单唾液酸神经节苷脂(GM-1)治疗急性脊髓损伤的对比研究

The role of GM-1ganglioside in acute spinal cord injury:a clinical controled investigation

目的:验证GM-1治疗急性脊髓损伤的疗效和安全性。方法:采用双盲、多中心的研究方法。将急性脊髓损伤患者随机按比例1:1分成A、B两组,分别给予标记药物A-1或B-1100mgi.v,qd×14d,然后A-2或B-240mgi.m,qd×7d。记录用药后21d、90d的ASIA损害分级及ASIA运动评分、感觉功能评价、大小便功能评价及不良反应。结果:72对患者完成试验。A、B两组在年龄、性别、用药初始时ASIA损害分级、受伤到用药时间等指标的统计学上无显著性差异。用药后21d、90dA组Benzel改良分级、ASIA运动评分、皮肤感觉功能、大小便功能评分显著优于B组,有显著差异(P<0.05),无明显不良反应。结论:经揭秘,A药为GM-1,显示GM-1治疗急性脊髓损伤有较好的疗效和安全性,不良反应少。

Objective:To verify the efficacy and safety of GM-1ganglioside in treating acute spinal cord injury.Method:This was a multicenter double-blind study in patients with acute spinal cord injury.The patients were randomized divided into A and B group and were given Drug A-1or Drug B-1100mg i.v,qd×14days,then Drug A-2or Drug B-1i.m,qd×7days.The ASIA motor score,Benzel grade score,sensation of touch?stab,function of bladder and bowel and adverse events were recorded after21days and90days.Result:72matched couples finished the test.There was no significant difference in age,sex,ASIA motor score and time of administration between A and B groups in the time of the first dose given.The group A patients had a significant improvement in ASIA motor score,Benzel grade score,sensation of touch,stab,function of bladder and bowel than group B.There were no adverse events.Conclusion:Drug A was GM-1when uncovered,these showed GM-1had a good efficacy and safety in treating acute spinal cord injury.