Nakwan Narongwit, Ruklerd Thidarat, Taptawee Pattarawadee
Division of Pulmonology, Department of Medicine, Hat Yai Medical Education Center, Hat Yai Hospital, Songkhla, Thailand.
Department of Nursing, Hat Yai Hospital, Songkhla, Thailand.
Tuberc Respir Dis (Seoul). 2022 Jul;85(3):227-236. doi: 10.4046/trd.2022.0038. Epub 2022 May 30.
The use of low-dose inhaled corticosteroid-formoterol as reliever monotherapy has recently been recommended in the asthma treatment guidelines. However, the efficacy of this treatment strategy has not yet been determined during the stepping-down period in moderate asthma. This study aimed to evaluate the feasibility of reducing treatment to as-needed budesonide-formoterol (BFM) in moderate asthma with complete remission.
We randomly assigned 31 patients (8 males and 23 females with a mean age of 57.2 years) with complete remission of asthma by inhaled BFM (160/4.5 μg) twice daily to receive BFM (160/4.5 μg) as needed (16 patients), or budesonide (BUD) (200 μg) twice daily (15 patients). The study was an open-label study done for 48 weeks, with the primary outcome as the cumulative percentages of patients with treatment failure (asthma exacerbation or loss of asthma control or lack of satisfaction after using medications) in the two groups.
Six patients (42%) using as-needed BFM had treatment failure, as compared with three patients (21.4%) using BUD maintenance (hazards ratio for as-needed BFM, 1.77; 95% confidential interval, 0.44-7.12; p=0.41). The changes in forced expiratory volume in 1 second were -211.3 mL with as-needed BFM versus -97.8 mL with BUD maintenance (difference, 113.5 mL; p=0.75) and the change in fractional exhaled nitric oxide was significantly higher in both groups, at 8.68 parts per billion (ppb) in the as-needed BFM group and 2.5 ppb. in the BUD maintenance group (difference, 6.18 ppb; p=0.049).
Compared with BUD maintenance, there were no significant differences in treatment failure rate in patients who received as-needed BFM during the stepping down period in moderate asthma. However, they showed reduced lung function and relapsed airway inflammation. The results are limited by imprecision, and further large RCTs are needed.
哮喘治疗指南最近推荐使用低剂量吸入性糖皮质激素-福莫特罗作为缓解药物单一疗法。然而，在中度哮喘降级治疗期间，这种治疗策略的疗效尚未确定。本研究旨在评估在完全缓解的中度哮喘患者中减少治疗至按需使用布地奈德-福莫特罗（BFM）的可行性。
我们将31例（8例男性和23例女性，平均年龄57.2岁）通过每日两次吸入BFM（160/4.5μg）实现哮喘完全缓解的患者随机分为两组，一组按需接受BFM（160/4.5μg）治疗（16例患者），另一组每日两次接受布地奈德（BUD）（200μg）治疗（15例患者）。该研究为开放标签研究，为期48周，主要结局是两组中治疗失败（哮喘加重或哮喘控制丧失或用药后不满意）患者的累积百分比。
按需使用BFM的6例患者（42%）出现治疗失败，而接受BUD维持治疗的患者有3例（21.4%）出现治疗失败（按需使用BFM的风险比为1.77；95%置信区间，0.44 - 7.12；p = 0.41）。按需使用BFM组1秒用力呼气量的变化为-211.3 mL，而BUD维持治疗组为-97.8 mL（差值为113.5 mL；p = 0.75），两组呼出一氧化氮分数的变化均显著升高，按需使用BFM组为8.68十亿分之一（ppb），BUD维持治疗组为2.5 ppb（差值为6.18 ppb；p = 0.049）。
与BUD维持治疗相比，中度哮喘降级治疗期间按需接受BFM治疗的患者治疗失败率无显著差异。然而，他们的肺功能下降，气道炎症复发。结果因不精确性而受限，需要进一步开展大型随机对照试验。
