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Hemodynamic profile effects of PM101 amiodarone formulation in patients with post-operative tachyarrhythmias
Cardiology in the Young ( IF 1 ) Pub Date : 2022-09-20 , DOI: 10.1017/s1047951122002888
Meredith DeCoy 1 , Christopher Page-Goertz 2 , Ryan Nofziger 2 , James Besunder 2 , Patricia Raimer 2 , David Gothard 3 , Miraides Brown 4 , Robert Stewart 5 , Cassandra Ruggles 2 , Kristen Breedlove 5 , John Clark 5
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Amiodarone may be considered for patients with junctional ectopic tachycardia refractory to treatment with sedation, analgesia, cooling, and electrolyte replacements. There are currently no published pediatric data regarding the hemodynamic effects of the newer amiodarone formulation, PM101, devoid of hypotensive agents used in the original amiodarone formulation. We performed a single-center, retrospective, descriptive study from January 2012 to December 2020 in a pediatric ICU. Thirty-three patients were included (22 male and 11 female) between the ages of 1.1 and 1,460 days who developed post-operative junctional ectopic tachycardia or other tachyarrhythmias requiring PM101. Data analysis was performed on hemodynamic parameters (mean arterial pressures and heart rate) and total PM101 (mg/kg) from hour 0 of amiodarone administration to hour 72. Adverse outcomes were defined as Vasoactive-Inotropic Score >20, patients requiring ECMO or CPR, or patient death. There was no statistically significant decrease in mean arterial pressures within the 6 hours of PM101 administration (p > 0.05), but there was a statistically significant therapeutic decrease in heart rate for resolution of tachyarrhythmia (p < 0.05). Patients received up to 25 mg/kg in an 8-hour time for rate control. Average rate control was achieved within 11.91 hours and average rhythm control within 62 hours. There were four adverse events around the time of PM101 administration, with three determined to not be associated with the medication. PM101 is safe and effective in the pediatric cardiac surgical population. Our study demonstrated that PM101 can be used in a more aggressive dosing regimen than previously reported in pediatric literature with the prior formulation.



中文翻译:

PM101 胺碘酮制剂对术后快速心律失常患者的血流动力学影响

对于镇静、镇痛、降温和电解质替代治疗无效的交界性异位心动过速患者,可考虑使用胺碘酮。目前尚无关于新型胺碘酮制剂 PM101 血流动力学影响的儿科数据,该制剂不含原胺碘酮制剂中使用的降血压药物。我们于 2012 年 1 月至 2020 年 12 月在儿科 ICU 进行了一项单中心、回顾性、描述性研究。纳入的 33 名患者(22 名男性和 11 名女性)年龄在 1.1 天至 1,460 天之间,术后出现交界性异位心动过速或其他需要 PM101 的快速心律失常。对胺碘酮给药第 0 小时至第 72 小时的血流动力学参数(平均动脉压和心率)和总 PM101 (mg/kg) 进行数据分析。不良结果定义为血管活性正性肌力评分 >20,需要 ECMO 或 CPR 的患者,或患者死亡。PM101 给药后 6 小时内,平均动脉压没有显着降低(p > 0.05),但心率出现统计学显着降低,以缓解快速性心律失常(p < 0.05)。患者在 8 小时内接受高达 25 mg/kg 的剂量以控制心率。11.91小时内实现平均心率控制,62小时内实现平均心律控制。在 PM101 给药期间发生了四起不良事件,其中三起被确定与药物无关。PM101 对于小儿心脏手术人群是安全有效的。我们的研究表明,与儿科文献中先前报道的先前配方相比,PM101 可以用于更积极的给药方案。

更新日期:2022-09-20
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