评价多层面计算机化抗菌药物管理干预在外科环境中的有效性和安全性：一项单中心整群随机对照试验。

Evaluation of the effectiveness and safety of a multi-faceted computerized antimicrobial stewardship intervention in surgical settings: A single-centre cluster-randomized controlled trial.

机构信息

State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China; Department of Cardiac Surgery, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.

Information Centre, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.

出版信息

Int J Antimicrob Agents. 2023 May;61(5):106787. doi: 10.1016/j.ijantimicag.2023.106787. Epub 2023 Mar 17.

DOI:10.1016/j.ijantimicag.2023.106787

PMID:36935089

Abstract

BACKGROUND

Inappropriate antimicrobial use is common among patients undergoing surgery. It remains unclear whether a multi-faceted computerized antimicrobial stewardship programme is effective and safe in reducing inappropriate antimicrobial use in surgical settings.

METHODS

A multi-faceted computerized antimicrobial stewardship intervention system was developed, and an open-label, cluster-randomized, controlled trial was conducted among 18 surgical teams that enrolled 2470 patients for open chest cardiovascular surgery. The surgical teams were divided at random into intervention and control groups at a ratio of 1:1. The primary endpoints were days of therapy (DOT)/1000 patient-days, defined daily dose (DDD)/1000 patient-days and length of therapy (LOT)/1000 patient-days.

RESULTS

Mean DOT, DDD and LOT per 1000 patient-days were significantly lower in the intervention group compared with the control group (472.2 vs 539.8, 459.5 vs 553.8, and 438.4 vs 488.7; P<0.05), with reductions of 14.2% [95% confidence interval (CI) 11.8-16.7%], 18.7% (95% CI 15.9-21.4%) and 11.9% (95% CI 9.6-14.1%), respectively. The daily risk of inappropriate antimicrobial use after discharge from the intensive care unit decreased by 23.9% [95% CI 15.5-31.5% (incidence risk ratio 0.76, 95% CI 0.69-0.85)] in the intervention group. There was no significant difference in rates of infection or surgical-related complications between the groups. Median antimicrobial costs were significantly lower in the intervention group {873.4 [interquartile range (IQR) 684.5-1255.4] RMB vs 1178.7 (IQR 869.1-1814.5) RMB; P<0.001} (1 RMB approximately equivalent to 0.16 US$ in 2022).

CONCLUSIONS

The multi-faceted computerized antimicrobial stewardship interventions reduced inappropriate antimicrobial use safely.

CLINICAL TRIAL REGISTRATION

Clinicaltrials.gov: NCT04328090.

摘要

背景

手术患者中普遍存在不适当的抗菌药物使用。目前尚不清楚多方面的计算机化抗菌药物管理计划是否能有效且安全地减少手术环境中不适当的抗菌药物使用。

方法

开发了一种多方面的计算机化抗菌药物管理干预系统，并在 18 个外科团队中进行了一项开放性、集群随机对照试验，该试验共纳入了 2470 例接受开胸心血管手术的患者。外科团队以 1:1 的比例随机分为干预组和对照组。主要终点是治疗日（DOT）/1000 患者日、定义日剂量（DDD）/1000 患者日和治疗日（LOT）/1000 患者日。

结果

与对照组相比，干预组的 DOT/1000 患者日、DDD/1000 患者日和 LOT/1000 患者日均显著降低（472.2 对 539.8、459.5 对 553.8 和 438.4 对 488.7；P<0.05），分别降低了 14.2%[95%可信区间（CI）11.8-16.7%]、18.7%（95% CI 15.9-21.4%）和 11.9%（95% CI 9.6-14.1%）。从重症监护病房出院后，每日不适当使用抗菌药物的风险降低了 23.9%[95%可信区间（CI）15.5-31.5%（发病率风险比 0.76，95% CI 0.69-0.85）]。两组感染或手术相关并发症发生率无显著差异。干预组的抗菌药物中位成本显著降低[873.4（四分位距[IQR] 684.5-1255.4）人民币比 1178.7（IQR 869.1-1814.5）人民币；P<0.001]（1 人民币约等于 2022 年 0.16 美元）。