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临床实践中糠酸氟替卡松-维兰特罗对COPD治疗的有效性
Effectiveness of Fluticasone Furoate-Vilanterol for COPD in Clinical Practice


Jørgen Vestbo ... 呼吸系统疾病 • 2016.09.29
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“真实世界”中吸入激素联合长效b受体激动剂治疗慢性阻塞性肺疾病的效果

 

陈亚红

北京大学第三医院呼吸与危重症医学科

 

慢性阻塞性肺疾病全球倡议(GOLD)2017修订版1是基于大量循证医学证据而制定的,很多治疗慢性阻塞性肺疾病(简称“慢阻肺”)的药物包括吸入激素/长效b受体激动剂(ICS/LABA)的研究证据来源于随机对照试验(RCT),其具有严格的入选标准,仅占慢阻肺患者的10%以下,同时排除了有合并症的患者,可能与真实世界的慢阻肺群体不完全吻合,因此临床试验的结果需要在真实世界更多的人群中得到进一步验证。《新英格兰医学杂志》在2016年9月29日发表的《临床实践中糠酸氟替卡松-维兰特罗治疗COPD的有效性》一文2,即Salford肺疾病研究3,即着眼于真实世界的数据。

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摘要


背景

多项基于严格纳入标准的药效试验筛选慢性阻塞性肺疾病(COPD)患者进行密切监测,提供了有关该疾病管理的研究证据。但是,有必要进行更贴近真实临床实践情况的随机试验。

 

方法

由75家全科诊所开展药物有效性对照试验,将2,799例COPD患者随机分为两组,一组每日接受一次按100 μg糠酸氟替卡松和25 μg维兰特罗配制的复方吸入剂(糠酸氟替卡松-维兰特罗组),另一组接受常规治疗(常规治疗组)。主要结局指标为试验开展前1年内发生过病情加重的患者的中度或重度加重率。次要结局指标为初级诊疗率(就诊于全科医生、护士或其他专业医护人员)、二级诊疗率(收治入院,就诊于专科门诊或急诊)、试验最初设定的COPD治疗方案的修改率,以及试验开展前3年内发生过病情加重的患者的加重率,进行事件发生时间分析。

 

结果

糠酸氟替卡松-维兰特罗治疗组的中度或重度加重率比常规治疗组低8.4%(95%置信区间[CI],1.1~15.2),差异有统计学显著性(P=0.02)。两组COPD相关年初级诊疗率和年二级诊疗率均无显著差异。事件发生时间分析中,首次中度或重度加重率的组间差异不显著,首次重度加重率的组间差异亦不显著。未见糠酸氟替卡松-维兰特罗组的肺炎严重不良事件发生率高于常规治疗组。两组的其他严重不良事件发生数相近。

 

结论

既往有加重史的COPD患者,每日接受一次糠酸氟替卡松-维兰特罗复方制剂治疗,其加重率低于接受常规治疗者,且严重不良事件发生风险未见升高(由葛兰素史克资助;索尔福德肺疾病研究[Salford Lung Study]在ClinicalTrials.gov注册号为NCT01551758)。





作者信息

Jørgen Vestbo, D.M.Sc., David Leather, M.B., Ch.B., Nawar Diar Bakerly, M.D., John New, M.B., B.S., J. Martin Gibson, Ph.D., Sheila McCorkindale, M.B., Ch.B., Susan Collier, M.B., Ch.B., Jodie Crawford, M.Sc., Lucy Frith, M.Sc., Catherine Harvey, D.Phil., Henrik Svedsater, Ph.D., and Ashley Woodcock, M.D., for the Salford Lung Study Investigators*
From the Centre for Respiratory Medicine and Allergy, Manchester Academic Health Sciences Centre, University of Manchester and University Hospital of South Manchester NHS Foundation Trust (J.V., A.W.), Manchester Academic Health Sciences Centre, University of Manchester and Salford Royal NHS Foundation Trust (J.M.G.), and NIHR Clinical Research Network Greater Manchester (S.M.), Manchester; Global Respiratory Franchise (D.L.) and Respiratory Research and Development (S.C., J.C., L.F., H.S.), GlaxoSmithKline UK, Brentford; Salford Royal NHS Foundation Trust (N.D.B., J.N., J.M.G.), NorthWest EHealth (J.N., J.M.G.), and NHS Salford Clinical Commissioning Group (S.M.), Salford; and Global Clinical Safety and Pharmacovigilance, Safety Evaluation and Risk Management, GlaxoSmithKline UK, Uxbridge (C.H.) — all in the United Kingdom.Address reprint requests to Dr. Vestbo at the Centre for Respiratory Medicine and Allergy, 2nd Fl., Education and Research Centre, University Hospital of South Manchester, Southmoor Rd., Manchester M23 9LT, United Kingdom, or at jorgen.vestbo@manchester.ac.uk. *A complete list of the investigators in the Salford Lung Study is provided in the Supplementary Appendix, available at NEJM.org.

 

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