依达拉奉注射液联合血栓通冻干粉治疗老年性脑梗死的临床研究

Clinical trial of edaravone injection combined with Xueshuantong freeze-dried powder in the treatment of senile cerebral infarction

目的观察依达拉奉联合血栓通治疗老年性脑梗死患者的临床疗效及安全性。方法将78例脑梗死患者随机分为对照组39例和试验组39例。对照组予以静脉滴注血栓通冻干粉针200 mg qd+静脉滴注胞磷胆碱钠0.25 g qd;试验组予以静脉滴注血栓通冻干粉针200 mg qd+静脉滴注依达拉奉30 mg bid。2组患者均治疗14 d。比较2组患者的临床疗效、治疗前和治疗后缺氧诱导因子-1(HIF-1)、半胱氨酸蛋白酶-3(Caspase-3)、肿瘤坏死因子-α(TNF-α)、血流动力学、美国国立卫生研究院卒中量表(NIHSS)评分、Barthel指数,以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为87.18%(34/39例)和74.36%(29/39例),差异无统计学意义(P>0.05)。治疗后,试验组和对照组的血清HIF-1分别为(713.63±115.72),(924.68±118.92)ng·m L^(-1);Caspase-3分别为(11.02±1.62),(12.08±1.68)ng·m L^(-1);TNF-α分别为(8.26±1.19),(11.53±1.78)pg·m L^(-1);全血高切黏度分别为(4.26±0.61),(4.63±0.65)m Pa·s-1;全血低切黏度分别为(11.38±1.72),(12.78±1.64)m Pa·s-1;血浆黏度分别为(1.23±0.18),(1.46±0.21)m Pa·s-1;纤维蛋白原分别为(2.72±0.33),(3.05±0.36)g·L^(-1);NIHSS评分分别为(7.36±1.08),(9.63±1.49)分;Barthel指数分别为(59.32±8.53),(51.78±7.34)分,差异均有统计学意义(P<0.05)。2组患者的药物不良反应以胃肠道反应和皮疹为主,且试验组和对照组的药物不良反应发生率分别为7.69%和10.26%,差异无统计学意义(P>0.05)。结论与胞磷胆碱钠联合血栓通相比,依达拉奉联合血栓通治疗老年性脑梗死的临床疗效和安全性相当,但后者能显著降低老年性脑梗死患者的血清HIF-1、Caspase-3、TNF-α水平,改善血流动力学。

Objective To investigate the clinical efficacy and safety of edaravone combined with Xueshuantong in the treatment of senile cere- bral infarction. Methods A total of 78 patients with senile cerebral in- farction were randomly divided into control group （rt = 39） and treatment group （n = 39 ）. Control group was treated with Xueshuantong 200 mg qd, intravenous injection ＋ citicoline sodium 0.25 g qd, intravenous in- jection. Treatment group was treated with Xueshuantong 200 mg qd, in- travenous injection ＋ edaravone 30 mg bid, intravenous injection. Two groups were treated for 14 d. The clinical efficacy, hypoxia inducible factor - 1 （ HIF - 1 ） , Caspase - 3, tumor necrosis factor - α （ TNF - α） , hemodynamics, National Institutes of Health Stroke Scale （NIHSS）score, Barthel index and adverse drug reactions were compared in two groups. Results After treatment, the total effective rates in treatment and control groups were 87.18 % （34/39） and 74. 36% （29/39）, without statistically significant difference （ P 〉 0. 05 ）. After treatment, the main indexes in control and treatment groups were compared, the serum levels of HIF - 1 were （713.63 ± 115.72）, （924. 68±118.92）ng mL-1; Caspase-3 were （11.02±1.62）, （12.08±1.68）ng mL-1; TNF-α were （8.26 ± 1.19）, （ 11.53 ±1.78 ） pg mL-1, the levels of whole blood high shear viscosity were （4.26 ±0. 61 ）, （4. 63 ±0. 65 ） mPa s -1; whole blood low shear viscosity were （ 11.38 ± 1.72）, （ 12. 78 ± 1.64） mPa s -1 ; plasma viscosity were （ 1.23 ±0. 18 ）, （ 1.46 ± 0. 21 ） mPa s -1 ; fibrinogen were （ 2. 72 ±0.33 ）, （ 3.05 ±0. 36 ） g L -1 ; the score of NIHSS were （7.36 ± 1.08）, （9.63 ± 1.49）; the Barthel index scores were （59.32 ± 8.53）, （51.78 ±7.34） point ; respectively, with statistically significant difference （ P 〈 0.05 ）. The adverse drug reactions were based on gastrointestinal reactions and rashes in two groups, the incidence of adverse drug reactions in treatment and control group were 7.69% and 10. 26%, without significant difference （ P 〉 0. 05 ）. Conclusion Edaravone combined with Xueshuantong has a definitive chnical efficacy and safety in the treatment of senile cerebral infarction, which can significantly reduce the levels of HIF - 1, Caspase - 3 and TNF -α, and improve the hemodynamics.