重组人TNK组织型纤溶酶原激活剂溶栓联合阿托伐他汀钙对急性脑梗死患者的疗效研究

doi:10.3760/cma.j.issn.1007-1245.2024.24.002

摘要/Abstract

摘要：

目的　研究重组人TNK组织型纤溶酶原激活剂（rhTNK-tPA）溶栓联合阿托伐他汀钙对急性脑梗死（ACI）患者的疗效。方法　本研究为随机对照试验。选取2021年5月至2023年12月西安医学院第三附属医院神经内科收治的90例ACI患者作为研究对象，采用随机数字表法，将患者分为对照组（45例）和观察组（45例）。对照组男23例，女22例；年龄（51.47±7.70）岁；体重指数（24.12±2.69）kg/m²。观察组男26例，女19例；年龄（53.18±8.45）岁；体重指数（23.68±2.40）kg/m²。对照组采用rhTNK-tPA溶栓治疗，观察组在对照组基础上联合阿托伐他汀钙治疗。两组均连续治疗2周，随访6个月。比较两组临床疗效，治疗前后血清可溶性细胞间黏附分子-1（sICAM-1）、髓鞘碱性蛋白（MBP）和脂蛋白相关磷脂酶（Lp-PL）A2水平，治疗前后和治疗后3个月神经功能［美国国立卫生研究院脑卒中量表（NIHSS）评分］、运动功能［Fugl-Meyer运动功能评定量表（FMA）评分］，治疗期间药物不良反应发生情况，随访期间预后情况（病死、血管再通、颅内出血）。采用独立样本t检验、χ²检验和Fisher确切概率法进行统计学分析。结果　观察组治疗总有效率高于对照组［93.33%（42/45）比77.78%（35/45）］（P<0.05）。治疗后，观察组血清sICAM-1、MBP和Lp-PLA2水平均低于对照组［（291.45±22.81）μg/L比（308.62±23.50）μg/L、（2.24±0.41）μg/L比（2.58±0.46）μg/L、（142.71±20.56）μg/L比（157.31±19.40）μg/L］（均P<0.05）。治疗后和治疗后3个月，观察组NIHSS评分均低于对照组，FMA评分均高于对照组［（5.56±1.08）分比（5.90±1.39）分、（3.64±0.75）分比（3.90±0.86）分、（68.73±10.46）分比（62.41±9.22）分、（79.44±10.34）分比（73.51±9.83）分］（均P<0.05）。治疗期间，两组不良反应总发生率比较，差异无统计学意义（P>0.05）。随访6个月后，观察组血管再通率高于对照组［95.56%（43/45）比82.22%（37/45）］（P<0.05）。结论　rhTNK-tPA联合阿托伐他汀钙治疗ACI患者可提高临床疗效，改善血清sICAM-1、MBP和Lp-PLA2水平和运动能力，提高血管再通率，安全可靠。

关键词:

急性脑梗死, 重组人TNK组织型纤溶酶原激活剂, 阿托伐他汀钙, 疗效, 血清标志物, 血管再通

Abstract:

Objective　To study the efficacy of recombinant human TNK tissue-type plasminogen activator (rhTNK-tPA) thrombolysis combined with atorvastatin calcium in patients with acute cerebral infarction (ACI). Methods　This study was a randomized controlled trial. A total of 90 ACI patients admitted to Department of Neurology, The Third Affiliated Hospital of Xi'an Medical University from May 2021 to December 2023 were selected as the study objects. The patients were divided into a control group (45 cases) and an observation group (45 cases) by the random number table method. The control group included 23 males and 22 females, aged (51.47±7.70) years, with a body mass index (BMI) of (24.12±2.69) kg/m². The observation group included 26 males and 19 females, aged (53.18±8.45) years, with a BMI of (23.68±2.40) kg/m². The control group was treated with rhTNK-tPA thrombolytic therapy, and the observation group was treated with atorvastatin calcium based on the control group. Both groups were treated for 2 weeks and followed up for 6 months. The clinical efficacy, serum levels of soluble intercellular adhesion molecule-1 (sICAM-1), myelin basic protein (MBP), and lipoprotein-associated phospholipase A2 (Lp-PLA2) before and after treatment, neurological function [National Institutes of Health Stroke Scale (NIHSS) score] and motor function [Fugl-Meyer Motor Function Assessment (FMA) score] before and after treatment and 3 months after treatment, occurrence of adverse drug reactions during treatment, and prognosis (death, vascular recanalization, and intracranial hemorrhage) during follow-up were compared between the two groups. Independent sample t test, χ² test and Fisher exact probability method were used for statistical analysis. Results　The total effective rate of the observation group was higher than that of the control group [93.33% (42/45) vs. 77.78% (35/45)] (P<0.05). After treatment, the levels of serum sICAM-1, MBP, and Lp-PLA2 in the observation group were lower than those in the control group [(291.45±22.81) μg/L vs. (308.62±23.50) μg/L, (2.24±0.41) μg/L vs. (2.58±0.46) μg/L, (142.71±20.56) μg/L vs. (157.31±19.40) μg/L] (all P<0.05). After treatment and 3 months after treatment, the NIHSS scores in the observation group were lower than those in the control group, and the FMA scores were higher than those in the control group [(5.56±1.08) points vs. (5.90±1.39) points, (3.64±0.75) points vs. (3.90±0.86) points, (68.73±10.46) points vs. (62.41±9.22) points, (79.44±10.34) points vs. (73.51±9.83) points] (all P<0.05). During treatment, there was no statistically significant difference in the total incidence of adverse reactions between the two groups (P>0.05). After 6 months of follow-up, the vascular recirculation rate in the observation group was higher than that in the control group [95.56% (43/45) vs. 82.22% (37/45)] (P<0.05). Conclusion　rhTNK-tPA combined with atorvastatin calcium in the treatment of ACI patients can improve the clinical efficacy, serum sICAM-1, MBP, and Lp-PLA2 levels and exercise ability, and increase the vascular revascularization rate, which is safe and reliable.

Key words:

Acute cerebral infarction, Recombinant human TNK tissue-type plasminogen activator, Atorvastatin calcium, Efficacy, Serum biomarkers, Vascular recanalization

周美宁刘晓娟.

重组人TNK组织型纤溶酶原激活剂溶栓联合阿托伐他汀钙对急性脑梗死患者的疗效研究 [J]. 国际医药卫生导报, 2024, 30(24): 4074-4078.

Zhou Meining, Liu Xiaojuan.

Efficacy of recombinant human TNK tissue-type plasminogen activator thrombolysis combined with atorvastatin calcium in patients with acute cerebral infarction [J]. International Medicine and Health Guidance News, 2024, 30(24): 4074-4078.

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