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[大剂量静脉注射氢化可的松治疗蛛网膜下腔出血后迟发性缺血性神经功能缺损——一项多中心对照双盲临床研究的结果]

[Intravenous hydrocortisone in large doses in the treatment of delayed ischemic neurological deficits following subarachnoid hemorrhage--results of a multi-center controlled double-blind clinical study].

作者信息

Hashi K, Takakura K, Sano K, Ohta T, Saito I, Okada K

机构信息

Department of Neurosurgery, Sapporo Medical College, Japan.

出版信息

No To Shinkei. 1988 Apr;40(4):373-82.

PMID:3042005
Abstract

Glucocorticoid in high dose has known to reduce vascular sensitivity to various vasoconstrictive stimuli. It inhibits phospholipase to reduce production of prostaglandins. It stabilizes the cell membrane and prevents cerebral edema. All these pharmacological effects indicate possible usefulness of this drug for the treatment of cerebral ischemia due to vasospasm. Based on these theoretical backgrounds a multi-center controlled double blind clinical study was carried out. The patient who showed manifestations of delayed cerebral ischemia due to vasospasm were selected for this study. As soon as the clinical manifestation appeared, the patient was given either 3 grams of hydrocortisone intravenously in a 60 ml solution or the placebo. The administration was repeated 6 times with interval of 12 hours. The patients were allowed to be treated according to the independent protocol of each institute except for the maximum daily use of glucocorticoid. The effect of the therapy was evaluated at 4th, 7th day and 1 month after the initiation. The study involved 52 institutes and a total of 140 patients, seventy-one patients who received hydrocortisone (group A) and 69 patients who received placebo (group P) was analysed. There were no significant differences in background data between both groups. In patients with grade I, II or III on admission, the favorable effects of hydrocortisone were demonstrated on changes in neurological findings. In group A, there were significantly more cases of improvement at 4th day for orientation about place and person. At 1 month or on discharge group A showed significant improvement almost in every aspect of neurological findings including mental, speech and motor functions.(ABSTRACT TRUNCATED AT 250 WORDS)

摘要

已知高剂量糖皮质激素可降低血管对各种血管收缩刺激的敏感性。它抑制磷脂酶以减少前列腺素的产生。它稳定细胞膜并预防脑水肿。所有这些药理作用表明该药物可能对治疗血管痉挛所致的脑缺血有用。基于这些理论背景,开展了一项多中心对照双盲临床研究。本研究选取了出现血管痉挛所致迟发性脑缺血表现的患者。一旦出现临床表现,患者即被给予60毫升溶液中含3克氢化可的松静脉注射或安慰剂。每隔12小时重复给药6次。除糖皮质激素的最大日用量外,允许患者按照各机构的独立方案进行治疗。在开始治疗后的第4天、第7天和1个月评估治疗效果。该研究涉及52个机构,共140例患者,分析了71例接受氢化可的松治疗的患者(A组)和69例接受安慰剂治疗的患者(P组)。两组的背景数据无显著差异。在入院时为I级、II级或III级的患者中,氢化可的松对神经学检查结果的变化显示出良好效果。在A组,第4天关于地点和人物定向的改善病例显著更多。在1个月时或出院时,A组在包括精神、言语和运动功能在内的几乎每个神经学检查方面均显示出显著改善。(摘要截选至250字)

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