急性脑梗死血管内治疗后静脉注射替罗非班的安全性和有效性分析

黄洁; 骆嵩; 李金平; 李小雄; 刘承春; 符晓燕; 周华东

doi:10.16766/j.cnki.issn.1674-4152.002449

急性脑梗死血管内治疗后静脉注射替罗非班的安全性和有效性分析

doi: 10.16766/j.cnki.issn.1674-4152.002449

1.
蚌埠医学院第一附属医院神经内科, 安徽蚌埠 233004
2.
陆军军医大学大坪医院神经内科, 重庆 400000

基金项目:

安徽高校自然科学研究项目 KJ2019A0364

重庆市技术创新与应用发展专项 cstc2019jscx-msxmX0254

详细信息

通讯作者:
周华东, E-mail：zhouhuad@163.com

中图分类号: R743.3
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出版历程
- 收稿日期: 2021-09-20
- 网络出版日期: 2022-09-05

Safety and efficacy of intravenous tirofiban after endovascular treatment of acute cerebral infarction

1.
Department of Neurology, the First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui 233004, China

摘要

摘要: 目的探讨急性脑梗死血管内治疗后静脉注射替罗非班的安全性和有效性。方法回顾性纳入2019年9月—2021年3月陆军军医大学大坪医院神经内科收治的急性脑梗死并行血管内治疗患者152例。根据血管内治疗后是否使用替罗非班静脉滴注将其分为替罗非班组和对照组。采用1∶ 1比例的倾向评分匹配分析平衡2组的基线资料。观察主要终点包括安全性和有效性。安全性为症状性颅内出血(sICH)、任何出血、90 d内复发和病死率；有效性为出院时美国国立卫生研究院卒中量表(NIHSS)评分及90 d预后良好率[改良Rankin量表(mRS)评分0~2分]。结果最终共纳入患者145例，其中替罗非班组70例，对照组75例，替罗非班组出院时NIHSS评分[4(2, 13) vs. 11(3, 16)，P=0.002]明显优于对照组患者；替罗非班组与对照组sICH发生率[7(10.0%) vs. 12(16.0%), P=0.284]、90 d预后良好率、任何出血、复发和病死率差异均无统计学意义(均P＞0.05)。经倾向性评分成功匹配47对，2组安全性及有效性指标比较差异无统计学意义(均P＞0.05)。结论急性脑梗死血管内治疗后静脉注射替罗非班治疗是安全的。匹配前替罗非班可以改善急性脑梗死血管内治疗后患者的出院时NIHSS评分，但在90 d预后良好率上并无获益；匹配后，替罗非班组患者在出院时及90 d的预后良好率均无获益。
- 急性脑梗死 /
- 血管内治疗 /
- 替罗非班 /
- 安全性 /
- 功能预后 /
- 倾向性评分匹配
Abstract: Objective To evaluate the safety and efficacy of intravenous tirofiban after endovascular treatment for patients with acute cerebral infarction. Methods A total of 152 patients with acute cerebral infarction undergoing endovascular treatment in the Department of Neurology of Daping Hospital, Army Military Medical University from September 2019 to March 2021 were retrospectively included. They were divided into the tirofiban group and control group according to whether tirofiban was injected intravenously after endovascular treatment. The baseline of the two groups was balanced by 1∶ 1 propensity score matching analysis. The main end points included safety and effectiveness. The safety was symptomatic intracranial haemorrhage (sICH), any haemorrhage, recurrence within 90 days and mortality. The effectiveness was National Institutes of Health Stroke Scale (NIHSS) score at discharge and 90-day good prognosis rate (modified Rankin score: 0-2). Results A total of 145 patients were included, including 70 in the tirofiban group and 75 in the control group. The NIHSS score of the tirofiban group at discharge [4(2, 13) vs. 11(3, 16), P=0.002] was significantly better than that of the control group. Moreover, there was no significant difference in the incidence of sICH [7(10.0%) vs. 12(16.0%), P=0.284] 90-day prognosis, any bleeding, recurrence and mortality (all P>0.05). Forty-seven pairs were successfully matched by propensity score. There was no significant difference in safety and effectiveness between the two groups (all P>0.05). Conclusion Intravenous tirofiban is safe after endovascular treatment of acute cerebral infarction. Pre-matching tirofiban can improve the NIHSS score at discharge of patients with acute cerebral infarction after endovascular treatment, but it has no benefit in the 90-day prognosis rate. After matching, there was no benefit in the good prognosis of tirofiban patients at discharge and 90 days.
- Acute cerebral infarction /
- Endovascular treatment /
- Tirofiban /
- Safety /
- Functional prognosis /
- Propensity score matching

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图 1 急性脑梗死血管内治疗患者倾向性评分匹配流程图

Figure 1. Flow chart of propensity score matching in patients with acute cerebral infarction treated with endovascular therapy

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表 1 2组急性大血管闭塞经血管内治疗患者倾向性评分匹配前临床特征比较

Table 1. Comparison of clinical characteristics before propensity score matching between two groups of patients with acute macrovascular occlusion treated by endovascular therapy

组别	例数	年龄[M(P₂₅, P₇₅), 岁]	性别(男/女，例)	心血管危险因素[例(%)]			TOAST分型[例(%)]
组别	例数	年龄[M(P₂₅, P₇₅), 岁]	性别(男/女，例)	高血压	冠心病	吸烟	大动脉粥样硬化型	心源性栓塞	其他
替罗非班组	70	64(54，72)	48/22	45(64.3)	14(20.0)	15(21.4)	35(50.0)	30(47.1)	5(7.1)
对照组	75	71(60，78)	36/39	46(61.3)	30(40.0)	14(18.7)	34(45.3)	38(50.7)	3(4.0)
统计量		-2.733^a	6.287^b	0.135^b	6.852^b	4.970^b	0.316^b	0.887^b
P值		0.006	0.012	0.713	0.009	0.026	0.574	0.346	0.483^c

组别	例数	基线NIHSS评分[M(P₂₅, P₇₅), 分]	静脉溶栓[例(%)]		入院收缩压(x±s, mm Hg)	发病到入院时间[M(P₂₅, P₇₅), 分]	穿刺到再通时间[M(P₂₅, P₇₅), 分]		血管再通[mTICI≥2b，例(%)]
替罗非班	70	11(5，19)	26(37.1)		150.40±25.81	364(183，563)	155(108，198)		59(84.3)
对照组	75	16(11，21)	42(56.0)		147.07±25.27	250(130，351)	115(83，182)		62(82.7)
统计量		-3.059^a	5.170^b		0.157^d	-2.315^a	-2.163^a		0.069^b
P值		0.002	0.023		0.433	0.021	0.031		0.793
注：^a为Z值，^b为χ²值，^c为采用Fisher精确检验, ^d为t值；1 mm Hg=0.133 kPa。

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表 2 2组急性大血管闭塞经血管内治疗患者倾向性评分匹配前安全性和有效性指标比较

Table 2. Comparison of safety and efficacy indicators before propensity score matching between two groups of patients with acute macrovascular occlusion treated with endovascular therapy

组别	例数	安全性指标				有效性指标
组别	例数	任何出血[例(%)]	sICH[例(%)]	90 d复发[例(%)]	90 d死亡[例(%)]	出院时NIHSS评分[M(P₂₅, P₇₅), 分]	90 d mRS 0~2分[例(%)]
替罗非班组	70	14(20.0)	7(10.0)	2(2.9)	3(4.3)	4(2，13)	57(81.4)
对照组	75	24(32.0)	12(16.0)	0	8(10.7)	11(3，16)	51(68.0)
统计量		2.696^a	1.144^a		2.103^a	-3.047^c	3.435^a
P值		0.101	0.284	0.497^b	0.147	0.002	0.064
注：^a为χ²值, ^b为采用Fisher精确检验, ^c为Z值。

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表 3 2组急性大血管闭塞经血管内治疗患者倾向性评分匹配后临床特征比较

Table 3. Comparison of clinical characteristics between two groups of patients with acute macrovascular occlusion treated by endovascular propensity score matching

组别	例数	年龄[M(P₂₅, P₇₅), 岁]	性别(男/女，例)	心血管危险因素[例(%)]			TOAST分型[例(%)]
组别	例数	年龄[M(P₂₅, P₇₅), 岁]	性别(男/女，例)	高血压	冠心病	吸烟	大动脉粥样硬化型	心源性栓塞型	其他
替罗非班组	47	67(53，74)	31/16	30(63.8)	11(23.4)	19(40.4)	30(63.8)	15(31.9)	2(4.3)
对照组	47	66(54，76)	29/18	26(55.3)	14(29.8)	16(34.0)	36(76.6)	10(21.3)	1(2.1)
统计量		-0.174^a	0.184^b	0.707^b	0.490^b	0.410^b	1.831^b	1.362^b
P值		0.862	0.668	0.401	0.484	0.522	0.176	0.243	0.999^c

组别	例数	基线NIHSS评分[M(P₂₅, P₇₅), 分]	静脉溶栓[例(%)]		入院收缩压(x±s, mm Hg)	发病到入院时间[M(P₂₅, P₇₅), 分]	穿刺到再通时间[M(P₂₅, P₇₅), 分]		血管再通(mTICI≥2b) [例(%)]
替罗非班组	47	14(6，20)	18(38.3)		151.38±25.80	369(180，570)	160(110，210)		40(85.1)
对照组	47	13(9，18)	27(54.4)		141.15±25.30	270(172，394)	120(85，210)		38(80.9)
统计量		-0.155^a	3.453^b		-1.388^d	-1.187^a	-1.161^a		0.301^b
P值		0.877	0.063		0.168	0.235	0.246		0.583
注：^a为Z值，^b为χ²值，^c为采用Fisher精确检验, ^d为t值。

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表 4 2组急性大血管闭塞经血管内治疗患者倾向性评分匹配后安全性和有效性指标比较

Table 4. Comparison of safety and efficacy indexes between two groups of patients with acute macrovascular occlusion treated by endovascular treatment after propensity score matching

组别	例数	安全性指标				有效性指标
组别	例数	任何出血[例(%)]	sICH[例(%)]	90 d复发[例(%)]	90 d死亡[例(%)]	出院时NIHSS评分[M(P₂₅, P₇₅), 分]	90 d mRS 0~2分[例(%)]
替罗非班组	70	11(23.4)	4(8.5)	0	3(6.4)	4(2, 15)	35(74.5)
对照组	75	16(34.0)	8(17.0)	1(2.1)	3(6.4)	10(3, 14)	36(76.6)
统计量		1.299^a	1.528^a			-0.885^c	0.058^a
P值		0.254	0.216	0.999^b	0.999^b	0.376	0.810
注：^a为χ²值, ^b为采用Fisher精确检验, ^c为Z值。

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