护理人员启动神经保护剂输注：在FAST-MAG关键试验（卒中治疗现场应用-镁）中成功达到目标血药浓度及所达到的血药浓度对临床结局的影响
Paramedic Initiation of Neuroprotective Agent Infusions: Successful Achievement of Target Blood Levels and Attained Level Effect on Clinical Outcomes in the FAST-MAG Pivotal Trial (Field Administration of Stroke Therapy - Magnesium).
作者信息
Shkirkova Kristina, Starkman Sidney, Sanossian Nerses, Eckstein Marc, Stratton Samuel, Pratt Frank, Conwit Robin, Hamilton Scott, Sharma Latisha, Liebeskind David, Restrepo Lucas, Valdes-Sueiras Miguel, Saver Jeffrey L
机构信息
From the David Geffen School of Medicine, University of California Los Angeles (K.S., S. Starkman, L.S., D.L., L.R., M.V.-S., J.L.S.); Keck School of Medicine, University of Southern California, Los Angeles (N.S.); Los Angeles Fire Department, CA (M.E.); Los Angeles EMS Agency, Santa Fe Springs, CA (S. Stratton); Orange County EMS Agency, Santa Ana, CA (F.P.); National Institute of Neurological Disorders and Stroke, Bethesda, MD (R.C.); and Stanford University, CA (S.H.).
出版信息
Stroke. 2017 Jul;48(7):1901-1907. doi: 10.1161/STROKEAHA.116.015664. Epub 2017 Jun 5.
BACKGROUND AND PURPOSE
Paramedic use of fixed-size lumen, gravity-controlled tubing to initiate intravenous infusions in the field may allow rapid start of neuroprotective therapy for acute stroke. In a large, multicenter trial, we evaluated its efficacy in attaining target serum levels of candidate neuroprotective agent magnesium sulfate and the relation of achieved magnesium levels to outcome.
METHODS
The FAST-MAG phase 3 trial (Field Administration of Stroke Therapy - Magnesium) randomized 1700 patients within 2 hours of onset to paramedic-initiated, a 15-minute loading intravenous infusion of magnesium or placebo followed by a 24-hour maintenance dose. The drug delivery strategy included fixed-size lumen, gravity-controlled tubing for field drug administration, and a shrink-wrapped ambulance kit containing both the randomized field loading and hospital maintenance doses for seamless continuation.
RESULTS
Among patient randomized to active treatment, magnesium levels in the first 72 hours were assessed 987 times in 572 patients. Mean patient age was 70 years (SD±14 years), and 45% were women. During the 24-hour period of active infusion, mean achieved serum level was 3.91 (±0.8), consistent with trial target. Mg levels were increased by older age, female sex, lower weight, height, body mass index, and estimated glomerular filtration rate, and higher blood urea nitrogen, hemoglobin, and higher hematocrit. Adjusted odds for clinical outcomes did not differ by achieved Mg level, including disability at 90 days, symptomatic hemorrhage, or death.
CONCLUSIONS
Paramedic infusion initiation using gravity-controlled tubing permits rapid achievement of target serum levels of potential neuroprotective agents. The absence of association of clinical outcomes with achieved magnesium levels provides further evidence that magnesium is not biologically neuroprotective in acute stroke.
背景与目的
护理人员在现场使用固定管径、重力控制的输液管开始静脉输液，可能有助于为急性卒中患者迅速启动神经保护治疗。在一项大型多中心试验中，我们评估了其在使候选神经保护剂硫酸镁达到目标血清水平方面的疗效，以及所达到的镁水平与预后的关系。
方法
FAST-MAG 3期试验（卒中治疗现场应用镁剂）将1700例发病2小时内的患者随机分为两组，一组由护理人员启动，静脉输注15分钟负荷剂量的镁剂或安慰剂，随后给予24小时维持剂量。给药策略包括用于现场给药的固定管径、重力控制的输液管，以及一个收缩包装的救护包，其中包含随机分组后的现场负荷剂量和医院维持剂量，以便无缝衔接。
结果
在随机接受积极治疗的患者中，对572例患者在最初72小时内进行了987次镁水平评估。患者平均年龄为70岁（标准差±14岁），45%为女性。在积极输注的24小时内，平均达到的血清水平为3.91（±0.8），与试验目标一致。镁水平随年龄增大、女性、体重较低、身高较矮、体重指数较低、估计肾小球滤过率较低以及血尿素氮、血红蛋白和血细胞比容较高而升高。根据达到的镁水平，临床结局的校正比值无差异，包括90天时的残疾、症状性出血或死亡。
结论
使用重力控制输液管由护理人员启动输液可迅速达到潜在神经保护剂的目标血清水平。临床结局与达到的镁水平之间缺乏关联，进一步证明镁在急性卒中中无生物学神经保护作用。
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