Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society · 2025
Correlates of FEV₁ deficit in pulmonary exacerbations of cystic fibrosis and associated clinical outcomes.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка NIH: внешняя программаПоддержка службы здравоохранения СШАПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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McElvaney Oliver J, Heltshe Sonya L, Sanders Don B, West Natalie E, Fogarty Barbra, VanDevanter Donald R, Flume Patrick A, Goss Christopher H, STOP2 Investigators
Аннотация
BACKGROUND: Forced expiratory volume in 1 second (FEV1) is commonly decreased in pulmonary exacerbations (PEx) of cystic fibrosis and often does not fully recover to the pre-PEx value after treatment. The CF subpopulations at risk for large PEx-associated FEV1 deficits, and the relationships between deficit magnitude and clinical outcomes, remain undefined.
METHODS: We performed a secondary analysis of STOP2 (NCT02781610), a multicenter randomized trial of intravenous antimicrobial treatment durations for CF PEx (n = 982). Factors associated with large FEV1 decreases from baseline were identified by multivariable logistic regression. Differences in clinical outcomes were assessed via propensity score matching.
RESULTS: The mean absolute decrease in percent-predicted FEV1 (ppFEV1) from baseline was 5.6 ± 8.0, a relative 10.0 ± 13.7% loss of the pre-PEx value. Large absolute ppFEV1 deficits (ppFEV1 decreases from baseline at the 75th percentile or higher) were associated with higher pre-PEx FEV1, Pseudomonas aeruginosa in airway cultures and serum C-reactive protein (CRP) concentration ≥30mg/L, but not CFTR modulator use. Participants with large initial FEV1 deficits demonstrated a greater absolute FEV1 improvement following intravenous antibiotics, but also had greater residual FEV1 deficits after completing treatment. Change in symptoms and weight recovery did not differ by initial FEV1 decrease. Large FEV1 deficits at PEx diagnosis were associated with an increased hazard of subsequent PEx over a 1-year follow-up period.
CONCLUSIONS: These data may help identify those at risk for incomplete spirometric resolution following PEx and future PEx hazard. The presence of systemic inflammation serves as a marker of PEx severity.
METHODS: We performed a secondary analysis of STOP2 (NCT02781610), a multicenter randomized trial of intravenous antimicrobial treatment durations for CF PEx (n = 982). Factors associated with large FEV1 decreases from baseline were identified by multivariable logistic regression. Differences in clinical outcomes were assessed via propensity score matching.
RESULTS: The mean absolute decrease in percent-predicted FEV1 (ppFEV1) from baseline was 5.6 ± 8.0, a relative 10.0 ± 13.7% loss of the pre-PEx value. Large absolute ppFEV1 deficits (ppFEV1 decreases from baseline at the 75th percentile or higher) were associated with higher pre-PEx FEV1, Pseudomonas aeruginosa in airway cultures and serum C-reactive protein (CRP) concentration ≥30mg/L, but not CFTR modulator use. Participants with large initial FEV1 deficits demonstrated a greater absolute FEV1 improvement following intravenous antibiotics, but also had greater residual FEV1 deficits after completing treatment. Change in symptoms and weight recovery did not differ by initial FEV1 decrease. Large FEV1 deficits at PEx diagnosis were associated with an increased hazard of subsequent PEx over a 1-year follow-up period.
CONCLUSIONS: These data may help identify those at risk for incomplete spirometric resolution following PEx and future PEx hazard. The presence of systemic inflammation serves as a marker of PEx severity.