Argentino C, Sacchetti M L, Toni D, Savoini G, D'Arcangelo E, Erminio F, Federico F, Milone F F, Gallai V, Gambi D
Dipartimento di Scienze Neurologiche, Roma, Italy.
Stroke. 1989 Sep;20(9):1143-9. doi: 10.1161/01.str.20.9.1143.
Eleven of 31 clinical centers participating in the Italian Acute Stroke Study--Hemodilution carried out a preliminary study on the effectiveness of ganglioside GM1 in acute stroke; 502 patients were randomized to GM1 (GM1, n = 121), GM1 plus hemodilution (GM1 + H, n = 128), placebo (P, n = 130), or placebo plus hemodilution (P + H, n = 123) groups less than or equal to 12 hours after onset of a hemispheric cerebral infarct. The patients were treated for 15 days and were evaluated on Days 21 and 120 after the onset of stroke. Intention-to-treat analysis failed to show any differences in neurologic deficit, mortality, or neurologic disability among the groups. Efficacy analysis showed a significantly higher degree of neurologic improvement in GM1 group patients compared with patients in the P group during the first 15 days. GM1-treated patients (GM1 and GM1 + H groups) showed a significantly higher degree of neurologic improvement during the first 10 days compared with the placebo-treated patients (P and P + H groups). These differences were no longer statistically significant at Day 120. Our results provide a rationale for the planning of a larger, multicenter trial of GM1 ganglioside in acute stroke.
参与意大利急性中风研究——血液稀释的31个临床中心中的11个，对神经节苷脂GM1在急性中风中的有效性进行了初步研究；502例半球性脑梗死发病后12小时内的患者被随机分为神经节苷脂GM1组（GM1，n = 121）、神经节苷脂GM1加血液稀释组（GM1 + H，n = 128）、安慰剂组（P，n = 130）或安慰剂加血液稀释组（P + H，n = 123）。患者接受治疗15天，并在中风发病后的第21天和第120天进行评估。意向性分析未显示各组在神经功能缺损、死亡率或神经功能障碍方面存在任何差异。疗效分析显示，在最初的15天内，GM1组患者的神经功能改善程度明显高于P组患者。与安慰剂治疗的患者（P和P + H组）相比，接受GM1治疗的患者（GM1和GM1 + H组）在最初的10天内神经功能改善程度明显更高。这些差异在第120天时不再具有统计学意义。我们的结果为开展更大规模的神经节苷脂GM1治疗急性中风的多中心试验提供了理论依据。
