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The association of patient weight and dose of fosphenytoin, levetiracetam, and valproic acid with treatment success in status epilepticus
Epilepsia ( IF 5.6 ) Pub Date : 2020-05-18 , DOI: 10.1111/epi.16534
Abhishek G Sathe 1 , Jordan J Elm 2 , James C Cloyd 1 , James M Chamberlain 3 , Robert Silbergleit 4 , Jaideep Kapur 5, 6 , Hannah R Cock 7 , Nathan B Fountain 8 , Shlomo Shinnar 9 , Daniel H Lowenstein 10 , Robin A Conwit 11 , Thomas P Bleck 12 , Lisa D Coles 1
Affiliation  

The Established Status Epilepticus Treatment Trial was a blinded, comparative‐effectiveness study of fosphenytoin, levetiracetam, and valproic acid in benzodiazepine‐refractory status epilepticus. The primary outcome was clinical seizure cessation and increased responsiveness without additional anticonvulsant medications. Weight‐based dosing was capped at 75 kg. Hence, patients weighing >75 kg received a lower mg/kg dose. Logistic regression models were developed in 235 adults to determine the association of weight (≤ or >75 kg, ≤ or >90 kg), sex, treatment, and weight‐normalized dose with the primary outcome and solely seizure cessation. The primary outcome was achieved in 45.1% and 42.5% of those ≤75 kg and >75 kg, respectively. Using univariate analyses, the likelihood of success for those >75 kg (odds ratio [OR] = 0.9, 95% confidence interval [CI] = 0.54‐1.51) or >90 kg (OR = 0.85, 95% CI = 0.42‐1.66) was not statistically different compared with those ≤75 kg or ≤90 kg, respectively. Similarly, other predictors were not significantly associated with primary outcome or clinical seizure cessation. Our findings suggest that doses, capped at 75 kg, likely resulted in concentrations greater than those needed for outcome. Studies that include drug concentrations and heavier individuals are needed to confirm these findings.

中文翻译:

患者体重和磷苯妥英、左乙拉西坦和丙戊酸剂量与癫痫持续状态治疗成功的关系

已建立的癫痫持续状态治疗试验是对苯二氮卓类药物难治性癫痫持续状态中的磷苯妥英、左乙拉西坦和丙戊酸进行的盲法、比较有效性研究。主要结果是临床癫痫发作停止和反应增加,无需额外的抗惊厥药物。基于体重的剂量上限为 75 公斤。因此,体重 > 75 kg 的患者接受的 mg/kg 剂量较低。在 235 名成人中建立了逻辑回归模型,以确定体重(≤ 或 >75 kg、≤ 或 >90 kg)、性别、治疗和体重标准化剂量与主要结局和单纯癫痫发作停止之间的关系。在≤75 kg 和 >75 kg 的患者中,主要结果分别为 45.1% 和 42.5%。使用单变量分析,那些 >75 kg 的人成功的可能性(优势比 [OR] = 0.9,95% 置信区间 [CI] = 0.54-1.51) 或 >90 kg (OR = 0.85, 95% CI = 0.42-1.66) 分别与≤75 kg 或≤90 kg 的患者相比无统计学差异。同样,其他预测因素与主要结果或临床癫痫发作停止没有显着相关性。我们的研究结果表明,上限为 75 公斤的剂量可能导致浓度高于结果所需的浓度。需要包括药物浓度和较重个体的研究来证实这些发现。可能导致浓度大于结果所需的浓度。需要包括药物浓度和较重个体的研究来证实这些发现。可能导致浓度大于结果所需的浓度。需要包括药物浓度和较重个体的研究来证实这些发现。
更新日期:2020-05-18
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