依达拉奉右莰醇联合丁苯酞治疗急性脑梗死患者的临床研究

Clinical trial of edaravone dexcamphorol combined with butylphthalein in the treatment of patients with acute cerebral infarction

目的 观察依达拉奉右莰醇注射用浓溶液联合丁苯酞注射液治疗急性脑梗死(ACI)患者的临床疗效及安全性。方法 将ACI患者随机分为对照组和试验组。对照组给予丁苯酞每次25 mg,静脉滴注,每天2次;试验组在对照组治疗的基础上,给予依达拉奉右莰醇每次15 mL,静脉滴注,每天2次。2组患者均治疗14 d。比较2组患者的临床疗效、神经功能、血液流变学、氧化应激、炎症因子,以及药物不良反应的发生情况。结果 试验组入组102例,脱落3例,最终99例纳入分析;对照组入组101例,脱落4例,最终97例纳入分析。治疗后,试验组和对照组的总有效率分别为90.91%(90例/99例)和79.38%(77例/97例),差异有统计学意义(P<0.05)。治疗后,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(4.31±0.57)和(4.82±0.69)分,血浆黏度分别为(1.51±0.29)和(1.75±0.32)mPa·s,全血高切黏度分别为(4.29±0.86)和(4.51±0.95)mPa·s,全血低切黏度分别为(7.85±1.31)和(8.26±1.43)mPa·s,晚期蛋白氧化产物分别为(14.13±2.85)和(16.02±3.11)μmoL·L^(-1),超氧化物歧化酶分别为(25.01±4.12)和(22.17±3.56)U·mL^(-1),活性氧簇分别为(121.34±15.18)和(136.54±17.23)U·mL^(-1),超敏C反应蛋白分别为(6.02±0.96)和(7.98±1.05)mg·L^(-1),肿瘤坏死因子-α分别为(69.11±8.31)和(85.47±10.62)ng·L^(-1),白细胞介素-6分别为(48.76±6.25)和(54.69±8.21)ng·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主要有头痛、恶心呕吐、发热和腹泻,对照组的药物不良反应主要有头痛、恶心呕吐和发热。试验组和对照组的总药物不良反应发生率分别为8.08%和5.15%,差异无统计学意义(P>0.05)。结论 依达拉奉右莰醇注射用浓溶液联合丁苯酞注射液治疗ACI患者的临床疗效确切,其能显著抑制患者的氧化应激损伤及炎症反应,纠正血液高黏状态,改善血液流变学,且安全性良好。

Objective To observe the clinical efficacy and safety of edaravone and dexborneol concentrated solution for injection combined with butylphthalein injection in the treatment of patients with acute cerebral infarction(ACI).Methods The patients were randomly divided into treatment group and control group.The control group was given butylphthalein 25 mg each time,intravenous drip,twice a day.On the basis of control group,the treatment group received edaravone and dexborneol 15 mL each time,intravenous drip,twice a day.Two groups were treated for 14 d.The clinical efficacy,neurological function,hemorheology,oxidative stress,inflammatory factors,and the occurrence of adverse drug reactions were compared between the two groups.Results In the treatment group,102 cases were enrolled,3 cases were shed,and 99 cases were finally included in the analysis.In the control group,101 cases were enrolled,4 cases fell off,and 97 cases were finally included in the analysis.After treatment,the total effective rates of treatment and control groups were 90.91%(90 cases/99 cases)and 79.38%(77 cases/97 cases)with significant difference(P<0.05).After treatment,the national institutes of health stroke scale scores of the treatment and the control group were(4.31±0.57)and(4.82±0.69)points;plasma viscosities were(1.51±0.29)and(1.75±0.32)mPa·s,whole blood high tangential viscosities were(4.29±0.86)and(4.51±0.95)mPa·s;whole blood low tangential viscositieswere(7.85±1.31)and(8.26±1.43)mPa·s;late protein oxidation products levels were(14.13±2.85)and(16.02±3.11)μmoL·L^(-1);superoxide dismutase levels were(25.01±4.12)and(22.17±3.56)U·mL^(-1);reactive 0xygen species levels were(121.34±15.18)and(136.54±17.23)U·mL^(-1);hypersensitive C-reactive protein levels were(6.02±0.96)and(7.98±1.05)mg·L^(-1);tumor necrosis factor-αlevels were(69.11±8.31)and(85.47±10.62)ng·L^(-1);interleukin-6 levels were(48.76±6.25)and(54.69±8.21)ng·L^(-1);the differences of above indexes were statistically significant(all P<0.05).The adverse drug reactions of treatment group were headache,nausea and vomiting,fever and diarrhea,while those in control group were headache,nausea and vomiting and fever.The total incidences of adverse drug reactions in treatment and control groups were 8.08%and 5.15%without significant difference(P>0.05).Conclusion Edaravone and dexborneol concentrated solution for injection combined with butylphthalide has a definitive clinical efficacy in the treatment of ACI patients,which can inhibit oxidative stress injury and inflammatory response,correct the hyperviscosity state of blood,improve hemorheology,with good safety.