Pai Zheng, Guangwei Che, Xueer Zhang, Haoming You, Jiayuan Peng, Yong Huang, Lihan Shi
{"title":"fondaparinux钠在高危静脉血栓栓塞患者前十字韧带重建中的抗凝和抗炎作用：一项随机对照、三盲、前瞻性研究","authors":"Pai Zheng, Guangwei Che, Xueer Zhang, Haoming You, Jiayuan Peng, Yong Huang, Lihan Shi","doi":"10.1002/ksa.70081","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>This study aimed to evaluate the anticoagulant and anti-inflammatory effects of fondaparinux sodium in patients at high risk of venous thromboembolism (VTE) undergoing anterior cruciate ligament (ACL) reconstruction.</p><p><strong>Methods: </strong>A single-centre, triple-blinded, randomised, controlled study enroled high-risk VTE patients (Caprini score ≥ 5) undergoing ACL reconstruction. Patients were randomised to receive either fondaparinux sodium (2.5 mg daily for 14 days) or enoxaparin sodium (4000 AxaIU daily for 14 days). Coagulation parameters, inflammatory markers, thromboelastography (TEG) and duplex ultrasound of the lower limbs were assessed at predefined time points.</p><p><strong>Results: </strong>A total of 72 patients were included. Baseline demographic characteristics, including age, gender and preoperative health status, were similar between the two groups. No cases of deep vein thrombosis (DVT) or pulmonary embolism (PE) were reported in either group. Group A showed significantly lower D-dimer levels on postoperative days 3, 7, and 13 and higher activated partial thromboplastin time (APTT) on Day 7 (p < 0.05). TEG showed that reaction time (R) was longer in Group A, and maximum amplitude (MA) increased postoperatively (p < 0.05). Inflammatory markers (ESR, CRP and IL-6) were significantly lower in Group A at multiple time points (p < 0.05). Knee circumference also decreased significantly in Group A on Days 3 and 7 (p < 0.05). No significant differences were found between the groups regarding pain, blood loss or postoperative complications (p > 0.05).</p><p><strong>Conclusion: </strong>In high-risk VTE patients undergoing ACL reconstruction, fondaparinux sodium exhibited superior anticoagulant and anti-inflammatory effects compared to enoxaparin sodium, with reduced knee swelling. No significant differences were observed in major postoperative VTE events or bleeding risks, suggesting fondaparinux sodium may be a preferable option for postoperative thromboprophylaxis.</p><p><strong>Level of evidence: </strong>Level I.</p>","PeriodicalId":520702,"journal":{"name":"Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA","volume":" ","pages":""},"PeriodicalIF":5.0000,"publicationDate":"2025-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Anticoagulant and anti-inflammatory effects of fondaparinux sodium during anterior cruciate ligament reconstruction in high risk VTE patients: A randomised controlled, triple blinded, prospective study.\",\"authors\":\"Pai Zheng, Guangwei Che, Xueer Zhang, Haoming You, Jiayuan Peng, Yong Huang, Lihan Shi\",\"doi\":\"10.1002/ksa.70081\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>This study aimed to evaluate the anticoagulant and anti-inflammatory effects of fondaparinux sodium in patients at high risk of venous thromboembolism (VTE) undergoing anterior cruciate ligament (ACL) reconstruction.</p><p><strong>Methods: </strong>A single-centre, triple-blinded, randomised, controlled study enroled high-risk VTE patients (Caprini score ≥ 5) undergoing ACL reconstruction. Patients were randomised to receive either fondaparinux sodium (2.5 mg daily for 14 days) or enoxaparin sodium (4000 AxaIU daily for 14 days). Coagulation parameters, inflammatory markers, thromboelastography (TEG) and duplex ultrasound of the lower limbs were assessed at predefined time points.</p><p><strong>Results: </strong>A total of 72 patients were included. Baseline demographic characteristics, including age, gender and preoperative health status, were similar between the two groups. No cases of deep vein thrombosis (DVT) or pulmonary embolism (PE) were reported in either group. Group A showed significantly lower D-dimer levels on postoperative days 3, 7, and 13 and higher activated partial thromboplastin time (APTT) on Day 7 (p < 0.05). TEG showed that reaction time (R) was longer in Group A, and maximum amplitude (MA) increased postoperatively (p < 0.05). Inflammatory markers (ESR, CRP and IL-6) were significantly lower in Group A at multiple time points (p < 0.05). Knee circumference also decreased significantly in Group A on Days 3 and 7 (p < 0.05). No significant differences were found between the groups regarding pain, blood loss or postoperative complications (p > 0.05).</p><p><strong>Conclusion: </strong>In high-risk VTE patients undergoing ACL reconstruction, fondaparinux sodium exhibited superior anticoagulant and anti-inflammatory effects compared to enoxaparin sodium, with reduced knee swelling. No significant differences were observed in major postoperative VTE events or bleeding risks, suggesting fondaparinux sodium may be a preferable option for postoperative thromboprophylaxis.</p><p><strong>Level of evidence: </strong>Level I.</p>\",\"PeriodicalId\":520702,\"journal\":{\"name\":\"Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":5.0000,\"publicationDate\":\"2025-09-29\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1002/ksa.70081\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1002/ksa.70081","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Anticoagulant and anti-inflammatory effects of fondaparinux sodium during anterior cruciate ligament reconstruction in high risk VTE patients: A randomised controlled, triple blinded, prospective study.
Purpose: This study aimed to evaluate the anticoagulant and anti-inflammatory effects of fondaparinux sodium in patients at high risk of venous thromboembolism (VTE) undergoing anterior cruciate ligament (ACL) reconstruction.
Methods: A single-centre, triple-blinded, randomised, controlled study enroled high-risk VTE patients (Caprini score ≥ 5) undergoing ACL reconstruction. Patients were randomised to receive either fondaparinux sodium (2.5 mg daily for 14 days) or enoxaparin sodium (4000 AxaIU daily for 14 days). Coagulation parameters, inflammatory markers, thromboelastography (TEG) and duplex ultrasound of the lower limbs were assessed at predefined time points.
Results: A total of 72 patients were included. Baseline demographic characteristics, including age, gender and preoperative health status, were similar between the two groups. No cases of deep vein thrombosis (DVT) or pulmonary embolism (PE) were reported in either group. Group A showed significantly lower D-dimer levels on postoperative days 3, 7, and 13 and higher activated partial thromboplastin time (APTT) on Day 7 (p < 0.05). TEG showed that reaction time (R) was longer in Group A, and maximum amplitude (MA) increased postoperatively (p < 0.05). Inflammatory markers (ESR, CRP and IL-6) were significantly lower in Group A at multiple time points (p < 0.05). Knee circumference also decreased significantly in Group A on Days 3 and 7 (p < 0.05). No significant differences were found between the groups regarding pain, blood loss or postoperative complications (p > 0.05).
Conclusion: In high-risk VTE patients undergoing ACL reconstruction, fondaparinux sodium exhibited superior anticoagulant and anti-inflammatory effects compared to enoxaparin sodium, with reduced knee swelling. No significant differences were observed in major postoperative VTE events or bleeding risks, suggesting fondaparinux sodium may be a preferable option for postoperative thromboprophylaxis.
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