Guo Yu, Guo Xin-Mei, Li Rui-Li, Zhao Kai, Bao Qiang-Ji, Yang Jin-Cai, Zhang Qiang, Yang Ming-Fei
Graduate School, Qinghai University, Xining, China.
Biomedical Engineering Research Center, Kunming Medical University, Kunming, China.
Front Neurol. 2021 Dec 20;12:761185. doi: 10.3389/fneur.2021.761185. eCollection 2021.
The role of tranexamic acid (TXA) in preventing hematoma expansion (HE) in patients with acute spontaneous intracerebral hemorrhage (ICH) remains unclear. We aim to investigate the efficacy and safety of TXA in acute spontaneous ICH with a particular focus on subgroups. Randomized controlled trials (RCTs) were retrieved from CENTRAL, Clinicaltrials.gov, EMBASE, PubMed, and WHO ICTRP. The primary outcome measurement was HE. The secondary outcome measurements included 3-month poor functional outcome (PFO), 3-month mortality, and major thromboembolic events (MTE). We conducted subgroup analysis according to the CT markers of HE (standard-risk population and high-risk population) and the time from onset to randomization (>4.5 and ≤4.5 h). We identified seven studies (representing five RCTs) involving 2,650 participants. Compared with placebo, TXA may reduce HE on subsequent imaging (odd ratio [OR] 0.825; 95% confidence interval [CI] 0.692-0.984; = 0.033; I = 0%; GRADE: moderate certainty). TXA and placebo arms did not differ in the rates of 3-month PFO, 3-month mortality, and MTE. Subgroup analysis indicated that TXA reduced the risk of HE in the high-risk population with CT markers of HE (OR 0.646; 95% CI 0.503-0.829; = 0.001; I = 0 %) and in patients who were treated within 4.5 h of symptom onset (OR 0.823; 95% CI 0.690-0.980; = 0.029; I = 0%), but this protective effect was not observed in the standard-risk population and patients who were treated over 4.5 h of symptom onset. Tranexamic acid (TXA) may decrease the risk of HE in patients with acute spontaneous ICH. Importantly, the decreased risk was observed in patients who were treatable within 4.5 h and with a high risk of HE, but not in those who were treatable over 4.5 h and in standard-risk population. However, PFO or mortality at 3 months did not significantly differ between patients who received TXA and those who received placebo. TXA is safe for acute spontaneous ICH without increasing MTE.
氨甲环酸（TXA）在预防急性自发性脑出血（ICH）患者血肿扩大（HE）方面的作用仍不明确。我们旨在研究TXA在急性自发性ICH中的疗效和安全性，特别关注亚组情况。从Cochrane系统评价数据库、美国国立医学图书馆临床试验数据库、荷兰医学文摘数据库、美国国立医学图书馆医学期刊数据库和世界卫生组织国际临床试验注册平台检索随机对照试验（RCT）。主要结局指标为HE。次要结局指标包括3个月时功能预后不良（PFO）、3个月死亡率和主要血栓栓塞事件（MTE）。我们根据HE的CT标志物（标准风险人群和高风险人群）以及发病至随机分组的时间（>4.5小时和≤4.5小时）进行亚组分析。我们纳入了7项研究（代表5项RCT），涉及2650名参与者。与安慰剂相比，TXA可能会降低后续影像学检查中HE的发生风险（比值比[OR] 0.825；95%置信区间[CI] 0.692 - 0.984；P = 0.033；I² = 0%；证据质量等级：中等确定性）。TXA组和安慰剂组在3个月时的PFO、3个月死亡率和MTE发生率方面无差异。亚组分析表明，TXA可降低具有HE的CT标志物的高风险人群中HE的风险（OR 0.646；95% CI 0.503 - 0.829；P = 0.001；I² = 0%）以及症状发作后4.5小时内接受治疗的患者中HE的风险（OR 0.823；95% CI 0.690 - 0.980；P = 0.029；I² = 0%），但在标准风险人群和症状发作后4.5小时以上接受治疗的患者中未观察到这种保护作用。氨甲环酸（TXA）可能会降低急性自发性ICH患者发生HE的风险。重要的是，在症状发作后4.5小时内可治疗且具有高HE风险的患者中观察到风险降低，但在症状发作后4.5小时以上可治疗的患者和标准风险人群中未观察到。然而，接受TXA治疗的患者与接受安慰剂治疗的患者在3个月时的PFO或死亡率方面无显著差异。TXA对急性自发性ICH患者是安全的，不会增加MTE的发生风险。
