Procalcitonin-Guided Use of Antibiotics for Lower Respiratory Tract Infection.
Procalcitonin-Guided Use of Antibiotics for Lower Respiratory Tract Infection.
复制标题
DOI：
10.1056/nejmoa1802670
复制
发表时间：
2018-07-19
期刊：
影响因子：
--
通讯作者：
ProACT Investigators
中科院分区：
文献类型：
--
作者：
Huang DT;Yealy DM;Filbin MR;Brown AM;Chang CH;Doi Y;Donnino MW;Fine J;Fine MJ;Fischer MA;Holst JM;Hou PC;Kellum JA;Khan F;Kurz MC;Lotfipour S;LoVecchio F;Peck-Palmer OM;Pike F;Prunty H;Sherwin RL;Southerland L;Terndrup T;Weissfeld LA;Yabes J;Angus DC;ProACT Investigators
降钙素原指导下使用抗生素治疗疑似下呼吸道感染的效果尚不清楚。在14家高度遵守肺炎治疗质量措施的美国医院中，我们为临床医生提供了关于下呼吸道感染治疗的国家临床实践建议和降钙素原测定的解释的指导。然后，我们将因疑似下呼吸道感染而到急诊科就诊的患者随机分配到两组中的一组，治疗医生不确定是否需要抗生素治疗：降钙素原组，为治疗临床医生提供实时初始（和系列，如果患者住院）降钙素原测定结果和抗生素使用指南，以及基于四层降钙素原水平的分级建议，或普通护理组。我们假设，在入组后30天内，原降钙素组的总抗生素使用天数将低于常规护理组，并且出现不良结果的患者百分比不会高出超过4.5个百分点。最终分析队列共纳入1656例患者（826例随机分配至降钙素原组，830例分配至常规治疗组），其中782例（47.2%）住院，984例（59.4%）在30天内接受抗生素治疗。治疗临床医生收到了降钙素原组826例患者中792例（95.9%）的降钙素原测定结果（从样本采集到测定结果的中位时间为77分钟）和常规护理组830例患者中18例（2.2%）的降钙素原测定结果。在这两组中，降钙素原水平与急诊科处方抗生素的决定有关。降钙素原组与常规治疗组比较，住院天数无显著性差异（平均值，分别为4.2和4.3天;差异，-0.05天; 95%置信区间[CI]，-0.6至0.5; P = 0.87）或发生不良结局的患者比例30天内（11.7% [96例患者]和13.1% [109例患者];差异，-1.5个百分点; 95% CI，-4.6至1.7;非劣效性P<0.001）。在疑似下呼吸道感染的患者中，向急诊科和医院临床医生提供降钙素原测定结果及其解释说明沿着，并没有导致抗生素的使用少于常规护理。（由国家普通医学科学研究所资助; ProACT ClinicalTrials.gov编号，NCT 02130986。
The effect of procalcitonin-guided use of antibiotics on treatment for suspected lower respiratory tract infection is unclear. In 14 U.S. hospitals with high adherence to quality measures for the treatment of pneumonia, we provided guidance for clinicians about national clinical practice recommendations for the treatment of lower respiratory tract infections and the interpretation of procalcitonin assays. We then randomly assigned patients who presented to the emergency department with a suspected lower respiratory tract infection and for whom the treating physician was uncertain whether antibiotic therapy was indicated to one of two groups: the procalcitonin group, in which the treating clinicians were provided with real-time initial (and serial, if the patient was hospitalized) procalcitonin assay results and an antibiotic use guideline with graded recommendations based on four tiers of procalcitonin levels, or the usual-care group. We hypothesized that within 30 days after enrollment the total antibiotic-days would be lower — and the percentage of patients with adverse outcomes would not be more than 4.5 percentage points higher — in the procalcitonin group than in the usual-care group. A total of 1656 patients were included in the final analysis cohort (826 randomly assigned to the procalcitonin group and 830 to the usual-care group), of whom 782 (47.2%) were hospitalized and 984 (59.4%) received antibiotics within 30 days. The treating clinician received procalcitonin assay results for 792 of 826 patients (95.9%) in the procalcitonin group (median time from sample collection to assay result, 77 minutes) and for 18 of 830 patients (2.2%) in the usual-care group. In both groups, the procalcitonin-level tier was associated with the decision to prescribe antibiotics in the emergency department. There was no significant difference between the procalcitonin group and the usual-care group in antibiotic-days (mean, 4.2 and 4.3 days, respectively; difference, −0.05 day; 95% confidence interval [CI], −0.6 to 0.5; P = 0.87) or the proportion of patients with adverse outcomes (11.7% [96 patients] and 13.1% [109 patients]; difference, −1.5 percentage points; 95% CI, −4.6 to 1.7; P<0.001 for noninferiority) within 30 days. The provision of procalcitonin assay results, along with instructions on their interpretation, to emergency department and hospital-based clinicians did not result in less use of antibiotics than did usual care among patients with suspected lower respiratory tract infection. (Funded by the National Institute of General Medical Sciences; ProACT ClinicalTrials.gov number, NCT02130986.)