Ohta T, Kikuchi H, Hashi K, Kudo Y
J Neurosurg. 1986 Mar;64(3):420-6. doi: 10.3171/jns.1986.64.3.0420.
A multi-center controlled double-blind clinical study was carried out to evaluate the effects of nizofenone in patients with subarachnoid hemorrhage who were treated within 2 weeks of the ictus. The test drug was administered as an addition to conventional therapy, which was maintained during the study. Of 208 patients studied, 102 were treated with nizofenone and 106 with placebo. Treatment with nizofenone was significantly more effective (p less than 0.05) than that with placebo based on functional recovery and other clinical findings. Although no significant difference was found in mortality rate between the nizofenone- and placebo-treated groups, a higher percentage of survivors in the former group exhibited a good outcome (p less than 0.05). The effects of nizofenone administration were found to be especially notable in patients with delayed ischemic symptoms, moderately severe preoperative deficits (Hunt and Hess Grade II or III), and diffuse high-density areas in pre- and postoperative computerized tomography scans. No significant side effects were observed.
开展了一项多中心对照双盲临床研究，以评估尼唑苯酮对发病2周内接受治疗的蛛网膜下腔出血患者的疗效。试验药物作为常规治疗的补充用药，在研究期间持续进行常规治疗。在研究的208例患者中，102例接受尼唑苯酮治疗，106例接受安慰剂治疗。基于功能恢复和其他临床结果，尼唑苯酮治疗比安慰剂治疗显著更有效（p<0.05）。虽然尼唑苯酮治疗组和安慰剂治疗组的死亡率没有显著差异，但前一组中更高比例的幸存者预后良好（p<0.05）。发现尼唑苯酮给药的效果在有延迟缺血症状、术前中度严重功能缺损（Hunt和Hess分级II或III级）以及术前和术后计算机断层扫描中有弥漫性高密度区域的患者中尤为显著。未观察到显著的副作用。
