Department of Critical Care Medicine, Zhongshan Hospital Fudan University, 180 Fenglin Road, Shanghai, China.
Department of Thoracic Surgery, Zhongshan Hospital Fudan University, 180 Fenglin Road, Shanghai, China.
Thromb Res. 2018 Jun;166:22-27. doi: 10.1016/j.thromres.2018.04.001. Epub 2018 Apr 4.
The methodology of thromboprophylaxis post minimally invasive esophagectomy (MIE) is unclear. Thus, we compared the efficacy and safety of fondaparinux and nadroparin on the prophylaxis of venous thromboembolism (VTE) after MIE.
We conducted a randomized, double-blind, treatment-controlled study. Consecutive patients undergoing MIE randomly received a single dose of either nadroparin 2850 AxaIU (Group H) or fondaparinux 2.5 mg (Group F) daily. We used ultrasonography to identify deep vein thrombosis (DVT) on postoperative day 7. The coagulation status was examined using thromboelastography (TEG) prior to and at 0, 24, 48, and 72 h after the operation. Bleeding events were recorded during anticoagulation therapy and analysis was performed on an intention-to-treat basis.
We randomly assigned the patients to Group H (n = 57) or Group F (n = 59). Symptomatic or asymptomatic DVT was identified in seven patients in Group H and one patient in Group F (12.28% vs. 1.69%, p = 0.031). Pulmonary embolism developed in one patient in Group H, and the VTE incidence was significantly lower in Group F than Group H (1.69% vs. 14.04%, RR: 0.121, 95% CI: 0.016-0.935, p = 0.016). TEG analysis showed a more inhibited coagulation profile of Group F compared with Group H reflected by the significantly prolonged R time at 48 h and 72 h after operation (6.8 ± 2.2 min vs. 8.4 ± 2.7 min, p = 0.005; 7.1 ± 1.6 min vs. 9.2 ± 3.7 min, p = 0.002). Bleeding events were not recorded in either group.
Fondaparinux could provide similar efficacy and safety in postoperative thromboprophylaxis following MIE compared with nadroparin.
微创食管切除术（MIE）后血栓预防的方法尚不清楚。因此，我们比较了那屈肝素钙和磺达肝癸钠在预防 MIE 后静脉血栓栓塞症（VTE）中的疗效和安全性。
我们进行了一项随机、双盲、治疗对照研究。连续接受 MIE 的患者随机接受单次那屈肝素钙 2850 AxaIU（H 组）或磺达肝癸钠 2.5mg（F 组），每天一次。术后第 7 天采用超声检查深静脉血栓形成（DVT）。在手术前和术后 0、24、48 和 72 小时使用血栓弹性描记术（TEG）检查凝血状态。记录抗凝治疗期间的出血事件，并进行意向治疗分析。
我们将患者随机分配到 H 组（n=57）或 F 组（n=59）。H 组有 7 例患者出现症状性或无症状性 DVT，F 组有 1 例（12.28% vs. 1.69%，p=0.031）。H 组有 1 例发生肺栓塞，F 组 VTE 发生率明显低于 H 组（1.69% vs. 14.04%，RR：0.121，95%CI：0.016-0.935，p=0.016）。TEG 分析显示，与 H 组相比，F 组凝血谱更为抑制，术后 48 小时和 72 小时 R 时间明显延长（6.8±2.2 分钟 vs. 8.4±2.7 分钟，p=0.005；7.1±1.6 分钟 vs. 9.2±3.7 分钟，p=0.002）。两组均未记录出血事件。
与那屈肝素钙相比，磺达肝癸钠在 MIE 后血栓预防方面具有相似的疗效和安全性。
