Lorazepam vs Diazepam for Pediatric Status Epilepticus A Randomized Clinical Trial
Lorazepam vs Diazepam for Pediatric Status Epilepticus A Randomized Clinical Trial
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DOI：
10.1001/jama.2014.2625
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发表时间：
2014-04-23
影响因子：
120.7
通讯作者：
Baren, Jill
中科院分区：
文献类型：
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作者：
Chamberlain, James M.;Okada, Pamela;Baren, Jill
苯二氮卓类药物被认为是小儿癫痫持续状态的一线治疗药物。一些研究表明，劳拉西泮可能是更有效或更安全的比地西泮，但劳拉西泮是没有食品和药物管理局批准用于此indication.Objective检验的假设，劳拉西泮有更好的疗效和安全性比地西泮治疗小儿癫痫持续状态。设计，设置，和参与者这一双盲，随机临床试验进行了从2008年3月1日至2012年3月14日。在11个美国学术儿科急诊科之一就诊的3个月至18岁以下惊厥性癫痫持续状态患者符合资格。有273例患者，140随机地西泮和133劳拉西泮。干预患者接受0.2毫克/公斤的地西泮或0.1毫克/公斤的劳拉西泮静脉注射，与一半的剂量重复5分钟，如果必要的。如果癫痫持续状态持续12分钟，磷苯妥英administer.Main结局和措施的主要疗效结果是停止癫痫持续状态10分钟内没有复发30分钟。主要安全性结局是辅助通气的性能。次要结局包括癫痫发作复发率和镇静率，以及癫痫持续状态停止和恢复基线精神状态的时间。结果地西泮组140例中有101例（72.1%）癫痫持续状态停止10 min，30 min内无复发，劳拉西泮组133例中有97例（72.9%），绝对疗效差异为0.8%（95%CI，-11.4%至9.8%）。每组中有26例患者需要辅助通气（16.0%给予地西泮，17.6%给予劳拉西泮;绝对风险差异为1.6%; 95% CI为-9.9%至6.8%）。除了劳拉西泮组患者更容易被镇静外，其他次要结局无统计学显著差异（分别为66.9%和50%;绝对风险差为16.9%; 95%CI，6.1%至27.7%）。结论和相关性在惊厥性癫痫持续状态的儿科患者中，与地西泮相比，用劳拉西泮治疗没有导致改善的功效或安全性。这些结果不支持劳拉西泮优先用于这种情况。
IMPORTANCE Benzodiazepines are considered first-line therapy for pediatric status epilepticus. Some studies suggest that lorazepam may be more effective or safer than diazepam, but lorazepam is not Food and Drug Administration approved for this indication.OBJECTIVE To test the hypothesis that lorazepam has better efficacy and safety than diazepam for treating pediatric status epilepticus.DESIGN, SETTING, AND PARTICIPANTS This double-blind, randomized clinical trial was conducted from March 1, 2008, to March 14, 2012. Patients aged 3 months to younger than 18 years with convulsive status epilepticus presenting to 1 of 11 US academic pediatric emergency departments were eligible. There were 273 patients; 140 randomized to diazepam and 133 to lorazepam.INTERVENTIONS Patients received either 0.2 mg/kg of diazepam or 0.1 mg/kg of lorazepam intravenously, with half this dose repeated at 5 minutes if necessary. If status epilepticus continued at 12 minutes, fosphenytoin was administered.MAIN OUTCOMES AND MEASURES The primary efficacy outcome was cessation of status epilepticus by 10 minutes without recurrence within 30 minutes. The primary safety outcome was the performance of assisted ventilation. Secondary outcomes included rates of seizure recurrence and sedation and times to cessation of status epilepticus and return to baseline mental status. Outcomes were measured 4 hours after study medication administration.RESULTS Cessation of status epilepticus for 10 minutes without recurrence within 30 minutes occurred in 101 of 140 (72.1%) in the diazepam group and 97 of 133 (72.9%) in the lorazepam group, with an absolute efficacy difference of 0.8%(95% CI, -11.4% to 9.8%). Twenty-six patients in each group required assisted ventilation (16.0% given diazepam and 17.6% given lorazepam; absolute risk difference, 1.6%; 95% CI, -9.9% to 6.8%). There were no statistically significant differences in secondary outcomes except that lorazepam patients were more likely to be sedated (66.9% vs 50%, respectively; absolute risk difference, 16.9%; 95% CI, 6.1% to 27.7%).CONCLUSIONS AND RELEVANCE Among pediatric patients with convulsive status epilepticus, treatment with lorazepam did not result in improved efficacy or safety compared with diazepam. These findings do not support the preferential use of lorazepam for this condition.