法舒地尔与丁咯地尔治疗急性缺血性脑卒中的临床研究

Clinical Efficacy of Fasudil in Treatment of Acute Ischemic Stroke

目的:应用临床病例对照试验评价Rho激酶抑制剂法舒地尔治疗急性缺血性脑卒中的临床疗效和安全性。方法:选择符合入选标准的72例急性缺血性脑卒中患者,在发病后72h内开始用盐酸法舒地尔及盐酸丁咯地尔进行治疗,观察治疗前后患者SSS评分及发病1个月后mRs评分的变化,并观察其不良反应。结果:法舒地尔及丁咯地尔治疗2周后神经功能均有显著改善(分别P<0.001,P<0.01),法舒地尔较丁咯地尔疗效更显著(P<0.01),且两者均可使发病1个月后的临床结局显著改善(分别P<0.001,P<0.05),法舒地尔较丁咯地尔更显著(P<0.01)。两组均无严重不良反应。结论:急性缺血性脑卒中发病后72h内用法舒地尔,可有效改善患者神经功能缺损和临床结局,无严重不良反应。

Aim： A case control study was conducted to investigate the clinical efficacy and safety of fasudil, a Rho-ldnase inhibitor, in treatment of acute ischemic stroke. Methods： A total of 72 patients, who were able to receive drug treatment within 72 h of acute ischemic stroke onset were enrolled. Patients received either 60 mg fasudil by intravenous injection over 1 mg·min^-1, twice daily （or 30 mg fasudil, three times daily, if the age was over 70） or 100mg buflomedil, once daily for 14 days. The primary end points were neurological status at 2 weeks after the start of treatment, and clinical outcome 1 month after the onset of symptoms. Scandinavian stroke scale（SSS） and modified Rankin scale（mRs） were used to evaluate the neurological status and clinical outcome respectively. Results ： Both fasudil and buflomedil treatment resulted in significantly improvements in neurological functions（P 〈 0.001, P 〈 0.01 respectively） and clinical outcome （P 〈 0.001, P 〈 0.05 respectively）. The improvement of both neurological functions and clinical outcome with fasudil treatment was greater than that with buflomedil treatment （P 〈 0.01, P 〈 0.01 respectively）. There were no serious adverse events reported during the treatment. Conclusion： Treatment with fasudil within 72 h of acute ischemic stroke onset significantly improved the patient＇s clinical outcome. This study found fasudil to be a useful and safe drug for patients with acute ischemic stroke.