Efficacy and safety of recombinant tissue plasminogen activator in patients with acute mild ischemic stroke

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

Abstract

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

CLC Number:

R743.3

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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URL: https://huicui.hebmu.edu.cn/EN/10.3969/j.issn.1004-583X.2023.03.005

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

Figures/Tables 3

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

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

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

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

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	-	-

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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