盐酸法舒地尔防治外伤性蛛网膜下腔出血后脑血管痉挛初步研究

Effects of fasudil hydrochloride on delayed cerebral vasospasm after traumatic subarachnoid hemorrhage

目的验证盐酸法舒地尔治疗外伤性蛛网膜下腔出血(tSAH)后脑血管痉挛的有效和安全性。方法以尼莫地平为对照,采用开放随机对照试验,探讨盐酸法舒地尔的疗效.并进行临床安全性评估。选取经CT证实tSAH的中—重型闭合性颅脑损伤患者40例,随机分为法舒地尔及尼莫地平治疗组,同时选取未行抗血管痉挛治疗的20例tSAH患者作为空白对照。应用经颅多普勒(TCD)观察伤后48h,72h,5d,7d和12d大脑中动脉,颈内动脉血流动力学变化及1个月后的Glasgow预后评分;并对患者的重要脏器功能及迟发出血发生率进行比较。结果盐酸法舒地尔与尼莫地平都可明显降低tSAH后脑血管的痉挛程度和改善患者预后,两药物之间疗效并无统计学差异。对照组有2例外伤后继发梗塞出现,治疗组未出现类似病例。临床安全性研究发现盐酸法舒地尔对肝、肾功能均无明显影响,且不会增加迟发性颅内出血的比例。结论对于tSAH后迟发脑血管痉挛的治疗,盐酸法舒地尔是一种安全有效的药物。

Objective To investigate the clinical efficacy and safety of fasudil Hydrochloride on delayed cerebral vasospasm after traumatic subarachniod hemorrhage（tSAH）. Methods Under a randomized control study, the vasodilative effect and clinical safety of fasudil were tested using nimodipine and blank groups as control. Sixty patients with tSAH were enrolled and divided into fasudil, nimodipine and blank groups. TCD examination of ICA and MCA were performed 2, 3, 5, 7, 12 days after head trauma, Glasgow Outcome Scale（GOS） after 1 month and patients＇ blood pressure were also evaluated. Results Both fasndil and Nimodipine could prevent the cerebral vasospasm after tSAH and improve outcome of patients without statistic difference. There are 2 CT detected low dense areas in the blank group. Fasudil did not affect patients＇ liver and renal function dramatically, both drugs did not increase the risk of delayed intracranial hemorrhage. Conclusion Fasudil is safe and effective for the prevention of cerebral vasospasm after tSAH.