Nakaharai Kazuhiko, Morita Kojiro, Jo Taisuke, Matsui Hiroki, Fushimi Kiyohide, Yasunaga Hideo
Department of Clinical Epidemiology and Health Economics, School of Public Health, The University of Tokyo, Tokyo, Japan; Department of Infectious Diseases and Infection Control, Jikei University School of Medicine, Tokyo, Japan.
Department of Clinical Epidemiology and Health Economics, School of Public Health, The University of Tokyo, Tokyo, Japan.
J Infect Chemother. 2018 Sep;24(9):753-758. doi: 10.1016/j.jiac.2018.05.009. Epub 2018 Jun 13.
Previous studies evaluating the clinical benefits of prophylactic antibiotics for severe acute pancreatitis (SAP) have generated inconsistent results due to heterogeneities among the study settings. We determined if early prophylactic antibiotics improved the outcomes of SAP patients using a study designed to overcome these previous methodological weaknesses.
We conducted a retrospective cohort study of SAP patients discharged between July 2010 and March 2016, using a Japanese nationwide inpatient database. We divided patients into those with early prophylactic carbapenem use (prophylaxis group) and those without prophylaxis (control group). The primary outcome was in-hospital mortality and the secondary outcomes included oral vancomycin use and others.
We identified a total of 3354 eligible patients, including 2493 in the prophylaxis group and 861 in the control group. The overall in-hospital mortality was 12.8%. Prophylactic antibiotics were not significantly associated reduced in-hospital mortality according to Cox regression analysis (hazard ratio (HR), 0.88; 95% confidence interval (CI), 0.62-1.23) or instrumental variable analysis (risk difference, -1.2%; 95% CI, -9.8%-7.4%). However, prophylactic antibiotic use was significantly associated with oral vancomycin use during hospitalization in a competing-risk model (subdistribution HR, 1.91; 95% CI, 1.02-3.56).
The present study suggests that routine early prophylactic antibiotic use have no significant clinical benefit in SAP patients but may increase the risk of hospital-acquired infections.
既往评估预防性使用抗生素对重症急性胰腺炎（SAP）临床益处的研究，因研究背景的异质性而产生了不一致的结果。我们采用一项旨在克服既往方法学缺陷的研究，来确定早期预防性使用抗生素是否能改善SAP患者的预后。
我们利用日本全国住院患者数据库，对2010年7月至2016年3月期间出院的SAP患者进行了一项回顾性队列研究。我们将患者分为早期预防性使用碳青霉烯类药物的患者（预防组）和未进行预防的患者（对照组）。主要结局是住院死亡率，次要结局包括口服万古霉素的使用情况等。
我们共纳入3354例符合条件的患者，其中预防组2493例，对照组861例。总体住院死亡率为12.8%。根据Cox回归分析（风险比（HR），0.88；95%置信区间（CI），0.62 - 1.23）或工具变量分析（风险差异，-1.2%；95%CI，-9.8% - 7.4%），预防性使用抗生素与降低住院死亡率无显著相关性。然而，在竞争风险模型中，预防性使用抗生素与住院期间口服万古霉素的使用显著相关（亚分布HR，1.91；95%CI，1.02 - 3.56）。
本研究表明，常规早期预防性使用抗生素对SAP患者无显著临床益处，但可能增加医院获得性感染的风险。
