Scholarlink

Background <p>Compared with alteplase, recombinant human prourokinase (rhPro-UK)—a next-generation specific plasminogen activator—offers advantages such as weight-independent dosing and cost effectiveness. While a 35-mg dose of rhPro-UK has been recommended in previous randomized controlled trials (RCTs), its efficacy and safety profile have yet to be fully elucidated, as no relevant systematic reviews or meta-analyses have been conducted to date.</p> Aim <p>This meta-analysis aimed to evaluate the safety and efficacy of 35&#xa0;mg of rhPro-UK compared with those of control treatments, including 50&#xa0;mg of rhPro-UK and alteplase monotherapy, in patients with acute ischemic stroke (AIS).</p> Method <p>Two independent reviewers systematically searched the PubMed, Embase, Cochrane Library, Scopus, and ClinicalTrials.gov electronic databases up to May 24, 2025, to identify RCTs assessing the effects of 35&#xa0;mg rhPro-UK versus control therapies in AIS patients. Study quality was assessed using the Cochrane RoB 2 tool. A random effects model was employed for the meta-analysis using Stata 18.0.</p> Results <p>Four RCTs involving 2412 patients were included. The 35-mg dose of rhPro-UK demonstrated comparable safety and efficacy to those of the other treatments. Notably, this dose was associated with the potential advantages of increasing early neurological recovery at 24&#xa0;h (SMD = −&#xa0;0.29, 95% CI −&#xa0;0.55 to −&#xa0;0.03, <i>P</i> = 0.03) and reducing systemic bleeding risk at 90&#xa0;days (RR = 0.59, 95% CI 0.48–0.73, <i>P</i> &lt; 0.001). Subgroup analysis suggested that 35&#xa0;mg of rhPro-UK might be associated with lower odds of SAEs than 50&#xa0;mg of rhPro-UK (I<sup>2</sup> = 0%, <i>P</i> = 0.039); however, there was no significant difference in rt-PA (I<sup>2</sup> = 0%, <i>P</i> = 0.413) at 90&#xa0;days.</p> Conclusion <p>This meta-analysis suggested that 35&#xa0;mg of rhPro-UK does not significantly differ from 50&#xa0;mg of rhPro-UK or alteplase in terms of clinical outcomes among AIS patients. However, the 35-mg dose of rhPro-UK has the potential advantages of enhancing early neurological recovery and reducing the risk of systemic bleeding. Subgroup analysis revealed that 35&#xa0;mg of rhPro-UK might be associated with a lower risk of SAEs than 50&#xa0;mg of rhPro-UK.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Efficacy and safety of 35 mg of recombinant human prourokinase for thrombolysis in acute ischemic stroke: a meta-analysis of randomized controlled trials

  • 期刊论文

  • 发表日期：

    2025年7月29日

查看全文
  • Ping He,
  • Suhong Wang,
  • Jie Chen,
  • Haodong Zhou,
  • Haibin Dai

摘要

Background

Compared with alteplase, recombinant human prourokinase (rhPro-UK)—a next-generation specific plasminogen activator—offers advantages such as weight-independent dosing and cost effectiveness. While a 35-mg dose of rhPro-UK has been recommended in previous randomized controlled trials (RCTs), its efficacy and safety profile have yet to be fully elucidated, as no relevant systematic reviews or meta-analyses have been conducted to date.

Aim

This meta-analysis aimed to evaluate the safety and efficacy of 35 mg of rhPro-UK compared with those of control treatments, including 50 mg of rhPro-UK and alteplase monotherapy, in patients with acute ischemic stroke (AIS).

Method

Two independent reviewers systematically searched the PubMed, Embase, Cochrane Library, Scopus, and ClinicalTrials.gov electronic databases up to May 24, 2025, to identify RCTs assessing the effects of 35 mg rhPro-UK versus control therapies in AIS patients. Study quality was assessed using the Cochrane RoB 2 tool. A random effects model was employed for the meta-analysis using Stata 18.0.

Results

Four RCTs involving 2412 patients were included. The 35-mg dose of rhPro-UK demonstrated comparable safety and efficacy to those of the other treatments. Notably, this dose was associated with the potential advantages of increasing early neurological recovery at 24 h (SMD = − 0.29, 95% CI − 0.55 to − 0.03, P = 0.03) and reducing systemic bleeding risk at 90 days (RR = 0.59, 95% CI 0.48–0.73, P < 0.001). Subgroup analysis suggested that 35 mg of rhPro-UK might be associated with lower odds of SAEs than 50 mg of rhPro-UK (I2 = 0%, P = 0.039); however, there was no significant difference in rt-PA (I2 = 0%, P = 0.413) at 90 days.

Conclusion

This meta-analysis suggested that 35 mg of rhPro-UK does not significantly differ from 50 mg of rhPro-UK or alteplase in terms of clinical outcomes among AIS patients. However, the 35-mg dose of rhPro-UK has the potential advantages of enhancing early neurological recovery and reducing the risk of systemic bleeding. Subgroup analysis revealed that 35 mg of rhPro-UK might be associated with a lower risk of SAEs than 50 mg of rhPro-UK.