Diers Moritz, Beschauner Juliane, Felsberg Maria, Zeh Alexander, Delank Karl-Stefan, Gutteck Natalia, Werneburg Felix
Department of Orthopaedic, and Trauma Surgery, Martin-Luther-University Halle-Wittenberg, 06120 Halle, Germany.
Antibiotics (Basel). 2025 Jul 31;14(8):775. doi: 10.3390/antibiotics14080775.
: Intravenous vancomycin remains a key agent in the treatment of complex orthopedic infections, particularly those involving methicillin-resistant (MRSA). However, its use is associated with significant risks, most notably nephrotoxicity. Despite guideline recommendations, standardized dosing and monitoring protocols are often absent in orthopedic settings, leading to inconsistent therapeutic drug exposure and preventable adverse events. This study evaluated the clinical impact of implementing a structured standard operating procedure (SOP) for intravenous vancomycin therapy in orthopedic inpatients. : We conducted a single-center, pre-post cohort study at a university orthopedic department. The intervention consisted of a standard operating procedure (SOP) for intravenous vancomycin therapy, which mandated weight-based loading doses, renal function-adjusted maintenance dosing, trough level monitoring, and defined dose adjustments. Patients treated before SOP implementation ( = 58) formed the control group; those treated under the SOP ( = 56) were prospectively included. The primary outcome was the incidence of vancomycin-associated acute kidney injury (VA-AKI) defined by KDIGO Stage 1 criteria. Secondary outcomes included therapeutic trough level attainment and infusion-related or ototoxic adverse events. All patients in the post-SOP group received a loading dose (100% vs. 31% pre-SOP, < 0.001). The range of measured vancomycin trough levels narrowed substantially after SOP implementation (7.1-36.2 mg/L vs. 4.0-80.0 mg/L). The proportion of patients reaching therapeutic trough levels increased, although this was not statistically significant. Most notably, VA-AKI occurred in 17.2% of patients in the control group, but in none of the patients after SOP implementation (0%, = 0.0013). No cases of ototoxicity were observed in either group. Infusion-related reactions decreased after the implementation of the SOP, though not significantly. : The introduction of a structured vancomycin protocol significantly reduced adverse drug events and improved dosing control in orthopedic inpatients. Incorporating such protocols into routine practice represents a feasible and effective strategy to strengthen antibiotic stewardship and clinical quality in surgical disciplines.
静脉注射万古霉素仍然是治疗复杂骨科感染的关键药物，尤其是那些涉及耐甲氧西林金黄色葡萄球菌（MRSA）的感染。然而，其使用伴随着重大风险，最显著的是肾毒性。尽管有指南推荐，但骨科环境中往往缺乏标准化的给药和监测方案，导致治疗药物暴露不一致和可预防的不良事件。本研究评估了在骨科住院患者中实施静脉注射万古霉素治疗结构化标准操作规程（SOP）的临床影响。我们在一所大学的骨科进行了一项单中心、前后队列研究。干预措施包括静脉注射万古霉素治疗的标准操作规程（SOP），该规程规定了基于体重的负荷剂量、根据肾功能调整的维持剂量、谷浓度监测以及明确的剂量调整。在SOP实施前接受治疗的患者（n = 58）组成对照组；前瞻性纳入在SOP下接受治疗的患者（n = 56）。主要结局是根据KDIGO 1期标准定义的万古霉素相关急性肾损伤（VA - AKI）的发生率。次要结局包括达到治疗性谷浓度以及与输注相关或耳毒性不良事件。SOP实施后组中的所有患者均接受了负荷剂量（100% vs. SOP实施前的31%，P < 0.001）。SOP实施后，所测万古霉素谷浓度范围大幅缩小（7.1 - 36.2 mg/L vs. 4.0 - 80.0 mg/L）。达到治疗性谷浓度的患者比例有所增加，尽管这在统计学上不显著。最值得注意的是，对照组中有17.2%的患者发生了VA - AKI，但SOP实施后无患者发生（0%，P = 0.0013）。两组均未观察到耳毒性病例。SOP实施后与输注相关的反应有所减少，但不显著。结构化万古霉素方案的引入显著减少了骨科住院患者的药物不良事件并改善了剂量控制。将此类方案纳入常规实践是加强外科领域抗生素管理和临床质量的一种可行且有效的策略。
