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目的探讨不同剂量布地奈德福莫特罗粉吸入剂应用维持和缓解治疗(SMART)方案治疗中重度持续性支气管哮喘的临床疗效及安全性。方法选取徐州市丰县人民医院2012—2015年收治的中重度持续性支气管哮喘患者95例,按照随机数字表法分为对照组(n=47)和观察组(n=48)。患者入院后均给予布地奈德福莫特罗粉吸入剂并采用SMART方案治疗,对照组患者给予常规维持剂量;观察组患者给予最大允许维持剂量,两组患者均持续治疗4个月。观察比较两组患者治疗前后哮喘控制测试(ACT)评分、哮喘急性发作次数、肺功能指标〔第1秒用力呼气容积占预计值百分比(FEV1%)、第1秒用力呼气容积与用力肺活量比值(FEV1/FVC)〕及嗜酸粒细胞(EOS)分数,并观察比较两组患者治疗期间不良反应发生情况。结果治疗前,两组患者ACT评分、哮喘急性发作次数、FEV1%、FEV1/FVC、EOS分数比较,差异无统计学意义(P>0.05);治疗后,观察组患者ACT评分高于对照组,哮喘急性发作次数少于对照组(P<0.05),但两组患者FEV1%、FEV1/FVC、EOS分数比较,差异无统计学意义(P>0.05);两组患者治疗后ACT评分高于治疗前,哮喘急性发作次数少于治疗前,FEV1%、FEV1/FVC高于治疗前,EOS分数低于治疗前(P<0.05)。两组患者不良反应发生率比较,差异无统计学意义(P>0.05)。结论取最大允许剂量(2吸/次、2次/d)布地奈德福莫特罗粉吸入剂应用SMART方案治疗中重度持续性支气管哮喘可有效缓解患者哮喘症状,减少哮喘急性发作次数,且安全性好。
Objective To investigate the clinical efficacy and safety of different doses of budesonide formoterol powder inhaler in maintenance and remission therapy (SMART) regimen in the treatment of moderate-moderate persistent bronchial asthma. Methods Ninety-five patients with moderate-to-severe bronchial asthma who were admitted to Fengxian People’s Hospital of Xuzhou from 2012 to 2015 were divided into control group (n = 47) and observation group (n = 48) according to random number table. Patients were given budesonide formoterol powder inhalation after SMART regimen and the treatment group, the control group were given conventional maintenance dose; observation group patients were given the maximum allowable maintenance dose, the two groups were treated for 4 months. The results of asthma control test (ACT), number of acute asthma attacks, pulmonary function indexes (forced expiratory volume in 1 second, predicted percentage (FEV1%), forced expiratory volume in 1 second and forced vital capacity Ratio (FEV1 / FVC)] and eosinophil (EOS) scores were observed and compared between the two groups during treatment of adverse reactions. Results Before treatment, there was no significant difference in ACT score, number of acute exacerbation episodes, FEV1%, FEV1 / FVC and EOS scores between the two groups (P> 0.05). After treatment, ACT score in observation group was higher than that in control group, There was no significant difference in FEV1%, FEV1 / FVC and EOS scores between the two groups (P> 0.05). The ACT score of the two groups was higher than that of the treatment group Before, the number of acute asthma attacks was less than before treatment, FEV1%, FEV1 / FVC higher than before treatment, EOS score was lower than before treatment (P <0.05). Two groups of patients with adverse reactions, the difference was not statistically significant (P> 0.05). Conclusions SMART regimen of budesonide formoterol powder inhaler with maximal allowable dose (2 inhalation / twice, twice daily) can effectively relieve asthma symptoms and reduce the number of acute asthma attacks in patients with moderate-severe persistent bronchial asthma Good safety.