflow limitation of phlegm-heat obstructing the lung and lung-spleen qi deficiency syndrome were randomly divided into treatment group and control group,with 36 cases in each group.On the basis of regular inhalation of tiotropium bromide inhalation spray,the treatment group was given Sufei Pingchuan Formula granules,and the control group was given Sufei Pingchuan Formula granule simulant.The course of treatment in both groups was 12 weeks.The pulmonary function of both groups before and after treatment was observed,specifically focusing on forced expiratory volume in one second(FEV1);the modified British Medical Research Council(mMRC)dyspnea scale,24-hour sputum volume,COPD assessment test(CAT),and traditional Chinese medicine(TCM)syndrome scores were assessed before treatment and after 4,8,and 12 weeks of treatment;acute exacerbations were recorded at weeks 4,8,and 12;additionally,changes in routine blood tests,urinalysis,liver and kidney function,and adverse events were monitored before and after treatment.Results After treatment,4 patients in the treatment group and 6 in the control group dropped out.After 12 weeks of treatment,FEV1 increased in both groups compared to pre-treatment levels(P<0.05),but the difference between groups was not statistically significant(P>0.05).Compared to before treatment,the treatment group showed a reduction in mMRC scores after 12 weeks(P<0.05)and a decrease in 24-hour sputum volume,CAT scores,and TCM syndrome scores at weeks 4,8,and 12(P<0.05).In the control group,24-hour sputum volume decreased after 12 weeks(P<0.05),and TCM syndrome scores decreased at weeks 8 and 12(P<0.05).Compared to the control group,the treatment group sho

关 键 词：支气管扩张症 气流受限 肃肺平喘方 肺功能 黏液高分泌 

分 类 号：R56[医药卫生—呼吸系统]