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术后氨甲环酸对慢性硬脑膜下血肿患者复发率及并发症的影响:一项随机对照临床试验的初步结果。

Effect of postoperative tranexamic acid on recurrence rate and complications in chronic subdural hematomas patients: preliminary results of a randomized controlled clinical trial.

机构信息

Department of Neurosurgery, Hospital do Servidor Público Estadual de São Paulo, IAMSPE, Rua Pedro de Toledo, 1800, Vila Clementino, São Paulo, 04029-000, Brazil.

出版信息

Neurosurg Rev. 2023 Apr 18;46(1):90. doi: 10.1007/s10143-023-01991-9.

Abstract

Chronic subdural hematoma (CSDH) is a frequent neurosurgical disease which mainly affects elderly patients. Tranexamic acid (TXA) has been hypothesized as an oral agent to avoid CSDH progression and/or recurrence. We performed an evaluation to determine whether the postoperative use of TXA reduces recurrence rate. A prospective, randomized, and controlled trial. Patients with unilateral or bilateral chronic subdural hematoma undergoing surgical treatment by burr-hole were randomized as to whether or not to use TXA in the postoperative period. We evaluated image and clinical recurrence of CSDH at follow up of 6 months and potential clinical and/or surgical complications impact of TXA. Twenty-six patients were randomized to the control group (52%) and twenty-four patients to the TXA group (48%). Follow-up ranged from 3 to 16 months. There were no significant difference between baseline data in groups regarding to age, gender, use of antiplatelet or anticoagulants, smoking, alcoholism, systemic arterial hypertension, diabetes mellitus, hematoma laterality, hematoma thickness, and drain use. Clinical and radiological recurrence occurred in three patients (6%), being two cases in TXA group (8.3%) and 1 in control group (3.8%). Postoperative complications occurred in two patients during follow-up (4%), being both cases in TXA group (8.3%), and none in the control group. Although TXA group had a higher recurrence rate (8.3%), there was no statistically significant difference between the two groups. Moreover, TXA group had two complications while control group had no complications. Although limited by experimental nature of study and small sample, our current data suggest that TXA should not be used as a potential agent to avoid recurrences of CSDH and might increase complication odds.

摘要

慢性硬脑膜下血肿(CSDH)是一种常见的神经外科疾病,主要影响老年患者。氨甲环酸(TXA)已被假设为一种口服药物,以避免 CSDH 的进展和/或复发。我们进行了一项评估,以确定 TXA 的术后使用是否降低复发率。一项前瞻性、随机、对照试验。接受颅骨钻孔手术治疗的单侧或双侧慢性硬脑膜下血肿患者随机分为术后是否使用 TXA 组。我们在 6 个月的随访中评估 CSDH 的影像学和临床复发情况,以及 TXA 对潜在临床和/或手术并发症的影响。26 例患者随机分为对照组(52%)和 TXA 组(48%)。随访时间为 3 至 16 个月。两组在年龄、性别、抗血小板或抗凝药物使用、吸烟、酗酒、动脉高血压、糖尿病、血肿侧、血肿厚度和引流管使用等基线数据方面无显著差异。临床和影像学复发发生在 3 例患者(6%)中,TXA 组 2 例(8.3%),对照组 1 例(3.8%)。术后并发症发生在 2 例患者中(4%),均发生在 TXA 组(8.3%),对照组无并发症。尽管 TXA 组的复发率较高(8.3%),但两组之间无统计学差异。此外,TXA 组有 2 例并发症,而对照组无并发症。尽管受研究的实验性质和样本量小的限制,但我们目前的数据表明,TXA 不应作为一种潜在的药物来避免 CSDH 的复发,并且可能会增加并发症的几率。

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