蚓激酶治疗急性缺血性脑卒中的潜力:疗效和安全性的荟萃分析。

IF 2.8 3区 医学 Q1 Pharmacology, Toxicology and Pharmaceutics
Therapeutics and Clinical Risk Management Pub Date : 2025-09-04 eCollection Date: 2025-01-01 DOI:10.2147/TCRM.S537232
Elvan Wiyarta, Rakhmad Hidayat, Mohammad Kurniawan, Bryanna Infinita Laviashna Saputro, Indira Laksmi Maharani, Derren David Christian Homenta Rampengan, Lucia Callista Tanudharma, Raymond Rubianto Tjandrawinata
{"title":"蚓激酶治疗急性缺血性脑卒中的潜力:疗效和安全性的荟萃分析。","authors":"Elvan Wiyarta, Rakhmad Hidayat, Mohammad Kurniawan, Bryanna Infinita Laviashna Saputro, Indira Laksmi Maharani, Derren David Christian Homenta Rampengan, Lucia Callista Tanudharma, Raymond Rubianto Tjandrawinata","doi":"10.2147/TCRM.S537232","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Acute ischemic stroke (AIS) requires rapid treatment. Although alteplase is a standard thrombolytic therapy, its limited availability in low-resource settings presents a challenge. Lumbrokinase, a fibrinolytic enzyme isolated from earthworms, has been proposed as an adjunct treatment option. This meta-analysis evaluated efficacy and safety in addition to supportive care.</p><p><strong>Methods: </strong>A systematic review of randomized controlled trials (RCTs) was conducted using multiple databases through July 2024 following PRISMA guidelines. The risk of bias was assessed using RoB 2.0, and evidence quality was graded using GRADE. Publication bias was evaluated using funnel plots. Meta-analyses employed a random-effects model and reported odds ratios (ORs) and mean differences (MDs) with 95% confidence intervals. Primary outcomes included the Barthel Index and NIHSS scores, and secondary outcomes included adverse events and laboratory results.</p><p><strong>Results: </strong>A total of 35 RCTs published between 2010 and 2024 were included. Compared with supportive care alone, lumbrokinase adjunct therapy significantly improved Barthel Index scores (MD = 15.17; 95% CI: 14.60 to 15.74) and reduced NIHSS scores (MD = -2.01; 95% CI: -2.06 to -1.97). Safety analyses revealed no significant increase in adverse events including gastrointestinal discomfort (OR = 1.00; 95% CI: 0.32 to 3.16) and GI bleeding (OR = 1.42; 95% CI: 0.55 to 3.67). Laboratory assessments indicated improvements in aPTT (MD = 1.93; 95% CI: 1.58 to 2.28), platelet aggregation rate (MD = -205.86; 95% CI, -206.77 to -204.96), and D-dimer levels (MD = -0.04; 95% CI: -0.05 to -0.03).</p><p><strong>Conclusion: </strong>Lumbrokinase may safely improve stroke outcomes; however, limited evidence warrants cautious use and further high-quality trials.</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"21 ","pages":"1319-1331"},"PeriodicalIF":2.8000,"publicationDate":"2025-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12417717/pdf/","citationCount":"0","resultStr":"{\"title\":\"Therapeutic Potential of Lumbrokinase in Acute Ischemic Stroke: A Meta-Analysis of Efficacy and Safety.\",\"authors\":\"Elvan Wiyarta, Rakhmad Hidayat, Mohammad Kurniawan, Bryanna Infinita Laviashna Saputro, Indira Laksmi Maharani, Derren David Christian Homenta Rampengan, Lucia Callista Tanudharma, Raymond Rubianto Tjandrawinata\",\"doi\":\"10.2147/TCRM.S537232\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Acute ischemic stroke (AIS) requires rapid treatment. Although alteplase is a standard thrombolytic therapy, its limited availability in low-resource settings presents a challenge. Lumbrokinase, a fibrinolytic enzyme isolated from earthworms, has been proposed as an adjunct treatment option. This meta-analysis evaluated efficacy and safety in addition to supportive care.</p><p><strong>Methods: </strong>A systematic review of randomized controlled trials (RCTs) was conducted using multiple databases through July 2024 following PRISMA guidelines. The risk of bias was assessed using RoB 2.0, and evidence quality was graded using GRADE. Publication bias was evaluated using funnel plots. Meta-analyses employed a random-effects model and reported odds ratios (ORs) and mean differences (MDs) with 95% confidence intervals. Primary outcomes included the Barthel Index and NIHSS scores, and secondary outcomes included adverse events and laboratory results.</p><p><strong>Results: </strong>A total of 35 RCTs published between 2010 and 2024 were included. Compared with supportive care alone, lumbrokinase adjunct therapy significantly improved Barthel Index scores (MD = 15.17; 95% CI: 14.60 to 15.74) and reduced NIHSS scores (MD = -2.01; 95% CI: -2.06 to -1.97). Safety analyses revealed no significant increase in adverse events including gastrointestinal discomfort (OR = 1.00; 95% CI: 0.32 to 3.16) and GI bleeding (OR = 1.42; 95% CI: 0.55 to 3.67). Laboratory assessments indicated improvements in aPTT (MD = 1.93; 95% CI: 1.58 to 2.28), platelet aggregation rate (MD = -205.86; 95% CI, -206.77 to -204.96), and D-dimer levels (MD = -0.04; 95% CI: -0.05 to -0.03).</p><p><strong>Conclusion: </strong>Lumbrokinase may safely improve stroke outcomes; however, limited evidence warrants cautious use and further high-quality trials.</p>\",\"PeriodicalId\":22977,\"journal\":{\"name\":\"Therapeutics and Clinical Risk Management\",\"volume\":\"21 \",\"pages\":\"1319-1331\"},\"PeriodicalIF\":2.8000,\"publicationDate\":\"2025-09-04\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12417717/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Therapeutics and Clinical Risk Management\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.2147/TCRM.S537232\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q1\",\"JCRName\":\"Pharmacology, Toxicology and Pharmaceutics\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Therapeutics and Clinical Risk Management","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.2147/TCRM.S537232","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/1 0:00:00","PubModel":"eCollection","JCR":"Q1","JCRName":"Pharmacology, Toxicology and Pharmaceutics","Score":null,"Total":0}
引用次数: 0

摘要

背景:急性缺血性卒中(AIS)需要快速治疗。虽然阿替普酶是一种标准的溶栓疗法,但其在低资源环境下的有限可用性提出了挑战。蚓激酶是一种从蚯蚓中分离出来的纤溶酶,被认为是一种辅助治疗方法。本荟萃分析评估了除支持治疗外的有效性和安全性。方法:根据PRISMA指南,对截至2024年7月的多个数据库进行随机对照试验(rct)的系统评价。使用RoB 2.0评估偏倚风险,使用GRADE对证据质量进行分级。采用漏斗图评价发表偏倚。meta分析采用随机效应模型,报告的优势比(ORs)和平均差异(MDs)有95%的置信区间。主要结局包括Barthel指数和NIHSS评分,次要结局包括不良事件和实验室结果。结果:共纳入2010 - 2024年间发表的35项rct。与单独支持治疗相比,蚓激酶辅助治疗显著提高了Barthel指数评分(MD = 15.17; 95% CI: 14.60 ~ 15.74),降低了NIHSS评分(MD = -2.01; 95% CI: -2.06 ~ -1.97)。安全性分析显示,胃肠道不适(OR = 1.00; 95% CI: 0.32至3.16)和胃肠道出血(OR = 1.42; 95% CI: 0.55至3.67)等不良事件没有显著增加。实验室评估显示aPTT (MD = 1.93; 95% CI: 1.58至2.28)、血小板聚集率(MD = -205.86; 95% CI: -206.77至-204.96)和d -二聚体水平(MD = -0.04; 95% CI: -0.05至-0.03)均有改善。结论:蚓激酶可安全改善脑卒中预后;然而,有限的证据需要谨慎使用和进一步的高质量试验。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Therapeutic Potential of Lumbrokinase in Acute Ischemic Stroke: A Meta-Analysis of Efficacy and Safety.

Therapeutic Potential of Lumbrokinase in Acute Ischemic Stroke: A Meta-Analysis of Efficacy and Safety.

Therapeutic Potential of Lumbrokinase in Acute Ischemic Stroke: A Meta-Analysis of Efficacy and Safety.

Therapeutic Potential of Lumbrokinase in Acute Ischemic Stroke: A Meta-Analysis of Efficacy and Safety.

Background: Acute ischemic stroke (AIS) requires rapid treatment. Although alteplase is a standard thrombolytic therapy, its limited availability in low-resource settings presents a challenge. Lumbrokinase, a fibrinolytic enzyme isolated from earthworms, has been proposed as an adjunct treatment option. This meta-analysis evaluated efficacy and safety in addition to supportive care.

Methods: A systematic review of randomized controlled trials (RCTs) was conducted using multiple databases through July 2024 following PRISMA guidelines. The risk of bias was assessed using RoB 2.0, and evidence quality was graded using GRADE. Publication bias was evaluated using funnel plots. Meta-analyses employed a random-effects model and reported odds ratios (ORs) and mean differences (MDs) with 95% confidence intervals. Primary outcomes included the Barthel Index and NIHSS scores, and secondary outcomes included adverse events and laboratory results.

Results: A total of 35 RCTs published between 2010 and 2024 were included. Compared with supportive care alone, lumbrokinase adjunct therapy significantly improved Barthel Index scores (MD = 15.17; 95% CI: 14.60 to 15.74) and reduced NIHSS scores (MD = -2.01; 95% CI: -2.06 to -1.97). Safety analyses revealed no significant increase in adverse events including gastrointestinal discomfort (OR = 1.00; 95% CI: 0.32 to 3.16) and GI bleeding (OR = 1.42; 95% CI: 0.55 to 3.67). Laboratory assessments indicated improvements in aPTT (MD = 1.93; 95% CI: 1.58 to 2.28), platelet aggregation rate (MD = -205.86; 95% CI, -206.77 to -204.96), and D-dimer levels (MD = -0.04; 95% CI: -0.05 to -0.03).

Conclusion: Lumbrokinase may safely improve stroke outcomes; however, limited evidence warrants cautious use and further high-quality trials.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
Therapeutics and Clinical Risk Management
Therapeutics and Clinical Risk Management HEALTH CARE SCIENCES & SERVICES-
CiteScore
5.30
自引率
3.60%
发文量
139
审稿时长
16 weeks
期刊介绍: Therapeutics and Clinical Risk Management is an international, peer-reviewed journal of clinical therapeutics and risk management, focusing on concise rapid reporting of clinical studies in all therapeutic areas, outcomes, safety, and programs for the effective, safe, and sustained use of medicines, therapeutic and surgical interventions in all clinical areas. The journal welcomes submissions covering original research, clinical and epidemiological studies, reviews, guidelines, expert opinion and commentary. The journal will consider case reports but only if they make a valuable and original contribution to the literature. As of 18th March 2019, Therapeutics and Clinical Risk Management will no longer consider meta-analyses for publication. The journal does not accept study protocols, animal-based or cell line-based studies.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:604180095
Book学术官方微信