Inhaled steroids reduce pain and sVCAM levels in individuals with sickle cell disease: A triple-blind, randomized trial.
Inhaled steroids reduce pain and sVCAM levels in individuals with sickle cell disease: A triple-blind, randomized trial.
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DOI：
10.1002/ajh.24742
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发表时间：
2017-07
影响因子：
12.8
通讯作者：
Meurer WJ
中科院分区：
文献类型：
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作者：
Glassberg J;Minnitti C;Cromwell C;Cytryn L;Kraus T;Skloot GS;Connor JT;Rahman AH;Meurer WJ
临床和临床前数据表明，肺生理改变(包括炎症增加、血流增加、呼吸道阻力和高反应性)是SCD的内在组成部分，可能导致SCD的过度发病率和死亡率。吸入糖皮质激素(ICS)是治疗哮喘肺部炎症的一种安全有效的治疗方法，可改善SCD患者肺生理环境的改变。通过这项单中心、纵向、随机、三盲、安慰剂对照试验，我们研究了ICS在54名非哮喘患者中的疗效和可行性。受试者每天接受一次呋喃莫米松220微克干粉雾化吸入或安慰剂治疗16周。主要结果是可行性(完成试验的人数除以登记的总人数)，具有预先指定的疗效结果，包括随时间推移的每日疼痛评分(患者报告)以及进入试验至8周期间可溶性血管细胞黏附分子(SVCAM)水平的变化。对于可行性的初步结果，意向治疗分析的结果为96%(52/54，95%CI 87%~99%)，而按方案分析的结果为83%(45/54，95%CI 71%~91%)。莫米松的调整治疗效果为每日疼痛评分减少1.42分(95%可信区间0.61~2.21，p=0.001)。与安慰剂组相比，莫美松组的血管细胞黏附分子水平降低了526.94 ng/m L(95%可信区间为50.66-1003.23，p=0.03)。这些结果支持了对SCD中ICS的进一步研究，包括多中心试验和更长的疗程。Www.Clinicaltrials.gov(NCT02061202)
Clinical and preclinical data demonstrate that altered pulmonary physiology (including increased inflammation, increased blood flow, airway resistance and hyperreactivity) is an intrinsic component of SCD and may contribute to excess SCD morbidity and mortality. Inhaled corticosteroids (ICS), a safe and effective therapy for pulmonary inflammation in asthma, may ameliorate the altered pulmonary physiologic milieu in SCD. With this single-center, longitudinal, randomized, triple-blind, placebo controlled trial we studied the efficacy and feasibility of ICS in 54 non-asthmatic individuals with SCD. Participants received once daily mometasone furoate 220 mcg dry powder inhalation or placebo for 16 weeks. The primary outcome was feasibility (the number who complete the trial divided by the total number enrolled) with pre-specified efficacy outcomes including daily pain score over time (patient reported) and change in soluble vascular cell adhesion molecule (sVCAM) levels between entry and 8-weeks. For the primary outcome of feasibility, the result was 96% (52 of 54, 95% CI 87% – 99%) for the intent-to-treat analysis and 83% (45 of 54, 95% CI 71% – 91%) for the per-protocol analysis. The adjusted treatment effect of mometasone was a reduction in daily pain score of 1.42 points (95%CI 0.61 – 2.21, p = 0.001). Mometasone was associated with a reduction in sVCAM levels of 526.94 ng/mL more than placebo (95% CI 50.66 – 1,003.23, p = 0.03). These results support further study of ICS in SCD including multi-center trials and longer durations of treatment. www.clinicaltrials.gov (NCT02061202)
DOI：
10.1080/10245332.2015.1101966
发表时间：
2016-05
期刊：
Hematology (Amsterdam, Netherlands)
影响因子：
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作者：
Meurer WJ;Connor JT;Glassberg J
通讯作者：
Glassberg J