糠酸氟替卡松加维兰特罗控制哮喘有效性的临床实践：一项非盲法、平行组、随机对照试验
2018/01/08
摘要
背景：哮喘管理的证据来自在高度选择患者组进行的严密监测有效性的试验。随机试验的一个要求是要更加贴近日常的临床实践。
方法：此项非盲法、随机、对照、双臂有效性试验是在英国索尔福德和南曼彻斯特的74家全科诊所中进行的。入组患者为18岁及以上的经全科医生诊断为有症状哮喘并坚持吸入治疗的患者。患者被随机分组，吸入复合制剂（100μg或200μg糠酸氟替卡松和25μg维兰特罗，每日一吸）或接受最佳常规治疗，随访时间为12个月。试验主要终点为在24周时哮喘控制测试（ACT）基线分数低于20分的患者（主要有效性分析人群）中，ACT分数达到20分及以上或较基线增加3分及以上的患者（称为应答者）的比例。所有有效性分析均遵循自愿接受治疗的原则。本研究在ClinicalTrials.gov注册登记，注册号码NCT01706198。
结果：2012年11月12日至1016年12月16日期间，共4725名患者登记，4233人随机分配接受糠酸氟替卡松和维兰特罗吸入治疗或常规治疗。1207名患者（605名常规治疗组，602名糠酸氟替卡松、维兰特罗治疗组）因ACT分数不低于20分被排除出主要有效性分析人群。24周时，糠酸氟替卡松、维兰特罗治疗组较常规治疗组中患者应答者比例更高（糠酸氟替卡松、维兰特罗治疗组(977/1373 [71%])：常规治疗组(784/1399 [56%])；比值比[OR] 2·00 [95% CI 1·70-2·34], p<0·0001）。24周时，糠酸氟替卡松、维兰特罗治疗组调整后的ACT平均值较基线提高4.4分，常规治疗组提高2.8分（相差1.6 [95% CI 1·3-2·0]，p<0·0001）。这一结果与全程结果一致。肺炎少见，组间无差异；其他严重不良事件无组间差异。
阐释：经全科医生诊断为有症状哮喘并坚持吸入治疗的患者中，接受每天一吸糠酸氟替卡松、维兰特罗混合制剂治疗的患者与最优常规治疗的患者相比，哮喘控制有提高，并且严重不良反应事件发生率无增加。
资助：葛兰素史克。
Effectiveness of fluticasone furoate plus vilanterol on asthma control in clinical practice: an open-label, parallel group, randomised controlled trial.
Woodcock A, Vestbo J, Bakerly ND, New J, Gibson JM, McCorkindale S, Jones R, Collier S, Lay-Flurrie J, Frith L, Jacques L, Fletcher JL, Harvey C, Svedsater H, Leather D; Salford Lung Study Investigators.
Abstract
BACKGROUND:A Evidence for management of asthma comes from closely monitored efficacy trials done in highly selected patient groups. There is a need for randomised trials that are closer to usual clinical practice.
METHODS:We did an open-label, randomised, controlled, two-arm effectiveness trial at 74 general practice clinics in Salford and South Manchester, UK. Patients aged 18 years or older with a general practitioner's diagnosis of symptomatic asthma and on maintenance inhaler therapy were randomly assigned to initiate treatment with a once-daily inhaled combination of either 100 μg or 200 μg fluticasone furoate with 25 μg vilanterol or optimised usual care and followed up for 12 months. The primary endpoint was the percentage of patients who achieved an asthma control test (ACT) score of 20 or greater or an increase in ACT score from baseline of 3 or greater at 24 weeks (termed responders), in patients with a baseline ACT score less than 20 (the primary effectiveness analysis population). All effectiveness analyses were done according to the intention-to-treat principle. This study is registered with ClinicalTrials.gov, number NCT01706198.
FINDINGS:Between Nov 12, 2012, and Dec 16, 2016, 4725 patients were enrolled and 4233 randomly assigned to initiate treatment with fluticasone furoate and vilanterol (n=2114) or usual care (n=2119). 1207 patients (605 assigned to usual care, 602 to fluticasone furoate and vilanterol) had a baseline ACT score greater than or equal to 20 and were thus excluded from the primary effectiveness analysis population. At week 24, the odds of being a responder were higher for patients who initiated treatment with fluticasone furoate and vilanterol than for those on usual care (977 [71%] of 1373 in the fluticasone furoate and vilanterol group vs 784 [56%] of 1399 in the usual care group; odds ratio [OR] 2·00 [95% CI 1·70-2·34], p<0·0001). At week 24, the adjusted mean ACT score increased by 4·4 points from baseline in patients initiated with fluticasone furoate and vilanterol, compared with 2·8 points in the usual care group (difference 1·6 [95% CI 1·3-2·0], p<0·0001). This result was consistent for the duration of the study. Pneumonia was uncommon, with no differences between groups; there was no difference in other serious adverse events between the groups.
INTERPRETATION:In patients with a general practitioner's diagnosis of symptomatic asthma and on maintenance inhaler therapy, initiation of a once-daily treatment regimen of combined fluticasone furoate and vilanterol improved asthma control without increasing the risk of serious adverse events when compared with optimised usual care.
FUNDING:GlaxoSmithKline.
背景：哮喘管理的证据来自在高度选择患者组进行的严密监测有效性的试验。随机试验的一个要求是要更加贴近日常的临床实践。
方法：此项非盲法、随机、对照、双臂有效性试验是在英国索尔福德和南曼彻斯特的74家全科诊所中进行的。入组患者为18岁及以上的经全科医生诊断为有症状哮喘并坚持吸入治疗的患者。患者被随机分组，吸入复合制剂（100μg或200μg糠酸氟替卡松和25μg维兰特罗，每日一吸）或接受最佳常规治疗，随访时间为12个月。试验主要终点为在24周时哮喘控制测试（ACT）基线分数低于20分的患者（主要有效性分析人群）中，ACT分数达到20分及以上或较基线增加3分及以上的患者（称为应答者）的比例。所有有效性分析均遵循自愿接受治疗的原则。本研究在ClinicalTrials.gov注册登记，注册号码NCT01706198。
结果：2012年11月12日至1016年12月16日期间，共4725名患者登记，4233人随机分配接受糠酸氟替卡松和维兰特罗吸入治疗或常规治疗。1207名患者（605名常规治疗组，602名糠酸氟替卡松、维兰特罗治疗组）因ACT分数不低于20分被排除出主要有效性分析人群。24周时，糠酸氟替卡松、维兰特罗治疗组较常规治疗组中患者应答者比例更高（糠酸氟替卡松、维兰特罗治疗组(977/1373 [71%])：常规治疗组(784/1399 [56%])；比值比[OR] 2·00 [95% CI 1·70-2·34], p<0·0001）。24周时，糠酸氟替卡松、维兰特罗治疗组调整后的ACT平均值较基线提高4.4分，常规治疗组提高2.8分（相差1.6 [95% CI 1·3-2·0]，p<0·0001）。这一结果与全程结果一致。肺炎少见，组间无差异；其他严重不良事件无组间差异。
阐释：经全科医生诊断为有症状哮喘并坚持吸入治疗的患者中，接受每天一吸糠酸氟替卡松、维兰特罗混合制剂治疗的患者与最优常规治疗的患者相比，哮喘控制有提高，并且严重不良反应事件发生率无增加。
资助：葛兰素史克。
(中日友好医院呼吸与危重症医学科 顾宪民 摘译 林江涛 审校)
(Lancet. 2017 Nov 18;390(10109):2247-2255.)
(Lancet. 2017 Nov 18;390(10109):2247-2255.)
Effectiveness of fluticasone furoate plus vilanterol on asthma control in clinical practice: an open-label, parallel group, randomised controlled trial.
Woodcock A, Vestbo J, Bakerly ND, New J, Gibson JM, McCorkindale S, Jones R, Collier S, Lay-Flurrie J, Frith L, Jacques L, Fletcher JL, Harvey C, Svedsater H, Leather D; Salford Lung Study Investigators.
Abstract
BACKGROUND:A Evidence for management of asthma comes from closely monitored efficacy trials done in highly selected patient groups. There is a need for randomised trials that are closer to usual clinical practice.
METHODS:We did an open-label, randomised, controlled, two-arm effectiveness trial at 74 general practice clinics in Salford and South Manchester, UK. Patients aged 18 years or older with a general practitioner's diagnosis of symptomatic asthma and on maintenance inhaler therapy were randomly assigned to initiate treatment with a once-daily inhaled combination of either 100 μg or 200 μg fluticasone furoate with 25 μg vilanterol or optimised usual care and followed up for 12 months. The primary endpoint was the percentage of patients who achieved an asthma control test (ACT) score of 20 or greater or an increase in ACT score from baseline of 3 or greater at 24 weeks (termed responders), in patients with a baseline ACT score less than 20 (the primary effectiveness analysis population). All effectiveness analyses were done according to the intention-to-treat principle. This study is registered with ClinicalTrials.gov, number NCT01706198.
FINDINGS:Between Nov 12, 2012, and Dec 16, 2016, 4725 patients were enrolled and 4233 randomly assigned to initiate treatment with fluticasone furoate and vilanterol (n=2114) or usual care (n=2119). 1207 patients (605 assigned to usual care, 602 to fluticasone furoate and vilanterol) had a baseline ACT score greater than or equal to 20 and were thus excluded from the primary effectiveness analysis population. At week 24, the odds of being a responder were higher for patients who initiated treatment with fluticasone furoate and vilanterol than for those on usual care (977 [71%] of 1373 in the fluticasone furoate and vilanterol group vs 784 [56%] of 1399 in the usual care group; odds ratio [OR] 2·00 [95% CI 1·70-2·34], p<0·0001). At week 24, the adjusted mean ACT score increased by 4·4 points from baseline in patients initiated with fluticasone furoate and vilanterol, compared with 2·8 points in the usual care group (difference 1·6 [95% CI 1·3-2·0], p<0·0001). This result was consistent for the duration of the study. Pneumonia was uncommon, with no differences between groups; there was no difference in other serious adverse events between the groups.
INTERPRETATION:In patients with a general practitioner's diagnosis of symptomatic asthma and on maintenance inhaler therapy, initiation of a once-daily treatment regimen of combined fluticasone furoate and vilanterol improved asthma control without increasing the risk of serious adverse events when compared with optimised usual care.
FUNDING:GlaxoSmithKline.
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