标准化治疗肺部加重（STOP）研究：患有肺部加重的囊性纤维化患者的医生治疗实践和结果。
Standardized Treatment of Pulmonary Exacerbations (STOP) study: Physician treatment practices and outcomes for individuals with cystic fibrosis with pulmonary Exacerbations.
机构信息
Department of Medicine, Johns Hopkins University, Baltimore, MD, United States.
Cystic Fibrosis Foundation Therapeutics Development Network Coordinating Center, Seattle Children's Research Institute, Seattle, WA, United States.
出版信息
J Cyst Fibros. 2017 Sep;16(5):600-606. doi: 10.1016/j.jcf.2017.04.003. Epub 2017 Apr 29.
BACKGROUND
Pulmonary Exacerbations (PEx) are associated with increased morbidity and mortality in individuals with CF. PEx management practices vary widely, and optimization through interventional trials could potentially improve outcomes. The object of this analysis was to evaluate current physician treatment practices and patient outcomes for PEx.
METHODS
The Standardized Treatment of Pulmonary Exacerbations (STOP) observational study enrolled 220 participants ≥12years old admitted to the hospital for PEx at 11 U.S. CF centers. Spirometry and daily symptom scores were collected during the study. Physicians were surveyed on treatment goals and their management practices were observed. Treatment outcomes were compared to stated goals.
RESULTS
The mean (SD) duration of IV antibiotic treatment was 15.9 (6.0) days. Those individuals with more severe lung disease (<50% FEV) were treated nearly two days longer than those with >50% FEV. Physician-reported FEV improvement goals were 10% (95% CI: 5%, 14%) lower for patients with 6-month baseline FEV ≤50% predicted compared with those with 6-month baseline FEV >50% predicted. There were clinically and statistically significant improvements in symptoms from the start of IV antibiotic treatment to the end of IV antibiotic treatment and 28days after the start of treatment. The mean absolute increase in FEV from admission was 9% predicted at end of IV antibiotic treatment, and 7% predicted at day 28. Only 39% fully recovered lost lung function, and only 65% recovered at least 90% of lost lung function. Treatment was deemed successful by 84% of clinicians, although 6-month baseline FEV was only recovered in 39% of PEx.
CONCLUSIONS
In this prospective observational study of PEx, treatment regimens and durations showed substantial variation. A significant proportion of patients did not reach physician's treatment goals, yet treatment was deemed successful.
背景
在 CF 患者中，肺部恶化（PEx）与发病率和死亡率增加有关。PEx 的管理实践差异很大，通过干预试验进行优化有可能改善结果。本分析的目的是评估当前医生治疗 PEx 的实践和患者结局。
方法
标准化肺部恶化治疗（STOP）观察性研究纳入了 11 个美国 CF 中心的 220 名年龄≥12 岁因 PEx 住院的患者。在研究期间收集了肺活量测定和每日症状评分。对医生进行了治疗目标调查，并观察了他们的管理实践。将治疗结果与既定目标进行了比较。
结果
静脉抗生素治疗的平均（SD）持续时间为 15.9（6.0）天。那些肺部疾病更严重（<50% FEV）的患者的治疗时间比 FEV>50%的患者长近两天。与 6 个月基线 FEV>50%预测值的患者相比，6 个月基线 FEV 预测值≤50%的患者，医生报告的 FEV 改善目标低 10%（95%CI：5%，14%）。从静脉抗生素治疗开始到结束以及治疗开始后 28 天，症状均有临床和统计学上的显著改善。静脉抗生素治疗结束时，FEV 绝对值较入院时增加 9%预测值，治疗 28 天后增加 7%预测值。仅 39%的患者完全恢复了丧失的肺功能，仅 65%的患者恢复了至少 90%的丧失的肺功能。84%的临床医生认为治疗成功，尽管只有 39%的患者在 6 个月时恢复了基线 FEV。
结论
在这项前瞻性观察性 PEx 研究中，治疗方案和持续时间存在很大差异。很大一部分患者未达到医生的治疗目标，但治疗被认为是成功的。
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