布地格福吸入气雾剂治疗稳定期慢性阻塞性肺疾病患者的临床研究  

Clinical trial of budesonide,glycopyrronium bromide and formoterol fumarate inhalation aerosol in the treatment of patients with stable chronic obstructive pulmonary disease

作　　者：孙莹 宋昕 王佳 侯艳芳 付群 张琦 赖杰 耿涛 李长新 霍佳慧 张影[4] 翁艳 SUN Ying;SONG Xin;WANG Jia;HOU Yan-fang;FU Qun;ZHANG Qi;LAI Jie;GENG Tao;LI Chang-xin;HUO Jia-hui;ZHANG Ying;WENG Yan(Comprehensive Medical Department,Emergency Management Department Emergency General Hospital,Beijing 100028,China;Respiratory and Critical Care Medicine Department,Emergency Management Department Emergency General Hospital,Beijing 100028,China;Gastroenterology Department,Emergency Management Department Emergency General Hospital,Beijing 100028,China;Supply Room,Jilin Province Integrated Traditional Chinese and Western Medicine Hospital,Jilin 132012,Jilin Province,China)

机构地区：[1]应急管理部应急总医院综合医疗科,北京100028 [2]应急管理部应急总医院呼吸与危重症医学科,北京100028 [3]应急管理部应急总医院消化内科,北京100028 [4]吉林省中西医结合医院供应室,吉林吉林132012

出　　处：《中国临床药理学杂志》2024年第23期3371-3375,共5页The Chinese Journal of Clinical Pharmacology

基　　金：应急总医院医学发展科研基金资助项目(KY202207)。

摘　　要：目的观察布地格福吸入气雾剂治疗稳定期慢性阻塞性肺疾病(COPD)患者对肺功能、炎症指标、运动耐量的影响。方法将稳定期COPD患者随机分为对照组和试验组。试验组吸入布地格福吸入气雾剂,每次1揿,bid;呼吸功能锻炼每次15 min,bid。对照组给予布地奈德福莫特罗吸入粉雾剂(Ⅱ),每次1揿,bid,呼吸功能锻炼方法同试验组。2组患者均连续治疗3个月。比较2组患者的临床疗效、肺功能[第1秒用力呼气容积(FEV_(1))、FEV_(1)占预期值的百分比(FEV_(1)%)、FEV_(1)/用力肺活量(FVC)]、炎症指标[白细胞介素-6(IL-6)、IL-10]、免疫功能指标[T淋巴细胞亚群(CD3^(+)、CD4^(+)、CD8^(+))、CD4^(+)/CD8^(+)]、运动耐量[6 min步行距离(6MWD)、峰值摄氧量(VO_(2)peak)、最大代谢当量(METs)],并进行安全性评价。结果试验组入组50例,脱落2例,最终有48例纳入统计分析;对照组入组50例,脱落2例,最终有48例纳入统计分析。治疗后,试验组和对照组的总有效率分别为91.67%(44例/48例)和75.00%(36例/48例),在统计学上差异有统计学意义(P<0.05)。治疗后,试验组和对照组的FEV_(1)分别为(1.99±0.19)和(1.79±0.21)L,FEV_(1)%分别为(64.18±5.85)%和(59.81±5.02)%,FEV_(1)/FVC分别为61.82±5.37和53.45±6.11,IL-6水平分别为(19.53±4.08)和(27.82±4.57)ng·L^(-1),IL-10水平分别为(22.49±3.71)和(17.69±3.05)ng·L^(-1),CD3^(+)水平分别为(67.11±5.09)%和(64.20±4.26)%,CD4^(+)水平分别为(38.76±2.89)%和(36.15±3.04)%,CD8^(+)水平分别为(27.28±2.35)%和(28.76±2.59)%,CD4^(+)/CD8^(+)比值分别为1.49±0.28和1.30±0.22,6MWD分别为(421.07±31.46)和(391.89±30.44)m,VO_(2)peak分别为(20.22±1.47)和(17.66±1.41)mL·min^(-1)·kg^(-1),METs分别为5.61±1.02和4.86±1.04,在统计学上差异均有统计学意义(均P<0.05)。试验组发生的药物不良反应有心悸、头痛;对照组发生的药物不良反应有心悸、头痛、声嘶。试验组与对照组的总药物不良反应发生率Objective To observe the effects of budesonide,glycopyrronium bromide and formoterol fumarate inhalation aerosol on lung function,inflammatory markers,and exercise tolerance in stable chronic obstructive pulmonary disease(COPD)patients.Methods Stable CO PD patients were randomly divided into control group and treatment group.The treatment group inhaled budesonide,glycopyrronium bromide and formoterol fumarate inhalation aerosol,1 shovel per time,twice a day,once in the morning and once in the evening;respiratory function exercise for 15 minutes each time,bid.The control group was given budesonide and formoterol fumarate powder for inhalation(Ⅱ),1 shovel each time,bid.The respiratory function exercise method was the same as that of the treatment group.Both groups of patients were treated continuously for 3 months.Compare the clinical efficacy of two groups of patients after treatment,and compare the lung function[forced expiratory volume in one second(FEV_(1)),percentage of FEV_(1) to expected value(FEV_(1)%),FEV_(1)/forced vital capacity(FVC)],inflammatory indicators[interleukin-6(IL-6),IL-10],immune function indicators[T lymphocyte subsets(CD3^(+)CD4^(+),CD8^(+)),CD4^(+)/CD8^(+)],exercise tolerance[6-minute walking distance(6MWD),peak oxygen uptake(VO_(2) peak),maximum metabolic equivalents(METs)],and safety evaluation.Results Fifty cases were enrolled in the treatment group,2 cases were dropped out,and ultimately 48 cases were included in the statistical analysis;50 cases were enrolled in the control group,2 cases were dropped out,and ultimately 48 cases were included in the statistical analysis.The total effective rates of the treatment group and the control group were 91.67%(44 cases/48 cases)and 75.00%(36 cases/48 cases),with significant difference(P<0.05).After treatment,the FEV_(1) of the treatment group and the control group were(1.99±0.19)and(1.79±0.21)L,the FEV_(1)%were(64.18±5.85)%and(59.81±5.02)%,the FEV_(1)/FVC were 61.82±5.37 and 53.45±6.11,the IL-6 levels were(19.53±4.08)and(27.82±4.57)ng

关 键 词：布地格福吸入气雾剂 慢性阻塞性肺疾病 呼吸功能锻炼 稳定期 

分 类 号：R974[医药卫生—药品]