在中国拟行胸腔镜下大型胸外科手术患者中，术前给予肝素进行血栓预防的安全性：一项前瞻性随机对照研究。
The safety profile of preoperative administration of heparin for thromboprophylaxis in Chinese patients intended for thoracoscopic major thoracic surgery: a pilot randomized controlled study.
作者信息
Deng Han-Yu, Shi Chang-Lin, Li Gang, Luo Jun, Wang Zhi-Qiang, Lin Yi-Dan, Liu Lun-Xu, Zhou Qing-Hua
机构信息
Department of Thoracic Surgery, West China Hospital, Sichuan University, Chengdu 610041, China.
Lung Cancer Center, West China Hospital, Sichuan University, Chengdu 610041, China.
出版信息
J Thorac Dis. 2017 Apr;9(4):1065-1072. doi: 10.21037/jtd.2017.03.148.
BACKGROUND
Patients undergoing major thoracic surgery especially for cancers are at a high risk of perioperative thromboembolism. Current guidelines recommended either heparin sodium (unfractionated heparin) or low-molecular-weight heparin (LMWH) for those patients at high risk of deep vein thrombosis (DVT). However, the rational timing of starting heparin has not yet been well established, because DVT can be caused by not only surgery but also comorbidities as well as prolonged hospital stay, and thoracic surgeons always concerned about heparin-related increased risk of intra- or post-operative bleeding. Therefore, this study aimed to establish the safety profile of preoperative administration of heparin for thromboprophylaxis in Chinese patients intended for thoracoscopic major thoracic surgery.
METHODS
From June to August 2016, patients intended for thoracoscopic lobectomy, esophagectomy, and thymectomy were randomly assigned into two groups: the case group (starting heparin sodium 5,000 U, bid preoperatively upon the admission into our department) and the control group (starting heparin sodium 5,000 U, bid postoperatively from postoperative day 1). The baseline data including demographic data and preoperative conditions were collected. The end points included operation time, intraoperative bleeding volume, postoperative chest tube drainage volume and duration as well as lab coagulation function data.
RESULTS
A total of 58 qualified patients were randomized into case group (29 patients) and control group (29 patients), and after excluding 6 conversion patients, the case group and control group each had 26 patients for analysis. The baseline data of the two groups were comparable. Operation time (P=0.368), intraoperative bleeding volume (P=0.231), postoperative drainage days (P=0.466), and mean drainage volume per day (P=0.108) were not significantly increased in case group compared with those of control group. Moreover, there were no significant differences of perioperative coagulation function between these two groups.
CONCLUSIONS
Preoperative administration of heparin for thromboprophylaxis in Chinese patients intended for thoracoscopic major thoracic surgery was safe and feasible.
TRIAL REGISTRATION
NCT02940444 (https://register.clinicaltrials.gov/).
背景
接受大型胸外科手术尤其是癌症手术的患者围手术期血栓栓塞风险很高。目前的指南推荐对那些有深静脉血栓形成（DVT）高风险的患者使用肝素钠（普通肝素）或低分子量肝素（LMWH）。然而，开始使用肝素的合理时机尚未完全确立，因为DVT不仅可由手术引起，还可由合并症以及住院时间延长导致，而且胸外科医生一直担心肝素会增加术中或术后出血的风险。因此，本研究旨在确立术前给予肝素对拟行胸腔镜大型胸外科手术的中国患者进行血栓预防的安全性。
方法
2016年6月至8月，将拟行胸腔镜肺叶切除术、食管切除术和胸腺切除术的患者随机分为两组：病例组（入院后术前开始给予肝素钠5000U，每日两次）和对照组（术后第1天起术后给予肝素钠5000U，每日两次）。收集包括人口统计学数据和术前情况在内的基线数据。终点指标包括手术时间、术中出血量、术后胸腔闭式引流液量及持续时间以及实验室凝血功能数据。
结果
共有58例合格患者被随机分为病例组（29例患者）和对照组（29例患者），排除6例中转患者后，病例组和对照组各有26例患者进行分析。两组的基线数据具有可比性。与对照组相比，病例组的手术时间（P = 0.368）、术中出血量（P = 0.231）、术后引流天数（P = 0.466）和每日平均引流量（P = 0.108）均无显著增加。此外，两组围手术期凝血功能无显著差异。
结论
术前给予肝素对拟行胸腔镜大型胸外科手术的中国患者进行血栓预防是安全可行的。
试验注册
NCT02940444（https://register.clinicaltrials.gov/）
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