依达拉奉注射液治疗颅脑外伤脑梗死的临床研究

Clinical trial of edaravone in the treatment of traumatic cerebral infarction

目的探究依达拉奉治疗外伤性脑梗死的临床疗效和安全性。方法 72例颅脑外伤性脑梗死患者随机分为对照组36例和试验组36例。对照组患者给予降颅压、神经营养及改善微循环等常规治疗,试验组患者在此基础上予以静脉滴注依达拉奉注射液20 mL+0.9%NaCl 200 m L,bid,共14天。治疗后,对比2组患者的血液流变学变化情况,并依据格拉斯哥评分情况对2组患者的预后恢复情况进行评价,同时对临床用药安全性进行评价比较。结果试验组和对照组的总有效率分别为91.67%(33/36例)和72.22%(26/36例),差异均有统计学意义(均P<0.05)。治疗14天后,试验组和对照组的高切全血黏度分别为(4.73±0.56),(5.36±0.78)m Pa·s;低切全血粘度分别为(8.15±1.03),(9.54±1.26)mPa·s;血浆黏度分别为(1.41±0.15),(1.76±0.19)mPa·s;红细胞压积分别为(37.15±3.21)%,(43.17±4.03)%;纤维蛋白为分别为(3.58±0.45),(4.67±0.54)g·L^(-1),差异均有统计学意义(均P<0.05)。试验组的药物不良反应发生率为5.56%(1/36例),对照组为2.78%(2/36例),差异无统计学意义(P>0.05)。结论依达拉奉能够显著改善颅脑外伤脑梗死患者的血液流变学指标,其治疗效果优于常规神经外科治疗,对颅脑外伤脑梗死的临床治疗起到积极作用。

Objective To study the clinical efficacy and safety of edaravone in the treatment of traumatic cerebral infarction. Methods A total of 72 patients with traumatic cerebral infarction were randomly divided into the control group（ n = 36） and the treatment group（ n = 36）. The control group received conventional treatments including intracranial pressure control,nerve nutrition and microcirculation regulation. The patients in treatment group were given intravenous infusion of edaravone 20 mL ＋ 0. 9% NaCl 200 mL on the basis of the conventional treatment,bid,14 d. The changes of hemorheologic parameters were measured and compared between the two groups respectively. The total effective rate were evaluated according to the Glasgow scores,and the safety of clinical medication was evaluated. Results The total effective rate of the treatment group was 91. 67%（ 33/36 cases） while that of the control group was 72. 22%（ 26/36 cases）,with statistically significant difference between the two groups（ P〈0. 05）. After treatment,high shear whole blood viscosity in the treatment group and the control group were（ 4. 73 ± 0. 56）,（ 5. 36 ± 0. 78） m Pa · s respectively,while low shear whole blood viscosity were（ 8. 15 ± 1. 03）,（ 9. 54 ± 1. 26） mPa·s,plasma viscosity were（ 1. 41 ± 0. 15）,（ 1. 76 ± 0. 19） mPa · s,red blood cell pressure were（ 37. 15 ± 3. 21） %,（ 43. 17 ± 4. 03） %,fibrin deposition were（ 3. 58 ± 0. 45）,（ 4. 67 ± 0. 54） g·L^（-1）,and the differences of all the parameters above between the two groups were statistically significant（ P〈0. 05）. The incidence of adverse drug reactions in the treatment group and control group were 5. 56%（ 1/36 cases） and 2. 78%（ 2/36 cases） respectively,while no statistical significance was observed（ P〈0. 05）. Conclusion Edaravone is able to improve hemorheology indexes in patients with traumatic brain injury complicated with cerebral infarction. The treatment effect is better than the routine nervous medical treatment,and edaravone has a positive effect on the clinical treatment of traumatic brain injury complicated with cerebral infarction.