重组组织型纤溶酶原激活剂治疗急性轻型缺血性脑卒中的有效性和安全性

doi:10.3969/j.issn.1004-583X.2023.03.005

摘要/Abstract

摘要：

目的观察基线美国国立卫生研究院卒中量表(National Institute of Health stroke scale, NIHSS)评分≤3分的急性轻型缺血性脑卒中患者应用重组组织型纤溶酶原激活剂(recombinant tissue plasminogen activator, rt-PA)的有效性和安全性。方法回顾性分析2020年1月至2021年12月于上海市嘉定区中心医院神经内科病房住院治疗的基线NIHSS评分≤3分,发病到就诊时间≤4.5 h的急性轻型缺血性脑卒中患者187例。按照是否应用rt-PA静脉溶栓治疗分为静脉溶栓组( $n$ =92),非静脉溶栓组( $n$ =95)。比较两组临床资料,判断急性轻型缺血性脑卒中患者应用rt-PA的有效性和安全性。结果两组性别,吸烟史,饮酒史,既往史,TOAST分型,低密度脂蛋白胆固醇,甘油三酯,总胆固醇,血同型半胱氨酸,尿素氮,血肌酐,糖化血红蛋白,基线、发病24 h NIHSS 评分,发病14 d NIHSS评分比基线增加≥1分占比,发病7 d、90 d mRS评分,发病90 d mRS评分比7 d mRS下降≥1分占比,差异均无统计学意义( $P$ >0.05)。与非静脉溶栓组比较,静脉溶栓组年龄较小,发病后7 d、14 d NIHSS评分较低,发病24 h、7 d和14 d的NIHSS评分比基线下降≥1分占比均较大,差异均有统计学意义( $P$ ≤0.05)。两组均未出现症状性颅内出血或死亡事件。静脉溶栓组出现颅内出血转化占比大于非静脉溶栓组,差异有统计学意义( $P$ <0.05),但静脉溶栓组的颅内出血转化均为非症状性出血转化,未造成临床症状加重或NIHSS评分分值的改变。结论急性轻型缺血性脑卒中(NIHSS评分≤3分)患者应用rt-PA静脉溶栓治疗可以改善急性期神经功能缺损,颅内出血转化风险有所增加,但无严重不良结局。

关键词: 缺血性卒中, 组织型纤溶酶原激活物, 治疗应用

Abstract:

Objective To observe the efficacy and safety of recombinant tissue plasminogen activator (rt-PA) on the treatment of acute mild ischemic stroke with a baseline National Institute of Health Stroke scale (NIHSS) score ≤3.Methods A total of 187 patients with acute mild ischemic stroke who were hospitalized in the Department of Neurology, Shanghai Jiading District Central Hospital from January 2020 to December 2021 with a baseline NIHSS score of ≤3 and the duration from the onset to medical visit ≤4.5 hours were retrospectively analyzed. According to the use of intravenous thrombolysis with rt-PA or not, they were divided into intravenous thrombolysis group ( $n$ =92) and non-intravenous thrombolysis group ( $n$ =95). The clinical data of the two groups were compared to determine the efficacy and safety of rt-PA on acute mild ischemic stroke. Results There were no significant differences in the gender, smoking history, drinking history, previous history, the of Trial Org 1072 in Acute Stroke Treatment (TOAST) classification, low density lipoprotein cholesterol, triglyceride, total cholesterol, blood homocysteine, urea nitrogen, blood creatinine, glycosylated hemoglobin, baseline and 24-hour NIHSS score, the proportion of NIHSS score increased by ≥1 point compared with the 7^th day on the 14^th day of the onset, modified Rankin Scale (mRS) score on the 90^th day of the onset, and the proportion of mRS score decreased by ≥1 point compared with the 7^th day on the 90^th day of the onset between groups ( $P$ >0.05). Compared with the non-intravenous thrombolysis group, patients in the intravenous thrombolysis group were younger, and the NIHSS score was lower on the 7^th and 14^th days after the onset. The proportion of patients with NIHSS score decreased by ≥ 1 point compared with the baseline on the 24 hours, 7^th and 14^th days after the onset of the disease was higher in the intravenous thrombolysis group and the difference was statistically significant ( $P$ ≤0.05). No symptomatic intracranial hemorrhage or death occurred in both groups. The proportion of intracranial hemorrhage transformation in the intravenous thrombolysis group was significantly higher than that in the non-intravenous thrombolysis group ( $P$ <0.05). The intracranial hemorrhage transformations in the intravenous thrombolysis group were all asymptomatic hemorrhagic transformations, which did not cause aggravation of clinical symptoms or changes in NIHSS scores.Conclusion The use of rt-PA in intravenous thrombolysis in patients with acute mild ischemic stroke (NIHSS score ≤ 3 points) can improve the neurological deficit in the acute stage, but increases the risk of intracranial hemorrhage conversion. It does not cause serious adverse events.

Key words: ischemic stroke, tissue plasminogen activator, therapeutic uses

中图分类号:

R743.3

姚美芬, 丁刚玉, 徐建华, 王国江. 重组组织型纤溶酶原激活剂治疗急性轻型缺血性脑卒中的有效性和安全性[J]. 临床荟萃, 2023, 38(3): 227-231.

Yao Meifen, Ding Gangyu, Xu Jianhua, Wang Guojiang. Efficacy and safety of recombinant tissue plasminogen activator in patients with acute mild ischemic stroke[J]. Clinical Focus, 2023, 38(3): 227-231.

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链接本文: https://huicui.hebmu.edu.cn/CN/10.3969/j.issn.1004-583X.2023.03.005

https://huicui.hebmu.edu.cn/CN/Y2023/V38/I3/227

图/表 3

表1 两组临床资料比较

Tab.1 Comparison of clinical data between groups

组别	例数		性别(例)		年龄 (岁)		吸烟史 (例)	饮酒史 (例)		既往史(例)						TOAST分型(例)
			男	女						高血压	糖尿病	心房颤动/ 扑动		大动脉粥样硬化型		小动脉闭塞型		心源性栓塞型	其他原因		原因不明
			静脉溶栓组	92						高血压	糖尿病	心房颤动/ 扑动		大动脉粥样硬化型		小动脉闭塞型		心源性栓塞型	其他原因		原因不明	59	33	65.185±10.815	38	16	76	38	9	17	59	9	1	6
非静脉溶栓组	95		64	31		69.137±12.833		31	19		84	35	12		28		51		9	2		5
统计值			χ²=0.218		$t$ =2.274		χ²=1.510	χ²=0.209		χ²=1.278	χ²=0.391	χ²=0.381		χ²=3.092		χ²=2.106		χ²=0.005	-		χ²=0.134
$P$ 值			0.641		0.024		0.219	0.647		0.258	0.532	0.537		0.079		0.147		0.943	0.512		0.715
组别		LDL-C(mmol/L)				TC(mmol/L)			TG(mmol/L)		Hcy(μmol/L)		BUN(mmol/L)				Cr(μmol/L)			HbA₁c(%)
静脉溶栓组		2.858±0.887				4.859±1.055			1.766±1.340		15.780±7.701		5.227±1.473				74.995±18.749			6.839±1.533
非静脉溶栓组		2.797±0.908				4.766±1.167			1.772±1.323		15.840±8.113		5.166±1.549				72.051±23.091			6.808±1.701
统计值		$t$ =0.465				$t$ =0.571			$t$ =0.031		$t$ =0.052		$t$ =0.276				$t$ =0.955			$t$ =0.131
$P$ 值		0.643				0.569			0.975		0.959		0.783				0.341			0.896

表1 两组临床资料比较

Tab.1 Comparison of clinical data between groups

组别	例数		性别(例)		年龄 (岁)		吸烟史 (例)	饮酒史 (例)		既往史(例)						TOAST分型(例)
			男	女						高血压	糖尿病	心房颤动/ 扑动		大动脉粥样硬化型		小动脉闭塞型		心源性栓塞型	其他原因		原因不明
			静脉溶栓组	92						高血压	糖尿病	心房颤动/ 扑动		大动脉粥样硬化型		小动脉闭塞型		心源性栓塞型	其他原因		原因不明	59	33	65.185±10.815	38	16	76	38	9	17	59	9	1	6
非静脉溶栓组	95		64	31		69.137±12.833		31	19		84	35	12		28		51		9	2		5
统计值			χ²=0.218		$t$ =2.274		χ²=1.510	χ²=0.209		χ²=1.278	χ²=0.391	χ²=0.381		χ²=3.092		χ²=2.106		χ²=0.005	-		χ²=0.134
$P$ 值			0.641		0.024		0.219	0.647		0.258	0.532	0.537		0.079		0.147		0.943	0.512		0.715
组别		LDL-C(mmol/L)				TC(mmol/L)			TG(mmol/L)		Hcy(μmol/L)		BUN(mmol/L)				Cr(μmol/L)			HbA₁c(%)
静脉溶栓组		2.858±0.887				4.859±1.055			1.766±1.340		15.780±7.701		5.227±1.473				74.995±18.749			6.839±1.533
非静脉溶栓组		2.797±0.908				4.766±1.167			1.772±1.323		15.840±8.113		5.166±1.549				72.051±23.091			6.808±1.701
统计值		$t$ =0.465				$t$ =0.571			$t$ =0.031		$t$ =0.052		$t$ =0.276				$t$ =0.955			$t$ =0.131
$P$ 值		0.643				0.569			0.975		0.959		0.783				0.341			0.896

表2 两组有效性比较

Tab.2 Comparison of efficacy between groups

组别		例数		NIHSS评分(分)
组别		例数		基线			发病24 h		发病7 d		发病14 d
静脉溶栓组		92		2.000(1.000, 3.000)			1.000(0.000, 2.000)		1.000(0.000, 1.750)		1.000(0.000, 1.000)
非静脉溶栓组		95		2.000(2.000, 2.000)			1.000(1.000, 2.000)		1.000(0.000, 2.000)		1.000(0.000, 2.000)
$Z$ /χ²值				0.013			1.335		1.963		2.273
$P$ 值				0.990			0.182		0.050		0.023
组别	NIHSS评分比基线下降≥1分(例)					14 d NIHSS评分比基线增加≥1分(例)		mRS评分(分)				90 d mRS评分比 7 d mRS下降≥1分(例)
组别	发病24 h		发病7 d		发病14 d	14 d NIHSS评分比基线增加≥1分(例)		7 d		90 d		90 d mRS评分比 7 d mRS下降≥1分(例)
静脉溶栓组	40		55		58	9		1.000(1.000,2.000)		1.000(1.000,1.750)		16
非静脉溶栓组	10		22		25	11		1.000(1.000,2.000)		1.000(1.000,2.000)		13
$Z$ /χ²值	25.907		25.833		24.769	0.158		0.916		0.554		0.490
$P$ 值	0.000		0.000		0.000	0.691		0.360		0.580		0.484

表2 两组有效性比较

Tab.2 Comparison of efficacy between groups

组别		例数		NIHSS评分(分)
组别		例数		基线			发病24 h		发病7 d		发病14 d
静脉溶栓组		92		2.000(1.000, 3.000)			1.000(0.000, 2.000)		1.000(0.000, 1.750)		1.000(0.000, 1.000)
非静脉溶栓组		95		2.000(2.000, 2.000)			1.000(1.000, 2.000)		1.000(0.000, 2.000)		1.000(0.000, 2.000)
$Z$ /χ²值				0.013			1.335		1.963		2.273
$P$ 值				0.990			0.182		0.050		0.023
组别	NIHSS评分比基线下降≥1分(例)					14 d NIHSS评分比基线增加≥1分(例)		mRS评分(分)				90 d mRS评分比 7 d mRS下降≥1分(例)
组别	发病24 h		发病7 d		发病14 d	14 d NIHSS评分比基线增加≥1分(例)		7 d		90 d		90 d mRS评分比 7 d mRS下降≥1分(例)
静脉溶栓组	40		55		58	9		1.000(1.000,2.000)		1.000(1.000,1.750)		16
非静脉溶栓组	10		22		25	11		1.000(1.000,2.000)		1.000(1.000,2.000)		13
$Z$ /χ²值	25.907		25.833		24.769	0.158		0.916		0.554		0.490
$P$ 值	0.000		0.000		0.000	0.691		0.360		0.580		0.484

表3 两组安全性比较(例)

Tab. 3 Comparison of safety between groups (cases)

组别	例数	出血转化	症状性出血转化	死亡
静脉溶栓组	92	5	0	0
非静脉溶栓组	95	0	0	0
$χ$ ²值		-	-	-
$P$ 值		0.027	-	-

表3 两组安全性比较(例)

Tab. 3 Comparison of safety between groups (cases)

组别	例数	出血转化	症状性出血转化	死亡
静脉溶栓组	92	5	0	0
非静脉溶栓组	95	0	0	0
$χ$ ²值		-	-	-
$P$ 值		0.027	-	-

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