PDF(Pubmed)
Abstract：
UNASSIGNED: Intracerebral haemorrhage (ICH) can be devastating, particularly if haematoma expansion occurs. The efficacy of tranexamic acid (TXA), an anti-fibrinolytic agent, in reducing haematoma expansion is now being studied worldwide. However, the optimal dosage of TXA has yet to be determined. This study was designed to further establish the potential of different doses of TXA.
UNASSIGNED: A double-blinded, randomised, placebo-controlled study was carried out among adults with non-traumatic ICH. Eligible study subjects were randomly assigned to receive placebo, 2-g TXA treatment or 3-g TXA treatment. Haematoma volumes before and after intervention were measured using the planimetric method.
UNASSIGNED: A total of 60 subjects with 20 subjects in each treatment group were recruited for this study. Among the 60 subjects, the majority were male (n = 36, 60%), had known cases of hypertension (n = 43, 71.7%) and presented with full Glasgow coma scale (GCS) (n = 41, 68.3%). The results showed that there was no statistically significant difference (P = 0.315) in the mean changes of haematoma volume when compared with three study groups using ANCOVA, although the 3-g TXA group was the only group that showed haematoma volume reduction (mean reduction of 0.2 cm3) instead of expansion as in placebo (mean expansion 1.8 cm3) and 2-g TXA (mean expansion 0.3 cm3) groups. Good recovery was observed in all study groups, with only three subjects being moderately disabled. No adverse effects were reported in any of the study groups.
UNASSIGNED: To the best of our knowledge, this is the first clinical study using 3 g of TXA in the management of non-traumatic ICH. From our study, 3 g of TXA may potentially be helpful in reducing haematoma volume. Nonetheless, a larger-scale randomised controlled trial should be carried out to further establish the role of 3 g of TXA in non-traumatic ICH.
UNASSIGNED: A double-blinded, randomised, placebo-controlled study was carried out among adults with non-traumatic ICH. Eligible study subjects were randomly assigned to receive placebo, 2-g TXA treatment or 3-g TXA treatment. Haematoma volumes before and after intervention were measured using the planimetric method.
UNASSIGNED: A total of 60 subjects with 20 subjects in each treatment group were recruited for this study. Among the 60 subjects, the majority were male (n = 36, 60%), had known cases of hypertension (n = 43, 71.7%) and presented with full Glasgow coma scale (GCS) (n = 41, 68.3%). The results showed that there was no statistically significant difference (P = 0.315) in the mean changes of haematoma volume when compared with three study groups using ANCOVA, although the 3-g TXA group was the only group that showed haematoma volume reduction (mean reduction of 0.2 cm3) instead of expansion as in placebo (mean expansion 1.8 cm3) and 2-g TXA (mean expansion 0.3 cm3) groups. Good recovery was observed in all study groups, with only three subjects being moderately disabled. No adverse effects were reported in any of the study groups.
UNASSIGNED: To the best of our knowledge, this is the first clinical study using 3 g of TXA in the management of non-traumatic ICH. From our study, 3 g of TXA may potentially be helpful in reducing haematoma volume. Nonetheless, a larger-scale randomised controlled trial should be carried out to further establish the role of 3 g of TXA in non-traumatic ICH.
摘要：
■脑出血（ICH）可能是毁灭性的，特别是如果血肿扩张发生。氨甲环酸（TXA）的疗效，一种抗纤维蛋白溶解剂,在减少血肿扩展方面，目前正在全球范围内进行研究。然而,TXA的最佳剂量尚未确定。本研究旨在进一步建立不同剂量TXA的潜力。
■双盲，随机化，在非创伤性ICH成人患者中进行了安慰剂对照研究.符合条件的研究对象被随机分配接受安慰剂，2-gTXA治疗或3-gTXA治疗。使用平面测量方法测量干预前后的血肿体积。
■本研究招募了总共60名受试者,每个治疗组中有20名受试者。在60个科目中，大多数是男性(n=36，60%)，有已知的高血压病例（n=43，71.7％），并具有完整的格拉斯哥昏迷量表（GCS）（n=41，68.3％）。结果表明，使用ANCOVA与三个研究组相比，血肿体积的平均变化没有统计学上的显着差异（P=0.315）。尽管3gTXA组是唯一显示血肿体积减少(平均减少0.2cm3)的组,而不是安慰剂组(平均扩大1.8cm3)和2gTXA组(平均扩大0.3cm3)的扩大.所有研究组均恢复良好，只有三个受试者是中度残疾。任何研究组均未报告不良反应。
■据我们所知,这是首次使用3gTXA治疗非创伤性ICH的临床研究.从我们的研究来看,3gTXA可能有助于减少血肿体积。尽管如此，应开展更大规模的随机对照试验,以进一步确定3gTXA在非创伤性ICH中的作用.
■双盲，随机化，在非创伤性ICH成人患者中进行了安慰剂对照研究.符合条件的研究对象被随机分配接受安慰剂，2-gTXA治疗或3-gTXA治疗。使用平面测量方法测量干预前后的血肿体积。
■本研究招募了总共60名受试者,每个治疗组中有20名受试者。在60个科目中，大多数是男性(n=36，60%)，有已知的高血压病例（n=43，71.7％），并具有完整的格拉斯哥昏迷量表（GCS）（n=41，68.3％）。结果表明，使用ANCOVA与三个研究组相比，血肿体积的平均变化没有统计学上的显着差异（P=0.315）。尽管3gTXA组是唯一显示血肿体积减少(平均减少0.2cm3)的组,而不是安慰剂组(平均扩大1.8cm3)和2gTXA组(平均扩大0.3cm3)的扩大.所有研究组均恢复良好，只有三个受试者是中度残疾。任何研究组均未报告不良反应。
■据我们所知,这是首次使用3gTXA治疗非创伤性ICH的临床研究.从我们的研究来看,3gTXA可能有助于减少血肿体积。尽管如此，应开展更大规模的随机对照试验,以进一步确定3gTXA在非创伤性ICH中的作用.
