惊厥性癫痫持续状态的神经保护低温治疗。
Hypothermia for Neuroprotection in Convulsive Status Epilepticus.
机构信息
From the Medical-Surgical Intensive Care Unit (S.L., V. Laurent, J.H.-G., B.P., S.M., J.-P.B.) and the Neurology and Stroke Department (F.P.), Centre Hospitalier de Versailles-Site André Mignot, Versailles, INSERM Unité 970 (Team 4), Paris Cardiovascular Research Center (S.L., A.C.), the Medical Intensive Care Unit (V. Lemiale, E.C., E.A.) and Department of Biostatistics and Medical Information (M.R.-R.), Saint Louis University Hospital, Assistance Publique-Hôpitaux de Paris (AP-HP), the Medical Intensive Care Unit, Cochin University Hospital, Hopitaux Universitaires-Paris Centre, AP-HP (F.D., G.G., N.M., A.C.), the Medical Intensive Care Unit (I.M.) and Neurophysiology Department (Y.-R.T.-D.), Lariboisière University Hospital, AP-HP, INSERM Unité 1153 (ECSTRA Team), Université Paris Diderot, Sorbonne Paris Cité (M.R.-R.), and Paris Descartes University, Sorbonne Paris Cité-Medical School (A.C.), Paris, the Medical Intensive Care Unit, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg (M. Schenck), and the Medical Intensive Care Unit, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg, and Fédération de Médecine Translationnelle de Strasbourg, Faculté de Médecine, Université de Strasbourg (J.B.-H.), Strasbourg, the Medical-Surgical Intensive Care Unit, Centre Hospitalier de Melun, Melun (J.C.), the Anesthesiology and Critical Care Department, Toulouse University Hospital, University Toulouse 3 Paul Sabatier, Toulouse (M. Srairi), the Medical-Surgical Intensive Care Unit, Centre Hospitalier de Montreuil, Montreuil (A.H.), the Medical-Surgical Intensive Care Unit, Centre Hospitalier du Mans, Le Mans (T.R.), the Intensive Care Units, Division of Anesthesia, Intensive Care, Pain, and Emergency Medicine, University Hospital of Nîmes, Nîmes (B.L.), and the Medical-Surgical Intensive Care Unit, Centre Hospitalier Victor Dupouy, Argenteuil (M.T.) - all in France.
出版信息
N Engl J Med. 2016 Dec 22;375(25):2457-2467. doi: 10.1056/NEJMoa1608193.
BACKGROUND
Convulsive status epilepticus often results in permanent neurologic impairment. We evaluated the effect of induced hypothermia on neurologic outcomes in patients with convulsive status epilepticus.
METHODS
In a multicenter trial, we randomly assigned 270 critically ill patients with convulsive status epilepticus who were receiving mechanical ventilation to hypothermia (32 to 34°C for 24 hours) in addition to standard care or to standard care alone; 268 patients were included in the analysis. The primary outcome was a good functional outcome at 90 days, defined as a Glasgow Outcome Scale (GOS) score of 5 (range, 1 to 5, with 1 representing death and 5 representing no or minimal neurologic deficit). The main secondary outcomes were mortality at 90 days, progression to electroencephalographically (EEG) confirmed status epilepticus, refractory status epilepticus on day 1, "super-refractory" status epilepticus (resistant to general anesthesia), and functional sequelae on day 90.
RESULTS
A GOS score of 5 occurred in 67 of 138 patients (49%) in the hypothermia group and in 56 of 130 (43%) in the control group (adjusted common odds ratio, 1.22; 95% confidence interval [CI], 0.75 to 1.99; P=0.43). The rate of progression to EEG-confirmed status epilepticus on the first day was lower in the hypothermia group than in the control group (11% vs. 22%; odds ratio, 0.40; 95% CI, 0.20 to 0.79; P=0.009), but there were no significant differences between groups in the other secondary outcomes. Adverse events were more frequent in the hypothermia group than in the control group.
CONCLUSIONS
In this trial, induced hypothermia added to standard care was not associated with significantly better 90-day outcomes than standard care alone in patients with convulsive status epilepticus. (Funded by the French Ministry of Health; HYBERNATUS ClinicalTrials.gov number, NCT01359332 .).
背景
癫痫持续状态常导致永久性神经功能损伤。我们评估了诱导性低温对癫痫持续状态患者神经结局的影响。
方法
在一项多中心试验中，我们随机分配 270 名接受机械通气的伴有癫痫持续状态的危重症患者接受低温（32 至 34°C 持续 24 小时）加标准治疗或仅接受标准治疗；268 名患者纳入分析。主要结局为 90 天时的良好功能结局，定义为格拉斯哥预后量表（GOS）评分为 5 分（范围 1 至 5 分，1 分代表死亡，5 分代表无或最小神经功能缺损）。主要次要结局为 90 天时的死亡率、第 1 天进展为脑电图（EEG）证实的癫痫持续状态、第 1 天难治性癫痫持续状态、“超难治性”癫痫持续状态（对全身麻醉耐药）和第 90 天的功能后遗症。
结果
在低温组的 138 名患者中有 67 名（49%）和对照组的 130 名患者中有 56 名（43%）的 GOS 评分为 5 分（调整后的共同优势比，1.22；95%置信区间 [CI]，0.75 至 1.99；P=0.43）。低温组第 1 天进展为 EEG 证实的癫痫持续状态的发生率低于对照组（11%比 22%；优势比，0.40；95%CI，0.20 至 0.79；P=0.009），但两组在其他次要结局方面无显著差异。低温组的不良事件发生率高于对照组。
结论
在这项试验中，与单独标准治疗相比，癫痫持续状态患者接受诱导性低温加标准治疗并未显著改善 90 天结局。（由法国卫生部资助；HYBERNATUS ClinicalTrials.gov 编号，NCT01359332）。
Zotero 插件