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氨甲环酸在动脉瘤性蛛网膜下腔出血中的安全性和有效性:一项随机对照试验的荟萃分析

Safety and Efficacy of Tranexamic Acid in Aneurysmal Subarachnoid Hemorrhage: A Meta-Analysis of Randomized Controlled Trials.

作者信息

Ren Junwei, Qian Dongxi, Wu Jiaming, Ni Lingyan, Qian Wei, Zhao Guozheng, Huang Chuanjun, Liu Xing, Zou Yu, Xing Weikang

机构信息

Department of Neurosurgery, Suzhou Ninth People's Hospital, Suzhou, China.

Department of Gastroenterology, Dushu Lake Hospital Affiliated to Soochow University, Suzhou, China.

出版信息

Front Neurol. 2022 Jan 24;12:710495. doi: 10.3389/fneur.2021.710495. eCollection 2021.

DOI:10.3389/fneur.2021.710495
PMID:35140671
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8818684/
Abstract

BACKGROUND

In recent decades, tranexamic acid (TXA) antifibrinolytic therapy before aneurysm clipping or embolization has been widely reported, but its safety and efficacy remain controversial. This meta-analysis evaluated the efficacy and safety of TXA therapy in aneurysmal subarachnoid hemorrhage (aSAH) patients, aiming to improve the evidence-based medical knowledge of treatment options for such patients.

METHODS

Pubmed, Web of Science, and Cochrane Library databases were searched up to 1 March 2021 for randomized controlled trials (RCTs). We extracted safety and efficacy outcomes and performed a meta-analysis using the Review Manager software. We performed two group analyses of TXA duration and daily dose.

RESULTS

Ten RCT studies, enrolling a total of 2,810 participants (1,410 with and 1,400 without TXA therapy), matched the selection criteria. In the TXA duration group: TXA did not reduce overall mortality during the follow-up period [RR 1.00 (95% CI 0.81-1.22)]. The overall rebleeding rate in the TXA group was 0.53 times that of the control group, which was statistically significant [RR 0.53 (95% CI 0.39-0.71)]. However, an RR of 0.43 was not statistically significant in the subgroup analysis of short-term therapy [RR 0.43 (95% CI 0.13-1.39)]. The overall incidence of hydrocephalus was significantly higher in the TXA group than in the control group [RR 1.13 (95% CI 1.02-1.24)]. However, the trend was not statistically significant in the subgroup analysis [short-term: RR 1.10 (95% CI 0.99-1.23); long-term: RR 1.22 (95% CI 0.99-1.50)]. Treatment with TXA did not cause significant delayed cerebral ischemia [RR 1.18 (95% CI 0.89-1.56)], and its subgroup analysis showed an opposite and insignificant effect [short-term: RR 0.99 (95% CI 0.79-1.25); long-term: RR 1.38 (95% CI 0.86-2.21)]. Results in the daily dose group were consistent with those in the TXA duration group.

CONCLUSIONS

Tranexamic acid does not reduce overall mortality in patients with aSAH, nor does it increase the incidence of delayed cerebral ischemia. Tranexamic acid in treating aSAH can reduce the incidence of rebleeding. However, there is no statisticalsignificance in the ultra-early short-term and low daily dose TXA therapy, which may be due to the lack of relevant studies, and more RCT experiments are needed for further study.

SYSTEMATIC REVIEW REGISTRATION

https://www.crd.york.ac.uk/PROSPERO/display_record.asp? PROSPERO, identifier: 244079.

摘要

背景

近几十年来,关于在动脉瘤夹闭或栓塞术前使用氨甲环酸(TXA)抗纤溶治疗的报道颇多,但其安全性和有效性仍存在争议。本荟萃分析评估了TXA治疗动脉瘤性蛛网膜下腔出血(aSAH)患者的有效性和安全性,旨在提高此类患者治疗选择的循证医学知识。

方法

检索截至2021年3月1日的Pubmed、Web of Science和Cochrane图书馆数据库,查找随机对照试验(RCT)。我们提取了安全性和有效性结果,并使用Review Manager软件进行荟萃分析。我们对TXA持续时间和每日剂量进行了两组分析。

结果

10项RCT研究符合入选标准,共纳入2810名参与者(1410名接受TXA治疗,1400名未接受TXA治疗)。在TXA持续时间组中:TXA在随访期间未降低总体死亡率[风险比(RR)1.00(95%置信区间0.81 - 1.22)]。TXA组的总体再出血率是对照组的0.

53倍,具有统计学意义[RR 0.53(95%置信区间0.39 - 0.71)]。然而,在短期治疗的亚组分析中,RR为0.43无统计学意义[RR 0.43(95%置信区间0.13 - 1.39)]。TXA组脑积水的总体发生率显著高于对照组[RR 1.13(95%置信区间1.02 - 1.24)]。然而,在亚组分析中该趋势无统计学意义[短期:RR 1.10(95%置信区间0.99 - 1.23);长期:RR 1.22(95%置信区间0.99 - 1.50)]。TXA治疗未导致显著的迟发性脑缺血[RR 1.18(95%置信区间0.89 - 1.56)],其亚组分析显示效果相反且无统计学意义[短期:RR 0.99(95%置信区间0.79 - 1.25);长期:RR 1.38(95%置信区间0.86 - 2.21)]。每日剂量组的结果与TXA持续时间组一致。

结论

氨甲环酸不会降低aSAH患者的总体死亡率,也不会增加迟发性脑缺血的发生率。氨甲环酸治疗aSAH可降低再出血的发生率。然而,超早期短期和低每日剂量的TXA治疗无统计学意义,这可能是由于缺乏相关研究,需要更多的RCT实验进行进一步研究。

系统评价注册

https://www.crd.york.ac.uk/PROSPERO/display_record.asp? PROSPERO,标识符:244079。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9bc1/8818684/ed2372f51d31/fneur-12-710495-g0007.jpg
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