血嗜酸性粒细胞计数是鉴别严重嗜酸性粒细胞哮喘患者的有效生物指标
2014/05/08
摘要
背景:唾液或血嗜酸性粒细胞检测可能有助于鉴别对单抗有应答的严重嗜酸性粒细胞哮喘患者。
目的:主要目的是比较单次血嗜酸性粒细胞检测和多次血嗜酸性粒细胞检测对未来几年嗜酸性粒细胞检测的预测价值。此外,我们检测了单次唾液或血嗜酸性粒细胞检测是否是单抗治疗疗效的有效生物预测指标。
方法:针对筛查时单次血嗜酸性粒细胞≥150/μL的安慰机组(N=155),我们检测了未来几年血嗜酸性粒细胞均值是否仍高于此水平。我们对 血嗜酸性粒细胞计数筛选部分亚组患者进行唾液嗜酸性粒细胞计数,并评估哮喘发作降低率。
指标和主要结果:筛查时共115例受试者嗜酸性粒细胞≥150/µL,其中98例(85%)筛查后嗜酸性粒细胞均值仍高于此水平。筛查后2、3或4次测量嗜酸性粒细胞均值≥150/µL的患者比例分别为97 (85%), 103 (90%) and 105 (92%)。基线唾液嗜酸性粒细胞≥3%的患者中单抗治疗能减少69%的哮喘发作率(95% 可信区间:0.41 - 83%),而基线唾液嗜酸性粒细胞<3%的患者单抗治疗减少66%的哮喘发作率(95%可信区间:7 -87%)。血嗜酸性粒细胞≥150/μL的患者哮喘发作降低率为72% (95%可信区间:41 to 83%),< 150/μL的降低率为30% (95%可信区间: -134% - 79%) 。
结论:单次测量嗜酸性粒细胞粒细胞≥150/µL的患者中,随后测量均值高于此水平的比例为85%。多次测量取平均值仅能稍微提高敏感性。唾液嗜酸性粒细胞计数不能预测对单抗的治疗疗效。
(刘国梁 审校)
Ann Am Thorac Soc. 2014 Mar 7. [Epub ahead of print]
Blood Eosinophil Count Is a Useful Biomarker to Identify Patients with Severe Eosinophilic Asthma.
Katz LE1, Gleich GJ, Hartley BF, Yancey SW, Ortega HG.
Abstract
RATIONALE: Measurement of sputum or blood eosinophils may allow identification of a severe eosinophilic asthma population responsive to mepolizumab.
OBJECTIVES: The primary objective was assessment of a single blood eosinophil measurement to predict future eosinophil measurements in the following year versus using multiple blood eosinophil measurements. Additionally, we examined whether a single sputum or blood eosinophil measurement was a useful biomarker for predicting treatment response to mepolizumab.
METHODS: Based on data from placebo subjects (N=155) we determined whether a blood eosinophil count of ≥150/μL at screening remained on average above this level during the following year. The rate of exacerbation reduction in the sputum sub-study population based on the screening blood eosinophil count and sputum eosinophils was evaluated.
MEASUREMENTS AND MAIN RESULTS: Of 115 patients with eosinophils ≥150/µL at screening, 98 (85%) remained above this level in their post-screening average. Using the average of two, three or four measurements ≥150/µL, 97 (85%), 103 (90%) and 105 (92%) have post-screening averages above 150/µL. Mepolizumab reduced exacerbations by 69% (95% CI: 0.41 to 83%) in subjects with baseline sputum eosinophils ≥3% compared to 66% (95% CI7 to 87%) in subjects with baseline sputum eosinophils <3%. The reduction was 72% (95% CI: 41 to 83%) in subjects with blood eosinophils ≥150/μL compared to 30% (95% CI: -134% to 79%) in subjects with blood eosinophils < 150/μL.
CONCLUSIONS: A single measurement ≥150/µL predicted the average of subsequent measurements being ≥150/µL in 85% of this population. Using an average of multiple measurements only marginally increases the sensitivity. Sputum eosinophils did not predict treatment response with mepolizumab.
Ann Am Thorac Soc. 2014 Mar 7. [Epub ahead of print]
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哮喘评估和治疗中的生物分子标志物
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