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美泊利珠单抗的真实世界研究:它兑现了承诺吗?

2020/04/07

   摘要
   背景:严重嗜酸性粒细胞哮喘患者群体中进行的随机对照试验表明,美泊利珠单抗(一种抗IL-5治疗)能够减少哮喘急性加重和口服糖皮质激素维持剂量,在一些研究中,能够改善哮喘控制和肺功能。
   目的:本研究的目的是证实在116例严重嗜酸性粒细胞哮喘患者中,应用美泊利珠单抗治疗后,他们每月在哮喘门诊随访至少18个月,在现实生活中的随机对照试验结果。
   方法:对重度哮喘患者进行FeNO、肺功能、哮喘控制及生活质量问卷调查、痰液诱导、基线、6个月后及每年一次血样测定。
   结果:6个月后,我们发现病情恶化率显著降低了85%(P<0.0001),并且随着时间的推移而保持。我们还发现口服皮质类固醇的剂量显著且持续减少50%(P<0.001)。6个月时,患者的ACT(+5.31分,P<0.0001)ACQ(-1.13分,P<0.0001)和AQLQ评分(+1.24分,P<0.0001)均得到改善,并在随访期间得到维持。只有37%达到哮喘控制(ACQ<1.5,ACT>20)。我们观察到使用支气管扩张剂后测定的FEV1逐渐增加并在18个月后达到显著性差异(190ml或11%,P<0.01)。FEV1改善的患者比不改善者有更高的基线痰嗜酸性粒细胞。研究发现6个月后痰嗜酸性粒细胞计数显著减少60%(P<0.01),血液嗜酸性粒细胞计数持续减少98%(P<0.0001)。
   结论:在我们的真实世界研究中,我们证实了RCT研究中公布的结果,研究显示急性发作和口服皮质类固醇剂量明显减少,哮喘控制和生活质量得到改善。

 
(中日友好医院呼吸与危重症医学科 李红雯 摘译 林江涛 审校)
(Clin Exp Allergy. 2020 Mar 21. doi: 10.1111/cea.13601.)
 
 
Real-word experience with Mepolizumab: Does it deliver what it has promised?

 
Schleich F, Graff S, Nekoee H, Moermans C, Henket M, Sanchez C, Paulus V, Guissard F, Donneau AF, Louis R.
 
Abstract
BACKGROUND: Randomized control trials performed in selected populations of severe eosinophilic asthmatics have shown that mepolizumab, an anti-IL5 therapy, was able to reduce exacerbations and OCS maintenance dose and in some studies, to improve asthma control and lung function.
OBJECTIVE: The aim of this study was to confirm the results of the RCTs in real-life in a population of 116 severe eosinophilic asthmatics treated with mepolizumab and who were followed up at the asthma clinic every month for at least 18 months.
METHODS: Severe asthmatics underwent FENO, lung function, asthma control and quality of life questionnaires, sputum induction and gave a blood sample at baseline, after 6 months and then every year.
RESULTS: We found a significant reduction in exacerbations by 85% after 6 months (P < .0001), which was maintained over time. We also found a significant and maintained reduction by 50% in the dose of oral corticosteroids (P < .001). Patients improved their ACT (+5.31pts, P < .0001) ACQ (-1.13pts, P < .0001) and their AQLQ score (+1.24, P < .0001) at 6 months and this was maintained during follow-up. Only 37% reached asthma control (ACQ < 1.5, ACT > 20). We observed a progressive increase in post-BD FEV1 that reached significance after 18 months (190ml or 11%, P < .01). Patients improving their FEV1 had higher baseline sputum eosinophils than those not improving airway caliber. We found a significant reduction in sputum eosinophil counts by 60% after 6 months (P < .01) and a maintained reduction in blood eosinophil counts by 98% (P < .0001).
CONCLUSION: In our real-life study, we confirm the results published in the RCTs showing a sharp reduction in exacerbation and oral corticosteroids dose and an improvement in asthma control and quality of life.




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