Wang Haitao, Sun Zhanfeng, Jiang Weiliang, Zhang Yingnan, Li Xianwei, Wu Yalei
Department of Vascular Surgery, The 2nd Affiliated Hospital of Harbin Medical University, Heilongjiang, China.
Department of Vascular Surgery, The 2nd Affiliated Hospital of Harbin Medical University, Heilongjiang, China
Vasc Med. 2015 Apr;20(2):117-21. doi: 10.1177/1358863X14564592. Epub 2015 Jan 19.
To analyze the necessity of venous thromboembolism (VTE) prophylaxis for patients undergoing high ligation and stripping of the great saphenous vein (GSV) and to estimate the efficacy and safety of different anticoagulant protocols in a single-center randomized controlled trial with large sample size. A total of 2196 patients undergoing high ligation and stripping of the GSV were randomized to one of the following postoperative VTE prophylaxis protocols: group A, no VTE prophylaxis (n=542); group B, subcutaneous low-dose unfractionated heparin (LDUH) hypodermic injection, 125 U/kg per day in three divided doses (n=531); group C, low-molecular-weight heparin (LMWH) 6000 IU once a day (n=573); and group D, LMWH 4000 IU twice daily (n=550). Groups were compared for the incidence of VTE and major hemorrhage within 1 month following surgery. Varicose vein severity was classified by CEAP (Clinical, Etiologic, Anatomic, Pathophysiologic elements) score. The clinical characteristics of the patients were equally matched between groups. Postoperative deep vein thrombosis (DVT) and pulmonary embolism (PE) were significantly higher in group A (DVT 5.17%, PE 1.48%) compared to groups B (0.56%, 0%), C (0.35%, 0%) and D (0.36%, 0%) (p<0.01). The incidence of VTE did not differ between the three active chemoprophylaxis arms. Hemorrhagic complications were low for each group but higher in group B (0.75%) compared to the other groups (group A 0.18%; group C 0.17%; group D 0.18%, p<0.01). Hemorrhagic complications did not differ amongst groups A, C and D. In conclusion, postoperative VTE chemoprophylaxis following high ligation and GSV stripping effectively reduces the venous thrombosis complications of this procedure. Of the three active strategies tested, no difference in efficacy was noted; however, thrice daily LDUH did increase bleeding complications.
在一项大样本量的单中心随机对照试验中，分析大隐静脉高位结扎剥脱术患者进行静脉血栓栓塞（VTE）预防的必要性，并评估不同抗凝方案的疗效和安全性。共有2196例行大隐静脉高位结扎剥脱术的患者被随机分为以下术后VTE预防方案之一：A组，不进行VTE预防（n = 542）；B组，皮下注射低剂量普通肝素（LDUH），每天125 U/kg，分三次注射（n = 531）；C组，低分子量肝素（LMWH）每天6000 IU一次（n = 573）；D组，LMWH 4000 IU每日两次（n = 550）。比较各组术后1个月内VTE和大出血的发生率。采用CEAP（临床、病因、解剖、病理生理因素）评分对静脉曲张严重程度进行分类。各组患者的临床特征均衡匹配。与B组（0.56%，0%）、C组（0.35%，0%）和D组（0.36%，0%）相比，A组术后深静脉血栓形成（DVT）和肺栓塞（PE）发生率显著更高（DVT 5.17%；PE 1.48%）（p<0.01）。三种积极化学预防方案组之间VTE发生率无差异。各组出血并发症发生率均较低，但B组（0.75%）高于其他组（A组0.18%；C组0.17%；D组0.18%，p<0.01）。A组、C组和D组之间出血并发症无差异。总之，大隐静脉高位结扎剥脱术后进行VTE化学预防可有效降低该手术的静脉血栓形成并发症。在所测试的三种积极策略中，疗效无差异；然而，每日三次注射LDUH确实增加了出血并发症。
