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[NEJM在线发表]:降钙素原指导抗生素治疗下呼吸道感染不能缩短抗生素疗程
2018年06月24日 时讯速递, 进展交流 暂无评论

ORIGINAL ARTICLE

Procalcitonin-Guided Use of Antibiotics for Lower Respiratory Tract Infection

David T. Huang, Donald M. Yealy, Michael R. Filbin, et al

Abstract

BACKGROUND 背景

The effect of procalcitonin-guided use of antibiotics on treatment for suspected lower respiratory tract infection is unclear.

降钙素原指导抗生素治疗疑似下呼吸道感染的作用尚不清楚。

METHODS 方法

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.

在肺炎治疗质量指标依从性较高的美国14家医院中,我们将有关治疗下呼吸道感染的国家临床实践推荐意见以及降钙素原检测结果解读等资料提供给临床医生。然后,我们将急诊就诊且医生不确定是否应当使用抗生素的疑似下呼吸道感染患者随机分为两组:即降钙素原组(向主治医生提供实时初始的降钙素原检测结果[若患者入院,还将提供动态监测结果]以及基于降钙素原水平的分级推荐抗生素使用指南)或常规治疗组。我们假设,在入选研究后30天内,与常规治疗组相比,降钙素原组抗生素总疗程缩短,且不良预后患者比例升高不超过4.5%。

RESULTS 结果

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.

共计1656名患者纳入最后的分析队列(826名随机分至降钙素原组,830名分至常规治疗组),782名(47.2%)住院接受治疗,984名 (59.4%) 患者在30天内接受抗生素治疗。降钙素原组826名患者中792名 (95.9%)患者的主治医生,以及常规治疗组830名患者中18名(2.2%)患者的主治医生收到了降钙素原检测结果(从采集标本至得到结果中位时间,77分钟)。在两组患者,根据降钙素原水平分层决定在急诊科使用抗生素。降钙素原组与常规治疗组30天内抗生素疗程(均值分别为4.2 和 4.3 天;差异,−0.05天;95%可信限 [CI],−0.6 to 0.5; P=0.87)或不良预后患者比例(11.7% [96名患者] 和 13.1% [109名患者];差异,−1.5%;95% CI, −4.6 to 1.7;非劣效P < 0.001)无显著差异。

CONCLUSIONS 结论

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.

对于疑似下呼吸道感染患者,向急诊科医生或其他临床医生提供降钙素原检测结果以及结果解读说明,与常规治疗相比,不能减少抗生素使用。

(Funded by the National Institute of General Medical Sciences; ProACT ClinicalTrials.gov number, NCT02130986.)

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