部分口服与静脉抗生素治疗心内膜炎。

Partial Oral versus Intravenous Antibiotic Treatment of Endocarditis.

机构信息

From the Department of Cardiology, Herlev-Gentofte University Hospital (K.I., M.S., C.F.K.), Department of Cardiology, the Heart Center, Rigshospitalet, Copenhagen University Hospital (N.I., D.E.H., E.L.F., L.K., H.B.), the Departments of Infectious Diseases (J.H.-L.) and Clinical Microbiology (C.M.), Rigshospitalet, the Department of Cardiology, Hillerød Hospital (N.T.), and the Department of Clinical Microbiology, Slagelse Hospital and Institute of Clinical Medicine (J.J.C.), University of Copenhagen, Copenhagen, the Departments of Cardiology (S.U.G.) and Clinical Microbiology (F.R.), Odense University Hospital, Odense, the Departments of Cardiology (T.M.) and Cardiology and Epidemiology and Biostatistics (C.T.-P.), Aalborg University Hospital, the Department of Clinical Microbiology, Aalborg University Hospital, Aalborg University (H.C.S.), and the Department of Health Science and Technology, Aalborg University (C.T.-P.), Aalborg, the Department of Cardiology, Zealand University Hospital, Roskilde (H.E.), the Department of Cardiology, Aarhus University Hospital, Aarhus (K.T.J.), the Department of Cardiology, University Hospital of Copenhagen, Gentofte (N.E.B.), and the Department of Bacteria, Parasites and Fungi, Statens Serum Institut, Copenhagen (K.F.) - all in Denmark.

出版信息

N Engl J Med. 2019 Jan 31;380(5):415-424. doi: 10.1056/NEJMoa1808312. Epub 2018 Aug 28.

DOI:10.1056/NEJMoa1808312

PMID:30152252

Abstract

BACKGROUND

Patients with infective endocarditis on the left side of the heart are typically treated with intravenous antibiotic agents for up to 6 weeks. Whether a shift from intravenous to oral antibiotics once the patient is in stable condition would result in efficacy and safety similar to those with continued intravenous treatment is unknown.

METHODS

In a randomized, noninferiority, multicenter trial, we assigned 400 adults in stable condition who had endocarditis on the left side of the heart caused by streptococcus, Enterococcus faecalis, Staphylococcus aureus, or coagulase-negative staphylococci and who were being treated with intravenous antibiotics to continue intravenous treatment (199 patients) or to switch to oral antibiotic treatment (201 patients). In all patients, antibiotic treatment was administered intravenously for at least 10 days. If feasible, patients in the orally treated group were discharged to outpatient treatment. The primary outcome was a composite of all-cause mortality, unplanned cardiac surgery, embolic events, or relapse of bacteremia with the primary pathogen, from the time of randomization until 6 months after antibiotic treatment was completed.

RESULTS

After randomization, antibiotic treatment was completed after a median of 19 days (interquartile range, 14 to 25) in the intravenously treated group and 17 days (interquartile range, 14 to 25) in the orally treated group (P=0.48). The primary composite outcome occurred in 24 patients (12.1%) in the intravenously treated group and in 18 (9.0%) in the orally treated group (between-group difference, 3.1 percentage points; 95% confidence interval, -3.4 to 9.6; P=0.40), which met noninferiority criteria.

CONCLUSIONS

In patients with endocarditis on the left side of the heart who were in stable condition, changing to oral antibiotic treatment was noninferior to continued intravenous antibiotic treatment. (Funded by the Danish Heart Foundation and others; POET ClinicalTrials.gov number, NCT01375257 .).

摘要

背景

患有左侧感染性心内膜炎的患者通常接受静脉抗生素治疗长达 6 周。一旦患者病情稳定，从静脉转为口服抗生素治疗是否会产生与继续静脉治疗相似的疗效和安全性尚不清楚。

方法

在一项随机、非劣效性、多中心试验中，我们将 400 名患有左侧心内膜炎的成年人随机分为两组，一组为稳定组，左侧心内膜炎由链球菌、粪肠球菌、金黄色葡萄球菌或凝固酶阴性葡萄球菌引起，正在接受静脉抗生素治疗；另一组为稳定组，正在接受静脉抗生素治疗。两组患者均接受至少 10 天的静脉抗生素治疗。如果可行，口服治疗组的患者出院接受门诊治疗。主要结局是从随机分组到抗生素治疗结束后 6 个月期间的全因死亡率、计划外心脏手术、栓塞事件或主要病原体复发性菌血症的复合结果。

结果

随机分组后，静脉治疗组抗生素治疗完成中位数为 19 天（四分位距，14 至 25），口服治疗组为 17 天（四分位距，14 至 25）（P=0.48）。静脉治疗组有 24 例（12.1%）和口服治疗组有 18 例（9.0%）患者发生主要复合结局（组间差异为 3.1 个百分点；95%置信区间为-3.4 至 9.6；P=0.40），符合非劣效性标准。