达比加群在门静脉血栓再通率、疾病进展及生存率方面的应用经验
Experience With Dabigatran on Rate of Portal Vein Thrombosis Recanalization, Disease Progression and Survival.
作者信息
Premkumar Madhumita, Bhujade Harish, Sharma Prerna, Nain Jasvinder, Ahluwalia Jasmina, Sandhu Anchal, Kumar Yogendra, Rathi Sahaj, Taneja Sunil, Duseja Ajay Kumar, Kulkarni Anand V, Singh Charanpreet, Naseem Shano, Karki Tanka, Gupta Pankaj, Chaluvashetty Sreedhara B, Lad Deepesh, Reddy K Rajender
机构信息
Department of Hepatology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
Department of Radiodiagnosis and Interventional Radiology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
出版信息
Aliment Pharmacol Ther. 2025 Mar;61(6):971-987. doi: 10.1111/apt.18474. Epub 2025 Jan 3.
BACKGROUND AND AIMS
We assessed clinical, procoagulant and genetic risk factors and clinical outcomes in dabigatran-treated patients with non-tumoural acute and acute-on-chronic portal vein thrombosis (PVT).
METHODS
Patients with a new diagnosis of non-tumoural acute and acute-on-chronic PVT between January 2021 and January 2024 (aged ≥ 18 years) in those without/with cirrhosis (Child-Pugh (CP)-A/B/C ≤ 10) were started on dabigatran and followed and compared with those on vitamin K antagonist (VKA) and untreated individuals.
RESULTS
Dabigatran was prescribed in 119 patients with PVT type 1 (61, 51.3%), type 2 (34, 28.6%), type 3 (24, 20.2%); 72 (60.5%) with cirrhosis [CP-A (27, 37.5%), CP-B (43, 59.7%) and CP-C10 (2, 2.8%)]. Procoagulant factors noted were JAK2V617F (10.1%), CALR (2.5%) and factor V Leiden (1.6%) mutations, antiphospholipid syndrome (APS, 15.2%), isolated Protein C (14.3%) and Protein S (16.8%) deficiency.
COMPARATORS
28 patients who declined anticoagulation/were unable to come for follow-up, and six with CP-C received VKA. Overall recanalization rate (RR) on dabigatran was 56 (47.1%); 25 (21%) complete recanalization, 31 (26%) partial recanalization and 63 (52.9%) stable PVT over median follow-up of 32 months. Patients not anticoagulated had a spontaneous RR in 21.4% (28 patients; p = 0.005 compared with dabigatran group) and none recanalized on VKA. On multivariable analysis, predictors of recanalization on dabigatran were Factor VIII Antigen level (FVIII:Ag, HR 0.6; 95% CI 0.3-0.9, p = 0.032), non-occlusive PVT (HR 3.5, 95% CI 1.9-5.6, p = 0.025) and acute PVT (HR 2.1; 95% CI 1.5-3.2, p = 0.003). Mortality was 14 (11.8%).
CONCLUSION
On dabigatran, 47% of 119 patients achieved portal vein recanalization over 32 months of follow-up which was higher than the spontaneous RR (21.4%) in an untreated cohort. High Factor VIII:Ag was a predictor of non-recanalization. Dabigatran was safe in cirrhosis (CP-A and B) while further work is needed in CP-C.
背景与目的
我们评估了接受达比加群治疗的非肿瘤性急性和慢性门静脉血栓形成（PVT）患者的临床、促凝血和遗传风险因素以及临床结局。
方法
2021年1月至2024年1月期间新诊断为非肿瘤性急性和慢性PVT的患者（年龄≥18岁），无论有无肝硬化（Child-Pugh（CP）-A/B/C≤10），均开始使用达比加群进行治疗，并进行随访，同时与接受维生素K拮抗剂（VKA）治疗的患者及未治疗的个体进行比较。
结果
119例PVT患者中，1型（61例，51.3%）、2型（34例，28.6%）、3型（24例，20.2%）接受了达比加群治疗；72例（60.5%）患有肝硬化[CP-A（27例，37.5%）、CP-B（43例，59.7%）和CP-C10（2例，2.8%）]。检测到的促凝血因素包括JAK2V617F（10.1%）、CALR（2.5%）和因子V Leiden（1.6%）突变、抗磷脂综合征（APS，15.2%）、单纯蛋白C缺乏（14.3%）和蛋白S缺乏（16.8%）。
对照
28例拒绝抗凝/无法前来随访的患者，以及6例CP-C患者接受了VKA治疗。在中位随访32个月期间，达比加群治疗组的总体再通率（RR）为56例（47.1%）；25例（21%）完全再通，31例（26%）部分再通，63例（52.9%）为稳定型PVT。未接受抗凝治疗的患者自发再通率为21.4%（28例患者；与达比加群组相比，p = 0.005），接受VKA治疗的患者无一例再通。多变量分析显示，达比加群治疗再通的预测因素为因子VIII抗原水平（FVIII:Ag，HR 0.6；95%CI 0.3-0.9，p = 0.032）、非闭塞性PVT（HR 3.5，95%CI 1.9-5.6，p = 0.025）和急性PVT（HR 2.1；95%CI 1.5-3.2，p = 0.003）。死亡率为14例（11.8%）。
结论
在达比加群治疗下，119例患者中有47%在32个月的随访期内实现了门静脉再通，高于未治疗队列中的自发再通率（21.4%）。高FVIII:Ag是未再通的预测因素。达比加群在肝硬化（CP-A和B）患者中是安全的，而CP-C患者则需要进一步研究。
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