Objective To explore the clinical efficacy of tenecteplase (TNK) intravenous thrombolysis combined with butylphthalide injection in the patients with acute cerebral infarction (ACI). Methods A total of 60 patients with ACI admitted to Characteristics Medical Center of Chinese People’s Armed Police Force from January 2024 to March 2025 were selected and randomly divided into a control group and a combined treatment group, with 30 patients in each group. Both groups were given the same basic treatment, and the control group was treated with TNK intravenous thrombolysis, while the combined treatment group was treated with TNK intravenous thrombolysis combined with butylphthalide injection. The modified Rankin scale (mRS) scores, serum inflammatory factor levels and adverse reactions were compared before and after treatment between the two groups, and the National Institutes of Health stroke scale (NIHSS) was used to assess the scores of the patients at admission, 24 h, 7 d, and 90 d after thrombolysis. Results There were no significant differences between the combined treatment group and the control group in mRS score and the levels of serum inflammatory factors at admission(P>0.05). The mRS score of the combined treatment group after treatment (1.30±0.47 points) was lower than that of the control group (2.40±0.50 points), with a statistically significant difference (P<0.05). The levels of serum inflammatory factors IL-6, IL-8, and IL-10 in the combined treatment group were (20.13±3.47) ng/L, (19.33±3.56) ng/L, and (8.34±0.38) ng/L, respectively, which were lower than (24.32±3.61) ng/L, (22.48±3.83) ng/L, and (9.29±0.64) ng/L, respectively in the control group, with a statistically significant difference (P<0.05); There were no significant differences between the combined treatment group and the control group in NIHSS scores at admission and 24 h after thrombolysis (P>0.05), but the NIHSS score of patients in the combined treatment group was (11.63±1.56) points 7 d after thrombolysis, which was lower than (13.13±1.63) points of the control group, with a statistically significant difference (P<0.05). The NIHSS score of patients in the combined treatment group was (8.47±1.07) points 90 d after thrombolysis, which was lower than (9.57±1.22) points of the control group, with a statistically significant difference (P<0.05).The incidence of adverse reactions in the combined treatment group compared to the control group showed no significant difference (P>0.05). Conclusions TNK intravenous thrombolysis combined with butylphthalide injection can improve the recovery of neurological dysfunction and reduce the levels of serum inflammatory factors of patients with ACI, without obvious adverse reactions, which is a safe and effective treatment method.
Key words
tenecteplase /
butylphthalide /
acute cerebral infarction /
intravenous thrombolysis /
clinical efficacy
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References
[1] Ma Q F,Li R,Wang L J,et al.Temporal trend and attributable risk factors of stroke burden in China,1990-2019:an analysis for the global burden of disease study 2019[J].Lancet Public Health,2021,6(12):e897-e906.
[2] 《中国脑卒中防治报告2021》编写组,王陇德.《中国脑卒中防治报告2021》概要[J].中国脑血管病杂志,2023,20(11):783-792,封3.
[3] 中华医学会神经病学分会,中华医学会神经病学分会脑血管病学组.中国急性缺血性脑卒中诊治指南2023[J].中华神经科杂志,2024,57(6):523-559.
[4] 中国卒中学会,《中国卒中学会急性缺血性卒中再灌注治疗指南2024》编写组,王拥军.中国卒中学会急性缺血性卒中再灌注治疗指南2024[J].中国卒中杂志,2024,19(12):1460-1478.
[5] 王瑞平. 随机对照临床试验设计中的样本量估算方法[J].上海医药,2023,44(1):48-52.
[6] 中华医学会神经病学分会,中华医学会神经病学分会脑血管病学组.急性缺血性卒中替奈普酶静脉溶栓治疗中国专家共识[J].中华神经精神疾病杂志,2022,48(11):641-651.
[7] 张 韬,赵德强,符彤琳.不同支架机械取栓治疗急性脑梗死的效果对比研究[J].武警医学,2022,33(3):234-237.
[8] Berge E,Whiteley W,Audebert H,et al.European Stroke Organisation (ESO) guidelines on intravenous thrombolysis for acute ischaemic stroke[J].Eur Stroke J,2021,6(1):1-13.
[9] Bivard A,Lin L T,Parsonsb M W.Review of stroke thrombolytics[J].J Stroke,2013,15(2):90-98.
[10] Burgos A M,Saver J L.Evidence that tenecteplase is noninferior to alteplase for acute ischemic stroke:meta-analysis of 5 randomized trials[J].Stroke,2019,50(8):2156-2162.
[11] Menon B K,Buck B H,Singh N,et al.Intravenous tenecteplase compared with alteplase for acute ischaemic stroke in Canada(AcT):a pragmatic,multicentre,open-label,registry-linked,randomized,controlled,non-inferiority trial[J].Lancet,2022,400(10347):161-169.
[12] Wang Y J,Li S Y,Pan Y S,et al.Tenecteplase versus alteplase in acute ischaemic cerebrovascular events(TRACE-2): a phase 3, multicentre, open-label, randomised controlled, non-inferiority trial[J]. Lancet,2023,401(10377):645-654.
[13] Meng X,Li S Y,Dai H G,et al.Tenecteplase vs. alteplase for patients with acute ischemic stroke:the original randomized clinical trial[J].JAMA,2024,332(17):1437-1445.
[14] Parsons M W,Yogendrakumar V,Churilov L,et al.Tenecteplase versus alteplase for thrombolysis in patients selected by use of perfusion imaging within 4.5 h of onset of ischaemic stroke (TASTE): a multicentre, randomized, controlled, phase 3 non-inferiority trial[J].Lancet Neurol,2024,23(8):775-786.
[15] Alhadid K,Oliveira L,Etherton M R.Intravenous thrombolytics in the treatment of acute ischemic stroke[J]. Curr Treat Options Cardiovasc Med,2023,25(1):15-28.
[16] Hall J,Thon J M,Heslin M,et al.Tenecteplase improves door-to-needle time in real-world acute stroke treatment[J].Stroke Vasc Interv Neurol,2021,1(1):e000102.
[17] 高 峰,王旭磊,刘峥翠.急性缺血性脑卒中患者应用替奈普酶和瑞替普酶静脉溶栓的临床有效性及安全性差异分析[J].中国中西医结合急救杂志,2024,31(5):561-565.
[18] Guo Z N,Yue B H,Fan L,et al.Effectiveness of butylphthalide on cerebral autoregulation in ischemic stroke patients with large artery atherosclerosis (EBCAS study): a randomized, controlled, multicenter trial[J].J Cereb Blood Flow Metab,2023,43(10):1702-1712.
[19] 杨 蓉,李寅珍,严首春.丁苯酞氯化钠注射液联合rt-PA超时间窗溶栓治疗急性脑梗死患者的效果评价[J]. 中国中西医结合急救杂志,2021,28(3):316-319.
[20] 徐 鹏, 侯双兴.丁苯酞注射液联合针刺对急性脑梗死患者临床疗效观察[J].武警医学,2021,32(12):1043-1047.
[21] 周慧文.高压氧联合丁苯酞治疗急性脑梗死的效果分析[J].中国临床医生杂志,2023,51(1):50-52.
[22] Askenase M H,Sansing L H.Stages of the inflammatory response in pathology and tissue repair after intracerebral hemorrhage[J].Semin Neurol,2016,36(3):288-297.
[23] Zeng Z,Gong X Y,Hu Z P.L-3-n-butylphthalide attenuates inflammation response and brain edema in rat intracerebral hemorrhage model[J].Aging,2020,12(12):11768-11780.
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