芪参补气胶囊治疗稳定期慢性阻塞性肺疾病肺气虚证的疗效观察  

Curative Effect Observation of Qishen Buqi Capsule in the Treatment of Pulmonary Qi Deficiency Syndrome of Chronic Obstructive Pulmonary Disease(COPD)in Stable Stage

作　　者：李梅 木尼热·艾尼瓦尔 王琦[2] 陈玉飞 艾熙 袁华 肖庆龄[3] LI Mei;Minire·Ainiwa;WANG Qi;CHEN Yufei;AI Xi;YUAN Hua;XIAO Qingling(Kezhou People′s Hospital of Xinjiang Uygur Autonomous Region,Atushi,845350,China;The Third Clinical Medical College of Nanjing University of Chinese Medicine,Nanjing 210028,China;Jiangsu Province Hospital of Integration Chinese and Western Medicine,Nanjing 210028,China)

机构地区：[1]新疆维吾尔自治区克州人民医院,阿图什845350 [2]南京中医药大学第三临床医学院,南京210028 [3]江苏省中西医结合医院,南京210028

出　　处：《世界中医药》2020年第24期3797-3801,3805,共6页World Chinese Medicine

基　　金：中国人口福利基金会慢病防控工程科研支撑计划项目(MBKY2017A003)。

摘　　要：目的:探索芪参补气胶囊治疗稳定期慢性阻塞性肺疾病(COPD)肺气虚证的临床疗效与安全性。方法:选取2017年10月16日至2018年11月20日在新疆维吾尔自治区克州人民医院呼吸内科门诊随诊的COPD稳定期肺气虚证患者480例作为研究对象,随机分为观察组和对照组,每组240例,进行为期52周的观察。2组患者均给予健康指导、家庭氧疗、沙美特罗替卡松粉吸入剂、竹沥胶囊等基础治疗;对照组在基础治疗上给予玉屏风胶囊口服,2粒/次,3次/d;观察组在基础治疗上给予芪参补气胶囊口服,3粒/次,3次/d。观察比较2组患者的相关指标。结果:观察组平均急性加重次数(1.62±0.93)次,对照组(1.83±0.97)次,观察组发作次数显著减少(t=2.262,P=0.012)。观察组相对于对照组的急性加重风险RR=0.869(0.763~0.988,P=0.032),降低了13.1%。伴有咳嗽、喘息、便秘或吸烟的患者,观察组急性加重风险更低(P<0.05)。观察组CAT评分、FEV1显著优于对照组(P<0.05)。观察组炎性反应指标(TNF-α、IL-6、IL-8)改善情况显著优于对照组。观察组不良事件发生率显著低于对照组。结论:芪参补气胶囊与玉屏风散均具有良好的提高免疫功能,改善COPD属肺气虚证者咳痰喘症状的作用。其中芪参补气胶囊减少急性加重风险的效果较玉屏风胶囊更好,且安全性良好,值得推广使用。Objective:To explore the clinical efficacy and safety of Qishen Buqi Capsule in the treatment of pulmonary qi deficiency syndrome of chronic obstructive pulmonary disease(COPD)in stable stage.Methods:By using the method of randomized controlled trial,a total of 480 cases of COPD patients with lung qi deficiency in stable stage were randomly divided into 2 groups,240 cases in each group,and observed for 52 weeks.Both groups were given basic treatment such as health guidance,family oxygen therapy,salmeterol and ticasone powder inhalation,Zhuli Capsule,etc.;the control group was given Yupingfeng Capsule orally,2 a time,3 times a day;the observation group was given Qishen Buqi Capsule orally,3 a time,3 times a day,on the basis of basic treatment.The main endpoint was the number of acute exacerbations in the 2 groups.The secondary indexes included:the CAT score and the respiratory function(FEV1、FVC、FEV1/FVC%)at the baseline,the 3rd,the 6th and the 12th month of treatment;immune function indexes(IGA,IgG,complement C3,CD4,CD8,CD4/CD8)and inflammatory reaction indexes(TNF-α,IL-6,IL-8)were measured at baseline and at the end of treatment in the first 96 patients;occurrence of adverse events in 2 groups.Results:There was no significant difference in drop off rate and lost visit rate between the 2 groups(P>0.05).There was no significant difference in baseline between the 2 groups(P>0.05).The average number of acute exacerbations in the observation group was 1.62±0.93 times,while that in the control group was 1.83±0.97 times.The frequency of seizures in the observation group was significantly reduced(t=2.262,P=0.012).The risk of acute exacerbation in the observation group was reduced by 13.1%,RR=0.869(0.763~0.988),P=0.032,compared with the control group.Qishen Buqi Capsule helped patients with cough,wheeze,constipation or smoking at baseline,with a lower risk of acute exacerbation(P<0.05).The CAT score and FEV1 in the observation group were significantly better than those in the control group(P<0.05).There were no sig

关 键 词：芪参补气胶囊 慢性阻塞性肺疾病稳定期 肺气虚证 随机对照研究 急性加重 CAT评分 呼吸功能 免疫功能 

分 类 号：R256.1[医药卫生—中医内科学]