布地格福吸入气雾剂治疗中、重度支气管哮喘患者的临床研究  

Clinical trial of budesonide,glycopyrronium bromide and formoterol fumarate inhalation aerosol in the treatment of patients with moderate and severe bronchial asthma

作　　者：张妍琦 李鑫 孙璐 陆思静 ZHANG Yan-qi;LI Xin;SUN Lu;LU Si-jing(Department of Respiratory Medicine,The First Affiliated Hospital of Jinzhou Medical University,Jinzhou Medical University,Jinzhou 121000,Liaoning Province,China)

机构地区：[1]锦州医科大学附属第一医院呼吸内科,辽宁锦州121000

出　　处：《中国临床药理学杂志》2022年第1期3-5,9,共4页The Chinese Journal of Clinical Pharmacology

基　　金：辽宁省科技厅基金资助项目(20170540400)。

摘　　要：目的观察布地格福吸入气雾剂治疗中、重度支气管哮喘患者的临床疗效与安全性。方法将42例患者根据临床症状及肺功能分为对照组21例(哮喘合并慢性阻塞性肺疾病患者)和试验组21例(单纯哮喘患者)。所有患者均给予布地格福吸入气雾剂每次344μg,bid,治疗1个月。比较2组患者的临床疗效、肺功能,以及药物不良反应的发生情况。结果试验过程中共脱落7例。治疗后,总控制率为91.43%(32例/35例);试验组和对照组的总控制率分别为93.75%(15例/16例)和89.47%(17例/19例),差异无统计学意义(P>0.05)。治疗后,试验组和对照组的用力肺活量(FVC)分别为(3.50±0.87)和(3.42±0.64)L,差异无统计学意义(P>0.05);第1秒用力呼气容积(FEV_(1))分别为(2.86±0.65)L和(2.00±0.55)L,FEV_(1)/FVC分别为(87.24±7.23)%和(63.28±8.71)%,差异均有统计学意义(均P<0.05)。治疗期间,2组患者发生药物不良反应均以口干和皮疹为主。试验组和对照组的总药物不良反应发生率分别为12.50%和10.53%,差异无统计学意义(P>0.05)。结论布地格福吸入气雾剂能够控制中、重度支气管哮喘患者的临床症状,有效改善患者的肺功能,且其对单纯支气管哮喘患者的肺功能改善更佳,也不增加药物不良反应的发生率。Objective To observe the clinical efficacy and safety of budesonide, glycopyrronium bromide and formoterol fumarate inhalation aerosol in the treatment of patients with moderate to severe bronchial asthma. Methods According to the clinical symptoms and lung function, 42 patients were divided into control group(n=21 cases, patients with asthma with chronic obstructive pulmonary disease) and treatment group(n=21 cases, patients with simple asthma). All patients were given budesonide, glycopyrronium bromide and formoterol fumarate inhalation aerosol 344 μg per times, bid. All patients were treated for 1 month. The clinical efficacy, lung function and adverse drug reactions were compared between two groups. Results Seven cases fell off during the treatment. After treatment, the total control rate was 91.43%(32 cases/35 cases);the total control rates of treatment and control groups were 93. 75%( 15 cases/16 cases) and 89. 47%( 17 cases/19 cases) without significant difference( P >0. 05). After treatment,the forced vital capacity( FVC) of the treatment and control groups was( 3. 50 ±0. 87)and( 3. 42 ± 0. 64) L without significant difference( P > 0. 05);the forced expiratory volume in the first second( FEV_(1)) was( 2. 86 ± 0. 65) and( 2. 00 ± 0. 55) L, and the FEV_(1)/FVC was( 87. 24 ± 7. 23) % and( 63. 28 ±8. 71) %,the differences were statistically significant( all P < 0. 05). During the treatment period,the adverse drug reactions of the two groups were mainly dry mouth and rash. The incidences of total adverse drug reactions in the treatment and control groups were 12. 5% and 10. 53% without significant difference( P > 0. 05). Conclusion Budesonide,glycopyrronium bromide and formoterol fumarate inhalation aerosol can control the clinical symptoms of patients with moderate to severe bronchial asthma,effectively improve the lung function of patients,and it can improve the lung function of patients with simple bronchial asthma better without increasing the incidence of adverse drug reactions.

关 键 词：布地格福吸入气雾剂 中、重度支气管哮喘 慢性阻塞性肺疾病 肺功能 安全性评价 

分 类 号：R974.3[医药卫生—药品]