低呼出气一氧化氮水平排除了疑似哮喘吸入糖皮质激素的短期获益：一项随机安慰剂对照试验
2021/05/26
摘要
背景：呼出气一氧化氮（FeNO）是一种反映IL-4/IL-13产生的非侵入性生物标志物，因此代表T2过敏性炎症。此前，FeNO曾用于指导哮喘患者吸入糖皮质激素(ICS)治疗。
目的：本研究目的是确定能否根据低FeNO(≤27 ppb)水平可靠地鉴别有哮喘症状而初始ICS治疗未受益的患者。
方法：将180名临床疑似哮喘且FeNO≤27ppb的未接受糖皮质激素治疗的成人随机400 μg/天布地奈德或安慰剂治疗3个月。主要结果是治疗组之间哮喘控制问卷7(ACQ7)的差异，且本项研究用于确定等效性。次要结果是FEV1、医学研究委员会和莱斯特咳嗽问卷评分的差异。
结果：134例患者(布地奈德68例，安慰剂66例)完成研究并纳入分析。从基线到研究结束，ACQ7值的组间平均差值为-0.25，该差值95%可信区间为-0.004～0.495，证实了等效性(p<0.05)。超过1s的用力呼气量和其他次要结果的差异也很小，在临床上并不重要。
结论：本项研究结果表明，有哮喘症状且FeNO≤为27 ppb的未经糖皮质激素治疗的患者不太可能从初始治疗超过3个月的ICS中受益。但是，建议在停止ICS治疗之前进行进一步研究以证实这些发现。
A low exhaled nitric oxide level excludes a short-term benefit from inhaled corticosteroids in suspected asthma: A randomized placebo-controlled trial
Lissa Sutherland, Karen Shaw, Clair Parrish, Nicola Singleton, Tricia M McKeever, Iain Stewart, Dominick Shaw, Matthew J Martin, Tim Harrison
Abstract
BACKGROUND:Fractional exhaled nitric oxide (FeNO) is a non-invasive biomarker that reflects IL-4/IL-13 production and therefore represents T2 allergic inflammation. FeNO has previously been used to guide inhaled corticosteroid (ICS) treatment in asthma.
OBJECTIVE：The purpose of this study was to determine if a low FeNO (≤27 ppb) could be used to reliably identify patients with symptoms suggestive of asthma who would not benefit from initiating treatment with an ICS.
METHODS: A total of 180 steroid-naïve adults with healthcare professional suspected asthma and an FeNO of ≤27 ppb were randomized to receive either 400 mcg of budesonide or placebo daily for 3 months. The primary outcome was the difference in the Asthma Control Questionnaire 7 (ACQ7) between treatment groups and the study was powered to determine equivalence. Secondary outcomes were the difference in FEV1 , Medical Research Council and Leicester Cough Questionnaire scores.
RESULTS: One hundred and thirty-four patients (68 budesonide and 66 placebo) completed the study and were included in the analysis. The between-group mean difference in ACQ7 from baseline to the end of the study was -0.25 and the 95% CI around this difference was -0.004 to 0.495 confirming equivalence (p < 0.05). Differences in forced expiratory volume over 1 s and other secondary outcomes were also small and clinically unimportant.
CONCLUSION: The results of this study suggest that steroid-naïve patients with symptoms suggestive of asthma and an FeNO ≤ 27 ppb are unlikely to benefit from initiating treatment with an ICS over 3 months. However, further research is recommended to confirm these findings before withholding ICS treatment.
背景：呼出气一氧化氮（FeNO）是一种反映IL-4/IL-13产生的非侵入性生物标志物，因此代表T2过敏性炎症。此前，FeNO曾用于指导哮喘患者吸入糖皮质激素(ICS)治疗。
目的：本研究目的是确定能否根据低FeNO(≤27 ppb)水平可靠地鉴别有哮喘症状而初始ICS治疗未受益的患者。
方法：将180名临床疑似哮喘且FeNO≤27ppb的未接受糖皮质激素治疗的成人随机400 μg/天布地奈德或安慰剂治疗3个月。主要结果是治疗组之间哮喘控制问卷7(ACQ7)的差异，且本项研究用于确定等效性。次要结果是FEV1、医学研究委员会和莱斯特咳嗽问卷评分的差异。
结果：134例患者(布地奈德68例，安慰剂66例)完成研究并纳入分析。从基线到研究结束，ACQ7值的组间平均差值为-0.25，该差值95%可信区间为-0.004～0.495，证实了等效性(p<0.05)。超过1s的用力呼气量和其他次要结果的差异也很小，在临床上并不重要。
结论：本项研究结果表明，有哮喘症状且FeNO≤为27 ppb的未经糖皮质激素治疗的患者不太可能从初始治疗超过3个月的ICS中受益。但是，建议在停止ICS治疗之前进行进一步研究以证实这些发现。
(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)
(Respirology. 2021 May 3. doi: 10.1111/resp.14055.)
(Respirology. 2021 May 3. doi: 10.1111/resp.14055.)
A low exhaled nitric oxide level excludes a short-term benefit from inhaled corticosteroids in suspected asthma: A randomized placebo-controlled trial
Lissa Sutherland, Karen Shaw, Clair Parrish, Nicola Singleton, Tricia M McKeever, Iain Stewart, Dominick Shaw, Matthew J Martin, Tim Harrison
Abstract
BACKGROUND:Fractional exhaled nitric oxide (FeNO) is a non-invasive biomarker that reflects IL-4/IL-13 production and therefore represents T2 allergic inflammation. FeNO has previously been used to guide inhaled corticosteroid (ICS) treatment in asthma.
OBJECTIVE：The purpose of this study was to determine if a low FeNO (≤27 ppb) could be used to reliably identify patients with symptoms suggestive of asthma who would not benefit from initiating treatment with an ICS.
METHODS: A total of 180 steroid-naïve adults with healthcare professional suspected asthma and an FeNO of ≤27 ppb were randomized to receive either 400 mcg of budesonide or placebo daily for 3 months. The primary outcome was the difference in the Asthma Control Questionnaire 7 (ACQ7) between treatment groups and the study was powered to determine equivalence. Secondary outcomes were the difference in FEV1 , Medical Research Council and Leicester Cough Questionnaire scores.
RESULTS: One hundred and thirty-four patients (68 budesonide and 66 placebo) completed the study and were included in the analysis. The between-group mean difference in ACQ7 from baseline to the end of the study was -0.25 and the 95% CI around this difference was -0.004 to 0.495 confirming equivalence (p < 0.05). Differences in forced expiratory volume over 1 s and other secondary outcomes were also small and clinically unimportant.
CONCLUSION: The results of this study suggest that steroid-naïve patients with symptoms suggestive of asthma and an FeNO ≤ 27 ppb are unlikely to benefit from initiating treatment with an ICS over 3 months. However, further research is recommended to confirm these findings before withholding ICS treatment.
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