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[择期全膝关节和髋关节置换术后抗血栓预防的安全性和有效性分析:一项前瞻性单中心真实世界研究]

[Analysis of the safety and effectiveness of antithrombotic prophylaxis after elective total knee and hip arthroplasty: a prospective single-center real-world study].

作者信息

Okisheva E А, Trushina O I, Madoyan M D, Fidanyan S E, Solonina A D, Zhidilyaev A V, Lychagin A V, Fomin V V

机构信息

Sechenov First Moscow State Medical University (Sechenov University).

出版信息

Ter Arkh. 2025 Jul 31;97(7):550-555. doi: 10.26442/00403660.2025.07.203279.

Abstract

AIM

To evaluate the safety and effectiveness of various antithrombotic prophylaxis regimens after elective total knee arthroplasty (TKA) and elective total hip arthroplasty (THA).

MATERIALS AND METHODS

Medical history, information about concomitant diseases and previously prescribed drug therapy was recorded in all participants. Subsequently, a prospective observation was performed to record specific antithrombotic drugs and the duration of their use after surgery, patient compliance with the rehabilitation regimen, all cases of thrombosis and bleeding; all patients were contacted by phone 1 and 3 months after surgery.

RESULTS

The study population included 271 males (34.7%) and 511 females (65.3%). 332 (42.5%) patients underwent THA and 450 (57.5%) patients underwent TKA. In the perioperative period, 769 patients (98.3%) received fraxiparine monotherapy as antithrombotic prophylaxis, and 13 (1.7%) patients received fraxiparine in combination with an antiplatelet agent due to previous percutaneous coronary intervention or very high cardiac risk. Within 1 month after surgery, 31 (4.0%) patients did not take any anticoagulants despite the prescriptions, 20 (2.6%) patients used aspirin instead of the prescribed anticoagulants. Other patients received direct oral anticoagulants (dabigatran, rivaroxaban, or apixaban) or warfarin as prescribed; among them 73 (9.3%) patients received concomitant antiplatelet agents. Seven (0.9%) patients used three anticoagulants concomitantly. During the first month after surgery, 9 cases (1.2%) of deep vein thrombosis were recorded (5 patients took no anticoagulants, another 4 participants were not compliant with the rehabilitation regimen). 5 (0.6%) cases of epistaxis, 4 (0.5%) cases of hemorrhoidal bleeding and 2 (0.2%) cases of hematoma in the surgical area were reported. All cases of thrombosis and bleeding were mild and resolved spontaneously. No statistically significant differences in the incidence of adverse events were found between different anticoagulant therapy regimens.

CONCLUSION

In a cohort of real-world patients undergoing elective TKA or THA, the differences between the effectiveness and safety of various anticoagulant prophylaxis regimens were not statistically significant. The incidence of thrombosis was low, and these complications were mainly reported in non-compliant patients. The incidence of bleeding in patients taking anticoagulants with antiplatelet agents was not elevated, however, the size of this subpopulation is small and does not allow to perform a significant assessment of the safety of this treatment regimen. Based on the findings, it is reasonable to develop additional methods to improve patient compliance in order to reduce the frequency of medication errors and decrease the incidence of possible complications.

摘要

目的

评估择期全膝关节置换术(TKA)和择期全髋关节置换术(THA)后各种抗血栓预防方案的安全性和有效性。

材料与方法

记录所有参与者的病史、伴随疾病信息和先前规定的药物治疗情况。随后,进行前瞻性观察,记录特定的抗血栓药物及其术后使用时长、患者对康复方案的依从性、所有血栓形成和出血病例;术后1个月和3个月通过电话联系所有患者。

结果

研究人群包括271名男性(34.7%)和511名女性(65.3%)。332例(42.5%)患者接受了THA,450例(57.5%)患者接受了TKA。围手术期,769例(98.3%)患者接受了氟哌啶醇单药治疗作为抗血栓预防,13例(1.7%)患者因先前的经皮冠状动脉介入治疗或极高的心脏风险接受了氟哌啶醇与抗血小板药物联合治疗。术后1个月内,31例(4.0%)患者尽管有处方但未服用任何抗凝剂,20例(2.6%)患者使用阿司匹林替代规定的抗凝剂。其他患者按规定接受直接口服抗凝剂(达比加群、利伐沙班或阿哌沙班)或华法林治疗;其中73例(9.3%)患者同时接受了抗血小板药物治疗。7例(0.9%)患者同时使用了三种抗凝剂。术后第一个月,记录到9例(1.2%)深静脉血栓形成(5例患者未服用抗凝剂,另外4名参与者未遵守康复方案)。报告了5例(0.6%)鼻出血、4例(0.5%)痔疮出血和2例(0.2%)手术区域血肿。所有血栓形成和出血病例均为轻度且自行缓解。不同抗凝治疗方案之间不良事件发生率无统计学显著差异。

结论

在接受择期TKA或THA的真实世界患者队列中,各种抗凝预防方案的有效性和安全性差异无统计学意义。血栓形成发生率较低,这些并发症主要发生在不依从的患者中。服用抗凝剂与抗血小板药物联合治疗的患者出血发生率未升高,然而,该亚组人群规模较小,无法对该治疗方案的安全性进行有效评估。基于这些发现,开发额外的方法以提高患者依从性,从而减少用药错误频率并降低可能并发症的发生率是合理的。

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