采用低剂量吸入糖皮质激素和长效β2激动剂得以控制的患者的哮喘控制治疗降级的实用性随机对照试验：SIGMA研究
2021/05/26
摘要
背景：当前的哮喘指南建议，当病情在一段时间内得到良好控制时，应停止控制性治疗。然而，对于接受低剂量吸入糖皮质激素(ICS）和长效β2激动剂（LABA）治疗控制良好的患者来说，其最佳的降级治疗策略尚不明确。
目的：这项研究是一项随机、开放、三臂平行的实用试验，比较了两种降级维持治疗的方法。
方法：纳入18岁及以上的低剂量ICS / LABA稳定期至少3个月的哮喘成年人。受试者(N=225)被随机分为三组(维持小剂量ICS/LABA[G1]、停用LABA[G2]和将ICS/LABA降至每天一次[G3])，并随访6个月。主要终点是随机化和最后6个月随访期间哮喘控制测试（ACT）评分的变化。
结果：按方案人群分析了ACT的变化，与维持组相比，两降级组均未表现出非劣势(差异95%置信区间[CI]：G2 vs G1=-1.40∼0.55，G3 vs G1=-1.19∼0.77)。虽然90%以上的患者痊愈，但降级组的治疗失败率较高(G1：0%，G2：9.46%，G3：9.09%，p=0.027)。两种降级方法在ACT改变和治疗失败方面无显著差异。
结论：两种降级治疗方法均不逊色于维持治疗。当患者病情稳定时，可尝试降级治疗，但需要进行适当的监测和监督，并注意预防疾病失控。
Pragmatic randomized controlled trial for stepping down of asthma controller treatment in patients controlled with low dose inhaled corticosteroid and long-acting beta2 agonist: SIGMA study
Sae-Hoon Kim, Taehoon Lee, An-Soo Jang, Chan Sun Park, Jae-Woo Jung, Min-Hye Kim 6, Jae-Woo Kwon, Ji-Yong Moon, Min-Suk Yang, Jaechun Lee, Jeong-Hee Choi, Yoo Seob Shin, Hee-Kyoo Kim, Sujeong Kim, Joo-Hee Kim, Suh-Young Lee, Young-Hee Nam, Sang-Hoon Kim, Tae-Bum Kim
Abstract
BACKGROUND：Current asthma guidelines recommend stepping down of controller treatment when the condition is well-controlled for a certain length of time. However, an optimal stepping-down strategy for well-controlled patients receiving a low-dose inhaled corticosteroid (ICS) with a long-acting β2 agonist (LABA) remains unclear.
OBJECTIVE:This study was a randomized, open-label, 3-arm parallel pragmatic trial comparing two kinds of step-down approaches for maintaining treatment.
METHODS:Adults with asthma, aged 18 years or older, who had been stable with low-dose ICS/LABA for at least 3 months were enrolled. Subjects (N=225) were randomly allocated into one of three groups (maintaining low-dose ICS/LABA [G1], discontinuing LABA [G2], and reducing ICS/LABA to once daily [G3]) and followed-up for 6 months. The primary endpoint was change in asthma control test (ACT) scores between randomization and the final 6-month follow-up.
RESULTS:The ACT change was analyzed in the per-protocol population, and non-inferiority was not demonstrated in either step-down groups compared to the maintenance group (95% confidence interval [CI] of the difference; G2 vs. G1 = -1.40∼0.55, G3 vs. G1 = -1.19∼0.77). Although over 90% of patients were fine, higher rates of treatment failure were observed in step-down groups (G1: 0%, G2: 9.46%, G3: 9.09%, p = 0.027). There were no significant differences between the step-down approaches in terms of ACT change or treatment failure.
CONCLUSION:Both step-down methods were not non-inferior to maintenance of treatment. Step-down therapy can be attempted when patients are stable, but appropriate monitoring and supervision are necessary with precautions for loss of disease control.
背景：当前的哮喘指南建议，当病情在一段时间内得到良好控制时，应停止控制性治疗。然而，对于接受低剂量吸入糖皮质激素(ICS）和长效β2激动剂（LABA）治疗控制良好的患者来说，其最佳的降级治疗策略尚不明确。
目的：这项研究是一项随机、开放、三臂平行的实用试验，比较了两种降级维持治疗的方法。
方法：纳入18岁及以上的低剂量ICS / LABA稳定期至少3个月的哮喘成年人。受试者(N=225)被随机分为三组(维持小剂量ICS/LABA[G1]、停用LABA[G2]和将ICS/LABA降至每天一次[G3])，并随访6个月。主要终点是随机化和最后6个月随访期间哮喘控制测试（ACT）评分的变化。
结果：按方案人群分析了ACT的变化，与维持组相比，两降级组均未表现出非劣势(差异95%置信区间[CI]：G2 vs G1=-1.40∼0.55，G3 vs G1=-1.19∼0.77)。虽然90%以上的患者痊愈，但降级组的治疗失败率较高(G1：0%，G2：9.46%，G3：9.09%，p=0.027)。两种降级方法在ACT改变和治疗失败方面无显著差异。
结论：两种降级治疗方法均不逊色于维持治疗。当患者病情稳定时，可尝试降级治疗，但需要进行适当的监测和监督，并注意预防疾病失控。
(中日友好医院呼吸与危重症医学科 王静茹 摘译 林江涛 审校)
(J Allergy Clin Immunol Pract. 2021 Apr 30;S2213-2198(21)00504-3. doi: 10.1016/j.jaip.2021.04.042.)
(J Allergy Clin Immunol Pract. 2021 Apr 30;S2213-2198(21)00504-3. doi: 10.1016/j.jaip.2021.04.042.)
Pragmatic randomized controlled trial for stepping down of asthma controller treatment in patients controlled with low dose inhaled corticosteroid and long-acting beta2 agonist: SIGMA study
Sae-Hoon Kim, Taehoon Lee, An-Soo Jang, Chan Sun Park, Jae-Woo Jung, Min-Hye Kim 6, Jae-Woo Kwon, Ji-Yong Moon, Min-Suk Yang, Jaechun Lee, Jeong-Hee Choi, Yoo Seob Shin, Hee-Kyoo Kim, Sujeong Kim, Joo-Hee Kim, Suh-Young Lee, Young-Hee Nam, Sang-Hoon Kim, Tae-Bum Kim
Abstract
BACKGROUND：Current asthma guidelines recommend stepping down of controller treatment when the condition is well-controlled for a certain length of time. However, an optimal stepping-down strategy for well-controlled patients receiving a low-dose inhaled corticosteroid (ICS) with a long-acting β2 agonist (LABA) remains unclear.
OBJECTIVE:This study was a randomized, open-label, 3-arm parallel pragmatic trial comparing two kinds of step-down approaches for maintaining treatment.
METHODS:Adults with asthma, aged 18 years or older, who had been stable with low-dose ICS/LABA for at least 3 months were enrolled. Subjects (N=225) were randomly allocated into one of three groups (maintaining low-dose ICS/LABA [G1], discontinuing LABA [G2], and reducing ICS/LABA to once daily [G3]) and followed-up for 6 months. The primary endpoint was change in asthma control test (ACT) scores between randomization and the final 6-month follow-up.
RESULTS:The ACT change was analyzed in the per-protocol population, and non-inferiority was not demonstrated in either step-down groups compared to the maintenance group (95% confidence interval [CI] of the difference; G2 vs. G1 = -1.40∼0.55, G3 vs. G1 = -1.19∼0.77). Although over 90% of patients were fine, higher rates of treatment failure were observed in step-down groups (G1: 0%, G2: 9.46%, G3: 9.09%, p = 0.027). There were no significant differences between the step-down approaches in terms of ACT change or treatment failure.
CONCLUSION:Both step-down methods were not non-inferior to maintenance of treatment. Step-down therapy can be attempted when patients are stable, but appropriate monitoring and supervision are necessary with precautions for loss of disease control.
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