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一种具有独立于凝血功能的止血机制的密封剂在胸主动脉择期和急诊手术中均有效。

A sealant with a hemostatic mechanism independent of the blood coagulation function was effective in both elective and emergency surgery for thoracic aorta.

机构信息

Department of Cardiovascular Surgery, National Hospital Organization Kyushu Medical Center, Fukuoka, Fukuoka, 810-8563, Japan.

Department of Cardiovascular Surgery, Kyoto Prefectural University of Medicine, Kyoto, Japan.

出版信息

Gen Thorac Cardiovasc Surg. 2023 Sep;71(9):505-514. doi: 10.1007/s11748-023-01918-7. Epub 2023 Mar 14.

Abstract

OBJECTIVES

Matsudaito is a unique surgical sealant with a powerful hemostatic effect that works independent of a patient's blood coagulation function. Because of its mechanism, this sealant is expected to be particularly useful in patients with a poor blood coagulation function, such as in cases of acute aortic syndrome requiring emergency surgery. We, therefore, evaluated the hemostatic static effect of the sealant in both emergency and elective surgery of the thoracic aorta.

METHODS

We used data obtained from post-marketing surveillance of the sealant. Patients who underwent replacement of the thoracic aorta were enrolled. The hemostatic effect was evaluated as effective if a further hemostatic procedure was not performed after applying the sealant.

RESULTS

From 46 hospitals in Japan, a total of 542 patients (327 elective and 215 emergency cases) were enrolled. Hospital mortality was 4.0% and 11.6% in elective and emergency cases, respectively (p < 0.05). Among the 1039 anastomoses (609 elective and 430 emergency cases), effective hemostasis was confirmed in 436 (71.6%) elective and 259 (60.2%) emergency cases. The data from the clinical trial of the sealant showed a hemostatic rate of 44.4% in elective control cases without the sealant.

CONCLUSION

Given that the hemostatic rate in emergency surgery with the sealant seemed to be better than that in elective surgery without the sealant (determined from the clinical trial), we concluded that the sealant was effective in both emergency and elective thoracic surgery of the aorta.

摘要

目的

Matsudaito 是一种独特的手术密封剂,具有强大的止血效果,且不受患者凝血功能的影响。由于其作用机制,该密封剂有望在凝血功能差的患者中特别有用,例如在需要紧急手术的急性主动脉综合征的情况下。因此,我们评估了该密封剂在胸主动脉的急诊和择期手术中的止血效果。

方法

我们使用该密封剂的上市后监测数据。纳入接受胸主动脉置换的患者。如果应用密封剂后无需进一步止血,则评估止血效果为有效。

结果

从日本的 46 家医院共纳入 542 名患者(327 例择期和 215 例急诊)。择期和急诊病例的医院死亡率分别为 4.0%和 11.6%(p<0.05)。在 1039 个吻合口(609 例择期和 430 例急诊)中,436 例(71.6%)择期和 259 例(60.2%)急诊病例确认有效止血。该密封剂临床试验的数据显示,无密封剂的择期对照病例的止血率为 44.4%。

结论

鉴于在使用密封剂的急诊手术中的止血率似乎优于无密封剂的择期手术(根据临床试验确定),我们得出结论,该密封剂在主动脉的急诊和择期胸外科手术中均有效。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/82dc/10421762/05c2de26cb0d/11748_2023_1918_Fig1_HTML.jpg

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