摘要
目的评估氨甲环酸治疗自发性脑出血的安全性和有效性。方法前瞻性纳入南京鼓楼医院急诊科和神经内科2015年12月至2018年12月期间收治的自发性脑出血患者,按照数字表法随机分为氨甲环酸组和对照组。入选患者均进行常规治疗,氨甲环酸组在此基础上给予1 g氨甲环酸注射液,溶于100 ml生理盐水,静脉推注10 min;此后再予1 g氨甲环酸,溶于250 ml生理盐水,持续静脉滴注8 h。对照组给予同等体积的生理盐水。主要转归指标为治疗后90 d时转归良好(定义为改良Rankin量表0~2分)和死亡。次要转归指标为治疗后24 h血肿体积增大以及治疗后7 d和30 d时美国国立卫生研究院卒中量表(National Institutes of Health Stroke Scale,NIHSS)评分。在治疗前和输注氨甲环酸结束后4 h检测血小板计数和纤维蛋白原水平。同时监测各种不良事件。结果共纳入150例患者,男性83例(55.3%)。氨甲环酸组73例,对照组77例。两组基线资料比较差异无统计学意义。氨甲环酸组90 d时转归良好率显著高于对照组(57.5%对40.3%;χ^2=4.476,P=0.034),而病死率(0%对1.3%;Fisher精确检验P=1.000)和24 h时发生血肿体积增大的患者比例(6.8%对15.6%;χ^2=2.845,P=0.092)差异无统计学意义。氨甲环酸组7 d时[(9.26±3.35)分对(11.68±4.25)分;t=3.859,P<0.001]和30 d时[(5.45±2.52)分对(7.38±3.28)分;t=4.030,P<0.001]NIHSS评分均显著低于对照组。氨甲环酸组治疗后纤维蛋白原较基线显著增高[(4.20±0.56)g/L对(3.33±0.60g/L);t=8.997,P<0.001],且显著高于对照组治疗后[(4.20±0.56)g/L对(3.30±0.55)g/L;t=9.906,P<0.001]。未观察到静脉血栓栓塞、缺血事件和癫痫发作等不良事件。结论氨甲环酸可促进急性自发性脑出血患者神经功能恢复,改善转归,且安全性良好。
Objective To evaluate the safety and effectiveness of tranexamic acid in the treatment of spontaneous intracerebral hemorrhage.Methods Patients with spontaneous intracerebral hemorrhage admitted to the Departments of Emergency and Neurology,Nanjing Drum Tower Hospital from December 2015 to December 2018 were enrolled prospectively.The patients were randomly divided into two groups according to a random number table:tranexamic acid group and control group.All patients received conventional treatment.On this basis,1 g of tranexamic acid injection was given to the tranexamic acid group,dissolved in 100 ml of normal saline,intravenous injection for 10 min;then 1 g of tranexamic acid was given,dissolved in 250 ml of normal saline,intravenous drip for 8 h.The control group was given an equal volume of normal saline.The main outcome measures were good outcome(defined as modified Rankin Scale score0-2)and mortality at 90 d after treatment.The secondary outcome was hematoma enlargement at 24 h after treatment and the National Institutes of Health Stroke Scale(NIHSS)score at 7 and 30 days after treatment.Platelet count and fibrinogen level were measured before treatment and 4 h after the infusion of tranexamic acid.Various adverse events were monitored.Results A total of 150 patients were included,including 83 males(55.3%).There were 73 patients in the tranexamic acid group and 77 in the control group.There was no statistically significant difference in baseline data between the two groups.The rate of good outcome in the tranexamic acid group at 90 d was significantly higher than that in the control group(57.5%vs.40.3%;χ^2=4.476,P=0.034),while there were no significant differences in mortality rate(0%vs.1.3%;Fisher's exact test P=1.000)and the proportion of patients with hematoma enlargement at 24 h(6.8%vs.15.6%;χ^2=2.845,P=0.092).The NIHSS score at 7 d(9.26±3.35 vs.11.68±4.25;t=3.859,P<0.001)and at 30 d(5.45±2.52 vs.7.38±3.28;t=4.030,P<0.001)in the tranexamic acid group were significantly lower than those of the con
作者
倪杰
王路娜
王芳
蒋敏
沙杜鹃
Ni Jie;Wang Luna;Wang Fang;Jiang Min;Sha Dujuan(Department of Emergency,Nanjing Drum Tower Hospital,Nanjing 210008,China)
出处
《国际脑血管病杂志》
2020年第4期266-270,共5页
International Journal of Cerebrovascular Diseases
关键词
脑出血
血肿
氨甲环酸
止血
治疗结果
Cerebral hemorrhage
Hematoma
Tranexamic acid
Hemostasis
Treatment outcome
