一项前瞻性、多中心、I 期研究：在接受根治性肝胆胰恶性肿瘤手术的患者中，术后依诺肝素治疗。
A Prospective, Multi-Center Phase I Study of Postoperative Enoxaparin Treatment in Patients Undergoing Curative Hepatobiliary-Pancreatic Surgery for Malignancies.
机构信息
Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Suita, Osaka, Japan,
Clinical Study Group of Osaka University, Hepatobiliary-Pancreatic Group, Osaka, Japan,
出版信息
Dig Surg. 2020;37(1):81-86. doi: 10.1159/000497451. Epub 2019 Jun 11.
BACKGROUND
Venous thromboembolism (VTE) is one of the critical complications that can occur after surgery. A positive association between cancer and VTE risk is well established; however, the safety and efficacy of VTE prophylaxis have not been established in hepatobiliary-pancreatic surgery, especially in surgery for malignancies.
METHODS
A prospective, multi-center Phase I study to determine the safety of enoxaparin was performed. Subcutaneous injection of enoxaparin was initiated 48-72 h after surgery and repeated for 8 days. The primary endpoint was the incidence of bleeding events. This study was registered with the University Hospital Medical Information Network Clinical Trials Registry (UMIN000007761).
RESULTS
A total of 154 patients was registered and 133 patients including 74 hepatectomies and 35 pancreaticoduodenectomies were analyzed. Three patients (2.3%) exhibited major bleeding events postoperatively, while 7 (5.2%) had minor bleeding. No Symptomatic VTE was observed.
CONCLUSIONS
Our study indicated that enoxaparin was well tolerated and safe for patients who received hepatobiliary-pancreatic surgery for malignancies.
背景
静脉血栓栓塞症（VTE）是手术后可能发生的严重并发症之一。癌症与 VTE 风险之间存在正相关关系已得到充分证实；然而，VTE 预防的安全性和有效性尚未在肝胆胰手术中得到证实，特别是在恶性肿瘤的手术中。
方法
进行了一项前瞻性、多中心的 I 期研究，以确定依诺肝素的安全性。手术 48-72 小时后开始皮下注射依诺肝素，并重复使用 8 天。主要终点是出血事件的发生率。该研究在大学医院医疗信息网络临床试验注册中心（UMIN000007761）注册。
结果
共登记了 154 例患者，其中 133 例包括 74 例肝切除术和 35 例胰十二指肠切除术进行了分析。术后有 3 例（2.3%）患者出现大出血事件，7 例（5.2%）患者有轻微出血。无症状性 VTE 发生。
结论
我们的研究表明，依诺肝素在接受肝胆胰恶性肿瘤手术的患者中耐受良好且安全。
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