哮喘联盟

   摘要
   背景及目的：布地奈德/ 福莫特罗维持缓解疗法(BFMRT)在哮喘控制中的作用在大型随机对照试验已得以良好验证。然而，其急性缓解作用及真实世界中的疗效少见报道。
   方法：本多中心试验入选未用激素，基线一氧化氮呼出值(FeNO)≥40ppb的症状性哮喘患者。共120例符合条件的患者被随机分组，分别接受吸入布地奈德/福莫特罗320/9μg(低剂量布地奈德/福莫特罗组，LDBF组)，640/18μg(高剂量布地奈德/福莫特罗组，HDBF组)，或特布他林1毫克(TERB组)。测定基线和给药6小时(急性期)诱导痰中炎症细胞和炎性介质，FeNO以及肺功能的水平。随后，所有患者实行真实世界的BFMRT法治疗，维持期共24周。
   结果：在急性期，HDBF组治疗后诱导痰的总嗜酸粒细胞计数，白细胞介素8（IL-8）和基质金属蛋白酶-9（MMP-9）比TERB组明显减少（P < 0.05）；给药后3小时后HDBF组FEV1的增加明显高于LDBF组和TERB组（P < 0.05）。在维持期，于治疗后4周及研究结束时均可见哮喘实际控制显著改善(指标包括FeNO、FEV1和ACQ5)。而患者随访率随时间下降(4周时87%，24周时42%)。
   结论：BFMRT法治疗症状性哮喘可以发挥急性、剂量依耐性的抗炎作用并改善患者FEV1水平。BFMRT能有效控制哮喘。然而，病人长期随访率下降是现实中有待解决的问题。

（南方医科大学南方医院 梁俊杰 赵海金）
Lin CH, Hsu JY, Hsiao YH, et al. Respirology. 2015 Feb;20(2):264-72.


 

Budesonide/formoterol maintenance and reliever therapy in asthma control: acute, dose-related effects and real-life effectiveness.

Lin CH, Hsu JY, Hsiao YH, et al. Respirology. 2015 Feb;20(2):264-72.

Abstract
BACKGROUND AND OBJECTIVE:The efficacy of budesonide/formoterol maintenance and reliever therapy (BFMRT) in asthma control is well documented in large randomized controlled trials. However, the acute reliever effects and real-life effectiveness are seldom reported.
METHODS:This multicenter trial enrolled steroid-naïve, symptomatic asthmatics with baseline exhaled nitric oxide (eNO) of ≥ 40 ppb. There were 120 eligible patients who were randomized and received a dose of inhaled budesonide/formoterol 320/9 μg (lower dose budesonide/formoterol), 640/18 μg (higher dose budesonide/formoterol (HDBF)), or terbutaline (TERB) 1 mg. Inflammatory cells and mediators in induced sputum, eNO and lung function were measured at baseline and 6 h (acute phase). Subsequently, all patients used BFMRT as real-life practice for 24 weeks (maintenance phase).
RESULTS:In the acute phase, the degree of post-treatment reduction in total eosinophil counts, interleukin-8 and matrix metalloproteinase-9 in induced sputum were significantly greater in group HDBF (vs TERB, P < 0.05). The increase in forced expiratory volume in first second (FEV1 ) in group HDBF was significantly higher (vs LDBF and TERB, P < 0.05) 3 h after dosing. In the maintenance phase, significant improvement of asthma control (presented by eNO, FEV1 and a five-item asthma control questionnaire) in real-life settings was observed at 4 weeks and sustained to the end of study. The rate of patients who followed scheduled visits declined over time (87% at week 4 and 42% at week 24).
CONCLUSIONS:Budesonide/formoterol as reliever exerts acute, dose-related anti-inflammatory effects and FEV1 improvement in symptomatic asthmatics. BFMRT is effective in asthma control. However, the decrease in long-term follow-up rate remains an issue to overcome in real-life settings.