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Abstract：
BACKGROUND: Previous studies have reported reduced acute exacerbation rates and improved symptom control in asthma patients treated using inhaled corticosteroids plus formoterol maintenance and reliever therapy (MART). Fluticasone furoate (FF) and vilanterol (VIL) also provide rapid bronchodilation and sustained anti-inflammatory effects, however no studies have investigated FF/VIL as MART for asthma control.
METHODS: From October 1, 2021 to September 30, 2023, this retrospective study included asthma patients classified as step 3 or 4 according to the Global Initiative for Asthma guidelines, who were then divided into two groups. One group received BUD/FOR as MART, while the other received FF/VIL as MART. Pulmonary function tests, exacerbation rates, Asthma Control Test (ACT), fractional exhaled nitric oxide (FeNO) levels, and blood eosinophil counts were measured before and after 12 months of treatment.
RESULTS: A total of 161 patients were included, of whom 36 received BUD/FOR twice daily as MART, and 125 received FF/VIL once daily as MART. After 12 months of treatment, the FF/VIL group showed a significant increase in ACT scores by 1.57 (p < 0.001), while the BUD/FOR group had an increase of 0.88 (p = 0.11). In terms of FeNO levels, the BUD/FOR group experienced a decline of -0.2 ppb (p = 0.98), whereas the FF/VIL group had a mild increase of + 0.8 ppb (p = 0.7). Notably, there was a significant difference in the change of FeNO between the two groups (∆ FeNO: -0.2 ppb in BUD/FOR; + 0.8 ppb in FF/VIL, p < 0.001). There were no significant alterations observed in FEV1, blood eosinophil count, or acute exacerbation decline in either group.
CONCLUSIONS: In the current study, patients treated with FF/VIL as MART showed improvements in ACT scores, while those treated with BUD/FOR as MART exhibited a reduction in FeNO levels. However, the difference between the two treatment groups did not reach clinical significance. Thus, FF/VIL as MART showed similar effectiveness to BUD/FOR as MART.
METHODS: From October 1, 2021 to September 30, 2023, this retrospective study included asthma patients classified as step 3 or 4 according to the Global Initiative for Asthma guidelines, who were then divided into two groups. One group received BUD/FOR as MART, while the other received FF/VIL as MART. Pulmonary function tests, exacerbation rates, Asthma Control Test (ACT), fractional exhaled nitric oxide (FeNO) levels, and blood eosinophil counts were measured before and after 12 months of treatment.
RESULTS: A total of 161 patients were included, of whom 36 received BUD/FOR twice daily as MART, and 125 received FF/VIL once daily as MART. After 12 months of treatment, the FF/VIL group showed a significant increase in ACT scores by 1.57 (p < 0.001), while the BUD/FOR group had an increase of 0.88 (p = 0.11). In terms of FeNO levels, the BUD/FOR group experienced a decline of -0.2 ppb (p = 0.98), whereas the FF/VIL group had a mild increase of + 0.8 ppb (p = 0.7). Notably, there was a significant difference in the change of FeNO between the two groups (∆ FeNO: -0.2 ppb in BUD/FOR; + 0.8 ppb in FF/VIL, p < 0.001). There were no significant alterations observed in FEV1, blood eosinophil count, or acute exacerbation decline in either group.
CONCLUSIONS: In the current study, patients treated with FF/VIL as MART showed improvements in ACT scores, while those treated with BUD/FOR as MART exhibited a reduction in FeNO levels. However, the difference between the two treatment groups did not reach clinical significance. Thus, FF/VIL as MART showed similar effectiveness to BUD/FOR as MART.
摘要：
背景：以前的研究报道，使用吸入糖皮质激素加福莫特罗维持和缓解治疗（MART）的哮喘患者可降低急性加重率并改善症状控制。糠酸氟替卡松（FF）和维兰特罗（VIL）也提供快速支气管扩张和持续的抗炎作用，然而，没有研究调查FF/VIL作为哮喘控制的MART。
方法：从2021年10月1日至2023年9月30日，这项回顾性研究纳入了根据全球哮喘倡议指南分类为第3步或第4步的哮喘患者，然后被分成两组。一组以MART的身份接受BUD/FOR，而另一个收到FF/VIL作为MART。肺功能检查,恶化率，哮喘控制测试（ACT），呼出气一氧化氮（FeNO）水平，治疗前和治疗12个月后测定血嗜酸性粒细胞计数。
结果：共纳入161例患者，其中36人每天两次作为MART接受BUD/FOR，125人每天接受一次FF/VIL作为MART。经过12个月的治疗，FF/VIL组ACT评分显著增加1.57(p<0.001)，而BUD/FOR组增加了0.88（p=0.11）。在FeNO水平方面,BUD/FOR组下降了-0.2ppb(p=0.98)，而FF/VIL组轻度增加+0.8ppb(p=0.7)。值得注意的是,两组之间的FeNO变化有显着差异（ΔFeNO：BUD/FOR-0.2ppb；FF/VIL-0.8ppb，p<0.001)。FEV1、血液嗜酸性粒细胞计数无明显改变，或两组急性加重下降。
结论：在当前的研究中，接受FF/VIL作为MART治疗的患者ACT评分改善，而用BUD/FOR作为MART治疗的患者表现出FeNO水平的降低。然而,两个治疗组之间的差异未达到临床意义。因此，作为MART的FF/VIL显示出与作为MART的BUD/FOR相似的有效性。
方法：从2021年10月1日至2023年9月30日，这项回顾性研究纳入了根据全球哮喘倡议指南分类为第3步或第4步的哮喘患者，然后被分成两组。一组以MART的身份接受BUD/FOR，而另一个收到FF/VIL作为MART。肺功能检查,恶化率，哮喘控制测试（ACT），呼出气一氧化氮（FeNO）水平，治疗前和治疗12个月后测定血嗜酸性粒细胞计数。
结果：共纳入161例患者，其中36人每天两次作为MART接受BUD/FOR，125人每天接受一次FF/VIL作为MART。经过12个月的治疗，FF/VIL组ACT评分显著增加1.57(p<0.001)，而BUD/FOR组增加了0.88（p=0.11）。在FeNO水平方面,BUD/FOR组下降了-0.2ppb(p=0.98)，而FF/VIL组轻度增加+0.8ppb(p=0.7)。值得注意的是,两组之间的FeNO变化有显着差异（ΔFeNO：BUD/FOR-0.2ppb；FF/VIL-0.8ppb，p<0.001)。FEV1、血液嗜酸性粒细胞计数无明显改变，或两组急性加重下降。
结论：在当前的研究中，接受FF/VIL作为MART治疗的患者ACT评分改善，而用BUD/FOR作为MART治疗的患者表现出FeNO水平的降低。然而,两个治疗组之间的差异未达到临床意义。因此，作为MART的FF/VIL显示出与作为MART的BUD/FOR相似的有效性。
