目的 探究不同剂量布地奈德联合噻托溴铵吸入治疗对老年慢性阻塞性肺疾病(COPD)患者的临床疗效.方法 将老年COPD患者随机分为对照组、低剂量组、中剂量组和高剂量组.对照组接受噻托溴铵粉雾剂吸入治疗,每次18μg,qd;低、中、高剂量组在对照组的基础上给予布地奈德混悬液吸入治疗(每次分别为1、2和3 mg,qd),连续治疗15 d.比较4组临床疗效,治疗前后患者肺功能、慢性阻塞性肺疾病评估测试(CAT)评分及免疫功能,记录治疗期间药物不良反应发生情况.结果 高、中、低剂量组和对照组分别纳入22例.治疗后,高、中、低剂量组及对照组的总有效率分别为95.45％(21例/22例)、72.73％(16 例/22 例)、72.73％(16 例/22 例)和 40.91％(13 例/22 例),高、中、低剂量组和对照组比较,高剂量组与低、中剂量组比较,在统计学上差异均有统计学意义(均P＜0.05).治疗后,高、中、低剂量组及对照组的第1秒用力呼气容积(FEV1)分别为(2.28±0.31)、(2.07±0.33)、(2.01±0.27)和(1.79±0.35)L,FEV1/用力肺活量(FEV1/FVC)分别为(68.26±7.35)％、(63.48±7.12)％、(62.35±7.04)％和(57.92±6.79)％,CAT 评分分别为(16.34±2.81)、(18.12±2.56)、(18.73±2.23)和(20.45±2.41)分,外周血 CD4+/CD8+分别为 1.38±0.25、1.15±0.18、1.12±0.23 和 0.96±0.21,上述指标:高、中、低剂量组与对照组比较,高剂量组与低、中剂量组比较,在统计学上差异均有统计学意义(均P＜0.05).高、中、低剂量组及对照组的总药物不良反应发生率分别为27.27％(6 例/22 例)、27.27％(6 例/22 例)、22.73％(5 例/22 例)和 18.18％(4例/22例),在统计学上差异均无统计学意义(均P＞0.05).结论 高剂量的布地奈德联合噻托溴铵吸入治疗能有效改善老年COPD患者的肺功能、免疫功能,提高临床疗效.
Objective To observe the clinical effects of different doses of budesonide combined with tiotropium bromide inhalation in the treatment of elderly patients with chronic obstructive pulmonary disease(COPD).Methods Elderly patients with COPD were randomly divided into the control group,the low-dose group,the medium-dose group and the high-dose group.The control group was treated with tiotropium bromide powder inhalation(18 μg,qd).The low-dose,medium-dose and high-dose groups were treated with with budesonide suspension(1 mg,2 mg,3 mg each time,qd)on the basis of control group.All patients were treated for 15 days.Clinical efficacy was compared.The changes of pulmonary function,COPD assessment test(CAT)scores,immune function and quality of life before and after treatment were evaluated.Adverse drug reactions that occurred during treatment were recorded.Results Twenty-two cases were included in the high-dose group,the medium-dose group,the low-dose group,and the control group,respectively.After treatment,the total effective rates in the high-dose group,the medium-dose group,the low-dose group and the control group were 95.45％(21 cases/22 cases),72.73％(16 cases/22 cases),72.73％(16 cases/22 cases)and 40.91％(13 cases/22 cases).There were statistically significant differences between the high-dose group,medium-dose group and low dose group and the control group,and between the high dose group and the low and medium dose groups(all P＜0.05).After treatment,forced expiratory volume in 1 second(FEV1)in the four groups were(2.28±0.31),(2.07±0.33),(2.01±0.27)and(1.79±0.35)L;FEV1/forced vital capacity(FEV1/FVC)were(68.26±7.35)％,(63.48±7.12)％,(62.35±7.04)％and(57.92±6.79)％;CAT scores were 16.34±2.81,18.12±2.56,18.73±2.23 and 20.45±2.41;CD4+/CD8+were 1.38±0.25,1.15±0.18,1.12±0.23 and 0.96±0.21.Compared with high,medium,low dose groups and the control group,high dose compared with low,medium dose groups,the differences of the obove indicators were statistically significant all(all P＜0.05).The total incidence rates of adverse drug reactions in the high-dose group,the medium-dose group,the low-dose group,and the control group were 27.27％(6 cases/22 cases),27.27％(5 cases/22 cases),22.73％(6 cases/22 cases),and 18.18％(4 cases/22 cases),without statistically significant difference among the groups(all P＞0.05).Conclusion The combined treatment of high-dose budesonide and tiotropium bromide inhalation can effectively improve pulmonary function,immune function and clinical efficacy in elderly patients with COPD with high safety.
方园圆;俞建洪
绍兴文理学院附属医院老年医学科,浙江绍兴 312000
药学
布地奈德;噻托溴铵;慢性阻塞性肺疾病;不同剂量;临床疗效;免疫功能
budesonide;tiotropium bromide;chronic obstructive pulmonary disease;different doses;clinical efficacy;immune function;quality of life
《中国临床药理学杂志》 2024 (006)
787-791 / 5
浙江省医药卫生科技计划基金资助项目(2022KY1314)
10.13699/j.cnki.1001-6821.2024.06.001
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