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用于腰椎融合术中止血评估的验证性术中出血严重程度量表(VIBe):一项前瞻性随机对照试验。

Validated intraoperative bleeding severity scale (VIBe) for hemostasis assessment in lumbar spinal fusion: a prospective, randomized controlled trial.

作者信息

Kim Namhoo, Park Sub-Ri, Shin Jae Won, Kwon Ji-Won, Park Si-Young, Park Jin-Oh, Suk Kyung-Soo, Moon Seong-Hwan, Kim Hak-Sun, Lee Byung Ho

机构信息

Department of Orthopedic Surgery, Yonsei University College of Medicine, Seoul, Republic of Korea.

出版信息

Eur Spine J. 2025 Sep 5. doi: 10.1007/s00586-025-09328-4.

Abstract

PURPOSE

Intraoperative bleeding remains a major challenge in lumbar spine surgery, with conventional assessment methods lacking standardization. The Validated Intraoperative Bleeding Severity Scale (VIBe) is a structured five-grade tool developed to objectively assess bleeding severity across surgical fields. This study evaluated the clinical utility of VIBe in lumbar spinal fusion by comparing it with conventional bleeding metrics across various hemostatic strategies, including hypotensive anesthesia and local hemostatic agent use.

METHODS

In this prospective, randomized controlled trial, 70 patients undergoing elective posterior lumbar decompression and fusion were randomized to normotensive or hypotensive anesthesia. Each group was further divided by hemostatic strategy: active agents alone or a combination of active and passive agents. VIBe grades were independently recorded by the surgeon and assistant for each bleeding site. Conventional bleeding metrics-including estimated blood loss (EBL), transfusion volume, and drain output-were also collected. Between group comparisons and inter-rater agreement were assessed, and correlation analysis was performed to evaluate the association between the VIBe and conventional bleeding metrics.

RESULTS

VIBe grades improved significantly after hemostasis in all patients (p < 0.001). Although intraoperative blood pressures were significantly lower in the hypotensive group, there were no significant differences in transfusion volume, EBL, drain output, or VIBe-based assessments. Outcomes were also comparable between patients receiving combined versus active-only hemostatic agents. Inter-rater agreement for VIBe scores before hemostasis, after hemostasis, and for score changes was near-perfect (κ = 0.934, 0.834, and 0.856 respectively, all p < 0.001). Operator-assigned VIBe scores significantly correlated with EBL (ρ = 0.305, p = 0.010) and transfusion volume (ρ = 0.264, p = 0.027); assistant correlated with EBL (ρ = 0.284, p = 0.017).

CONCLUSION

VIBe is a reliable and reproducible tool for intraoperative bleeding assessment in lumbar spine fusion. Active hemostatic agents were effective, and the addition of passive agents offered no measurable advantage.

摘要

目的

术中出血仍是腰椎手术中的一项重大挑战,传统评估方法缺乏标准化。经过验证的术中出血严重程度量表(VIBe)是一种结构化的五级工具,旨在客观评估各手术区域的出血严重程度。本研究通过将VIBe与包括控制性低血压麻醉和局部止血剂使用在内的各种止血策略下的传统出血指标进行比较,评估了VIBe在腰椎融合手术中的临床实用性。

方法

在这项前瞻性随机对照试验中,70例行择期后路腰椎减压融合术的患者被随机分为正常血压麻醉组或控制性低血压麻醉组。每组再根据止血策略进一步分组:单独使用活性药物或活性与被动药物联合使用。外科医生和助手分别独立记录每个出血部位的VIBe分级。同时收集传统出血指标,包括估计失血量(EBL)、输血量和引流液量。评估组间差异和评分者间一致性,并进行相关性分析以评估VIBe与传统出血指标之间的关联。

结果

所有患者止血后VIBe分级均显著改善(p < 0.001)。虽然控制性低血压组术中血压显著较低,但在输血量、EBL、引流液量或基于VIBe的评估方面无显著差异。接受联合止血剂与仅使用活性止血剂的患者的结果也具有可比性。止血前、止血后VIBe评分以及评分变化的评分者间一致性接近完美(κ分别为0.934、0.834和0.856,均p < 0.001)。术者指定的VIBe评分与EBL(ρ = 0.305,p = 0.010)和输血量(ρ = 0.264,p = 0.027)显著相关;助手的评分与EBL(ρ = 0.284,p = 0.017)相关。

结论

VIBe是一种用于腰椎融合术中出血评估的可靠且可重复的工具。活性止血剂有效,添加被动止血剂并无明显优势。

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