Meijer R J, Postma D S, Kauffman H F, Arends L R, Koëter G H, Kerstjens H A M
Department of Pulmonary Diseases, University Hospital Groningen, Groningen, The Netherlands.
Clin Exp Allergy. 2002 Jul;32(7):1096-103. doi: 10.1046/j.1365-2222.2002.01412.x.
There is a large variability in clinical response to corticosteroid treatment in patients with asthma. Several markers of inflammation like eosinophils and eosinophil cationic protein (ECP), as well as exhaled nitric oxide (NO), are good candidates to predict clinical response.
We wanted to determine whether we could actually predict a favourable response to inhaled corticosteroids in individual patients.
One hundred and twenty patients with unstable asthma were treated with either prednisolone 30 mg/day, fluticasone propionate 1000 microg/day b.i.d. or fluticasone propionate 250 microg/day b.i.d., both via Diskhaler. They were treated during 2 weeks, in a double-blind, parallel group, double dummy design. We measured eosinophils and ECP in blood and sputum, and exhaled nitric oxide as inflammatory parameters before and after 2 weeks in order to predict the changes in forced expiratory volume in 1 s (FEV1), provocative concentration of methacholine causing a 20% fall in FEV1 (PC20 Mch), and asthma quality of life (QOL). Secondly, to test whether these results were applicable in clinical practice we determined the individual prediction of corticosteroid response.
We found that changes in FEV1, PC20 Mch and QOL with corticosteroids were predominantly predicted by their respective baseline value and to a smaller extent by eosinophils in blood or sputum. ECP, measured in blood or sputum, was certainly not better than eosinophils in predicting clinical response to corticosteroids. Smoking status was an additional predictor for change in FEV1, but not for change in PC20 Mch or QOL. Prediction of a good clinical response was poor. For instance, high sputum eosinophils (> or = 3%) correctly predicted an improvement in PC20 Mch in only 65% of the patients.
Our findings show that baseline values of the clinical parameters used as outcome parameters are the major predictors of clinical response to corticosteroids. Eosinophil percentage in blood or sputum adds to this, whereas ECP provides no additional information. Correct prediction of clinical response in an individual patient, however, remains poor with our currently used clinical and inflammatory parameters.
哮喘患者对皮质类固醇治疗的临床反应存在很大差异。多种炎症标志物，如嗜酸性粒细胞和嗜酸性粒细胞阳离子蛋白（ECP），以及呼出一氧化氮（NO），都是预测临床反应的良好指标。
我们想确定是否能够实际预测个体患者对吸入性皮质类固醇的良好反应。
120例不稳定型哮喘患者接受以下治疗：泼尼松龙30mg/天、丙酸氟替卡松1000μg/天，每日两次，或丙酸氟替卡松250μg/天，每日两次，均通过都保吸入。采用双盲、平行组、双模拟设计，治疗2周。在治疗前和治疗2周后，我们测量血液和痰液中的嗜酸性粒细胞和ECP，以及呼出一氧化氮作为炎症参数，以预测第1秒用力呼气量（FEV1）、使FEV1下降20%的乙酰甲胆碱激发浓度（PC20 Mch）和哮喘生活质量（QOL）的变化。其次，为了测试这些结果是否适用于临床实践，我们确定了皮质类固醇反应的个体预测。
我们发现，皮质类固醇治疗后FEV1、PC20 Mch和QOL的变化主要由其各自的基线值预测，血液或痰液中的嗜酸性粒细胞在较小程度上起预测作用。血液或痰液中测量的ECP在预测皮质类固醇的临床反应方面肯定不比嗜酸性粒细胞更好。吸烟状态是FEV1变化的另一个预测因素，但不是PC20 Mch或QOL变化的预测因素。对良好临床反应的预测较差。例如，痰液嗜酸性粒细胞比例高（≥3%）仅在65%的患者中正确预测了PC20 Mch的改善。
我们的研究结果表明，用作结局参数的临床参数的基线值是皮质类固醇临床反应的主要预测因素。血液或痰液中的嗜酸性粒细胞百分比对此有补充作用，而ECP则不提供额外信息。然而，使用我们目前的临床和炎症参数，对个体患者临床反应的正确预测仍然较差。
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