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新型三元聚合物 SEC-1 coat™ 在儿科心肺转流回路中的临床应用:一项前瞻性随机试验研究。

Clinical application of a new ternary polymer, SEC-1 coat™, for pediatric cardiopulmonary bypass circuits: a prospective randomized pilot study.

机构信息

Department of Pediatric Critical Care Medicine, Hyogo Prefectural Kobe Children's Hospital, Kobe, Japan.

Department of Cardiovascular Surgery, Hyogo Prefectural Kobe Children's Hospital, Kobe, Japan.

出版信息

Perfusion. 2020 Nov;35(8):826-832. doi: 10.1177/0267659120915387. Epub 2020 Apr 20.

DOI:10.1177/0267659120915387
PMID:32308128
Abstract

OBJECTIVE

The use of biocompatible materials to reduce the systemic activation of inflammation and coagulation pathways is expanding rapidly. However, there have been few clinical studies of biocompatible circuits for pediatric cardiopulmonary bypass. This pilot study aimed to preliminarily evaluate the biocompatibility of SEC-1 coat™ (SEC) for cardiopulmonary bypass circuits in pediatric cardiac surgery.

METHODS

Twenty infants undergoing cardiac surgery for isolated ventricular septal defects at Kobe Children's Hospital were assigned randomly to an SEC-coated (SEC group, n = 10) or heparin-coated (control group, n = 10) circuit. Perioperative data and the following markers were prospectively analyzed: platelet counts and interleukin-6, interleukin-8, C3a, β-thromboglobulin, and thrombin-antithrombin complex levels.

RESULTS

Neither patient characteristics nor postoperative clinical outcomes differed significantly between the SEC and control groups. Platelet counts markedly decreased during cardiopulmonary bypass in both groups, but were significantly better preserved in the SEC group. Fewer patients needed postoperative platelet transfusions in the SEC group. After cardiopulmonary bypass termination, serum levels of β-thromboglobulin and thrombin-antithrombin complex were significantly lower in the SEC than in the control group. Although the differences were not statistically significant, serum levels of interleukin-6, interleukin-8, and C3a had a tendency toward being lower in the SEC group, with good preservation of leukocyte counts, fibrinogen, and antithrombin III.

CONCLUSION

SEC-1 coat™ for cardiopulmonary bypass circuits have good biocompatibility with regard to platelet preservation and in terms of attenuating inflammatory reaction or coagulation activation during pediatric cardiac surgery. It can be beneficial in pediatric as well as adult cardiac surgery.

摘要

目的

使用生物相容性材料来减少炎症和凝血途径的全身激活正在迅速扩展。然而,关于儿科体外循环的生物相容性回路的临床研究甚少。本初步研究旨在评估 SEC-1 涂层(SEC)在儿科心脏手术中用于体外循环回路的生物相容性。

方法

在神户儿童医院接受单独室间隔缺损心脏手术的 20 名婴儿被随机分配到 SEC 涂层(SEC 组,n=10)或肝素涂层(对照组,n=10)回路。前瞻性分析围手术期数据和以下标志物:血小板计数和白细胞介素 6、白细胞介素 8、C3a、β-血栓球蛋白和凝血酶-抗凝血酶复合物水平。

结果

SEC 和对照组的患者特征和术后临床结果均无显著差异。两组在体外循环期间血小板计数明显下降,但 SEC 组保存得更好。SEC 组中有较少的患者需要术后血小板输注。体外循环终止后,SEC 组的β-血栓球蛋白和凝血酶-抗凝血酶复合物血清水平明显低于对照组。尽管差异无统计学意义,但 SEC 组的白细胞介素 6、白细胞介素 8 和 C3a 血清水平有降低的趋势,白细胞计数、纤维蛋白原和抗凝血酶 III 得到良好保存。

结论

SEC-1 涂层用于体外循环回路具有良好的生物相容性,可在儿科心脏手术中保留血小板,并减轻炎症反应或凝血激活。它对儿科和成人心脏手术都有益。

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