NEJM:钟南山院士发现噻托溴铵能明显改善慢阻肺患者肺功能(Tie-COPD研究)

2017-09-08 MedSci MedSci原创

“这是一项地地道道的中国创造、中国制造的涉及近亿慢阻肺患者福音的研究。此研究所积累的慢阻肺管理经验,不仅是钟南山院士及其研究团队的财富,更是中国慢阻肺疾病防治的财富!” 研究背景 流行病学研究发现,在整体慢阻肺人群中,轻度和中度 (GOLD 1级和2级) 患者的比例超过了70%。由于这两类患者没有明显的呼吸道症状和活动受限、或症状轻微,患者通常不会主动就医。

“这是一项地地道道的中国创造、中国制造的涉及近亿慢阻肺患者福音的研究。此研究所积累的慢阻肺管理经验,不仅是钟南山院士及其研究团队的财富,更是中国慢阻肺疾病防治的财富!

研究背景

流行病学研究发现,在整体慢阻肺人群中,轻度和中度 (GOLD 1级和2级) 患者的比例超过了70%。由于这两类患者没有明显的呼吸道症状和活动受限、或症状轻微,患者通常不会主动就医。

然而研究表明这些患者的肺功能正处于快速下降期:轻度患者FEV1下降速率显著高于高危人群 ,而中度患者的FEV1下降速率要快于重至极重度患者。

如果等到出现明显症状后才开始治疗,肺功能往往已经下降50%左右,错过了最佳的治疗时间。因此,将治疗关口前移、重视对轻中度患者的药物干预是提升慢阻肺管理水平的突破口

遗憾的是,目前鲜有研究评价针对轻度和早期中度患者 (FEV1%预计值≥60%) 的药物干预效果,此前也没有药物能够有效延缓肺功能的下降速率。UPLIFT研究的一项亚组分析显示,噻托溴铵有改善此两类患者FEV1和FVC的趋势。为了在前瞻性研究中进一步评价噻托溴铵对轻至中度慢阻肺患者FEV1的作用,钟南山院士牵头开展了Tie-COPD研究,论文发表于2017年9月7日的《New England Journal of Medicine》(IF=72.4)。

研究设计

Tie-COPD研究是一项多中心、随机双盲、安慰剂对照的IV期研究,于2011年10月至2015年9月在我国进行。受试者按1:1随机接受噻托溴铵吸乐® 18μg治疗或安慰剂,1个月后进行第1次随访,之后每3个月随访1次,共随访2年。研究流程详见图1。

图1: 研究流程图

受试者招募

本研究通过社区筛选招募受试者,关键纳入标准包括年龄40-85岁、患有轻至中度慢阻肺:使用支扩剂后FEV1/FVC<0.7,有呼吸道症状和/或风险因素暴露史,使用400μg沙丁胺醇20分钟后FEV1%预计值≥50%。

关键排除标准包括筛选前4周发生过慢阻肺急性加重,大气道疾病 (如癌症),哮喘和严重的全身性疾病。

研究终点

主要终点是24个月后,使用支扩剂前两组FEV1自基线变化值之差。

次要终点包括:24个月后,使用支扩剂后两组FEV1自基线变化值之差、使用支扩剂前/后FVC自基线的变化值、FEV1年下降速率、使用支扩剂前/后的FEV1%预计值、研究第30天到第24个月的FEV1/FVC,第24个月CAT评分、CCQ评分、mMRC评分自基线的变化值,急性加重的持续时间和严重程度,距首次急性加重的时间,急救药物的使用。

主要结果

Tie-COPD研究共招募了841例受试者,其中367例轻度患者、474例中度患者。共计585例受试者完成了2年的随访。在包含771例受试者的全分析集中,噻托溴铵组有388例,安慰剂组有383例,两组间基线数据相仿。

肺功能

作为研究的主要终点,在治疗24个月后,噻托溴铵相比安慰剂显著提高轻中度患者使用支扩剂前的FEV1达157ml (P<0.001)。在每次随访中,噻托溴铵较安慰剂均显著改善吸入支扩剂前/后的FEV1 (图2, P<0.001) 和FVC (图3, P<0.05)。

图2: 噻托溴铵较安慰剂显著改善吸入支扩剂前/后的FEV1

图3: 噻托溴铵较安慰剂显著改善吸入支扩剂前/后的FVC


如图4所示,从研究第30天到第24个月,噻托溴铵较安慰剂有延缓轻中度患者吸入支扩剂前FEV1年下降速率的趋势 (38 vs 53 ml/年, P=0.06),同时较安慰剂显著降低吸入支扩剂后FEV1的年下降速率 (29 vs 51 ml/年, P=0.006)。在FEV1%预计值方面也观察到了一致的变化。

图4: 噻托溴铵较安慰剂延缓肺功能年下降速率、改善FEV1%预计值

急性加重

在随访过程中,噻托溴铵组有112例 (28.9%) 受试者发生了急性加重,少于安慰剂组的150例 (39.2%)。与安慰剂相比,噻托溴铵显著延长轻中度患者距首次急性加重的发生时间,降低急性加重发生风险 (图5, HR=0.60, P<0.001)。

图5: 噻托溴铵较安慰剂显著降低急性加重风险

如图6所示,噻托溴铵相比安慰剂显著降低轻中度患者的急性加重年发生率 (0.27 vs 0.50 次/患者年, RR=0.53, P<0.001) 和住院率 (0.03 vs 0.07 次/患者年, P=0.009)。

图6: 噻托溴铵较安慰剂显著降低急性加重年发生率和住院率

生活质量

除了研究的第1、3和12个月,噻托溴铵改善mMRC、CAT评分效果均始终优于安慰剂;除了研究的第12月,噻托溴铵始终较安慰剂改善CCQ评分。

不良事件

除了口干和咽部不适,两组受试者在所有和严重不良事件的发生率、以及死亡率方面均相仿。

亚组分析

本研究中有614例 (73.0%) 受试者基线CAT评分<10分。在此类患者的亚组分析中,噻托溴铵较安慰剂显著降低吸入支扩剂后的FEV1年下降速率 (28 vs 47 ml/年, P=0.03),显著延长距首次急性加重的发生时间 (P=0.0077),显著降低所有 (P=0.0013) 以及中到重度 (P=0.0017) 急性加重的发生风险;同时,噻托溴铵在第15、21和24个月时,较安慰剂有临床意义的改善mMRC评分。

根据GOLD气流受限分级 (1/2级) 和分组 (A/B组) 的亚组分析也得到了一致的结果。

研究结论

对于轻到中度的慢阻肺患者 (GOLD 1/2级),噻托溴铵治疗2年较安慰剂能够显著提高FEV1,降低使用支扩剂后的FEV1年下降速率。


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    2018-04-13 871538379

    为钟南山鼓掌!

    0

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    2017-09-09 fcbgyb

    不知道数据有加工过没有?

    0

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    2017-09-09 1ddf0692m34(暂无匿称)

    学习了.涨知识

    0

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    2017-09-09 戒馋,懒,贪

    超厉害的说

    0

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    2017-09-08 luckymini

    享受政府的高待于.做点事也是应该的.有什么可吹的.

    0

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    2017-09-08 luckymini

    xiangshou

    0

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    2017-09-08 lovetcm

    终于又发表了新英格兰杂志了!终南山院士威武

    0

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