糠酸莫米松联合福莫特罗与糠酸莫米松治疗的严重哮喘事件比较
2020/01/02
摘要
背景：将长效β受体激动剂加入吸入性皮质类固醇治疗持续性哮喘是否安全一直存在争议。
目的：探究与单用糠酸莫米松相比，福莫特罗-糠酸莫米松联合使用是否会增加严重哮喘结局的风险。
方法：我们在35个国家患持续性哮喘的青少年和成年患者（≥12岁）中开展了为期26周的随机双盲试验，以评估与单用糠酸莫米松相比糠酸莫米松-福莫特罗联用是否会增加严重哮喘结局的风险（包括需要住院治疗、插管或死亡）。将哮喘急性发作（住院时长≥24小时，急诊就诊24小时内需要全身性糖皮质激素，或需应用全身糖皮质激素连续3天以上）定义为主要疗效终点。
结果：在11,729名患者（糠酸莫米松-福莫特罗联用组，n = 5868;糠酸莫米松组，n = 5861）中，在71名患者中观察到81次严重的需住院治疗的哮喘急性发作;其中45次事件发生于39名糠酸莫米松-福莫特罗组患者，36次事件发生于32名应用糠酸莫米松患者。糠酸莫米松-福莫特罗组与糠酸莫米松组的第一次严重哮喘发作的风险比为1.22（95％CI：0.76-1.94，p = 0.411）。1487名患者出现哮喘急性发作; 其中708例发生于糠酸莫米松-福莫特罗组，779例发生于糠酸莫米松组。糠酸莫米松-福莫特罗组与糠酸莫米松组的第一次哮喘急性发作的风险比为0.89（95％CI：0.80-0.98，p = 0.021）。
结论：在莫米松维持治疗的基础上额外应用福莫特罗不会增加严重哮喘相关事件的风险，降低了哮喘急性发作的风险。
Serious Asthma Events with Mometasone Furoate Plus Formoterol Compared With Mometasone Furoate
Cindy L.J, et al. J Allergy Clin Immunol. 2018 Dec 8.
Abstract
Background ：The safety of long-acting beta agonists added to inhaled corticosteroids for the treatment of persistent asthma has been controversial.
Objective ：To determine whether administering formoterol in combination with mometasone furoate increases the risk of serious asthma outcomes compared to mometasone furoate alone.
Methods ：We conducted a 26-week, randomized, double-blind trial in adolescent and adult patients (≥12 years) with persistent asthma in 35 countries with the primary objective of evaluating whether mometasone furoate-formoterol increases the risk of serious asthma outcomes (adjudicated hospitalization, intubation, or death) compared to mometasone furoate alone. The key efficacy endpoint was asthma exacerbation (composite of hospitalizations ≥24 h, emergency visits <24 h requiring systemic corticosteroid, or systemic corticosteroid for ≥3 consecutive days).
Results ：Among 11,729 patients (mometasone furoate-formoterol, n=5868; mometasone furoate, n=5861), a total of 81 serious asthma outcomes, all asthma-related hospitalizations, were observed in 71 patients; 45 events from 39 patients on mometasone furoate-formoterol and 36 events from 32 patients on mometasone furoate. The hazard ratio for the first serious asthma outcome in the mometasone furoate-formoterol versus mometasone furoate group was 1.22 (95% CI: 0.76 to 1.94, p=0.411). Asthma exacerbation occurred in 1487 patients; 708 on mometasone furoate-formoterol and 779 on mometasone furoate. The hazard ratio for the first asthma exacerbation in the mometasone furoate-formoterol versus mometasone furoate group was 0.89 (95% CI: 0.80 to 0.98, p=0.021).
Conclusions ：The addition of formoterol to mometasone maintenance therapy did not increase the risk of serious asthma-related events and reduced the risk of asthma exacerbation.
背景：将长效β受体激动剂加入吸入性皮质类固醇治疗持续性哮喘是否安全一直存在争议。
目的：探究与单用糠酸莫米松相比，福莫特罗-糠酸莫米松联合使用是否会增加严重哮喘结局的风险。
方法：我们在35个国家患持续性哮喘的青少年和成年患者（≥12岁）中开展了为期26周的随机双盲试验，以评估与单用糠酸莫米松相比糠酸莫米松-福莫特罗联用是否会增加严重哮喘结局的风险（包括需要住院治疗、插管或死亡）。将哮喘急性发作（住院时长≥24小时，急诊就诊24小时内需要全身性糖皮质激素，或需应用全身糖皮质激素连续3天以上）定义为主要疗效终点。
结果：在11,729名患者（糠酸莫米松-福莫特罗联用组，n = 5868;糠酸莫米松组，n = 5861）中，在71名患者中观察到81次严重的需住院治疗的哮喘急性发作;其中45次事件发生于39名糠酸莫米松-福莫特罗组患者，36次事件发生于32名应用糠酸莫米松患者。糠酸莫米松-福莫特罗组与糠酸莫米松组的第一次严重哮喘发作的风险比为1.22（95％CI：0.76-1.94，p = 0.411）。1487名患者出现哮喘急性发作; 其中708例发生于糠酸莫米松-福莫特罗组，779例发生于糠酸莫米松组。糠酸莫米松-福莫特罗组与糠酸莫米松组的第一次哮喘急性发作的风险比为0.89（95％CI：0.80-0.98，p = 0.021）。
结论：在莫米松维持治疗的基础上额外应用福莫特罗不会增加严重哮喘相关事件的风险，降低了哮喘急性发作的风险。
(中国医科大学附属一院呼吸与危重症学科 李文扬 摘译 杨冬 审校)
(Cindy L.J, et al. J Allergy Clin Immunol. 2018 Dec 8.)
(Cindy L.J, et al. J Allergy Clin Immunol. 2018 Dec 8.)
Serious Asthma Events with Mometasone Furoate Plus Formoterol Compared With Mometasone Furoate
Cindy L.J, et al. J Allergy Clin Immunol. 2018 Dec 8.
Abstract
Background ：The safety of long-acting beta agonists added to inhaled corticosteroids for the treatment of persistent asthma has been controversial.
Objective ：To determine whether administering formoterol in combination with mometasone furoate increases the risk of serious asthma outcomes compared to mometasone furoate alone.
Methods ：We conducted a 26-week, randomized, double-blind trial in adolescent and adult patients (≥12 years) with persistent asthma in 35 countries with the primary objective of evaluating whether mometasone furoate-formoterol increases the risk of serious asthma outcomes (adjudicated hospitalization, intubation, or death) compared to mometasone furoate alone. The key efficacy endpoint was asthma exacerbation (composite of hospitalizations ≥24 h, emergency visits <24 h requiring systemic corticosteroid, or systemic corticosteroid for ≥3 consecutive days).
Results ：Among 11,729 patients (mometasone furoate-formoterol, n=5868; mometasone furoate, n=5861), a total of 81 serious asthma outcomes, all asthma-related hospitalizations, were observed in 71 patients; 45 events from 39 patients on mometasone furoate-formoterol and 36 events from 32 patients on mometasone furoate. The hazard ratio for the first serious asthma outcome in the mometasone furoate-formoterol versus mometasone furoate group was 1.22 (95% CI: 0.76 to 1.94, p=0.411). Asthma exacerbation occurred in 1487 patients; 708 on mometasone furoate-formoterol and 779 on mometasone furoate. The hazard ratio for the first asthma exacerbation in the mometasone furoate-formoterol versus mometasone furoate group was 0.89 (95% CI: 0.80 to 0.98, p=0.021).
Conclusions ：The addition of formoterol to mometasone maintenance therapy did not increase the risk of serious asthma-related events and reduced the risk of asthma exacerbation.
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吸入糖皮质激素联合沙美特罗以及不联合沙美特罗治疗哮喘的严重不良事件
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生物制剂在哮喘中的作用
