短期（3 天）依诺肝素预防胃癌手术后静脉血栓栓塞症的疗效和安全性：一项单中心前瞻性队列研究。

Efficacy and safety of short-term (3 days) enoxaparin in preventing venous thromboembolism after gastric cancer surgery: A single-center, prospective cohort study.

机构信息

Department of Gastroenterological Surgery, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan; Center for Innovative Clinical Medicine, Okayama University Hospital, Okayama, Japan.

Department of Gastroenterological Surgery, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan; Minimally Invasive Therapy Center, Okayama University Hospital, Okayama, Japan.

出版信息

Int J Surg. 2021 May;89:105946. doi: 10.1016/j.ijsu.2021.105946. Epub 2021 Apr 20.

DOI:10.1016/j.ijsu.2021.105946

PMID:33892160

Abstract

BACKGROUND

Pharmacologic prophylaxis such as enoxaparin for venous thromboembolism (VTE) is rarely used in Japan, even following abdominal cancer surgery, for which it is recommended in relevant guidelines (at least 7 days of use) along with mechanical prophylaxis with intermittent pneumatic compression. Reasons for enoxaparin's unpopularity include concerns over postoperative bleeding and its inconvenience in clinical practice. Here, we conducted a prospective clinical study of short-term (3 days) use of enoxaparin, which is considered to minimally impact postoperative management without increasing bleeding risk.

METHODS

Gastric cancer patients who underwent gastrectomy received enoxaparin for 3 days from postoperative day (POD) 1-4. The primary endpoint was the incidence of deep vein thrombosis (DVT), which was examined primarily via Doppler ultrasonography of the lower limbs between POD 8 and 14. The planned sample size was 70, which was calculated based on an estimated incidence rate of 9% and an upper limit of incidence rate of 20%, with alpha of 0.05 and beta of 0.2.

RESULTS

A total of 70 gastric cancer patients were enrolled, and ultimately, 68 patients received the protocol intervention and DVT evaluation. Sixty-seven patients completed 6 enoxaparin injections, but 1 patient did not complete the course due to abdominal bleeding after initiation. The incidence of DVT was 4.4% (3/68), and the 95% upper confidence interval was 12.2%, lower than the 20% threshold we set as the upper limit of DVT incidence. DVT was detected only in the peripheral veins of the lower extremities in all 3 affected patients. The incidence of bleeding-related complications, which were not severe, was 1.5% (1/68).

CONCLUSIONS

Short-term (3 days) use of enoxaparin was shown to be effective and safe for VTE prophylaxis, comparable to regular use (at least 7 days), in postoperative management of gastric cancer surgery.

摘要

背景

在日本，即使是在接受腹部癌症手术后，也很少使用依诺肝素等药物预防静脉血栓栓塞症（VTE），尽管相关指南推荐（至少使用 7 天），同时联合间歇性气动压缩的机械预防措施。依诺肝素不受欢迎的原因包括对术后出血的担忧以及在临床实践中的不便。在这里，我们进行了一项短期（3 天）使用依诺肝素的前瞻性临床研究，认为这不会显著影响术后管理，且不会增加出血风险。

方法

接受胃切除术的胃癌患者从术后第 1 天（POD）1 至 4 天开始接受依诺肝素治疗 3 天。主要终点是深静脉血栓形成（DVT）的发生率，主要通过 POD 8 至 14 之间的下肢多普勒超声检查来检查。计划的样本量为 70 例，这是基于估计的发生率 9%和发生率上限 20%，α 值为 0.05 和β 值为 0.2 计算得出的。

结果

共纳入 70 例胃癌患者，最终 68 例患者接受了方案干预和 DVT 评估。67 例患者完成了 6 次依诺肝素注射，但 1 例患者因开始后腹部出血而未完成疗程。DVT 的发生率为 4.4%（3/68），95%置信区间上限为 12.2%，低于我们设定的 20%作为 DVT 发生率上限。所有 3 例受影响的患者均仅在下肢外周静脉中检测到 DVT。无严重出血相关并发症的发生率为 1.5%（1/68）。