依达拉奉右莰醇联合丁苯酞注射液治疗急性进展性脑梗死患者的临床研究

Clinical trial of edaravone dexborneol combined with butylphthalide injection in the treatment of patients with acute progressive cerebral infarction

目的 观察依达拉奉右莰醇联合丁苯酞注射液治疗急性进展性脑梗死的临床效果及用药安全性。方法 将急性进展性脑梗死患者按照治疗方法分为对照组和试验组。2组均进行常规治疗。对照组给予静脉滴注丁苯酞氯化钠注射液100 mL,每天2次。试验组在对照组基础上给予依达拉奉右莰醇注射用浓溶液15 mL静脉滴注,每天2次。2组患者均连续治疗2周。比较2组患者的临床疗效,神经功能恢复情况、炎症因子指标、血清自由基相关指标及药物不良反应情况。结果 试验组和对照组分别纳入100例。治疗后,试验组和对照组的总有效率分别为89%(89例/100例)和65%(65例/100例);2组的美国国立卫生研究院卒中量表(NIHSS)评分为(5.44±0.97)和(9.68±1.03)分;超敏C反应蛋白(hs-CRP)水平、肿瘤坏死因子-α(TNF-α)水平、白细胞介素-8(IL-8)水平分别为(3.09±0.37)和(7.15±0.87) mg·L^(-1),(0.40±0.08)和(0.76±0.11) ng·mL^(-1),(13.26±2.41)和(23.71±2.60) ng·L^(-1);2组的活性氧簇(ROS)水平、一氧化氮(NO)水平、超氧化物歧化酶(SOD)水平分别为(488.93±38.09)和(573.75±39.38)μmol·L^(-1),(5.23±0.81)和(7.08±0.97)μmol·L^(-1),(110.64±13.01)和(75.28±12.35)μU·L^(-1);2组以上参数比较差异均有统计学意义(均P<0.05)。试验组和对照组的药物不良反应主要有发热、恶心呕吐、头晕、皮疹,发生率分别为10%和12%,差异无统计学意义(P>0.05)。结论 依达拉奉右莰醇联合丁苯酞注射液治疗急性进展性脑梗死的临床疗效确切,可有效降低患者的炎症因子水平和血清自由基水平,改善患者的神经功能,减轻脑细胞损伤,且安全性较高。

Objective To observe the clinical efficacy and safety of edaravone dextromethorphan combined with butylphthalide injection in the treatment of acute progressive cerebral infarction.Methods Patients with acute progressive cerebral infarction were divided into control group and treatment group according to treatment methods.Conventional treatment was performed in both groups.The control group was given intravenous butylphthalide 100 mL twice a day.The treatment group was given edaravone dextromethamine concentrated solution for injection 15m L+0.9%sodium chloride aqueous solution 100 mL intravenous drip twice a day on the basis of the control group.Patients in both groups were continuously treated for 2 weeks.The clinical efficacy,neurological recovery,inflammatory factors,serum free radical indicators and adverse drug reactions were compared between the two groups.Results The control group and the treatment group included 100 patients,respectively.After treatment,the overall response rate was 89%(89 cases/100 cases) and 65%(65 cases/100 cases) in the test group and the control group,respectively;the National Institutes of Health Stroke Scale (NIHSS) scores were 5.44±0.97 and 9.68±1.03in the two groups;the high-sensitivity C-reactive protein (hs-CRP) level,tumor necrosis factor-α(TNF-α)level,and interleukin-8 (IL-8) level were (3.09±0.37) and (7.15±0.87) mg·L^(-1),(0.40±0.08) and(0.76±0.11) ng·m L^(-1),(13.26±2.41) and (23.71±2.60) ng·L^(-1),respectively;the reactive oxygen species(ROS) level,nitric oxide (NO) level,and superoxide dismutase (SOD) level were (488.93±38.09) and(573.75±39.38)μmol·L^(-1),(5.23±0.81) and (7.08±0.97)μmol·L^(-1),(110.64±13.01) and(75.28±12.35)μU·L^(-1),respectively.There were significant differences in the above values (all P<0.05).The main adverse drug reactions in the treatment group and the control group were fever,nausea and vomiting,dizziness and rash,with incidences of 10%and 12%,respectively,and the differences were not statistically significant(P>0.05).Conclusion Edaravone dextromethorphan combined with butylphthalide injection is effective and safe in the treatment of acute progressive cerebral infarction.