NEJM:支气管扩张剂并不能改善有症状和肺功能正常的烟草暴露者的呼吸道症状

2022-09-16 小文子 MedSci原创

研究检验了使用双重支气管扩张剂对有呼吸道症状、肺功能正常的烟草暴露者的疗效和安全性。

许多有吸烟史的人有明显的呼吸道症状,尽管通过肺活量测定没有气流阻塞。慢性阻塞性肺疾病(COPD)通常接受药物治疗,但缺乏该治疗的支持性证据。The New England Journal of Medicine杂志近日发表了一项研究,检验使用双重支气管扩张剂对有呼吸道症状、肺功能正常的烟草暴露者的疗效和安全性。

研究纳入40~80岁的患者,目前或既往吸烟至少10包-年,有呼吸道症状(定义为 CAT 评分≥10),FEV1/FVC至少为0.70,且使用支气管扩张剂后 FVC 至少为预测值的70%。将患者以1:1的比例随机分组,接受茚达特罗(27.5μg)加格隆溴铵(15.6 μg)或安慰剂治疗,每日2次,共12周。

主要结局是12周后 SGRQ 评分下降(即改善)4分以上,无治疗失败。将治疗失败定义为导致使用长效支气管扩张剂、糖皮质激素或抗生素治疗的下呼吸道症状增加。次要结局包括 CAT 评分至少下降2分,TDI评分至少下降1分,SGRQ评分至少下降4分且 TDI 评分至少下降1分,均无治疗失败。

共535例受试者接受了随机分组,261名被分配接受药物治疗,274名接受安慰剂,471例纳入改良的意向治疗分析。

对改良意向治疗人群的主要分析中,未观察到治疗效果;治疗组227例参与者中的128例(56.4%)和安慰剂组244例参与者中的144例(59.0%)SGRQ 评分至少降低4分(改善),且无治疗失败(差异,−2.6 个百分点;95%CI,−11.6 ~ 6.3;校正OR=0.91,95%CI,0.60 ~ 1.37;P=0.65)。

在敏感性分析中均未发现明显的治疗效果。治疗组170例参与者中有101例 (59.4%),安慰剂组176例参与者中有110例(62.5%)SGRQ评分至少下降4分,无治疗失败(OR=0.88;95%CI,0.65~1.20)。治疗失败不常见,仅发生在治疗组5例受试者(2.2%)和安慰剂组9例受试者(3.7%)中。

治疗组 FEV1 占预计值百分比的平均变化为2.48个百分点(95%CI,1.49~3.47),安慰剂组为-0.09个百分点(95%CI,-1.06~0.89),深吸气量的平均变化为0.12L(95%CI,0.07~0.18),安慰剂组为0.02L(95%CI,-0.03~0.08)。治疗组发生4起严重不良事件,安慰剂组发生11起;均认为与治疗或安慰剂不存在相关性。

通过肺活量测定,吸入双重支气管扩张剂治疗并未减轻有症状、肺功能正常的烟草暴露者的呼吸道症状。

原文出处:

M.K. Han, W. Ye, D. Wang, et al, Bronchodilators in Tobacco-Exposed Persons with Symptoms and Preserved Lung Function, The New England Journal of Medicine, 2022, DOI: 10.1056/NEJMoa2204752.

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    2022-11-15 lsj637
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    2022-09-16 mnda
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    2022-09-16 ms6000000656440728

    很好的研究

    0

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