病态肥胖患者袖状胃切除术后口服利伐沙班预防静脉血栓栓塞是否安全?前瞻性随机临床试验

Mahmoud A. Eissa, Tamer M. Elmahdy, S. Elgarf, A. Swelam, Gamal Mousa, Amr S. Ghobara, S. Saber
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引用次数: 0

摘要

背景:深静脉血栓形成和肺栓塞仍然是肥胖症患者进行减重手术后最关键的问题之一。许多预防静脉血栓栓塞(VTE)的技术已被记录和常规应用,尤其是那些高危人群,如病态肥胖患者(体重指数大于 40 kg/m 2 )、老年患者以及既往有 VTE 病史和开放手术或翻修手术史的患者。患者和方法:我们在 2021 年 1 月至 2023 年 1 月期间进行了这项随机前瞻性临床试验,对 500 名接受袖状胃切除术以减轻体重的肥胖患者分为两组:在 A 组的 250 名患者中,我们使用术后低分子量肝素(LMWH)40 毫克,每天一次皮下注射预防 VTE,而 B 组(250 名患者)则使用口服抗凝药物(利伐沙班)。研究结果本研究旨在比较两种药物在并发症(包括 VTE 和出血)方面的效果。在出血方面,出血的表现多种多样,有轻微的症状,如口腔部位血肿、胃周血肿或吐血、黑血等。就研究组患者的年龄而言,两组之间没有明显的统计学差异。两组患者的轻微出血、中重度出血和危及生命的出血发生率几乎相同,无明显统计学差异。在整个研究过程中,LMWH 组仅出现一例肠胃门血栓。在整个研究过程中,无临床疑似下肢深静脉血栓形成,无需进行下肢静脉双折线检查。结论利伐沙班是最常用的新型口服抗凝药之一,其安全性和有效性与 LMWH 相似,可用于减重袖状胃切除术后的 VTE 预防,是 LMWH 的理想口服替代药物。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Oral rivaroxaban for postoperative prophylaxis of venous thromboembolism after sleeve gastrectomy in patients with morbid obesity, is it safe: A prospective randomized clinical trial
Background: Deep vein thrombosis and pulmonary embolism are still one of the most crucial problems after weight-reducing surgeries in patients suffering from obesity. Many techniques were documented and routinely applied to prevent venous thromboembolism (VTE), particularly in those who are at high risk as morbid obese patients (BMI >40 kg/m 2 ), geriatric patients, and those who had previous history of VTE and open or revisional surgery. Patients and Methods: We conducted this randomized prospective clinical trial during the period from January 2021 to January 2023 on 500 obese patients who underwent sleeve gastrectomy for weight reduction divided into two groups: In the 250 patients of group A we used postoperative low-molecular-weight heparins (LMWH) 40 mg once daily subcutaneous injection for VTE prophylaxis, while group B (250 patients) were given oral anticoagulants (rivaroxaban) on the other hand. Results: This study aimed to compare the results of using both drugs as regards complications including both VTE and bleeding. Regarding bleeding, it also can present with a wide range of manifestations ranging from mild symptoms like port site hematoma, perigastric hematoma, or hematemesis, and melena. Regarding the age of patients in the studied groups there was no statistically significant difference between both groups. The incidence of minor, moderate to major, and life-threatening bleeding was nearly the same between both groups with no statistically significant difference. Throughout the study, only one case of porto-mesenteric thrombosis in the LMWH group. No clinically suspected Lower Limb deep vein thrombosis throughout the study with no need to do lower limb venous duplex. Conclusion: The safety and efficacy of Rivaroxaban as one of the most commonly used new Oral anticoagulants resembles that of the LMWH as a prophylaxis of VTE following weight-reducing sleeve gastrectomy surgery and could be a good oral alternative for LMWH.
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