依达拉奉右莰醇注射液治疗急性大动脉粥样硬化型脑梗死患者的临床研究

Clinical trial of edaravone dexborneol injection in the treatment of patients with acute large artery atherosclerotic cerebral infarction

目的 观察依达拉奉右莰醇注射液治疗急性大动脉粥样硬化型脑梗死患者的临床疗效和安全性。方法 将急性大动脉粥样硬化型脑梗死患者随机分为对照组和试验组。对照组给予脑梗死常规治疗;试验组在对照组的治疗基础上,给予依达拉奉右莰醇浓溶液15 mL,静脉滴注,bid。2组患者均连续治疗14 d。比较2组患者的临床疗效、谷胱甘肽过氧化物酶(GSH-Px)、活性氧簇(ROS)、肿瘤坏死因子-α(TNF-α)、白细胞介素-1β(IL^(-1)β),以及药物不良反应的发生情况。结果 试验组和对照组各入组40例,治疗过程中无患者脱落;随访期间脱落8例。治疗后,试验组和对照组的总有效率分别为95.00%(38例/40例)和77.50%(31例/40例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的GSH-Px分别为(40.06±8.12)和(35.32±5.68)U·L^(-1),ROS分别为(1.07±0.25)和(2.64±0.82)mol·L^(-1),TNF-α分别为(1.62±0.70)和(2.06±1.13)ng·L^(-1),IL^(-1)β分别为(11.43±1.62)和(25.85±2.37)ng·L^(-1),差异均有统计学意义(均P<0.05)。治疗后3个月,试验组和对照组的美国国立卫生研究院卒中量表评分分别为(5.77±1.54)和(9.48±1.29)分,改良Rankin量表评分分别为(1.82±0.27)和(1.97±0.29)分,差异均有统计学意义(均P<0.05)。试验组的药物不良反应主要有胃肠道反应和肝功能异常,对照组的药物不良反应主要有出血性脑梗死、胃肠道反应和肝功能异常。试验组和对照组的总药物不良反应发生率均为10.00%,差异无统计学意义(P>0.05)。结论 依达拉奉右莰醇注射液能抑制急性大动脉粥样硬化型脑梗死患者的过氧化反应,清除氧自由基,抑制炎症反应,从而起到神经保护作用。

Objective To observe the clinical efficacy and safety of edaravone dexborneol injection in the treatment of patients with acute large artery atherosclerotic cerebral infarction. Methods The patients with acute large artery atherosclerotic cerebral infarction were randomly divided into control and treatment groups. Control group was given routine treatment of cerebral infarction. Treatment group received intravenous infusion of edaravone dexborneol 15 mL, bid, on the basis of control group. Two groups were treated for 14 d. The clinical efficacy, neurological function scores, the levels of glutathione peroxidase(GSH-Px), reactive oxygen species(ROS), tumor necrosis factor-α(TNF-α), interleukin-1β(IL^(-1)β) and adverse drug reactions were compared between two groups.Results Forty cases were enrolled in the treatment and control groups, none was drop out duringthe treatment, but 8 patients were drop out in the follow-up. After treatment, the total effective rates of treatment andcontrol groups were 95. 00%(38 cases/40 cases) and 77. 50%(31 cases/40 cases) with significant difference(P< 0. 05). After treatment, the levels of GSH-Px in treatment and control groups were(40. 06 ± 8. 12) and(35. 32 ± 5. 68)U·L^(-1), the levels of ROS were(1. 07 ± 0. 25) and(2. 64 ± 0. 82)mol·L^(-1), the levels of TNF-αwere(1. 62 ± 0. 70) and(2. 06 ± 1. 13)ng·L^(-1), the levels of IL^(-1)β were(11. 43 ± 1. 62) and(25. 85 ± 2. 37)ng·L^(-1). The above-mentioned indicators showed significant differences between treatment group and control group(allP< 0. 05). After three months of the treatment, the scores of National Institute of Health stroke scale in treatmentand control groups were( 5. 77 ± 1. 54) and( 9. 48 ± 1. 29) points, the scores of modified Rankin scale were(1. 82 ± 0. 27) and(1. 97 ± 0. 29) points, the differences were statistically significant(allP< 0. 05). The adversedrug reactions of treatment group were digestive tract reaction and abnormal liver function, which in control group werehemorrhagic infarction, digestive tract reaction and abnormal liver function. The total incidences of adverse drugreactions in both groups were 10. 00% without significant differences(P> 0. 05).Conclusion Edaravone dexborneolinjection can effectively inhibit peroxidatic reaction, reduce the oxidative stress and level of inflammation factors,improve neuroprotection with significant therapeutic effects in the treatment of acute large artery atherosclerotic cerebralinfarction patients.