法舒地尔对急性缺血性卒中的疗效:一项前瞻性安慰剂对照的双盲试验结果  

Effects of fasudil in acute ischemic stroke: Results of a prospective placebo-controlled double-blind trial

作　　者：Shibuya M. Hirai S. Seto M. S.-I. Satoh 周永 

机构地区：[1]Scientific Affairs and Sales Promotion Dept., Asahi Kasei Pharma Corporation, 9-1, Kanda Mitoshirocho, Chiyoda-ku, Tokyo 101-8481, Japan

出　　处：《世界核心医学期刊文摘（神经病学分册）》2006年第3期14-14,共1页Digest of the World Core Medical Journals:Clinical Neurology

摘　　要：Background: A multicenter, double-blind, placebo-controlled study was conducted to assess the efficacy and safety of fasudil, a Rhokinase inhibitor (RKI), in the treatment of acute ischemic stroke. Methods: A total of 160 patients, who were able to receive drug treatment within 48 h of acute ischemic stroke onset were enrolled. Patients received either 60 mg fasudil or a placebo (saline) by intravenous injection over 60 min, twice daily for 14 days. The primary end points were neurological status at 2 weeks after the start of treatment, and clinical outcome at 1 month after the onset of symptoms. Results: Fasudil treatment resulted in significantly greater improvements in both neurological functions (p = 0.0013), and clinical outcome (p = 0.0015). There were no serious adverse events reported in the fasudil group. The average trough value (12 h values)of active metabolite hydroxyfasudil, another RKI, in healthy elderl y volunteers receiving 60 mg of fasudil was 0.077 μM a concentration well above that needed to inhibit Rho-kinase (0.025-0.05 μM). Conclusion: Treatment wit h fasudil within 48 h of acute ischemic stroke onset significantly improved the patient’s clinical outcome. This study found fasudil to be a useful and safe dr ug for patients with acute ischemic stroke. Further evaluations, for example, 3 -month functional outcomes in a larger clinical trial, may help to define the e fficacy of fasudil in acute ischemic stroke.Background: A multicenter, double-blind, placebo-controlled study was conducted to assess the efficacy and safety of fasudil, a Rhokinase inhibitor (RKI), in the treatment of acute ischemic stroke. Methods: A total of 160 patients, who were able to receive drug treatment within 48 h of acute ischemic stroke onset were enrolled. Patients received either 60 mg fasudil or a placebo (saline) by intravenous injection over 60 min, twice daily for 14 days. The primary end points were neurological status at 2 weeks after the start of treatment, and clinical outcome at 1 month after the onset of symptoms. Results: Fasudil treatment resulted in significantly greater improvements in both neurological functions (p = 0.0013), and clinical outcome (p = 0.0015). There were no serious adverse events reported in the fasudil group. The average trough value (12 h values)of active metabolite hydroxyfasudil, another RKI, in healthy elderl y volunteers receiving 60 mg of fasudil was 0.077 μM a concentration well above that needed to inhibit Rho-kinase (0.025-0.05 μM). Conclusion: Treatment wit h fasudil within 48 h of acute ischemic stroke onset significantly improved the patient's clinical outcome. This study found fasudil to be a useful and safe dr ug for patients with acute ischemic stroke. Further evaluations, for example, 3 -month functional outcomes in a larger clinical trial, may help to define the e fficacy of fasudil in acute ischemic stroke.

关 键 词：急性缺血性卒中 法舒地尔 安慰剂对照 双盲试验 谷浓度 活性代谢产物 激酶抑制剂 临床试验 

分 类 号：R743.3[医药卫生—神经病学与精神病学]