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中国患者肺叶切除术后静脉血栓栓塞症和出血的发生率:机械预防或机械预防联合药物预防:一项随机对照试验。

Incidence of venous thromboembolism and hemorrhage in Chinese patients after pulmonary lobectomy: mechanical prophylaxis or mechanical prophylaxis combined with pharmacological prophylaxis: a randomized controlled trial.

作者信息

Hong Yun, Zhang Yanfang, Xiang Yangwei, Ye Ziqi, Lu Xiaoyang

机构信息

Department of Clinical Pharmacy, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.

Department of Lung Transplantation and Thoracic Surgery, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.

出版信息

Ann Transl Med. 2021 Sep;9(18):1478. doi: 10.21037/atm-21-4231.

DOI:10.21037/atm-21-4231
PMID:34734030
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8506730/
Abstract

BACKGROUND

Venous thromboembolism (VTE) and postoperative bleeding are important complications of lung resection surgery. We investigated the preventive effect of mechanical prophylaxis versus pharmacological prophylaxis after lobectomy, and evaluated the effect of both on the incidence of hemorrhagic events.

METHODS

A prospective study of 424 lobectomies with moderate to high risk of VTE (Caprini risk score <5) in a single center was performed from April 2020 to March 2021. Patients were 1:1 randomly allocated to mechanical prophylaxis or to the low-molecular-weight heparin (LMWH)-combination-prophylaxis. The incidence of postoperative thrombotic and bleeding events and relevant factors of the two groups were analyzed.

RESULTS

A total of 410 participants, with 202 and 208 in the mechanical prophylaxis and LMWH-combination-prophylaxis groups respectively, were selected for analysis. Both groups had similar baseline and clinical characteristics. There were no cases of VTE or major bleeding during the study, but the incidence rate of minor bleeding in the LMWH-combination-prophylaxis group was significantly higher than mechanical prophylaxis group [odds ratio (OR) 0.035, 95% confidence interval (CI): 0.011-0.113].

CONCLUSIONS

A case-by-case risk assessment of VTE and hemorrhage remains necessary to determine the most appropriate method of thrombosis prophylaxis for patients undergoing pulmonary surgery. Mechanical prophylaxis may be preferable for lung cancer patients with moderate to high risk of VTE (Caprini risk score <5) undergoing lobectomy.

TRIAL REGISTRATION

Chinese Clinical Trial Registry ChiCTR2100051073.

摘要

背景

静脉血栓栓塞症(VTE)和术后出血是肺切除手术的重要并发症。我们研究了肺叶切除术后机械预防与药物预防的预防效果,并评估了两者对出血事件发生率的影响。

方法

2020年4月至2021年3月在单中心进行了一项前瞻性研究,纳入424例行肺叶切除术且VTE风险为中度至高度(Caprini风险评分<5)的患者。患者按1:1随机分配至机械预防组或低分子肝素(LMWH)联合预防组。分析两组术后血栓形成和出血事件的发生率及相关因素。

结果

共选取410名参与者进行分析,其中机械预防组202例,LMWH联合预防组208例。两组的基线和临床特征相似。研究期间无VTE或大出血病例,但LMWH联合预防组的轻微出血发生率显著高于机械预防组[比值比(OR)0.035,95%置信区间(CI):0.011 - 0.113]。

结论

对于接受肺部手术的患者,仍有必要进行VTE和出血的个体化风险评估,以确定最合适的血栓预防方法。对于接受肺叶切除术且VTE风险为中度至高度(Caprini风险评分<5)的肺癌患者,机械预防可能更可取。

试验注册

中国临床试验注册中心ChiCTR2100051073

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6556/8506730/30b5a0803e29/atm-09-18-1478-f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6556/8506730/30b5a0803e29/atm-09-18-1478-f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6556/8506730/30b5a0803e29/atm-09-18-1478-f1.jpg

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2
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3
Dynamics of D-dimer in non-small cell lung cancer patients receiving radical surgery and its association with postoperative venous thromboembolism.
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Thorac Cancer. 2020 Sep;11(9):2483-2492. doi: 10.1111/1759-7714.13559. Epub 2020 Jul 13.
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