Abstract：
BACKGROUND: To potentially improve impaired vasomotion of patients with multiple organ dysfunction syndrome (MODS), we tested whether an electromagnetic field of low flux density coupled with a biorhythmically defined impulse configuration (Physical Vascular Therapy BEMER®, PVT), in addition to standard care, is safe and feasible and might improve disturbed microcirculatory blood flow and thereby improve global haemodynamics.
METHODS: In a prospective, monocentric, one-arm pilot study, 10 MODS patients (APACHE II score 20-35) were included. Patients were treated, in addition to standard care, for 4 days with PVT (3 treatment periods of 8 min each day; day 1: field intensity 10.5 μT; day 2:14 μT, day 3:17.5 μT; day 4:21.0 μT). Primary endpoint was the effect of PVT on sublingual microcirculatory perfusion, documented by microvascular flow index (MFI). Patient safety, adverse events, and outcomes were documented.
RESULTS: An increase in MFI by approximately 25% paralleled 4-day PVT, with the increase starting immediately after the first PVT and lasting over the total 4-day treatment period. Concerning global haemodynamics (secondary endpoints), halving vasopressor use within 24 h, and haemodynamic stabilisation paralleled 4-day PVT with an increase in cardiac index, stroke volume index, and cardiac power index by 30%-50%. No adverse events (AEs) or serious adverse events (SAEs) were classified as causally related to the medical product (PVT) or study. Three patients died within 28 days and one patient between 28 and 180 days.
CONCLUSIONS: PVT treatment was feasible and safe and could be performed without obstruction of standard patient care. An increase in microcirculatory blood flow, a rapid reduction in vasopressor use, and an improvement in global haemodynamics paralleled PVT treatment. Findings of this pilot study allowed forming a concept for a randomized trial for further proof.
METHODS: In a prospective, monocentric, one-arm pilot study, 10 MODS patients (APACHE II score 20-35) were included. Patients were treated, in addition to standard care, for 4 days with PVT (3 treatment periods of 8 min each day; day 1: field intensity 10.5 μT; day 2:14 μT, day 3:17.5 μT; day 4:21.0 μT). Primary endpoint was the effect of PVT on sublingual microcirculatory perfusion, documented by microvascular flow index (MFI). Patient safety, adverse events, and outcomes were documented.
RESULTS: An increase in MFI by approximately 25% paralleled 4-day PVT, with the increase starting immediately after the first PVT and lasting over the total 4-day treatment period. Concerning global haemodynamics (secondary endpoints), halving vasopressor use within 24 h, and haemodynamic stabilisation paralleled 4-day PVT with an increase in cardiac index, stroke volume index, and cardiac power index by 30%-50%. No adverse events (AEs) or serious adverse events (SAEs) were classified as causally related to the medical product (PVT) or study. Three patients died within 28 days and one patient between 28 and 180 days.
CONCLUSIONS: PVT treatment was feasible and safe and could be performed without obstruction of standard patient care. An increase in microcirculatory blood flow, a rapid reduction in vasopressor use, and an improvement in global haemodynamics paralleled PVT treatment. Findings of this pilot study allowed forming a concept for a randomized trial for further proof.
摘要：
背景：为了潜在地改善多器官功能障碍综合征（MODS）患者的受损血管舒缩，我们测试了低通量密度的电磁场是否与生物节律定义的脉冲配置（物理血管治疗BEMER®，PVT),除了标准护理，是安全可行的，可能会改善受干扰的微循环血流，从而改善全球血流动力学。
方法：在前瞻性中，单心,单臂试点研究，纳入10例MODS患者（APACHEII评分20-35）。患者接受治疗，除了标准护理，用PVT治疗4天（3个治疗期，每天8分钟；第1天：场强10.5μT；第2天：14μT，第3天：17.5μT；第4天：21.0μT）。主要终点是PVT对舌下微循环灌注的影响，通过微血管血流指数（MFI）记录。患者安全,不良事件,并记录了结果。
结果：与4天PVT相比，MFI增加约25%，增加在第一次PVT后立即开始，并持续4天的总治疗期。关于全球血流动力学（次要终点），在24小时内将升压药的使用减半，血流动力学稳定与4天PVT平行，心脏指数增加，每搏输出量指数,和心脏功率指数30%-50%。没有不良事件（AE）或严重不良事件（SAE）被归类为与医疗产品（PVT）或研究相关的因果关系。三名患者在28天内死亡，一名患者在28至180天内死亡。
结论：PVT治疗是可行和安全的，可以在不妨碍标准患者护理的情况下进行。微循环血流量增加,血管升压药的使用迅速减少,与PVT治疗平行的全球血流动力学改善。这项初步研究的结果允许形成一个随机试验的概念，以进一步证明。
方法：在前瞻性中，单心,单臂试点研究，纳入10例MODS患者（APACHEII评分20-35）。患者接受治疗，除了标准护理，用PVT治疗4天（3个治疗期，每天8分钟；第1天：场强10.5μT；第2天：14μT，第3天：17.5μT；第4天：21.0μT）。主要终点是PVT对舌下微循环灌注的影响，通过微血管血流指数（MFI）记录。患者安全,不良事件,并记录了结果。
结果：与4天PVT相比，MFI增加约25%，增加在第一次PVT后立即开始，并持续4天的总治疗期。关于全球血流动力学（次要终点），在24小时内将升压药的使用减半，血流动力学稳定与4天PVT平行，心脏指数增加，每搏输出量指数,和心脏功率指数30%-50%。没有不良事件（AE）或严重不良事件（SAE）被归类为与医疗产品（PVT）或研究相关的因果关系。三名患者在28天内死亡，一名患者在28至180天内死亡。
结论：PVT治疗是可行和安全的，可以在不妨碍标准患者护理的情况下进行。微循环血流量增加,血管升压药的使用迅速减少,与PVT治疗平行的全球血流动力学改善。这项初步研究的结果允许形成一个随机试验的概念，以进一步证明。
