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目的对中重度持续性哮喘采用布地耐德和福莫特罗复合制剂(布地耐德160μg,福莫特罗4.5μg)维持和缓解治疗(SMART)方案,其中的维持剂量分别采用每次2吸、每日2次与每次1吸、每日2次,对比两种方案的治疗效果及副反应。方法纳入符合入选标准的61例中重度持续性哮喘患者,按照维持剂量的不同分为2组。常规剂量组30例,每次1吸、每日2次;高维持剂量组31例,每次2吸、每日2次。两组患者均可根据自觉症状随时增加药物的吸入次数,每日总剂量≤6吸。观察时间为4个月,对比2组患者的以下指标:哮喘控制评分(ACT)、急性发作次数、肺功能指标第一秒用力呼气容积(FEV1),诱导痰中嗜酸粒细胞(EOS)比例以及药物的不良反应。结果所有患者治疗过程中均未发生严重药物不良反应。治疗4个月后,高维持剂量组患者ACT评分显著高于常规剂量组,急性发作次数较常规剂量组显著减少(均P<0.05),但2组患者FEV1指标、诱导痰中EOS的比率差异均无统计学意义(均P>0.05);2组患者每日药物的使用剂量差异无统计学意义(P=0.052)。2组患者肺功能FEV1改善率与ACT评分的改善率呈正相关。结论对于中重度持续性哮喘,以布地耐德和福莫特罗复合制剂SMART策略对进行治疗时,维持剂量采用每日2吸,每日2次能更有效改善患者的临床症状并减少急性发作次数,而无显著不良反应。
OBJECTIVE To establish a maintenance and remission treatment (SMART) regimen of budesonide and formoterol combination (budesonide 160 μg, formoterol 4.5 μg) for moderate and severe persistent asthma with maintenance dose of 2 inhalation , 2 times a day with each suction 1, 2 times a day, compared the efficacy of the two programs and side effects. Methods Sixty-one patients with moderate-to-severe persistent asthma who met the inclusion criteria were divided into two groups according to the maintenance dose. The conventional dose group of 30 cases, each suction 1, 2 times a day; high maintenance dose group of 31 patients, each 2 suction, 2 times a day. Two groups of patients can be based on symptoms at any time increase the number of drug inhalation, the total daily dose ≤ 6 suction. The duration of the observation was 4 months. The following indicators were compared between the two groups: ACT, number of exacerbations, FEV1, eosinophilic sputum, Proportion and adverse drug reactions. Results All patients did not experience serious adverse drug reactions during the course of treatment. After 4 months of treatment, the ACT score of high maintenance dose group was significantly higher than that of conventional dose group, and the number of acute attacks was significantly lower than that of conventional dose group (all P <0.05). However, the difference of FEV1 index and induced sputum EOS ratio (P> 0.05). There was no significant difference in the daily dose of drugs between the two groups (P = 0.052). The improvement rate of pulmonary function FEV1 in two groups was positively correlated with the improvement rate of ACT score. Conclusions For medium and severe persistent asthma, when using the SMART strategy of combination of budesonide and formoterol for treatment, the maintenance dose of 2-daily absorption, 2 times a day can be more effective in improving the clinical symptoms of patients and reduce acute attacks Frequency, without significant adverse reactions.