SENSCIS 试验中系统性硬化症相关间质性肺病患者的呼吸困难和咳嗽。
Dyspnoea and cough in patients with systemic sclerosis-associated interstitial lung disease in the SENSCIS trial.
机构信息
Department of Medicine, Division of Rheumatology, University of California, David Geffen School of Medicine, Los Angeles, CA, USA.
Center for Interstitial and Rare Lung Diseases, Pneumology and Respiratory Care Medicine, Thoraxklinik, University of Heidelberg, Member of the German Center for Lung Research, Heidelberg, Germany.
出版信息
Rheumatology (Oxford). 2022 Nov 2;61(11):4397-4408. doi: 10.1093/rheumatology/keac091.
OBJECTIVE
The aim of these analyses was to investigate the rate of decline in forced vital capacity (FVC) in patients with SSc-associated interstitial lung disease (SSc-ILD) with and without cough or dyspnoea in the SENSCIS trial.
METHODS
Patients in the SENSCIS trial were randomized to receive nintedanib or placebo. Subgroups with and without cough or dyspnoea at baseline were defined by responses to the St George's Respiratory Questionnaire.
RESULTS
At baseline, 114/575 patients (19.8%) did not have cough and 172/574 patients (30.0%) did not have dyspnoea. In the placebo group, the rate of FVC decline over 52 weeks was similar in patients with and without cough (-95.6 and -83.4 mL/year, respectively) or dyspnoea (-95.8 and -87.7 mL/year, respectively). The effect of nintedanib vs placebo on reducing the rate of FVC decline was numerically more pronounced in patients without than with cough [difference: 74.4 (95% CI -11.1, 159.8) vs 31.5 (-11.1, 74.1)] and without than with dyspnoea [79.8 (9.8, 149.7) vs 25.7 (-19.9, 71.3)], but interaction P-values did not indicate heterogeneity in the treatment effect between these subgroups (P = 0.38 and P = 0.20, respectively).
CONCLUSION
In the placebo group of the SENSCIS trial, the rate of FVC decline was similar irrespective of the presence of cough or dyspnoea at baseline. The effect of nintedanib on reducing the rate of FVC decline was numerically more pronounced in patients without than with cough or dyspnoea at baseline, but no statistically significant heterogeneity was observed between the subgroups.
TRIAL REGISTRATION
ClinicalTrials.gov, https://clinicaltrials.gov, NCT02597933.
目的
本分析旨在研究 SENSCIS 试验中，有无咳嗽或呼吸困难的 SSc-ILD 患者的用力肺活量（FVC）下降率。
方法
SENSCIS 试验中的患者被随机分配接受尼达尼布或安慰剂。通过圣乔治呼吸问卷的反应，定义基线时有无咳嗽或呼吸困难的亚组。
结果
基线时，575 例患者中有 114 例（19.8%）无咳嗽，574 例患者中有 172 例（30.0%）无呼吸困难。在安慰剂组中，52 周时 FVC 下降率在有咳嗽和无咳嗽的患者中相似（分别为-95.6 和-83.4 mL/年），或在有呼吸困难和无呼吸困难的患者中相似（分别为-95.8 和-87.7 mL/年）。尼达尼布与安慰剂相比，在无咳嗽患者中降低 FVC 下降率的效果更为显著[差异：74.4（95%CI-11.1，159.8）与 31.5（-11.1，74.1）]，在无呼吸困难患者中也更为显著[79.8（9.8，149.7）与 25.7（-19.9，71.3）]，但交互 P 值未提示这些亚组之间治疗效果存在异质性（P=0.38 和 P=0.20）。
结论
在 SENSCIS 试验的安慰剂组中，FVC 下降率在基线时无论有无咳嗽或呼吸困难均相似。尼达尼布对降低 FVC 下降率的作用在无咳嗽或呼吸困难的患者中更为显著，但在亚组之间未观察到统计学上显著的异质性。
试验注册
ClinicalTrials.gov，https://clinicaltrials.gov，NCT02597933。
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