实验室评分对不明原因发热儿童抗生素处方率的影响：一项随机对照试验。
Impact of the lab-score on antibiotic prescription rate in children with fever without source: a randomized controlled trial.
作者信息
Lacroix Laurence, Manzano Sergio, Vandertuin Lynda, Hugon Florence, Galetto-Lacour Annick, Gervaix Alain
机构信息
Pediatric Emergency Medicine Department, Child and Adolescent Medicine, Geneva University Hospital, Geneva, Switzerland.
出版信息
PLoS One. 2014 Dec 11;9(12):e115061. doi: 10.1371/journal.pone.0115061. eCollection 2014.
BACKGROUND
The Lab-score, based on the combined determination of procalcitonin, C-reactive protein and urinary dipstick results, has been shown accurate in detecting serious bacterial infections (SBI) in children with fever without source (FWS) on retrospective cohorts. We aimed to prospectively assess the utility of the Lab-score in safely decreasing antibiotic prescriptions in children with FWS and to determine its diagnostic characteristics compared to common SBI biomarkers.
METHODS
Randomized controlled trial in children 7 days to 36 months old with FWS, allocated either to the Lab-score group (Lab-score reported, blinded WBC count) or to the control group (WBC, bands and C-reactive protein determined, blinded procalcitonin and Lab-score), followed up until recovery. Demographic data, antibiotic prescription rate, admission rate and diagnostic properties of the Lab-score were analyzed.
RESULTS
271 children were analyzed. No statistically significant difference concerning antibiotic prescription rate was observed: 41.2% (54 of 131) in the Lab-score group and 42.1% (59 of 140) in the control group (p = 1.000). If recommendations based on the Lab-score had been strictly applied, a hypothetical 30.6% treatment rate would have been encountered, compared to the overall 41.7% observed rate (p = 0.0095). A Lab-score ≥3 showed the following characteristics: sensitivity 85.1% (95% CI: 76.5-93.6%), specificity 87.3% (95% CI: 82.7-91.8%), positive predictive value 68.7% (95% CI: 58.7-78.7%), negative predictive value 94.1% (95% CI: 91.5-97.9%), positive and negative likelihood ratios: 6.68 and 0.17 respectively. Area under the receiver operating characteristic curve was best for the Lab-score (0.911, 95% CI: 0.871-0.950).
DISCUSSION
No difference regarding antibiotic treatment rate was observed when using the Lab-score, due to lack of adherence to the related recommendations. However, if strictly followed, a significant 26.5% reduction of antibiotic prescriptions would have been encountered. Medical education needs to be reinforced in order to observe rather than treat low-risk well-appearing children with FWS.
TRIAL REGISTRATION
ClinicalTrials.gov NCT02179398.
背景
基于降钙素原、C反应蛋白联合检测及尿试纸结果的实验室评分，在回顾性队列研究中已被证明可准确检测不明原因发热（FWS）儿童的严重细菌感染（SBI）。我们旨在前瞻性评估实验室评分在安全减少FWS儿童抗生素处方方面的效用，并确定其与常见SBI生物标志物相比的诊断特征。
方法
对7天至36个月大的FWS儿童进行随机对照试验，分为实验室评分组（报告实验室评分，白细胞计数设盲）或对照组（测定白细胞、杆状核细胞和C反应蛋白，降钙素原和实验室评分设盲），随访至康复。分析人口统计学数据、抗生素处方率、住院率及实验室评分的诊断特性。
结果
分析了271名儿童。在抗生素处方率方面未观察到统计学显著差异：实验室评分组为41.2%（131例中的54例），对照组为42.1%（140例中的59例）（p = 1.000）。如果严格应用基于实验室评分的建议，预计治疗率为30.6%，而实际观察到的总体治疗率为41.7%（p = 0.0095）。实验室评分≥3显示出以下特征：敏感性85.1%（95%CI：76.5 - 93.6%），特异性87.3%（95%CI：82.7 - 91.8%），阳性预测值68.7%（95%CI：58.7 - 78.7%），阴性预测值94.1%（95%CI：91.5 - 97.9%），阳性和阴性似然比分别为6.68和0.17。受试者工作特征曲线下面积以实验室评分为最佳（0.911，95%CI：0.871 - 0.950）。
讨论
使用实验室评分时，由于未遵守相关建议，在抗生素治疗率方面未观察到差异。然而，如果严格遵循，抗生素处方可显著减少26.5%。需要加强医学教育，以便对FWS中外观良好的低风险儿童进行观察而非治疗。
试验注册
ClinicalTrials.gov NCT02179398。
Zotero 插件