Liu Mingyong, Pan Yuesong, Zhou Lichun, Wang Yongjun
a Department of Neurology , Beijing Chaoyang Hospital, Capital Medical University , Beijing , China.
f Department of Epidemiology and Health Statistics, School of Public Health , Capital Medical University , Beijing , China.
Neurol Res. 2019 May;41(5):473-479. doi: 10.1080/01616412.2019.1580454. Epub 2019 Mar 1.
Recombinant tissue plasminogen activator (rt-PA) has been used as the standard treatment for acute ischemic stroke (AIS). The following study investigates whether low-dose rt-PA can decrease the incidence of symptomatic intracranial haemorrhage (sICH) in AIS patients with high-risk sICH compared to standard-dose rt-PA.
Data from the Thrombolysis Implementation and Monitor of Acute Ischemic Stroke in China (TIMS-China) studies were assessed to explore risk factors for sICH after intravenous thrombolysis. For high-risk sICH patients (age ≧70 years old, or with diabetes, or serum glucose on admission >9.0 mmol/L, or NIHSS on admission>20, or with cardioembolism), standard-dose rt-PA (0.85 to 0.95 mg/kg) and low- dose rt-PA (0.5 to 0.7 mg/kg) were compared. Primary outcome measure was the incidence of sICH, and the secondary outcome measures were 7-day mortality and 90-day functional independence outcome (modified Rankin scale, 0-2).
A total of 554 patients were enrolled (60 cases for low dose, and 494 cases for standard dose). Median rt-PA doses were 0.63 and 0.90 mg, respectively. After adjustment for the baseline variables, low-dose rt-PA did not decrease the incidence of sICH (per SITS-MOST criteria, 3.33% versus 2.23%, P = 0.3467) compared to low dose. The low-dose group revealed less functional independence outcomes (modified Rankin scale, 0-2) compared to standard-dose group (36.67% versus 52.43%; odds ratio = 0.49; p = 0.0204) at 90 days.
Our study suggests that low-dose intravenous rt-PA for high-risk sICH stroke in Chinese patients may not decrease the incidence of sICH, and concomitant with a poor outcome compared to standard-dose rt-PA.
rt-PA: recombinant tissue plasminogen activator; AIS: acute ischemic stroke; sICH: symptomatic intracranial haemorrhage.
重组组织型纤溶酶原激活剂（rt-PA）已被用作急性缺血性卒中（AIS）的标准治疗方法。以下研究调查了与标准剂量rt-PA相比，低剂量rt-PA是否能降低具有症状性颅内出血（sICH）高风险的AIS患者发生sICH的发生率。
对中国急性缺血性卒中溶栓实施与监测（TIMS-中国）研究的数据进行评估，以探索静脉溶栓后sICH的危险因素。对于sICH高风险患者（年龄≧70岁，或患有糖尿病，或入院时血糖>9.0 mmol/L，或入院时美国国立卫生研究院卒中量表[NIHSS]>20，或患有心源性栓塞），比较标准剂量rt-PA（0.85至0.95 mg/kg）和低剂量rt-PA（0.5至0.7 mg/kg）。主要结局指标是sICH的发生率，次要结局指标是7天死亡率和90天功能独立结局（改良Rankin量表，0-2）。
共纳入554例患者（低剂量组60例，标准剂量组494例）。rt-PA的中位剂量分别为0.63和0.90 mg。在对基线变量进行调整后，与标准剂量相比，低剂量rt-PA并未降低sICH的发生率（根据SITS-MOST标准，分别为3.33%和2.23%，P = 0.3467）。在90天时，低剂量组与标准剂量组相比，功能独立结局（改良Rankin量表，0-2）较少（分别为36.67%和52.43%；优势比=0.49；P = 0.0204）。
我们的研究表明，中国患者中用于sICH高风险卒中的低剂量静脉rt-PA可能不会降低sICH的发生率，并且与标准剂量rt-PA相比结局较差。
rt-PA：重组组织型纤溶酶原激活剂；AIS：急性缺血性卒中；sICH：症状性颅内出血
