■腹部癌症手术后,术后静脉血栓栓塞(VTE)风险明显。依诺肝素在预防胃肠道静脉血栓栓塞方面显示出希望,妇科,和泌尿系癌症,但由于出血问题,其在肝胆胰恶性肿瘤手术后的应用一直未得到充分评价.我们证实了依诺肝素在接受根治性肝胆胰手术治疗恶性肿瘤的患者中的安全性,多中心,第一阶段研究。
■该研究于2015年4月至2021年5月在八个专业中心进行。患者(n=262)随机接受术后8天的依诺肝素预防(n=131)或对照组(n=131)。主要终点是降低VTE的疗效。次要终点检查安全性。
■完整的分析集包括259名患者(131名对照,129依诺肝素)。符合方案的人群包括233名患者(117名对照,116依诺肝素)。大多数病例是肝脏恶性肿瘤(111个对照,111依诺肝素)。依诺肝素的中位给药时间为7天,92%的人每天接收4000个单位。尽管术后服用依诺肝素降低了VTE的相对风险(RR),结果不显着(对照:4例,3.4%与治疗:2例,1.7%;RR0.50,95%CI0.09-2.70;p=0.6834)。出血事件发生率无显著差异(对照:5例,4.3%vs.治疗:5例,4.3%,RR1.00,95%CI0.53-1.89;p=1.0000)。
■依诺肝素在肝胆胰恶性肿瘤的围手术期给药是可行且安全的。然而,进一步的病例积累和调查是必要的,以评估其在减少VTE发生方面的潜力.
UNASSIGNED: Postoperative venous thromboembolism (VTE) risk is pronounced after abdominal cancer surgery. Enoxaparin shows promise in preventing VTE in gastrointestinal, gynecological, and urological cancers, but its application after surgery for hepatobiliary-pancreatic malignancy has been under-evaluated due to bleeding concerns. We confirmed the safety of enoxaparin administration in patients undergoing curative hepatobiliary-pancreatic surgery for malignancies in a prospective, multi-center, phase I study.
UNASSIGNED: The study was conducted from April 2015 to May 2021 across eight specialized centers. Patients (n = 262) were randomized to enoxaparin prophylaxis given postoperatively for 8 days (n = 131) or control (n = 131). The primary endpoint was the efficacy in reducing VTE. Secondary endpoints examined safety.
UNASSIGNED: The full analysis set included 259 patients (131 control, 129 enoxaparin). The per-protocol population included 233 patients (117 control, 116 enoxaparin). Most cases were hepatic malignancies (111 control, 111 enoxaparin). The median administration duration of enoxaparin was 7 days, with 92% receiving 4000 units/day. Despite a reduction in the relative risk (RR) of VTE due to postoperative enoxaparin administration, the results were not significant (control: four cases, 3.4% vs. treatment: two cases, 1.7%; RR 0.50, 95% CI 0.09-2.70; p = 0.6834). No significant difference was found in the incidence of bleeding events (control: five cases, 4.3% vs. treatment: five cases, 4.3%, RR 1.00, 95% CI 0.53-1.89; p = 1.0000).
UNASSIGNED: The perioperative administration of enoxaparin in hepatobiliary-pancreatic malignancies is feasible and safe. However, further case accumulation and investigation are necessary to assess its potential in reducing the occurrence of VTE.