丁苯酞联合阿替普酶治疗缺血性卒中临床疗效的观察性研究

目的 探讨丁苯酞联合阿替普酶静脉溶栓治疗缺血性卒中的临床疗效及安全性。 方法 回顾性分析青岛大学附属烟台毓璜顶医院急性缺血性卒中行静脉溶栓患者205例的队列，其 中联合治疗组（阿替普酶+丁苯酞组）112例，阿替普酶组93例。分析两组患者溶栓后即刻及14 d后 NIHSS评分，90 d的mRS评分，并分析不同急性卒中治疗低分子肝素试验（Trial of Org 10 172 in Acute Stroke Treatment，TOAST）分型中的临床疗效。同时分析溶栓后14 d症状性颅内出血及死亡情况。 结果 ①溶栓后两组NIHSS评分差异无统计学意义。溶栓后14 d联合治疗组NIHSS评分低于阿替普 酶组，差异有统计学意义（ 4.82±0.44）分 vs（6.40±0.66）分，P=0.041]。联合治疗组90 d预后良好 率高于阿替普酶组，差异有统计学意义（72.3% vs 55.9%，P =0.014）；其中LAA亚型中联合治疗组患 者NI HSS评分（P =0.023）及预后良好率（P =0.045）均高于阿替普酶组，差异有统计学意义。②治疗 后90 d两组死亡率及14 d颅内出血率差异无统计学意义。③多因素回归分析结果显示丁苯酞是改善 缺血性卒中溶栓患者预后的保护因素（OR 0.425，95%CI 0.216～0.835，P =0.013）；年龄＞60岁（OR 2.233，95%CI 1.047～4.766，P =0.038）、入院时收缩压＞160 mm Hg（OR 2.295，95%CI 1.126～4.679， P =0.022）、溶栓前NIHSS评分＞10分（OR 9.354，95%CI 4.049～21.610，P＜0.001）是预后的独立危险 因素。 结论 丁苯酞联合阿替普酶静脉溶栓治疗缺血性卒中患者能改善90 d临床预后，对LAA患者可能更 有效。

The Effect of Butylphthalide Combined with Alteplase Thrombolysis in Patients with Ischemic Stroke

Objective To investigate the clinical effect of butylphthalide in ischemic stroke patients with
intravenous thrombolysis.
Methods A retrospective analysis of 205 ischemic stroke patients treated by intravenous
thrombolysis from Yantai Yuhuangding Hospital Affiliated to Qingdao University was performed.
The patients were divided into combination group (n =112, rt-PA+butylphthalide) and rt-PA group
(n =93). Clinical efficacy was assessed by the NIHSS scores immediately after thrombolysis, the
NIHSS scores at 14 days after thrombolysis and the mRS scores at 90 days after thrombolysis. The
difference in clinical efficacy among different TOAST subtypes were also analyzed. The safety
outcome was evaluated by intracranial hemorrhage within 14 days and mortality at 90 days. The
difference of clinical efficacy and safety between the two groups were compared.
Results (1) There was no statistical difference in the NIHSS score immediately after thrombolysis
between two groups. The NIHSS score at 14 days in combination group significantly decreased than
that in rt-PA group (4.82±0.44) vs (6.40±0.66), P =0.041]. The good prognosis (mRS ≤2 score) rate
at 90 days was higher in combination group than that in rt-PA group (72.3% vs 55.9%, P =0.014).Of all TOAST subgroups in combination group, the clinical efficacy (14-day NIHSS score and 90-
day mRS score) in large-artery atherosclerosis (LAA) subgroup was best and significantly better
than that in rt-PA group. (2) There were no statistical difference in safety outcome between the two
groups. (3) Multiple-factor analysis showed butylphthalide was protective factor (OR 0.425, 95%CI
0.216-0.835, P =0.013) for prognosis in ischemic stroke patients, and age >60 years (OR 2.233,
95%CI 1.047-4.766, P =0.038), systolic blood pressure>160 mm Hg at admission (OR 2.295, 95%CI
1.126-4.679, P =0.022), and NIHSS score >10 before thrombolysis (OR 9.354, 95%CI 4.049-
21.610, P <0.01) were independent risk factors for prognosis in stroke patients with intravenous
thrombolysis.
Conclusions Butylphthalide injection used in ischemic stroke patients with intravenous
thrombolysis can further improved short-term prognosis comparing with only intravenous
thrombolysis, especially in LAA subgroup.