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与安慰剂相比,静脉注射氨甲环酸对预防脑外伤患者脑出血进展的效果:一项随机临床试验。

The effect of intravenous tranexamic acid on preventing the progress of cerebral hemorrhage in patients with brain traumatic injuries compared to placebo: A randomized clinical trial.

作者信息

Mojallal Fatemeh, Nikooieh Mehrnaz, Hajimaghsoudi Majid, Baqherabadi Mehdi, Jafari Mohammadali, Esmaeili Alireza, Karimi Naser Mohammad, Zarepur Ehsan

机构信息

Trauma Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.

School of Medicine, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.

出版信息

Med J Islam Repub Iran. 2020 Aug 27;34:107. doi: 10.34171/mjiri.34.107. eCollection 2020.

Abstract

Head trauma is one of the common reasons for patient attendance in the emergency ward. This study investigated the effect of tranexamic acid as a cheap, easily available antifibrinolytic drug on reducing the progress of cerebral hemorrhage compared to placebo. This double-blind controlled clinical trial was performed on 120 traumatized patients presenting to the emergency room of Shahid Rahnemoon hospital during 2014-2015, Yazd, Iran. Those patients who met the inclusion criteria were randomly allocated into 2 groups. Group A received tranexamic acid, while group B received placebo parenterally. Finally, 56 patients in Group A and 44 in Group B were analyzed. The patients underwent brain CT scan and were followed up for ICU stay in days. Also, the number of patients who died during the first 7 days of hospitalization was recorded. The data were analyzed with SPSS20 using independent samples t test and chi-square test. The mean age of the patients was 41±20.27 years. Also, 20 patients (20%) were female and 80 were male (80%). There was no significant difference between the drug group and placebo group in the rate of hemorrhage volume progress (p=0.824). Regarding patients' ICU stay, the ICU stay of the tranexamic acid group decreased significantly compared to the placebo group (p=0.001). No significant difference was found between the intervention group and placebo group in the mortality rate of patients during the first 7 days of hospitalization (p=0.236). Tranexamic acid has no effect on reducing cerebral hemorrhage volume in patients. Although this drug was not effective in reducing mortality rate in patients, it decreased their ICU stay.

摘要

头部创伤是患者前往急诊病房就诊的常见原因之一。本研究调查了氨甲环酸作为一种廉价、易于获取的抗纤维蛋白溶解药物,与安慰剂相比,在减少脑出血进展方面的效果。这项双盲对照临床试验于2014 - 2015年在伊朗亚兹德的沙希德拉赫内穆恩医院急诊室对120名创伤患者进行。符合纳入标准的患者被随机分为两组。A组接受氨甲环酸治疗,而B组接受安慰剂注射。最后,对A组的56名患者和B组的44名患者进行了分析。患者接受脑部CT扫描,并对其在重症监护病房(ICU)的住院天数进行随访。此外,记录了住院前7天内死亡的患者数量。使用独立样本t检验和卡方检验,通过SPSS20对数据进行分析。患者的平均年龄为41±20.27岁。此外,20名患者(20%)为女性,80名患者(80%)为男性。药物组和安慰剂组在出血量进展率方面无显著差异(p = 0.824)。关于患者在ICU的住院时间,氨甲环酸组的ICU住院时间与安慰剂组相比显著缩短(p = 0.001)。在住院前7天患者的死亡率方面,干预组和安慰剂组之间未发现显著差异(p = 0.236)。氨甲环酸对减少患者脑出血量没有作用。虽然这种药物在降低患者死亡率方面无效,但它缩短了患者在ICU的住院时间。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dc09/7722959/8e0643e7b61e/mjiri-34-107-g001.jpg

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