Local Use of Hydrogel with Amiodarone in Cardiac Surgery: Experiment and Translation to the Clinic.
Local Use of Hydrogel with Amiodarone in Cardiac Surgery: Experiment and Translation to the Clinic.
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DOI：
10.3390/gels7010029
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发表时间：
2021-03-10
期刊：
影响因子：
--
通讯作者：
Bockeria L
中科院分区：
文献类型：
--
作者：
Shvartz V;Kanametov T;Sokolskaya M;Petrosyan A;Le T;Bockeria O;Bockeria L
本研究的目的是研究基于海藻酸钠（“Colegel”）的水凝胶生物聚合物与药物物质胺碘酮在心脏手术中预防术后房颤（POAF）的用途。研究的实验部分在46只家兔上进行。成立了五个小组：在第一组中，水凝胶中胺碘酮的剂量为1 mg;在第二组中为3 mg;在第三组中为6 mg;在第四组中，使用水凝胶而不使用胺碘酮;在第五组中，静脉内施用60 mg胺碘酮。在3、7和14天后，将每组动物从实验中取出，进行心脏的病理形态学研究。研究终点为：心率控制;心脏传导系统阻塞的发展;以及根据实验室病理形态学研究的炎症的发展。转化临床部分涉及一项随机临床试验，包括60例患者，平均年龄为62 ± 8.5岁。将所有患者随机分为两组：研究组（n = 30，应用胺碘酮水凝胶）和对照组（n = 30，不应用胺碘酮水凝胶）。对于所有患者，水凝胶材料中胺碘酮的剂量为60 mg。连续5天监测心律。主要终点是POAF的发生。次要终点为：心率的动态变化; QT和PQ间期的持续时间;心脏传导系统阻塞的发展;以及AST和ALT的动态。根据实验部分的结果，发现通过水凝胶材料局部心外膜递送胺碘酮的方法是安全的。与对照组和静脉给药组相比，含有胺碘酮的水凝胶在动物实验中可有效降低心率。胺碘酮在水凝胶中的最佳剂量为1 mg/1 kg。根据临床部分的结果，发现胺碘酮作为水凝胶材料的局部心外膜递送方法证明了其安全性。与对照组相比，60 mg胺碘酮水凝胶可有效预防冠状动脉旁路移植术（CABG）后患者的POAF（p < 0.001）。年龄和胺碘酮凝胶应用程序与POAF显著相关（分别为p = 0.009和p = 0.011）。水凝胶与胺碘酮的使用使POAF的发生率降低了18.9倍。以水凝胶材料形式局部心外膜递送胺碘酮的方法是安全的。CABG后使用胺碘酮水凝胶可降低发生POAF的可能性。
The objective of this study was to study the use of the hydrogel biopolymer based on sodium alginate (“Colegel”) with a drug substance—amiodarone—for the prevention of postoperative atrial fibrillation (POAF) in cardiac surgery. The experimental part of the study was performed on 46 rabbits. Five groups were formed: in the first group, the dose of amiodarone in hydrogel was 1 mg; in the second group—3 mg; in the third group—6 mg; in the fourth group, hydrogel was used without amiodarone; in the fifth group, 60 mg amiodarone was administered intravenously. The animals from each group were removed from the experiment for the pathomorphological study of the heart after 3, 7 and 14 days. The studied endpoints were: the heart rate control; the development of the blockades of the conduction system of the heart; and the development of inflammation according to laboratory pathomorphological studies. The translational clinical part involved a randomized clinical trial which included 60 patients, with an average age of 62 ± 8.5 years. All patients were randomized into two groups: the study group (n = 30, with the application of amiodarone hydrogel) and the control group (n = 30, without the application of amiodarone hydrogel). The dose of amiodarone in the hydrogel material was 60 mg for all patients. The heart rhythm was monitored during 5 days. The primary endpoint was the development of POAF. Secondary endpoints were: the dynamics of heart rate; the duration of the QT and PQ intervals; the development of blockades of the cardiac conduction system; as well as the dynamics of AST and ALT. According to the results of the experimental part, it was found that the method of the local epicardial delivery of amiodarone by the hydrogel material was safe. Hydrogel with amiodarone is effective for reducing the heart rate in the animal experiment in comparison to the control group and the group with the intravenous administration of the drug. The optimal dose of amiodarone in hydrogel was 1 mg per 1 kg. According to the results of the clinical part, it was found that the method of the local epicardial delivery of amiodarone as a hydrogel material proved its safety. Hydrogel with amiodarone at a dose of 60 mg was effective in preventing POAF in patients after coronary artery bypass grafting (CABG) operations in comparison to the control group (p < 0.001). The age and procedure of application of the amiodarone gel were significantly associated with POAF (p = 0.009 and p = 0.011, respectively). The use of hydrogel with amiodarone reduced the probability of developing POAF 18.9-fold. The method of the local epicardial delivery of amiodarone in the form of a hydrogel material is safe. The use of hydrogel with amiodarone after CABG reduced the probability of developing POAF.
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影响因子：
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