Rabin Harvey R, Butler Steven M, Wohl Mary Ellen B, Geller David E, Colin Andrew A, Schidlow Daniel V, Johnson Charles A, Konstan Michael W, Regelmann Warren E
Foothills Medical Center and University of Calgary, Calgary, Alberta, Canada.
Pediatr Pulmonol. 2004 May;37(5):400-6. doi: 10.1002/ppul.20023.
The clinical characteristics most relevant to the decision to treat for a pulmonary exacerbation with antibiotics in cystic fibrosis patients were determined. Variables including age, increased cough frequency and sputum production, new crackles and wheezing, asthma, symptomatic sinusitis, hemoptysis, decreased lung function, weight loss, and new acquisition of Pseudomonas aeruginosa were collected in a large prospective multicenter database (Epidemiologic Study of Cystic Fibrosis). During a 12-month baseline period, data from 11692 patients were compared with data collected during the subsequent 6-month study period. Because pulmonary function assessments were unavailable for patients <6 years of age, separate analyses were done for those <6 and >or=6 years of age. The outcome of interest was any antibiotic treatment in the 6-month study period reported as indicated for an exacerbation. Characteristics with the most discriminatory power were determined using stepwise multiple logistic regression. For patients <6 years of age, the strongest independent associations with treatment for a pulmonary exacerbation were new crackles, increased cough frequency, decline in weight, and increased sputum production. For those patients >or=6 years of age, the strongest independent associations were a relative decrease in percent predicted forced expired volume in 1 sec, increased cough frequency, new crackles, and hemoptysis. The presence of three or more of these key characteristics was strongly associated with the occurrence of a treated exacerbation. The reproducibility of the model over time was confirmed by application to a subsequent set of data. This model has potential for use as an outcome measure in clinical trials, and to assist in treatment decisions for individual patients.
确定了与囊性纤维化患者肺部加重期使用抗生素治疗决策最相关的临床特征。在一个大型前瞻性多中心数据库（囊性纤维化流行病学研究）中收集了包括年龄、咳嗽频率增加、痰液生成增多、新出现的湿啰音和哮鸣音、哮喘、症状性鼻窦炎、咯血、肺功能下降、体重减轻以及新获得铜绿假单胞菌等变量。在12个月的基线期内，将11692例患者的数据与随后6个月研究期内收集的数据进行比较。由于<6岁患者无法进行肺功能评估，因此对<6岁和≥6岁的患者分别进行分析。感兴趣的结局是在6个月研究期内报告的因病情加重而进行的任何抗生素治疗。使用逐步多元逻辑回归确定具有最大鉴别力的特征。对于<6岁的患者，与肺部加重期治疗最强的独立关联因素是新出现的湿啰音、咳嗽频率增加、体重下降和痰液生成增多。对于≥6岁的患者，最强的独立关联因素是1秒用力呼气容积预测值百分比相对下降、咳嗽频率增加、新出现的湿啰音和咯血。这些关键特征中存在三个或更多与接受治疗的病情加重的发生密切相关。通过应用于后续一组数据证实了该模型随时间的可重复性。该模型有潜力用作临床试验中的结局指标，并协助个体患者的治疗决策。
