摘要
目的观察布地格福吸入气雾剂治疗中、重度慢性阻塞性肺疾病(COPD)患者的临床疗效与安全性。方法将150例中、重度COPD患者随机分为对照A组50例、对照B组50例和试验组50例。对照A组给予噻托溴铵粉吸入剂每次18μg,qd,吸入治疗+沙美特罗替卡松每次300μg,bid,吸入治疗;对照B组给予布地奈德福莫特罗每次164.5~329.0μg,bid,吸入治疗;试验组给予布地格福吸入气雾剂每次172~344μg,bid,吸入治疗。3组患者均治疗6个月。比较3组患者的肺功能和药物不良反应的发生情况。结果试验过程中共脱落10例。治疗6个月后,试验组、对照A组和对照B组的用力肺活量分别为(2.53±0.62),(2.14±0.46)和(2.03±0.52) L,第1秒用力呼气量分别为(1.54±0.41),(1.32±0.35)和(1.22±0.44) L,试验组的上述指标与对照A组和对照B组比较,差异均有统计学意义(均P <0.05)。3组患者发生的药物不良反应有上呼吸道感染、肺炎和鼻咽炎等为主。试验组、对照A组和对照B组的总药物不良反应发生率分别为23.40%,30.43%和25.53%,差异均无统计学意义(均P> 0.05)。结论布地格福吸入气雾剂用于治疗中、重度COPD患者能够更有效地改善肺功能,且不增加药物不良反应的发生率。
Objective budegofol inhaled aerosol in the treatment of patients with moderate-to-severe chronic obstructive pulmonary disease( COPD). Methods A total of 150 patients with moderate-to-severe COPD were randomly divided into control A,control B and treatment groups with 50 cases per group. Control A group was given tiotropium bromide powder inhalation18 μg per time,qd,inhalation treatment + salmeterol and ticasone 300μg per time,bid,inhalation treatment. Control B group was given budesonide formoterol each time 164. 5-329. 0 μg,bid,inhalation treatment. Treatment group was given budegofol inhalation aerosol 172-344 μg per time,bid,inhalation treatment. Three groups were treated for 6 months. The lung function and adverse drug reactions were compared among three groups. Results A total of 10 cases were shed during the trial process. After 6 months of treatment,the forced vital capacity of treatment,control A and control B groups was( 2. 53 ± 0. 62),( 2. 14 ± 0. 46) and( 2. 03 ± 0. 52) L,the forced expiratory volume in one second was( 1. 54 ± 0. 41),( 1. 32 ± 0. 35) and( 1. 22 ± 0. 44) L. The above indicators of the treatment group were compared with those of control A and control B groups,the differences were statistically significant( all P < 0. 05).The adverse drug reactions of the three groups were upper respiratory tract infection,pneumonia and nasopharyngitis.The incidences of total adverse drug reactions in the treatment,control A and control B groups were 23. 40%,30. 43%and 25. 53% without significant differences( all P > 0. 05). Conclusion Budigefor inhaled aerosol in the treatment of moderate-to-severe COPD can improve lung function more effectively,without increasing the incidence of adverse drug reactions.
作者
章邱东
梅晓冬
ZHANG Qiu-dong;MEI Xiao-dong(Department of Respiratory Medicine,Provincial Hospital Affiliated to Anhui Medical University,Hefei 230000,Anhui Province,China;Department of Geriatrics,Fuyang People’s Hospital,Fuyang 236000,Anhui Province,China)
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2022年第3期203-206,共4页
The Chinese Journal of Clinical Pharmacology
基金
安徽省自然科学基金资助项目(1308085MH115)。
关键词
布地格福吸入气雾剂
慢性阻塞性肺疾病
安全性评价
budesonide inhalation aerosol
chronic obstructive pulmonary disease
safety evaluation
