系统性硬化症临床试验中需考虑的间质性肺疾病要点。
Interstitial lung disease points to consider for clinical trials in systemic sclerosis.
作者信息
Khanna Dinesh, Seibold James, Goldin Jonathan, Tashkin Donald P, Furst Daniel E, Wells Athol
机构信息
Department of Medicine, University of Michigan Scleroderma Program, University of Michigan, Ann Arbor, MI.
Scleroderma Consultants LLC, Litchfield, CT.
出版信息
Rheumatology (Oxford). 2017 Sep 1;56(suppl_5):v27-v32. doi: 10.1093/rheumatology/kex203.
Abstract
Interstitial lung disease causes major morbidity and mortality in patients with systemic sclerosis (SSc-ILD). Large randomized clinical trials in SSc-ILD have provided important information regarding the feasibility, reliability and validity of outcome measures. Forced vital capacity percentage predicted should be considered as a primary outcome measure, with inclusion of appropriate radiological and patient-reported measures. We provide practical recommendations for trial design in SSc-ILD.
摘要
间质性肺病在系统性硬化症（SSc-ILD）患者中导致了严重的发病和死亡。针对SSc-ILD的大型随机临床试验提供了有关结局指标的可行性、可靠性和有效性的重要信息。预计的用力肺活量百分比应被视为主要结局指标，并纳入适当的影像学和患者报告指标。我们为SSc-ILD的试验设计提供实用建议。
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