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

IF 3.2 4区医学 Q2 PHARMACOLOGY & PHARMACY

International Journal of Clinical Pharmacy Pub Date : 2025-07-29 DOI:10.1007/s11096-025-01973-5

Ping He, Suhong Wang, Jie Chen, Haodong Zhou, Haibin Dai

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引用次数: 0

Abstract

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.

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重组人普罗激酶35mg用于急性缺血性卒中溶栓的疗效和安全性：一项随机对照试验的荟萃分析

背景：与阿替普酶相比，重组人原激酶（rhPro-UK）是下一代特异性纤溶酶原激活剂，具有不依赖剂量和成本效益等优势。虽然在之前的随机对照试验（rct）中推荐使用35mg剂量的rhPro-UK，但其有效性和安全性尚未得到充分阐明，因为迄今尚未进行相关的系统评价或荟萃分析。目的：本荟萃分析旨在评估35 mg rhPro-UK与对照治疗（包括50 mg rhPro-UK和阿替普酶单药治疗）在急性缺血性卒中（AIS）患者中的安全性和有效性。方法：两位独立审稿人系统地检索了PubMed、Embase、Cochrane Library、Scopus和ClinicalTrials.gov电子数据库，检索时间截止到2025年5月24日，以确定评估35 mg rhPro-UK与对照治疗在AIS患者中的效果的随机对照试验。使用Cochrane RoB 2工具评估研究质量。meta分析采用随机效应模型，采用Stata 18.0软件。结果：纳入4项随机对照试验，共2412例患者。35毫克剂量的rhPro-UK显示出与其他治疗相当的安全性和有效性。值得注意的是，该剂量与增加24小时早期神经恢复（SMD = - 0.29, 95% CI - 0.55至- 0.03,P = 0.03）和降低90天全身出血风险（RR = 0.59, 95% CI 0.48至0.73,P 2 = 0%, P = 0.039）的潜在优势相关；然而，90 d时rt-PA无显著差异（I2 = 0%, P = 0.413）。结论：这项荟萃分析表明，在AIS患者的临床结果方面，35 mg rhPro-UK与50 mg rhPro-UK或阿替普酶没有显著差异。然而，35mg剂量的rhPro-UK具有增强早期神经恢复和降低全身性出血风险的潜在优势。亚组分析显示，35 mg的rhPro-UK可能比50 mg的rhPro-UK发生SAEs的风险更低。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

International Journal of Clinical Pharmacy PHARMACOLOGY & PHARMACY-

CiteScore

4.10

自引率

8.30%

发文量

131

审稿时长

4-8 weeks

期刊介绍： The International Journal of Clinical Pharmacy (IJCP) offers a platform for articles on research in Clinical Pharmacy, Pharmaceutical Care and related practice-oriented subjects in the pharmaceutical sciences. IJCP is a bi-monthly, international, peer-reviewed journal that publishes original research data, new ideas and discussions on pharmacotherapy and outcome research, clinical pharmacy, pharmacoepidemiology, pharmacoeconomics, the clinical use of medicines, medical devices and laboratory tests, information on medicines and medical devices information, pharmacy services research, medication management, other clinical aspects of pharmacy. IJCP publishes original Research articles, Review articles , Short research reports, Commentaries, book reviews, and Letters to the Editor. International Journal of Clinical Pharmacy is affiliated with the European Society of Clinical Pharmacy (ESCP). ESCP promotes practice and research in Clinical Pharmacy, especially in Europe. The general aim of the society is to advance education, practice and research in Clinical Pharmacy . Until 2010 the journal was called Pharmacy World & Science.