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Effect of fasudil hydrochloride on cerebral vasospasm following aneurysmal subarachnoid hemorrhage in phase II clinical trial

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机构: [l]Department of Neurosurgery, General Hospital, Tianjin Medical University, Tianjin, China [2]Department of Neurosurgery, Xuanwu Hospital , Capital University, Beijing, China [3]Department of Neurosurgery, Tianjin Huanhu Hospital ,Tianjin, China [4]Department of Neurosurgery, Tianjin First Center Hospital ,Tianjin, China [5]Department of Biological Statistics, Second Medical University, Shanghai , China
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关键词: Aneurysm Cerebral vasospasm Delayed ischemic neurological deficits Fasudil hydrochloride Subarachoid hemorrhage

摘要:
Objective: The aim of this clinical phase II trial was to investigate the therapeutic effect, adverse reactions as well as safety of fasudil hydrochloride (FSD) on cerebral vasospasm (CVS), and delayed ischemic neurological deficits(DINDs) in patients with aneurysmal subarachnoid hemorrhage (SAH). Methods: A total of 67 patients with acute aneurysmal SAH diagnosed by digital subtraction angiography (DSA), admitted to the Department of Neurosurgery, General Hospital, Tianjin Medical University, entered the prospective, double-blind, randomized, controlled trial of FSD. Three patients were excluded because of violation of the trial protocol. The remaining 64 patients were divided into A and B groups. There were 32 cases in each group according to randomized code, who received either 30 mg FSD + 40 ml saline (A, treatment group) or 8 mg (40 ml) nimodipine (B, positive control group) by intravenous injection over 30 min/one time, 3 times/d for 14 d, following clipping surgery or intravascular thrombosed therapy within 4 d after onset of SAH. Results: It was found that FSD reduced new low-density areas due to vasospasm on CT scans to 3.13% (from 18.75% to 3.13% in group A, P <0. 05; from 6.25% to 3.13% in group B, P < 0.05) on the 14th day after treatment during the clinical trial. The average values of blood flow in the middle cerebral artery (MCA) were measured by TCD from 97.15 ± 51.01 cm 3 /s (before treatment) to 78.5 ± 25.62 cm 3 /s (on 14th day after treatment), P = 0. 0002 in group A. Total effective rates of cure and good results were 93.94% (PP), 93.94% (ITT) as well as 93.94% (GOS) in group A;96.88% (PP),94.12% (ITT) as well as 96.88% (GOS) in group B, respectively. But there was no significant difference between group A and group B, P= 1.0 (PP); 1.0 (ITT) and 1.0 (GOS) respectively. There were no side-effects or serious adverse events reported in the FSD group. Conclusion: The data suggested a significant amelioration of delayed ischemic neurological deficits following cerebral vasospasm in patients with aneurysmal SAH by intravenous FSD which is safe and effect.

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第一作者机构: [l]Department of Neurosurgery, General Hospital, Tianjin Medical University, Tianjin, China [*]Department of Neurosurgery, General Hospital, Tianjin Medical University, An Shan Road 154#. He Ping District, Tianjin 300052, China
通讯作者:
通讯机构: [*]Department of Neurosurgery, General Hospital, Tianjin Medical University, An Shan Road 154#. He Ping District, Tianjin 300052, China
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