布地奈德福莫特罗吸入粉雾剂治疗老年咳嗽变异性哮喘患者的临床研究  

Clinical trial of budesonide and formoterol fumarate powder for inhalation in the treatment of elderly patients with cough variant asthma

作　　者：孙莹 宋昕 王佳 侯艳芳 付群 张琦 赖杰 耿涛 李长新 霍佳慧 张影[4] 翁艳 SUN Ying;SONG Xin;WANG Jia;HOU Yan-fang;FU Qun;ZHANG Qi;LAI Jie;GENG Tao;LI Chang-xin;HUO Jia-hui;ZHANG Ying;WENG Yan(Comprehensive Medical Department,Emergency Management Department Emergency General Hospital,Beijing 100028,China;Respiratory and Critical Care Medicine Department,Emergency Management Department Emergency General Hospital,Beijing 100028,China;Gastroenterology Department,Emergency Management Department Emergency General Hospital,Beijing 100028,China;Supply Department,Jilin Province Integrated Traditional Chinese and Western MedicineHospital,Jilin132012,Jilin Province,China)

机构地区：[1]应急管理部应急总医院综合医疗科,北京100028 [2]应急管理部应急总医院呼吸与危重症医学科,北京100028 [3]应急管理部应急总医院消化内科,北京100028 [4]吉林省中西医结合医院供应室,吉林吉林132012

出　　处：《中国临床药理学杂志》2025年第1期1-5,共5页The Chinese Journal of Clinical Pharmacology

摘　　要：目的比较不同剂量的布地奈德福莫特罗吸入粉雾剂(Ⅱ)联合孟鲁司特钠片治疗咳嗽变异性哮喘(CVA)患者的效果及对气道功能、炎症因子的改善情况。方法将老年CVA患者随机分为A组、B组。2组患者均接受布地奈德福莫特罗吸入粉雾剂(Ⅱ)联合孟鲁司特钠片治疗。A组给予布地奈德福莫特罗吸入粉雾剂,每日早晚各1次,每次2吸;B组给予布地奈德福莫特罗吸入粉雾剂(Ⅱ),每日早晚各1次,每次4吸。布地奈德福莫特罗吸入粉雾剂持续治疗6个月,孟鲁司特钠片1次10mg,1日1次,持续治疗至少3个月。比较2组患者治疗前和治疗后的夜间咳嗽评分,比较2组患者1秒钟用力呼气量(FEV_(1))占预计值百分比、最大呼气中期流速(MMEF)、呼出气一氧化氮(FeNO)、白细胞介素-5(IL-5)、1年内的复发率,并进行安全性评价。结果A组入组45例,B组入组45例。治疗后9个月,A组和B组的夜间咳嗽评分分别为(0.93±0.42)和(0.65±0.29)分,FEV_(1)占预计值百分比分别为(97.75±9.67)%和(100.93±11.06)%,MMEF分别为(2.81±1.04)和(3.08±1.09)L·s^(-1),FeNO分别为(18.94±9.75)和(15.94±7.96)ppb,IL-5分别为(10.88±7.06)和(8.11±5.56)pg·mL^(-1)。B组的上述指标与A组比较,在统计学上差异均有统计学意义(均P<0.05)。A组与B组的药物不良反应总发生率分别为8.89%(5例/45例)和13.33%(6例/45例),复发率分别为15.56%(7例/45例)和13.33%(6例/45例)。B组的上述指标与A组比较,在统计学上差异均无统计学意义(均P>0.05)。结论对于老年CVA患者,用较高剂量的布地奈德福莫特罗吸入粉雾剂(Ⅱ)联合孟鲁司特钠片可以更好地改善咳嗽症状,降低气道高反应性和炎性因子水平,降低复发率,且患者耐受良好。Objective To compare the effects of different doses of budesonide and formoterol fumarate powder for inhalation combined with montelukast sodium tablet in the treatment of cough variant asthma(CVA)and the improvement of airway function and inflammatory factors.Methods Elderly patients with cough variant asthma were randomly divided into group A and group B.Both groups of patients received budesonide and formoterol fumarate powder for inhalation combined with montelukast sodium tablet.Group A was given budesonide and formoterol fumarate powder for inhalation(Ⅱ),2 inhalation per time,twice a day;Group B was given budesonide and formoterol fumarate powder for inhalation,4 inhalation per time,twice a day;budesonide fumatrol inhalation powder mist for continuous treatment for 6 months,and montelukast sodium tablet 10 mg once a day for at least 3 months.The nighttime cough scores of the two groups were compared before treatment and after treatment.The percentage of forced expiratory volume in one second(FEV_(1))in the predicted value,the maximum mid expiratory flow(MMEF),the fractional exhaled nitric oxide(FeNO),interleukin-5(IL-5)and eosinophils were compared between the two groups.The incidence of adverse drug reactions and the recurrence rate within 1 year were compared between the two groups.Results A total of 45 cases were enrolled in both the group A and the group B.At 9 months after treatment,the nocturnal cough scores of the group A and the group B were(0.93±0.42)and(0.65±0.29)points,respectively;the percentage of FEV_(1) in the predicted value were(97.75±9.67)% and(100.93±11.06)%,respectively;the MMEF values were(2.81±1.04)and(3.08±1.09)L·s^(-1),respectively;the FeNO values were(18.94±9.75)and(15.94±7.96)ppb,respectively;the IL-5 levels were(10.88±7.06)and(8.11±5.56)pg·mL^(-1),respectively.The above indicators in group B showed statistically significant differences compared to group A(all P<0.05).The total incidence of adverse drug reactions in group A and group B were 8.89%(5 cases/45 cases)and

关 键 词：布地奈德福莫特罗吸入粉雾剂(Ⅱ) 孟鲁司特钠片 咳嗽变异性哮喘 剂量 老年患者 小气道功能 

分 类 号：R974[医药卫生—药品]