布地格福吸入气雾剂治疗稳定期中重度慢性阻塞性肺疾病患者的临床研究

Clinical study of butigfo inhalation aerosol in the treatment of moderate to severe chronic obstructive pulmonary disease at stable stage

目的探讨布地格福吸入气雾剂治疗稳定期中重度慢性阻塞性肺疾病(COPD)的临床疗效和安全性。方法选取2020年8月至2021年8月于莆田学院附属医院呼吸与危重症医学科就诊的123例稳定期中重度COPD患者作为研究对象,随机分为治疗组(n=60)与对照组(n=63)。对照组给予布地奈德福莫特罗粉吸入剂+噻托溴铵粉吸入剂治疗,治疗组给予布地格福吸入气雾剂治疗。比较两组治疗前后第1秒用力呼气容积占预测值百分比(FEV_(1)%Pred)、第1秒用力呼气容积占用力肺活量比值(FEV_(1)/FVC)、改良版英国医学研究委员会呼吸困难问卷(mMRC)、COPD患者自我评估测试(CAT)和圣乔治呼吸问卷(SGRQ)评分、6 min步行试验(6MWT)、急性发作次数、药物不良反应情况。结果治疗后,两组FEV_(1)%Pred、FEV_(1)/FVC均高于治疗前,6MWT长于治疗前,mMRC、CAT及SGRQ评分均低于治疗前,治疗组FEV_(1)%Pred、FEV_(1)/FVC均高于对照组,6MWT长于对照组,差异有统计学意义(P<0.05);两组mMRC、CAT及SGRQ评分比较差异无统计学意义。治疗组急性发作次数少于对照组,差异有统计学意义(P<0.05);两组药物不良反应发生率比较差异无统计学意义。结论布地格福气雾剂能更好地改善患者的肺功能和运动耐力,减少急性发作次数,且不增加药物不良反应。

Objective To investigate the clinical efficacy and safety of budigafol inhalation aerosol in the treatment of moderate to severe chronic obstructive pulmonary disease(COPD)at stable stage.Methods A total of 123 patients with moderate to severe COPD who were treated in the department of Respiratory and Critical Care Medicine of the Affiliated Hospital of Putian University from August 2020 to August 2021 were selected as the study subjects,and they were randomly divided into the treatment group(n=60)and the control group(n=63).The control group was given budesonide formoterol powder inhalation+tiotropium bromide powder inhalation,the treatment group was given budegforo inhalation aerosol.The percentage of forced expiratory volume in one second to predicted value(FEV_(1)%Pred),forced expiratory volume in one second/forced bital capacity(FEV_(1)/FVC),the modified Medical Research Council dyspnea questionnaire(mMRC),COPD self-assessment test(CAT)and St.George's respiratory questionnaire(SGRQ)before and after treatment,6 min walking test(6MWT),number of acute attacks,adverse drug reactions were compared between the two groups.Results After treatment,the FEV_(1)%Pred,FEV_(1)/FVC of the two groups were higher than those before treatment,6MWT was longer than that before treatment,and the scores of mMRC,CAT and SGRQ were lower than those before treatment,the FEV_(1)%Pred,FEV_(1)/FVC in the treatment group were higher than those in the control group,6MWT was longer than that in the control group,the differences were statistically significant(P<0.05);there were no significant differences in mMRC,CAT and SGRQ scores between the two groups.The number of acute attacks in the treatment group was less than that in the control group,and the difference was statistically significant(P<0.05);there was no significant difference in the total incidence of adverse drug reactions between the two groups.Conclusion Budesonide aerosol can better improve lung function and exercise endurance of patients,reduce the number of acute attacks and do not increase adverse drug reactions.