严重嗜酸性粒细胞性哮喘患者的抗IL-5治疗 - 临床疗效及治疗反应标准
2018/11/02
摘要
背景：白细胞介素-5（IL-5）抗体是重症嗜酸性粒细胞性哮喘患者一种具有前景的治疗选择。 迄今为止，尚无官方的疗效标准。 在这项研究中，用适用于所有哮喘患者的疗效标准来评估此次研究的临床疗效及治疗反应后的预测。
方法：数据分析了至少使用美伯利单抗治疗6个月的42例严重嗜酸粒细胞性哮喘患者。 应用临床实践中评估治疗反应的标准：FEV1增加≥12％或≥200ml，血嗜酸性粒细胞减少（<150 /μl或<基线的80％）和主观条件改善（患者判断的主观改善或治疗后恶化）。 如果满足以上两条标准，则认为患者对此治疗有反应。
结果：42名患者中有32名（76％[61-87％]）被认为治疗有反应者。 在此组中（有反应者与无反应者），美伯利单抗治疗使FEV1显着变化（+ 600 ml vs -100 ml，p = 0.003），氧合（+ 8 mmHg vs -3 mmHg，p = 0.001），质量 生命（视觉模拟评分; + 28％vs - 5％，p = 0.004）和哮喘控制测试（+ 8 vs + 1分，p = 0.002）。 在有反应者组中，观察到12个月内恶化率显着降低（1.45vs0.45，p = 0.002）。 基线特征（性别，BMI，吸烟史，过敏史，嗜酸性粒细胞基线水平）未预测治疗反应。
结论：应用肺功能的改善，嗜酸性粒细胞的减少及主观条件的改善作为反应标准，76％的治疗患者可归类为治疗有反应者，证明了抗IL-5治疗在临床实践中的有效性。
Anti-IL-5 therapy in patients with severe eosinophilic asthma – clinical efficacy and possible criteria for treatment response
Drick N, Seeliger B, Welte T, Fuge J, Suhling H.
Abstract
Background：Interleukin-5 (IL-5) antibodies represent a promising therapeutic option for patients with severe eosinophilic asthma. To date, no official treatment response criteria exist. In this study, simple criteria for treatment response applicable to all asthma patients were used to evaluate clinical efficacy and predictors for treatment response in a real-life setting.
Methods：Data from 42 patients with severe eosinophilic asthma treated with mepolizumab for at least six months were analysed. Simple criteria to assess treatment response in clinical practice were used: increase of FEV1 ≥ 12% or ≥ 200 ml, reduction of blood eosinophils (< 150/μl or < 80% from baseline) and improvement of subjective condition (patient-judged subjective improvement or worsening following therapy). Patients were considered treatment responders if two criteria were fulfilled.
Results：Thirty-two out of 42 patients (76% [61–87%]) were classified as responders. Within the groups (responder vs non-responder), treatment with mepolizumab led to significant increase in FEV1 (+ 600 ml vs -100 ml, p = 0.003), oxygenation (+ 8 mmHg vs -3 mmHg, p = 0.001), quality of life (visual analogue scale; + 28% vs − 5%, p = 0.004) and Asthma Control Test (+ 8 vs + 1 points, p = 0.002). In the responder group a significant decrease in the exacerbation rate over 12 months (1.45 vs 0.45, p = 0.002) was observed. Baseline characteristics (sex, BMI, smoking history, allergies, baseline level of eosinophils) did not predict treatment response.
Conclusion：Using improvement of lung function, decrease of eosinophils and improvement of subjective condition as response criteria, 76% of treated patients could be classified as treatment responders, demonstrating the efficacy of anti-IL-5 therapy in clinical practice.
背景：白细胞介素-5（IL-5）抗体是重症嗜酸性粒细胞性哮喘患者一种具有前景的治疗选择。 迄今为止，尚无官方的疗效标准。 在这项研究中，用适用于所有哮喘患者的疗效标准来评估此次研究的临床疗效及治疗反应后的预测。
方法：数据分析了至少使用美伯利单抗治疗6个月的42例严重嗜酸粒细胞性哮喘患者。 应用临床实践中评估治疗反应的标准：FEV1增加≥12％或≥200ml，血嗜酸性粒细胞减少（<150 /μl或<基线的80％）和主观条件改善（患者判断的主观改善或治疗后恶化）。 如果满足以上两条标准，则认为患者对此治疗有反应。
结果：42名患者中有32名（76％[61-87％]）被认为治疗有反应者。 在此组中（有反应者与无反应者），美伯利单抗治疗使FEV1显着变化（+ 600 ml vs -100 ml，p = 0.003），氧合（+ 8 mmHg vs -3 mmHg，p = 0.001），质量 生命（视觉模拟评分; + 28％vs - 5％，p = 0.004）和哮喘控制测试（+ 8 vs + 1分，p = 0.002）。 在有反应者组中，观察到12个月内恶化率显着降低（1.45vs0.45，p = 0.002）。 基线特征（性别，BMI，吸烟史，过敏史，嗜酸性粒细胞基线水平）未预测治疗反应。
结论：应用肺功能的改善，嗜酸性粒细胞的减少及主观条件的改善作为反应标准，76％的治疗患者可归类为治疗有反应者，证明了抗IL-5治疗在临床实践中的有效性。
（中日友好医院呼吸与危重症医学科 张鑫 摘译 林江涛 审校）
（BMC Pulm Med. 2018 Jul 18;18(1):119.）
（BMC Pulm Med. 2018 Jul 18;18(1):119.）
Anti-IL-5 therapy in patients with severe eosinophilic asthma – clinical efficacy and possible criteria for treatment response
Drick N, Seeliger B, Welte T, Fuge J, Suhling H.
Abstract
Background：Interleukin-5 (IL-5) antibodies represent a promising therapeutic option for patients with severe eosinophilic asthma. To date, no official treatment response criteria exist. In this study, simple criteria for treatment response applicable to all asthma patients were used to evaluate clinical efficacy and predictors for treatment response in a real-life setting.
Methods：Data from 42 patients with severe eosinophilic asthma treated with mepolizumab for at least six months were analysed. Simple criteria to assess treatment response in clinical practice were used: increase of FEV1 ≥ 12% or ≥ 200 ml, reduction of blood eosinophils (< 150/μl or < 80% from baseline) and improvement of subjective condition (patient-judged subjective improvement or worsening following therapy). Patients were considered treatment responders if two criteria were fulfilled.
Results：Thirty-two out of 42 patients (76% [61–87%]) were classified as responders. Within the groups (responder vs non-responder), treatment with mepolizumab led to significant increase in FEV1 (+ 600 ml vs -100 ml, p = 0.003), oxygenation (+ 8 mmHg vs -3 mmHg, p = 0.001), quality of life (visual analogue scale; + 28% vs − 5%, p = 0.004) and Asthma Control Test (+ 8 vs + 1 points, p = 0.002). In the responder group a significant decrease in the exacerbation rate over 12 months (1.45 vs 0.45, p = 0.002) was observed. Baseline characteristics (sex, BMI, smoking history, allergies, baseline level of eosinophils) did not predict treatment response.
Conclusion：Using improvement of lung function, decrease of eosinophils and improvement of subjective condition as response criteria, 76% of treated patients could be classified as treatment responders, demonstrating the efficacy of anti-IL-5 therapy in clinical practice.
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规律使用口服糖皮质激素治疗的哮喘患者的医疗资源利用与成本 – 一项瑞典观察性队列研究（PACEHR）
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在轻度哮喘患者中按需使用布地奈德-福莫特罗与维持使用布地奈德的研究
