【摘要】 目的通过Ⅱ期临床试验评价盐酸法舒地尔(FSD)注射液治疗蛛网膜下腔出血 (SAH)所致脑血管痉挛(CVS)的临床疗效和安全性。方法采用随机双盲双模拟、阳性药物对照方法。观察64例颅内动脉瘤破所致SAH。分为A、8两组各32例。治疗方式:手术夹闭47例,介入治疗17例。治疗方法:A组FSD 30mg+生理盐水40mL／次、3次／d,B组尼莫地平8mg(40ml)／次、3次／d。比较用药前后两组临床表现、意识变化以GCS、病情以Hunt&Hess分级、预后以GOS 为指标,CT、TCD,生命体征,肝、肾功能、血K、Na、Cl及血、尿、便常规。结果(1)总体病情两组均明显好转,但两组间差异无统计学意义(P=0．3028)。(2)头颅CT:用药前无低密度区者用药后亦未见到改变。(3)TCD:治疗前MCA平均流速(单位:cm／s)A组97．15±51．01,治疗后第 7、14天分别下降为90．64±40．93,78．52±25．62;B组91．06±22．20,治疗后第7、14天分别为84．53± 26．17,85．88±35．80,两组比较无统计学意义(P>0．06)。(4)预后:总有效率A组93．94％(PP)、 93．94％(ITT)和93．94%(GOS);B组相应为96．88％、94．12％和96．88％。两组间差异无统计学意义。(5)对于肝、肾功能、电解质和血、尿、便常规没有任何影响。结论此药具有安全、可靠和有效性．无毒副作用及不良反应。是一种新型抗CVS药物。更多还原

【Abstract】 Objective To evaluate the effect and safe of fasudil hydrochloride (FSD) on cerebral vasospasm ( CVS) following subarachnoid hemorrhage ( SAH) in patients with a ruptured cerebral aneurysm through phase Ⅱ study in clinic. Methods We now report the results of a prospective randomized positive-controlled double-blind-simulated trials of FSD in 64 patients with aneurismal SAH, divided into A and B groups, there were 32 cases in each group. 47/64 cases were underwent by surgery, 17/64 cases by intravascular thrombosed. All patients were received by either 30mg fasudil + 40ml normal saline or 8mg (40ml) nimodipine by intravenous, 3 times a day for 14 days following surgery or intravascular therapy. Comparison of clinical datas between per and post-therapy in the two groups was done by the statistical analysis, such as clinical manifestation, the level of consciousness as GCS; the conditions of patients as Hunt&Hess; clinical outcome as GOS and CT, TCD and the function of liver, kidney, K+, Na+, Cl-, and blood, urina routine before and the 7th, 14th day after treatmen. Results A group using FSD, B using nimodipine. 1. This study showed siginificantly better clinical outcome in the patients receiving A or B, but there is no significant difference between two groups, P = 0.3028. There were no changes graded of GCS in two groups before and 7th, 14th day after treatment, P=>0.2, >0.6, respectively. 2. CT: There were no the low-density area on CT 7th day 26 cases (81.12%) in A group, 30 cases (93.75%) in B group; 14th day 31 cases (96.87%) in A group, 31 cases (96.87%) in B group after treatment. 3. TCD: The mean blood flow of MCA (unit: cm/s) was 97.15±51.01 before treatment in A group, reduced to 90.64±40.93 (7th day) , P > 0.04; to 78.52 25.62 (14th day) , P = 0.0002, separately after treatment. 91.06±22.20 before treatment in B group reduced to 84.53±26.17 (7th day) , P > 0.3, to 85.88 ±35.80 (14th day) , P > 0.063,separately after treatment. But, there was no siginificant difference between two groups, P>0.06. 4. Prognosis: Total effective rate was 93.94% (PP) , 93.94% (ITT) and 93.94% (COS) in A group, separately; 96.88% (PP) , 94.12% (ITT) and 96.88 % (GOS) in B group, separately. However, there were no siginificant difference between two groups P -1.0 (PP) , = 1.0 (ITT) and1.0 (GOS) , respectively. 5. There were no any poisonous, adverse reactions and other side effects. Conclusion This study shows FSD to be a safe, effective and useful drag on CVS after SAH, as a new unique anti-vasospasm agent.更多还原