布地奈德/格隆溴铵/福莫特罗三联制剂治疗中重度老年慢性阻塞性肺疾病患者的临床研究

Clinical trial of budesonide/glycopyrronium bromide/formoterol triplet in the treatment of elderly patients with moderate-to-severe chronic obstructive pulmonary disease

目的观察布地奈德/格隆溴铵/福莫特罗三联制剂对中重度老年慢性阻塞性肺疾病(COPD)患者动脉血气、呼吸功能和运动耐力的影响。方法将中重度老年COPD患者按照治疗方式分为对照组和试验组。对照组给予格隆溴铵/福莫特罗吸入气雾剂,经口吸入给药,每次2吸,每天2次,治疗12周。试验组给予布地奈德/格隆溴铵/福莫特罗三联制剂治疗,经口吸入给药,每次2吸,每天2次,治疗12周。比较2组患者动脉血气指标[二氧化碳分压(PaCO_(2))、血氧分压(PaO_(2))及酸碱度(pH)]、呼吸功能指标[用力肺活量(FVC)、第1秒用力呼气量(FEV_(1))及FEV_(1)占预计值的百分比(FEV_(1)%pred)]、圣乔治呼吸问卷(SGRQ)评分、6 min步行距离,以及药物不良反应发生情况。结果试验过程中共脱落8例,最终试验组和对照组分别纳入48例和50例。治疗后,试验组和对照组的PaCO_(2)分别为(41.37±4.69)和(46.64±4.83)mmHg,PaO_(2)分别为(74.34±6.17)和(69.31±5.75)mmHg,pH分别为7.35±0.09和7.26±0.06,FVC分别为(2.39±0.36)和(2.23±0.31)L,FEV_(1)分别为(1.45±0.43)和(1.27±0.41)L、FEV_(1)%pred分别为(69.56±10.07)%和(65.08±9.32)%,6 min步行距离分别为(404.62±43.51)和(377.54±45.87)m,SGRQ评分分别为(47.50±2.64)和(51.49±2.87)分,差异均有统计学意义(均P<0.05)。试验组药物不良反应有口腔感染、咽干、恶心呕吐、心悸等,对照组药物不良反应有皮疹、恶心呕吐、头痛、肺炎等。试验组和对照组药物不良反应总发生率分别为20.83%和16.00%,差异无统计学意义(P>0.05)。结论布地奈德/格隆溴铵/福莫特罗三联制剂治疗中重度COPD可有效改善患者动脉血气、呼吸功能,提升其运动耐力和生活质量,未增加药物不良反应发生率。

ObjectiveTo observe the effects of budesonide/glycopyrronium bromide/formoterol triplet preparation on arterial blood gas,respiratory function and exercise tolerance in elderly patients with moderate-to-severe chronic obstructive pulmonary disease(COPD).Methods Patients with moderate-to-severe COPD were divided into control group and treatment group according to the treatment methods.Control group was treated with glycopyrronium bromide/formoterol aerosol inhalation(oral inhalation,twice inhalations per time,bid,12 weeks),and the treatment group was treated with budesonide/glycopyrronium bromide/formoterol triplet preparation(oral inhalation,twice inhalations per time,bid,12 weeks).Arterial blood gas indicators[partial pressure of carbon dioxide(PaCO_(2)),partial pressure of oxygen(PaO_(2)),potential of hydrogen(pH)],respiratory function indicators[forced vital capacity(FVC),forced expiratory volume in the first second(FEV_(1)),percentage of FEV_(1)to predicted value(FEV_(1)%pred)],St.George Respiratory questionnaire(SGRQ)score,6-minute walking distance and occurrence of adverse drug reactions were compared between the two group of patients.Results Eight patients fell off during the treatment,thus finally 48 cases were included in treatment group and 50 cases in control group.After treatment,PaCO_(2)values in treatment group and control group were(41.37±4.69)and(46.64±4.83)mmHg;PaO_(2)values were(74.34±6.17)and(69.31±5.75)mm Hg;pH values were 7.35±0.09 and 7.26±0.06;the FVC values were(2.39±0.36)and(2.23±0.31)L;FEV_(1)values were(1.45±0.43)and(1.27±0.41)L;FEV_(1)%pred values were(69.56±10.07)%and(65.08±9.32)%;the 6-minute walking distances were(404.62±43.51)and(377.54±45.87)m;the SGRQ scores were(47.50±2.64)and(51.49±2.87)points,the difference were all statistically significant(all P<0.05).The adverse drug reactions in treatment group included oral infection,dry throat,nausea and vomiting,and palpitations,while the adverse drug reactions in control group included erythra,nausea and vomiting,headache and pneumonia.The total incidence rates of adverse drug reactions in treatment group and control group were 20.83%and 16.00%respectively(P>0.05).Conclusion Budesonide/glycopyrronium bromide/formoterol closed triplet preparation can effectively improve the arterial blood gas and respiratory function,and enhance the exercise tolerance and quality of life in patients with moderate-to-severe COPD,without increasing adverse drug reactions.