A comparison of lorazepam, diazepam, and placebo for the treatment of out-of-hospital status epilepticus

A comparison of lorazepam, diazepam, and placebo for the treatment of out-of-hospital status epilepticus
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DOI:
10.1056/nejmoa002141
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发表时间:
2001-08-30
影响因子:
158.5
通讯作者:
Lowenstein, DH
Lowenstein, DH
中科院分区:
医学1区
文献类型:
--
作者:
Alldredge, BK;Gelb, AM;Lowenstein, DH

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背景:目前尚不确定护理人员使用苯二氮卓类药物治疗院外癫痫持续状态是否有效和安全。方法:我们进行了一项随机、双盲试验,评价护理人员静脉注射苯二氮类药物治疗院外癫痫持续状态的效果。长期(持续5分钟或以上)或反复全身性惊厥发作的成人接受静脉注射安定(5毫克)、劳拉西潘(2毫克)或安慰剂。结果:在205名入选的患者中,66名接受劳拉西潘治疗,68名接受安定治疗,71名接受安慰剂治疗。接受劳拉西潘或安定治疗的患者(59.1%)或接受安定治疗的患者(42.6%)比接受安慰剂治疗的患者(21.1%)更多地在到达急诊科时终止癫痫持续状态(P=0.001)。在调整协变量后,与安慰剂组相比,劳拉西潘组在到达时终止癫痫持续状态的优势比为4.8(95%可信区间,1.9至13.0)。与安定组相比,劳拉西潘组的优势比为1.9(95%可信区间,0.8~4.4),与安慰剂组相比,优势比为2.3(95%可信区间,1.0~5.9)。治疗后呼吸或循环并发症的发生率分别为10.6%、10.3%和22.5%(P=0.08)。结论:护理人员使用苯二氮卓类药物治疗成人癫痫院外持续状态是安全有效的。劳拉西潘可能是一种比地西潘更好的治疗方法。(N Engl J Med 2001;345:631-7)版权所有(C)2001年马萨诸塞州医学会。
Background: It is uncertain whether the administration of benzodiazepines by paramedics is an effective and safe treatment for out-of-hospital status epilepticus.Methods: We conducted a randomized, double-blind trial to evaluate intravenous benzodiazepines administered by paramedics for the treatment of out-of-hospital status epilepticus. Adults with prolonged (lasting five minutes or more) or repetitive generalized convulsive seizures received intravenous diazepam (5 mg), lorazepam (2 mg), or placebo. An identical second injection was given if needed.Results: Of the 205 patients enrolled, 66 received lorazepam, 68 received diazepam, and 71 received placebo. Status epilepticus had been terminated on arrival at the emergency department in more patients treated with lorazepam (59.1 percent) or diazepam (42.6 percent) than patients given placebo (21.1 percent) (P=0.001). After adjustment for covariates, the odds ratio for termination of status epilepticus by the time of arrival in the lorazepam group as compared with the placebo group was 4.8 (95 percent confidence interval, 1.9 to 13.0). The odds ratio was 1.9 (95 percent confidence interval, 0.8 to 4.4) in the lorazepam group as compared with the diazepam group and 2.3 (95 percent confidence interval, 1.0 to 5.9) in the diazepam group as compared with the placebo group. The rates of respiratory or circulatory complications after the study treatment was administered were 10.6 percent for the lorazepam group, 10.3 percent for the diazepam group, and 22.5 percent for the placebo group (P=0.08).Conclusions: Benzodiazepines are safe and effective when administered by paramedics for out-of-hospital status epilepticus in adults. Lorazepam is likely to be a better therapy than diazepam. (N Engl J Med 2001;345:631-7.) Copyright (C) 2001 Massachusetts Medical Society.