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3个月瑞舒伐他汀辅助治疗对深静脉血栓形成后血栓后综合征的影响:一项随机临床试验

The Effects of 3-Month Rosuvastatin Adjuvant Therapy on Post Thrombotic Syndrome following Deep Vein Thrombosis; a Randomized Clinical Trial.

作者信息

Pishgahi Mehdi, Ghane Fard Shirin, Lak Tabriz Rahil, Karimi Toudeshki Kimia, Talebi Zahra

机构信息

Department of Cardiology, Shohadaye Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Pediatric Endocrinologist, Shohadaye Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

出版信息

Arch Acad Emerg Med. 2023 Jun 10;11(1):e43. doi: 10.22037/aaem.v11i1.1972. eCollection 2023.

DOI:10.22037/aaem.v11i1.1972
PMID:37609533
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10440755/
Abstract

INTRODUCTION

Statins are known to have anticoagulation and anti-inflammatory effects. This study aimed to investigate the effect of Rosuvastatin in reduction of post thrombotic syndrome (PTS) following deep vein thrombosis (DVT).

METHODS

In this randomized clinical trial, patients who were diagnosed with DVT of lower extremity were randomly assigned to 4 treatment groups: group 1: Warfarin, group 2: Warfarin + Rosuvastatin, group 3: Rivaroxaban, and group 4: Rivaroxaban + Rosuvastatin. The treatments were followed for 3 months and prevalence of PTS (as primary outcome), as well as the changes in serum levels of D-dimer and C reactive protein (CRP), and the extent of thrombosis before and after the intervention (as secondary outcomes) were compared between groups.

RESULTS

182 patients with the mean age of 55.22 ± 4.1 years finished the trial period (51.64% male). There was no significant difference between the groups regarding the baseline characteristics. Based on the Brandjes score, 31 (17.03%) patients had PTS at the end of the study. The occurrence of PTS was significantly lower in the groups taking statins (p<0.0001). Although the change in the mean difference of legs circumference before and after intervention, were significant in all groups (p < 0.05), the differences was more prominent in groups 2 and 4 (p < 0.0001). After 3 months of taking medication, decrease of CRP was more prominent in the statin groups (p = 0.001), and most cases with normal CRP were in statin groups. Among the patients with the serum D-dimer level above 10000 ng/mL, patients in the statin groups experienced significantly more reduction in D-dimer levels than the other groups (p<0.001).

CONCLUSION

Rosuvastatin administration in combination with rivaroxaban or warfarin significantly reduces the level of inflammatory factors including CRP and D-dimer, compared to patients receiving anticoagulants alone. Rosuvastatin administration can significantly reduce the incidence of PTS and cause a difference in the size of the lower limbs within 3 months.

摘要

引言

已知他汀类药物具有抗凝和抗炎作用。本研究旨在探讨瑞舒伐他汀对降低深静脉血栓形成(DVT)后血栓形成后综合征(PTS)的效果。

方法

在这项随机临床试验中,被诊断为下肢DVT的患者被随机分配到4个治疗组:第1组:华法林;第2组:华法林+瑞舒伐他汀;第3组:利伐沙班;第4组:利伐沙班+瑞舒伐他汀。治疗持续3个月,比较各组PTS的患病率(作为主要结局)、血清D-二聚体和C反应蛋白(CRP)水平的变化以及干预前后血栓形成的程度(作为次要结局)。

结果

182例平均年龄为55.22±4.1岁的患者完成了试验期(男性占51.64%)。各组的基线特征无显著差异。根据布兰德杰斯评分,31例(17.03%)患者在研究结束时患有PTS。服用他汀类药物的组中PTS的发生率显著较低(p<0.0001)。虽然所有组干预前后腿部周长的平均差异变化均有统计学意义(p<0.05),但第2组和第4组的差异更为显著(p<0.0001)。服药3个月后,他汀类药物组CRP的下降更为显著(p = 0.001),且大多数CRP正常的病例在他汀类药物组。在血清D-二聚体水平高于10000 ng/mL的患者中,他汀类药物组患者的D-二聚体水平下降明显多于其他组(p<0.001)。

结论

与单独接受抗凝剂治疗的患者相比,联合使用利伐沙班或华法林的同时给予瑞舒伐他汀可显著降低包括CRP和D-二聚体在内的炎症因子水平。给予瑞舒伐他汀可显著降低PTS的发生率,并在3个月内使下肢大小出现差异。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/430f/10440755/ea164e3a27da/aaem-11-e43-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/430f/10440755/ea164e3a27da/aaem-11-e43-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/430f/10440755/ea164e3a27da/aaem-11-e43-g001.jpg

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