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随机对照研究中手术患者血栓弹力描记术测定舒更葡糖钠的凝血效果。

Coagulation Effect of Sugammadex as Determined by Thromboelastography in a Randomized Controlled Study of Surgical Patients.

机构信息

Department of Anesthesiology and Pain Medicine, Eulji University Hospital, Seoul, Korea.

Department of Anesthesiology and Pain Medicine, Korea University Guro Hospital, Seoul, Korea.

出版信息

Int J Med Sci. 2021 Jan 21;18(6):1318-1324. doi: 10.7150/ijms.42563. eCollection 2021.

Abstract

: Sugammadex has been shown to be associated with prolongation of prothrombin time and activated partial thromboplastin time. However, it is not known whether it could be associated with enhancing postoperative hypocoagulation. The objective of this study was to analyze the effect of 4 mg/kg of sugammadex on thromboelastography (TEG) parameters in surgical patients. After Institutional Review Board approval, a prospective double-blinded randomized controlled study was conducted between September 2016 and April 2017. Sixty adult patients scheduled for laparoscopic abdominal surgery were randomly allocated to receive either sugammadex 4 mg/kg (sugammadex group) or pyridostigmine 0.15 mg/kg in combination with glycopyrrolate 0.4 mg (control group) to reverse rocuronium-induced neuromuscular blockade at the completion of surgery. Blood samples were collected three time points; After the final suture of surgery (baseline) (T1), and at 10 min (T2) and 1 h (T3) after administration of the study drug. Whole blood was analyzed by TEG using TEG 5000 (Hemonetics Corp, Braintree, MA, USA). The primary endpoints were comparison of coagulation time (K, time to 20 mm clot amplitude), R (reaction time), alpha angle, and maximal amplitude (MA) between two groups. Coagulation time was significantly prolonged in sugammadex group after 10 min of the study drug administration compared to control group (mean value 1.3 ± 0.4 vs. 1.5 ± 0.4, P = 0.03). However, R, alpha angle and MA value were not different between two groups. Sugammadex 4 mg/kg showed an increase in coagulation time in surgical patients. Physician should aware the potential enhancement of hypocoagulation by sugammadex in the setting of high risk of postoperative bleeding.

摘要

: 舒更葡糖已被证明与凝血酶原时间和部分激活凝血活酶时间延长有关。然而,目前尚不清楚它是否会与增强术后低凝状态有关。本研究的目的是分析 4mg/kg 舒更葡糖钠对手术患者血栓弹力图(TEG)参数的影响。在机构审查委员会批准后,于 2016 年 9 月至 2017 年 4 月进行了一项前瞻性、双盲、随机对照研究。60 名择期行腹腔镜腹部手术的成年患者被随机分配接受舒更葡糖钠 4mg/kg(舒更葡糖钠组)或顺苯磺酸阿曲库铵 0.15mg/kg 联合格隆溴铵 0.4mg(对照组),以逆转手术结束时罗库溴铵诱导的神经肌肉阻滞。在三个时间点采集血样:手术最后缝合时(基础)(T1),以及给药后 10min(T2)和 1h(T3)。使用 TEG5000(Hemonetics 公司,马萨诸塞州布伦特里)对全血进行 TEG 分析。主要终点是比较两组间凝血时间(K,达到 20mm 血凝块振幅的时间)、R(反应时间)、α角和最大振幅(MA)。与对照组相比,舒更葡糖钠组在给药后 10min 时凝血时间明显延长(平均值 1.3±0.4 比 1.5±0.4,P=0.03)。然而,两组间 R、α角和 MA 值无差异。4mg/kg 舒更葡糖钠可增加手术患者的凝血时间。医生应注意在术后出血高风险的情况下,舒更葡糖钠可能增强低凝状态。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/177c/7893551/8eca2a7d77f1/ijmsv18p1318g001.jpg

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