南方医科大学学报

南方医科大学学报 ›› 2021, Vol. 41 ›› Issue (9): 1426-1430.doi: 10.12122/j.issn.1673-4254.2021.09.20

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静脉溶栓治疗急性重度脑梗死的疗效及预后的不良相关危险因素：152例随机对照临床试验

翟跃芬，王虎清，展淑琴，吴海琴   

  1. 陕西师范大学医院内科，陕西 西安 710062；西安交通大学第二附属医院神经内科，陕西 西安 710004
  • 出版日期:2021-09-20 发布日期:2021-09-30

Efficacy of intravenous thrombolysis for acute severe cerebral infarction and risk factors of poor prognosis: a randomized controlled trial in 152 cases

ZHAI Yuefen, WANG Huqing, ZHAN Shuqin, WU Haiqin   

  1. Department of Internal Medicine, Hospital of Shaanxi Normal University, Xi'an 710062, China; Department of Neurology, Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an 710004, China
  • Online:2021-09-20 Published:2021-09-30

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摘要： 目的 探讨静脉溶栓治疗急性重度脑梗死的疗效、安全性，分析溶栓后预后不良相关危险因素。方法 采用前瞻性随机对照研究，共纳入152例急性重度脑梗死患者，发病时间均在4.5 h之内，随机信封法分为对照组（76例）和观察组（76例），对照组给予抗血小板聚集、调脂固斑、神经保护及活血药物等常规治疗，观察组在常规治疗的同时给予阿替普酶静脉溶栓治疗。记录两组患者治疗24 h、1周和1月后的NIHSS评分；治疗3月后的mRS评分；治疗1周后发生症状性颅内出血的例数。依据治疗3月 后mRS评分将观察组患者分为预后良好组（30例）、预后不良组（46例），对影响预后的相关危险因素进行单因素及多因素Logistic回归分析。结果 观察组治疗24 h、1周及1月后的NIHSS评分显著低于对照组（F=24.684，P<0.001）。治疗3月后，观察组mRS评分显著低于对照组（t=4.396，P<0.001），预后良好率明显高于对照组（χ2=13.636，P<0.001）。治疗1周后，观察组和对照 组分别发生症状性颅内出血4例和2例，无明显差异（χ2=0.694，P=0.405）。发病至溶栓间隔时间（OR=0.173，P=0.035）、溶栓前收缩压（OR=0.869，P=0.019）及入院时NIHSS评分（OR=0.466，P=0.011）是静脉溶栓治疗急性重度脑梗死预后不良的独立危险因素。结论 急性重度脑梗死应用静脉溶栓治疗是有效且安全的；发病至溶栓间隔时间、溶栓前收缩压及入院时NIHSS评分是 静脉溶栓后预后不良的独立危险因素。

关键词: 重度脑梗死；静脉溶栓；疗效；安全性；危险因素

Abstract: Objective To investigate the clinical efficacy and safety of intravenous thrombolysis in patients with acute severe cerebral infarction and analyze the risk factors of poor prognosis after thrombolysis. Methods This randomized controlled trial was conducted among 152 patients with acute severe cerebral infarction, with the onset time all within 4.5 h. The patients were randomized into control group (76 cases) and observation group (76 cases) and received treatment with routine therapy (antiplatelet aggregation, statins, neuroprotection and drugs that stimulate blood flow) and intravenous thrombolytic therapy with alteplase in addition to the routine therapy, respectively. The NIHSS scores were recorded at 24 h, 1 week and 1 month after the treatment. The mRS scores at 3 months and the incidence of symptomatic intracranial hemorrhage at one week after the treatment were compared between the two groups. According to mRS scores at 3 months, the patients in the observation group were divided into good prognosis group (30 patients) and poor prognosis group (46 patients), and the risk factors for poor prognosis were analyzed using univariate and multivariate Logistic regression analysis. Results At 24 h,1 week and 1 month after the treatment, the reduction of NIHSS scores was more significant in the observation group than in the control group (F=24.684, P<0.001). At 3 months after the treatment, the mRS scores were significantly lower (t=4.396, P<0.001) and the good prognosis rate was significantly higher (χ2=13.636, P<0.001) in the observation group than those of the control group. Symptomatic intracranial hemorrhage occurred in 4 cases in the observation group and in 2 cases in the control group within 1 week after the treatment (χ2=0.694, P=0.405). The time from onset to thrombolysis (OR=0.173, P=0.035), prethrombolytic systolic pressure (OR=0.869, P=0.019) and baseline NIHSS score (OR=0.466, P=0.011) were identified as independent risk factors for poor prognosis after intravenous thrombolysis. Conclusion Intravenous thrombolysis is effective and safe for patients with acute severe cerebral infarction, and the time from onset to thrombolysis, prethrombolytic systolic pressure and baseline NIHSS score are independent risk factors for a poor prognosis after intravenous thrombolysis.

Key words: severe cerebral infarction; intravenous thrombolysis; therapeutic effect; safety; risk factors