【原】利伐沙班或低分子肝素在非大型骨科手术中的应用

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Rivaroxaban or Enoxaparin in Nonmajor Orthopedic Surgery

背景与目的

下肢非大型骨科手术导致的暂时性活动能力下降，可致患者出现静脉血栓栓塞的风险增加。在预防这类患者出现下肢主要静脉血栓栓塞方面，利伐沙班的作用可能并不强于低分子肝素。

方  法

本项国际性、平行、随机、双盲、非劣效性试验中，我们随机分配施行下肢非大型骨科手术的成年患者接受利伐沙班或低分子肝素治疗，根据研究者的判断，这些患者出现静脉血栓栓塞的风险较大。下肢大静脉血栓栓塞的主要治疗结果是治疗期间手术部位的远端或近端深静脉血栓形成、肺栓塞或静脉血栓栓塞相关死亡，或治疗结束时未手术部位的近端深静脉血栓形成。如果利伐沙班被证明并不比低分子肝素疗效差，则计划进行优越性试验。对于所有结果，均采用多重填补法来解释缺失的数据。预先指定的安全性结果包括大出血（致命的、严重的或临床上明显的出血或需要干预的手术部位出血）和非大量的临床相关性出血。

结 果  

3604例患者随机分组，1809例患者接受利伐沙班治疗，1795例接受低分子肝素治疗。1661例利伐沙班组患者中有4例(0.2%)发生大静脉血栓栓塞，而1640例低分子肝素组患者中有18例(1.1%)发生大静脉血栓栓塞(多重归责风险比为0.25;95%CI 0.09 ~ 0.75;非劣效性P<0.001;优越性P=0.01)。利伐沙班组和低分子肝素组的出血发生率无显著差异（大出血或非大量的临床相关性出血分别为1.1%和1.0%；大出血分别为0.6%和0.7%）。

结 论

下肢非大型骨科手术后制动期间，利伐沙班可比低分子肝素更有效地预防静脉血栓栓塞事件发生。

原始文献摘要

Samama CM, Laporte S, Rosencher N, et al. Rivaroxaban or Enoxaparin in Nonmajor Orthopedic Surgery.[J].N Engl J Med,2020,382(20):1916-1925.

BACKGROUND

Nonmajor orthopedic surgery of the lower limbs that results in transient reduced mobility places patients at risk for venous thromboembolism. Rivaroxaban may be noninferior to enoxaparin with regard to the prevention of major venous thromboembolism in these patients.

METHODS

In this international, parallel-group, randomized, double-blind, noninferiority trial, we randomly assigned adult patients undergoing lower-limb nonmajor orthopedic surgery who were considered to be at risk for venous thromboembolism on the basis of the investigator’s judgment to receive either rivaroxaban or enoxaparin. The primary efficacy outcome of major venous thromboembolism was a composite of symptomatic distal or proximal deep-vein thrombosis, pulmonary embolism, or venous thromboembolism–related death during the treatment period or asymptomatic proximal deep-vein thrombosis at the end of treatment. A test for superiority was planned if rivaroxaban proved to be noninferior to enoxaparin. For all outcomes, multiple imputation was used to account for missing data. Prespecified safety outcomes included major bleeding (fatal, critical, or clinically overt bleeding or bleeding at the surgical site leading to intervention) and nonmajor clinically relevant bleeding.

RESULTS

A total of 3604 patients underwent randomization; 1809 patients were assigned to receive rivaroxaban, and 1795 to receive enoxaparin. Major venous thromboembolism occurred in 4 of 1661 patients (0.2%) in the rivaroxaban group and in 18 of 1640 patients (1.1%) in the enoxaparin group (risk ratio with multiple imputation, 0.25; 95% confidence interval, 0.09 to 0.75; P<0.001 for noninferiority; P=0.01 for superiority). The incidence of bleeding did not differ significantly between the rivaroxaban group and the enoxaparin group (1.1% and 1.0%, respectively, for major bleeding or nonmajor clinically relevant bleeding; 0.6% and 0.7%, respectively, for major bleeding).

CONCLUSIONS

Rivaroxaban was more effective than enoxaparin in the prevention of venous thromboembolic events during a period of immobilization after nonmajor orthopedic surgery of the lower limbs.

(Funded by Centre Hospitalier Universitaire de Saint-Etienne and Bayer; PRONOMOS ClinicalTrials.gov number, NCT02401594.)

罂粟花

麻醉学文献进展分享

贵州医科大学高鸿教授课题组

翻译：冯玉蓉  编辑：冯玉蓉  审校：王贵龙