Hsu C Y, Norris J W, Hogan E L, Bladin P, Dinsdale H B, Yatsu F M, Earnest M P, Scheinberg P, Caplan L R, Karp H R
Department of Neurology, Medical University of South Carolina, Charleston 29425.
Stroke. 1988 Jun;19(6):716-22. doi: 10.1161/01.str.19.6.716.
The efficacy and safety of pentoxifylline were assessed in 297 adult patients with ischemic stroke in a multicenter, double-blind, randomized and placebo-controlled trial. Treatment was started within 12 hours after the stroke onset. Study medication was administered intravenously continuously (16 mg/kg/day, maximum 1,200 mg/day) for 3 days and per os (400 mg t.i.d.) for the remainder of 28 days. Demographic data were comparable, and functional impairment and mortality (pentoxifylline 12%, placebo 10%) were not different between the two groups. Neurologic deficit scores improved from baseline admission scores during the 4-week study in both groups but did not differ between groups at admission or throughout the study except during the first few days when the consciousness level (Days 1 and 2), motor function (Days 1 and 2), cranial nerve function (Days 1-4), and total neurologic deficit scores (Days 1 and 2) were better in the pentoxifylline group than in the placebo group, especially in a subset of patients with severe deficits at admission. Laboratory values and side effects were also comparable between groups. Our study indicates that pentoxifylline can be given safely in patients with acute ischemic stroke. Although pharmacologic effects were present during the first few days, the clinical benefits were small and not sustained.
在一项多中心、双盲、随机、安慰剂对照试验中，对297例成年缺血性脑卒中患者评估了己酮可可碱的疗效和安全性。在卒中发作后12小时内开始治疗。研究药物连续静脉给药（16mg/kg/天，最大1200mg/天）3天，之后28天口服给药（400mg，每日三次）。两组间人口统计学数据具有可比性，功能障碍和死亡率（己酮可可碱组为12%，安慰剂组为10%）无差异。在为期4周的研究中，两组的神经功能缺损评分均较基线入院评分有所改善，但入院时及整个研究过程中两组间无差异，仅在最初几天，己酮可可碱组的意识水平（第1天和第2天）、运动功能（第1天和第2天）、颅神经功能（第1 - 4天）及总神经功能缺损评分（第1天和第2天）优于安慰剂组，尤其是入院时有严重缺损的部分患者。两组间实验室检查值和副作用也具有可比性。我们的研究表明，己酮可可碱可安全用于急性缺血性脑卒中患者。虽然在最初几天有药理作用，但临床获益较小且未持续。
