Thompson V, Mayer-Hamblett N, Kloster M, Bilton D, Flume P A
Seattle Children's Research Institute, 2001 8th Ave Ste 400, Seattle, WA 98145-5005, United States.
Seattle Children's Research Institute, 2001 8th Ave Ste 400, Seattle, WA 98145-5005, United States; Department of Biostatistics, University of Washington, Seattle, WA, United States; Department of Pediatrics, University of Washington, 4800 Sand Point Way N.E., Box 5371, Seattle, WA 98105-0371, United States.
J Cyst Fibros. 2015 Sep;14(5):632-8. doi: 10.1016/j.jcf.2015.02.003. Epub 2015 Feb 25.
Cystic fibrosis (CF) is characterized by airway infection and inflammation resulting in respiratory complications including hemoptysis. The objectives of this study were to characterize the risk of hemoptysis attributable to underlying disease and in the presence of standard of care therapy.
This retrospective cohort study estimated hemoptysis rates overall and by relevant risk factors utilizing adverse event data from longitudinal prospective CF clinical trials.
Of the 1008 participants, 73% were ≤18 years old; of 929 with available spirometry, 27% had an FEV1<70% predicted. During the average 8.2 months of follow-up, 8% experienced ≥1 hemoptysis events (95% CI: 6%, 10%). Of the 125 events, 76% were mild in severity and only 9% were serious. Hemoptysis rates were greater among adults than children, those with FEV1<70% predicted, and participants infected with P. aeruginosa but not with S. aureus.
Hemoptysis is a common adverse event among CF clinical trial participants, and particularly in adults with more severe lung disease. These results can be used to predict event occurrence in future clinical trials.
囊性纤维化（CF）的特征是气道感染和炎症，可导致包括咯血在内的呼吸道并发症。本研究的目的是确定潜在疾病以及在标准治疗存在的情况下咯血的风险。
这项回顾性队列研究利用纵向前瞻性CF临床试验的不良事件数据，总体上以及按相关风险因素估算咯血发生率。
1008名参与者中，73%年龄≤18岁；929名有肺功能测定数据者中，27%的第一秒用力呼气容积（FEV1）<预测值的70%。在平均8.2个月的随访期间，8%的人经历了≥1次咯血事件（95%置信区间：6%，10%）。在125次事件中，76%为轻度，只有9%为重度。成人、FEV1<预测值的70%者以及感染铜绿假单胞菌但未感染金黄色葡萄球菌的参与者咯血发生率更高。
咯血是CF临床试验参与者中常见的不良事件，尤其是在患有更严重肺部疾病的成人中。这些结果可用于预测未来临床试验中事件的发生。
