CAJ | 학술논문

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2 092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30 mg/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.
목적 법서지이치료주망막하강출혈(SAH)후뇌혈관경련(CVS)적림상료효화안전성.방법 74가의원공수치2 092례동맥류성SAH환자,진행Ⅳ기림상시험.소유병례술후균정맥적주법서지이30 mg/차,매일3차,공14d.관찰치료전여후제3、7화14천환자적림상표현급신경계통평분、혈생화、경로다보륵(TCD)적유효성화안전성.결과 용약후14d환자적림상표현명현개선,TCD현시CVS적완해솔위94.36％(P=0.0000),대뇌중동맥평균류속강지정상.총유효솔91.21％.균미발현임하불량반응,주요혈화험지표미견이상.결론 정맥법서지이치료SAH후CVS비상유효병구유안전성화가고성；시치료화예방CVS적일충신방법.
Objective To investigate the clinical efficiency and safety of fasudil hydrochoride therapy on cerebral vasospasm after aneurysmal subarachoid hemorrhage.Method The open multicenter,large sample clinical study in phase Ⅳ,with a total of 2 092 patients with aneurysmal subarachoid hemorrhage treated by fasudil hydrochoride were included,was conducted in accordance with guidelines laid down by departments of neurosurgery of 74 hospitals in China.Fasudil ( 30 mg ) was prescribed for intravenous administration every 8 hours a day.Fasudil therapy was generally started after aneurysmal surgery or introvascular therapy and continued for 14 consecutive days.The determination of its safty and efficiacy was defined as:the clincal manifestation,general condition graded according to the Hunt and Hess scale as well as Glasgow Coma Scale,routine examinations,biochemical criterion and the average values of blood flow(cm/s) of MCA measured by TCD at the third,seventh and fourteenth days after the begining of treatment.Results The neurological deficits of patients were improved significantly after the treatment for 14 days( the rate of CVS was 94.36％,the mean blood flow of MCA was normal,the total effective rate was 91.21％).The vital signs were not influenced after treatment.The blood examinations were normal.Conclusions The fasudil hydrochloride treatment is not only effective,but also safe for treatment and prevention of cerebral vascular spasm following subarachoid hemorrhage due to ruptured aneurysm.This drug may provide a new therapurtic measure in clinic for treating and suppressing cerebral vasospasm.