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探索重组人尿激酶原在急性下肢深静脉血栓形成患者导管直接溶栓中的疗效。

Exploring the efficacy of recombinant human pro-urokinase in catheter-directed thrombolysis for acute lower extremity deep venous thrombosis patients.

作者信息

Ma Tao, Li Cangtuo, Song Guang, Yao Shaoxin

机构信息

Intervention Department, Tangshan Gongren Hospital, 27 Wenhua Road, Lubei District, Tangshan City, 063000, Hebei Province, China.

出版信息

BMC Cardiovasc Disord. 2025 Apr 30;25(1):342. doi: 10.1186/s12872-025-04800-x.

Abstract

BACKGROUND

Effective and innovative treatment for patients with acute lower-extremity deep venous thrombosis (DVT) is lacking. This study explored the use of recombinant human pro-urokinase (rhPro-UK) in catheter-directed thrombolysis for acute DVT patients.

METHODS

A retrospective analysis included 85 acute DVT patients undergoing CDT from January 2021 to December 2023. Patients were divided into an observation group (n = 43, rhPro-UK) and a control group (n = 42, UK). Outcomes assessed included total effective rate, venous patency score, limb circumference differences, coagulation parameters (PT, APTT, Fg), adverse events (BARC criteria), and post-thrombotic syndrome (PTS) incidence at 6 months (Villalta scale).

RESULTS

The observation group treated with rhPro-UK demonstrated superior clinical outcomes compared to the control group receiving urokinase. The total effective rate was significantly higher in the rhPro-UK group (P = 0.011), with improved venous patency reflected by a lower post-treatment patency score (P = 0.009) and higher patency rate (80.86% vs. 72.86%, P = 0.045). Limb swelling reduction was more pronounced in the rhPro-UK group, evidenced by smaller thigh (P = 0.002) and calf circumference differences (P = 0.001). Coagulation function improved significantly, with prolonged PT (P = 0.002) and APTT (P = 0.001), alongside reduced fibrinogen levels (P < 0.001). Safety outcomes favored rhPro-UK, with fewer total bleeding events (14.29% vs. 4.65%, P = 0.039) and no major bleeding (BARC Type 3) observed. At 6-month follow-up, the rhPro-UK group exhibited a markedly lower incidence of post-thrombotic syndrome (9.3% vs. 26.2%, P = 0.034) and sustained venous patency, confirming its long-term efficacy.

CONCLUSION

CDT with rhPro-UK significantly improves venous patency, reduces limb swelling, optimizes coagulation function, and minimizes complications compared to UK. Its fibrin-targeted mechanism enhances clinical efficacy and safety, supporting its adoption as a superior thrombolytic for acute DVT.

TRIAL REGISTRATION

Not applicable.

摘要

背景

目前缺乏针对急性下肢深静脉血栓形成(DVT)患者的有效且创新的治疗方法。本研究探讨了重组人尿激酶原(rhPro-UK)在急性DVT患者导管定向溶栓中的应用。

方法

一项回顾性分析纳入了2021年1月至2023年12月期间接受导管定向溶栓(CDT)的85例急性DVT患者。患者分为观察组(n = 43,rhPro-UK)和对照组(n = 42,尿激酶)。评估的结果包括总有效率、静脉通畅评分、肢体周径差异、凝血参数(PT、APTT、Fg)、不良事件(BARC标准)以及6个月时的血栓后综合征(PTS)发生率(Villalta量表)。

结果

与接受尿激酶治疗的对照组相比,接受rhPro-UK治疗的观察组显示出更好的临床效果。rhPro-UK组的总有效率显著更高(P = 0.011),治疗后通畅评分更低(P = 0.009)以及通畅率更高(80.86%对72.86%,P = 0.045),表明静脉通畅情况得到改善。rhPro-UK组肢体肿胀减轻更为明显,大腿(P = 0.002)和小腿周径差异更小(P = 0.001)。凝血功能显著改善,PT(P = 0.002)和APTT延长(P = 0.001),同时纤维蛋白原水平降低(P < 0.001)。安全性方面rhPro-UK更具优势,总出血事件更少(14.29%对4.65%,P = 0.039),且未观察到严重出血(BARC 3型)。在6个月随访时,rhPro-UK组血栓后综合征的发生率显著更低(9.3%对26.2%,P = 0.034),且静脉持续保持通畅,证实了其长期疗效。

结论

与尿激酶相比,rhPro-UK进行导管定向溶栓可显著改善静脉通畅情况,减轻肢体肿胀,优化凝血功能,并将并发症降至最低。其靶向纤维蛋白的机制提高了临床疗效和安全性,支持其作为急性DVT的更优溶栓药物被采用。

试验注册

不适用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4a4d/12042414/27ef0eceb9aa/12872_2025_4800_Fig1_HTML.jpg

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