法舒地尔治疗蛛网膜下腔出血后脑血管痉挛有效性和安全性的临床评价Ⅳ期临床试验报告.pdfVIP

法舒地尔治疗蛛网膜下腔出血后脑血管痉挛 有效性和安全性的临床评价 ——Ⅳ期临床试验报告 马景鑑 王东 张建军 陈炳为 [摘要] 目的 法舒地尔治疗蛛网膜下腔出血(SAH)后脑血管痉挛(CVS)的临床疗效和安全 性。方法 74家医院共收治2092例动脉瘤性SAH患者，进行Ⅳ期临床试验。所有病例术后均静脉 滴注法舒地尔30mg/次，每日3次，共14d。观察治疗前与后第3、7和14天患者的临床表现及神经 系统评分、血生化、经颅多普勒(TCD)的有效性和安全性。结果 用药后14d患者的临床表现明显 改善，TCD显示CVS的缓解率为94.36％(P=0.0000)，大脑中动脉平均流速降至正常。总有效率 91.21％。均未发现任何不良反应，主要血化验指标未见异常。结论 静脉法舒地尔治疗SAH后 CVS非常有效并具有安全性和可靠性；是治疗和预防CVS的一种新方法。 蛛网膜下腔出血；脑血管痉挛； 法舒地尔 Efficiencyandsafetyoffasudilhydrochloridetherapyinpatientswithcerebralvasospasmfollowing subarachnoidhemorrhage——clinicaltrialinphaseⅣ MAJing-jian WANGDongZHANGJian- junCHENBing-weiDepartmentofNeurosurgery,GenerayHospital,TianjinMedicalUniversity,Tianjin 300052,China Objective Toinvestigatetheclinicalefficiencyandsafetyoffasudilhydrochoride therapyoncerebralvasospasmafteraneurysmalsubarachoidhemorrhage.Method Theopenmulticenter, largesampleclinicalstudyinphaseⅣ,withatotalof2092patientswithaneurysmalsubarachoid hemorrhagetreatedbyfasudilhydrochoridewereincluded,wasconductedinaccordancewithguidelineslaid downbydepartmentsofneurosurgeryof74hospitalsinChina. Fasudil(30mg) wasprescribedfor intravenousadministrationevery8hoursaday. Fasudiltherapywasgenerallystartedafteraneurysmal surgeryorintrovasculartherapyandcontinuedfor14consecutivedays.Thedeterminationofitssaftyand efficiacywasdefinedas:theclincalmanifestation,generalconditiongradedaccordingtotheHuntandHess scaleaswellasGlasgowComaScale,routineexaminations,biochemicalcriterionandtheaveragevaluesof bloodflow(cm/s)ofMCAmeasuredbyTCDatthethird,seventhandfourteenthdaysafterthebeginingof treatment.Results Theneurologicaldeficitsofpatientswereimprovedsignificantlyafterthetreatmentfor 14days(therateofCVSwas94.36％,themeanbloodflowofMCAwasnormal,thetotaleffectiveratewas 91.21％). The vital signs were not influenced after treatment. The blood examinations were normal.Conclusions Thefasudilhydrochloridetreatmentisnotonlyeffective,butalsosafefortreatment andpreventionofcerebralvascu