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一项评估诊断性支气管镜检查后预防性使用抗生素疗效的开放标签前瞻性临床研究。

An open-label, prospective clinical study to evaluate the efficacy of prophylactic antibiotics after diagnostic bronchoscopy.

作者信息

Yamamoto Masatsugu, Nagano Tatsuya, Okuno Keiko, Nakata Kyosuke, Takenaka Kazuhiro, Kobayashi Kazuyuki, Ishikawa Yumiko, Sakashita Akihiro, Kotani Yoshikazu, Funada Yasuhiro, Nishimura Yoshihiro

机构信息

Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.

出版信息

Kobe J Med Sci. 2012 Dec 13;58(4):E110-8.

Abstract

The aim of this study was to prospectively examine the effect of prophylactic antibiotic use on the development of respiratory infections and on the worsening of symptoms after diagnostic fiberoptic bronchoscopy procedures. This study was an open-label, multicenter, controlled, clinical trial. Patients were alternately assigned to a group given prophylactic antibiotics after bronchoscopy (prophylaxis(+) group) and a group not given antibiotic prophylaxis after bronchoscopy (prophylaxis(-) group), and they were followed-up for 1 week. 158 patients were assigned to the prophylaxis(-) group and 153 to the prophylaxis(+) group. Therapeutic antibiotic administration was needed in 3 patients (1.90%) in the prophylaxis(-) group and 5 patients (3.27%) in the prophylaxis(+) group (risk ratio 1.014, 95% confidence interval 0.978-1.052; p=0.446). Worsening of symptoms after bronchoscopy occurred in 57.6% of all patients by day 7, but no significant differences were observed between the 2 study groups. Prophylactic antibiotic use after bronchoscopy did not prevent the development of infectious events and worsening of symptoms, suggesting that prophylactic antibiotics might not be necessary for routine diagnostic bronchoscopic procedures.

摘要

本研究的目的是前瞻性地研究预防性使用抗生素对呼吸道感染发生以及诊断性纤维支气管镜检查术后症状恶化的影响。本研究为开放标签、多中心、对照临床试验。患者被交替分配至支气管镜检查后给予预防性抗生素的组(预防(+)组)和支气管镜检查后未给予抗生素预防的组(预防(-)组),并随访1周。158例患者被分配至预防(-)组,153例患者被分配至预防(+)组。预防(-)组有3例患者(1.90%)需要给予治疗性抗生素,预防(+)组有5例患者(3.27%)需要给予治疗性抗生素(风险比1.014,95%置信区间0.978 - 1.052;p = 0.446)。到第7天,所有患者中有57.6%的患者支气管镜检查术后症状恶化,但两个研究组之间未观察到显著差异。支气管镜检查后预防性使用抗生素并不能预防感染事件的发生和症状恶化,这表明对于常规诊断性支气管镜检查,预防性使用抗生素可能没有必要。

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