吸入糖皮质激素/长效β_2受体激动剂复合制剂治疗中、重度持续支气管哮喘的疗效研究

Clinical study of treatment with combined corticosteroids and long-acting β_2 agonist powder for inhalation in moderate to severe bronchial asthma

目的观测联合吸入糖皮质激素(布地奈德)/长效β2受体激动剂(福莫特罗)干粉吸入剂治疗期间支气管哮喘(简称哮喘)患者诱导痰嗜酸粒细胞(EOS)计数、肺功能与哮喘临床症状的关系。方法本院健康呼吸中心就诊的中、重度持续哮喘患者33例(哮喘组)联合吸入糖皮质激素/长效β2受体激动剂复合制剂治疗6个月,测定肺功能(FEV1、FEV1/FVC、PEF),诱导痰中EOS计数,记录哮喘控制得分(ACT)及患者哮喘生命质量评分。哮喘组在治疗开始后1个月、2个月、3个月和6个月时进行重复测定。且以10名健康者做为对照组,同期测定上述观察指标。同时记录吸入用药后的不良反应。结果研究共纳入38例患者,共有33例完成6个月或更长的随访观察。吸入糖皮质激素/长效β2受体激动剂复合制剂治疗后1个月,FEV1值明显改善[分别为(2.53±0.46)L,(2.89±0.62)L,P<0.01];3个月后上述变化更为显著达(3.19±0.47)L,与治疗1个月后相比发生显著变化(P<0.05);哮喘组诱导痰中EOS显著升高达(0.156±0.047)×106(P<0.05),激素吸入治疗过程中可见显著性变化,3个月降至(0.072±0.015)×106,6个月后痰中EOS计数明显减少,与治疗前相比较差异有统计学意义(q=6.58,P<0.05)。吸入治疗后ACT评分明显改善,从治疗前(8±5)分增加至治疗后2个月(15±6)分,治疗后3个月到(20±4)分,与治疗前相比较差异有统计学意义(F=5.72,P<0.05)。治疗6个月后,患者哮喘生命质量评分明显提高(P<0.05)。哮喘组中共有12例患者(36.36%)获得完全控制。结论联合吸入糖皮质激素/长效β2受体激动剂复合制剂治疗哮喘明显改善患者肺功能,减少痰EOS计数,有较好的临床疗效,且应至少连用6个月或以上。

Objective To analyze the changes of eosinophil counts in induced sputum and lung function from patients with bronchial asthma（asthma） and their correlations to asthma clinical symptom in inhaled corticosteroids （budesonide） and long-acting β2 agonist （formoterol） powder for inhalation treatment. Methods Thirty-three outpatients with moderate to sever persistent asthma from Beijing Chaoyang Hospital Health Clinic Center were treated with combined medications of inhaled corticosteroids plus long-acting β2 agonist for six months. Asthma control test （ACT） scores were recorded, and lung function （represented by FEV1 and PEF） and eosinophil（EOS） counts in induced sputum were measured at regular intervals. Ten volunteers served as control and lung function and EOS counts in induced sputum were measured. The lung function, EOS counts in induced sputum, clinical symptoms, and adverse reaction of inhaled corticosteroids plus long-acting β2 agonist powder for inhalation were evaluated after treatment. Results A total of 38 subjects were enrolled,of whom 33 completed six months or longer follow-up. FEV1 of 33 subjects before treatment was （2.53±0.46） L,which became （2.89±0.62） L at the first month,and then maintained at a very high level （3.19 ± 0.47） L after the third month, which showed significant difference with the first month（ P 〈0.05）. EOS counts decreased from （0. 156±0. 047） × 10^6 to （0. 072± 0. 015）× 10^6 by the third month, EOS counts clear decreased by the six month, which was significantly different from untreatment（ q =6.58, P〈0.05）. ACT increased from （8±5） scores to （15±6） scores by the second month（ q =6.83, P 〈0. 05）,and （20±4） scores by the third month, which showed significant difference with normal control（ F = 5.72, P 〈0.05）. At the end of six months treatment, asthma quality of life scores were improved significantly（ P 〈0.05）. There were 12 （36.36% ） patients achieving the criteria for being well controlled. Conclusions The clinical effect of inhaled corticosteroids plus long acting β2 agonist powder for inhalation on asthma is satisfactory accompanied with improving lung function, better symptom control,decreased EOS counts in induced sputum, provided six months treatment had been taken.