| 摘要: |
| ［摘要］ 目的 观察高龄（≥80岁）急性缺血性卒中（AIS）患者接受国产注射用重组人替奈普酶（TNK）组织型纤溶酶原激活剂（rhTNK-tPA）静脉溶栓的疗效与安全性。方法 回顾性分析2023年11月至2025年9月广西河池市四家卒中中心（广西医科大学第一附属医院河池医院、东兰县人民医院、大化瑶族自治县人民医院、凤山县人民医院）收治的起病4.5 h内应用国产rhTNK-tPA（0.25 mg/kg）静脉溶栓治疗的132例AIS患者的临床资料。按年龄将其分为高龄组（≥80岁，44例）和非高龄组（<80岁，88例）。比较两组患者的临床资料、临床结局指标。采用多因素logistic回归分析高龄对各项临床结局的影响。结果 与非高龄组比较，高龄组女性、卒中史和心源性栓塞型占比较高，溶栓前美国国立卫生研究院卒中量表（NIHSS）评分较高，起病后90 d预后极好［改良Rankin量表（mRS）评分0～1分］率（40.91% vs 60.23%）较低，预后不良（mRS评分≥3分）率（50.00% vs 31.82%）和全因死亡率（25.00% vs 7.95%）较高，差异有统计学意义（P<0.05）。两组症状性颅内出血（sICH）发生率（11.36% vs 4.55%）比较差异无统计学意义（P>0.05）。多因素logistic回归分析显示，高龄与起病后90 d预后极好［OR（95%CI）=0.640（0.247～1.659）］、预后不良［OR（95%CI）=1.233（0.448～3.392）］、全因死亡［OR（95%CI）=1.929（0.507～7.341）］及sICH发生［OR（95%CI）=0.730（0.079～6.748）］均无显著关联（P>0.05）。结论 与非高龄AIS患者相比，应用国产rhTNK-tPA（0.25 mg/kg）静脉溶栓治疗同样可使高龄AIS患者获益，而且sICH发生率、起病后90 d全因死亡率不增加。 |
| 关键词: 缺血性卒中 年龄因素 替奈普酶 血栓溶解疗法 颅内出血 |
| DOI：10.3969/j.issn.1674-3806.2026.08.08 |
| 分类号:R 743.3 |
| 基金项目:国家自然科学基金项目（编号：82260243） |
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| Efficacy and safety of domestic recombinant human TNK tissue-type plasminogen activator injection for intravenous thrombolysis in acute ischemic stroke patients aged ≥80 years: an observational study |
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Bi Yuansheng1, Huang Xiulin1, Wei Shirong2, Wei Feng3, Tang Yunli4, Lu Lin5, Liang Zhijian1
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1.Intensive Care Unit, Department of Neurology, the First Affiliated Hospital of Guangxi Medical University, Nanning 530021, China; 2.Department of Neurology, Hechi Hospital, the First Affiliated Hospital of Guangxi Medical University, Hechi 547000, China; 3.Second Department of Internal Medicine, Donglan County People′s Hospital, Hechi 547499, China; 4.Third Department of Internal Medicine, the People′s Hospital of Dahua Yao Autonomous County, Hechi 530800, China; 5.First Department of Internal Medicine, People′s Hospital of Fengshan County, Hechi 547600, China
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| Abstract: |
| ［Abstract］ Objective To observe the efficacy and safety of domestic recombinant human tenecteplase(TNK) tissue-type plasminogen activator injection(rhTNK-tPA) for intravenous thrombolysis in acute ischemic stroke(AIS) patients aged ≥80 years. Methods A retrospective analysis was conducted on the clinical data of 132 patients with AIS who were admitted to 4 stroke centers(Hechi Hospital, the First Affiliated Hospital of Guangxi Medical University; Donglan County People′s Hospital, the People′s Hospital of Dahua Yao Autonomous County and People′s Hospital of Fengshan County) in Hechi city, Guangxi from November 2023 to September 2025. All these patients received intravenous thrombolytic therapy with domestic rhTNK-tPA(0.25 mg/kg) within 4.5 hours of stroke onset. The patients were divided into the advanced age group(≥80 years, n=44) and the non-advanced age group(<80 years, n=88) according to their ages. The clinical data and clinical outcome indicators were compared between the two groups. Multivariate logistic regression was used to analyze the impact of advanced age on clinical outcomes. Results Compared with the non-advanced age group, the advanced age group had higher proportions of female patients, patients with a history of stroke and patients with cardioembolic stroke, higher pre-thrombolysis scores of National Institutes of Health Stroke Scale(NIHSS), lower rate of excellent outcome［modified Rankin Scale(mRS) scores: 0-1 point］ at 90 days after onset(40.91% vs 60.23%), and higher rates of poor outcome(mRS scores ≥3 points)(50.00% vs 31.82%) and all-cause mortality(25.00% vs 7.95%), with statistically significant differences between the two groups(P<0.05). There was no statistically significant difference in the incidence of symptomatic intracranial hemorrhage(sICH) between the two groups(11.36% vs 4.55%)(P>0.05). Multivariate logistic regression analysis showed that advanced age was not significantly associated with excellent outcome［OR(95%CI)=0.640( 0.247-1.659)］, poor outcome［OR(95%CI)=1.233(0.448-3.392)］, all-cause death［OR(95%CI)=1.929(0.507-7.341)］, and the occurrence of sICH［OR(95%CI)=0.730(0.079-6.748)］(P>0.05) at 90 days after onset. Conclusion Compared with non-advanced age patients with AIS, advanced age patients with AIS may also benefit from intravenous thrombolytic therapy with domestic rhTNK-tPA(0.25 mg/kg), and the incidence of sICH and all-cause mortality at 90 days after onset do not increase in the advanced age patients. |
| Key words: ischemic stroke age factor tenecteplase(TNK) thrombolytic therapy intracranial hemorrhage |
