Novo Nordisk公司研发的治疗颅内出血的药物已经完成

一项评估新药物治疗颅内出血的精确性和效能的最大规模的临床试验刚刚完成。

颅内出血是脑中风致死率最高治疗方法最少的一种形式。在临床试验中使用的新型重组激活因子，叫做NovoSeven凝集因子VIIa(rFVIIa)，是由期刊研制开发的。试验结果显示：这种药物可以限制出血的进一步增加，与安慰剂相比较减少了死亡率和发病率。

“颅内出血死亡率和发病率最强大的预测指标是血肿体积，使用NovoSeven之后，血肿增长得到了限制限制。”Setpnah Mayer医生说，他是这项试验的首席研究员，哥伦比亚大学医学中心神经重症监护室的副教授和主任。“当前对颅内出血的的药物和外科手术治疗效果并不理想。35％～50％患者在1月内死亡，即使能够存活，他们会并发严重的神经系统疾病。”

这项结果证实：在出项症状的4小时之内使用这种药物进行颅内出血的治疗，除了减少血肿增长速度之外，还降低了死亡率而且改善了3个月的临床转归，尽管血栓发生事件发生的频率更多。这项临床试验包括399例患者，都在颅内出血发病3小时内由CT明确诊断。这项试验结果发表在2005年3月3日《新英格兰医学期刊》。
 
 
New Therapy for Cerebral Hemorrhage
 
The largest clinical trial evaluating the accuracy and efficacy of a new drug for intracerebral hemorrhage (ICH) has just been completed.

ICH is the most lethal and least treatable form of stroke. The new recombinant activated factor used in the trial, called NovoSeven coagulation factor VIIa (rFVIIa), was developed by Novo Nordisk, Inc. (Bagsv?rd, Denmark). The findings of the study show that this agent restricted hematoma growth and reduced mortality and morbidity compared to placebo.

“One of the strongest predictors of mortality and morbidity in ICH patients is hematoma volume, and with the administration of NovoSeven, hematoma growth was significantly limited,” said lead researcher Dr. Stephan Mayer, associate professor and director, neurological intensive care unit, Columbia University Medical Center (New York, NY, USA). “The current medical and surgical treatment options for ICH are not effective. Thirty-five to 50% of patients die within one month and if they survive, they are living with serious neurological deficits.”

The findings demonstrated that treatment of ICH with this medication within four hours of the beginning of symptoms reduced mortality and improved the three-month clinical outcome, in addition to reducing hematoma growth and in spite of a greater frequency of thromboembolic events. The trial included 399 patients, all diagnosed by computed tomography (CT) imaging within three hours of ICH onset. The study results were published in the March 3, 2005, issue of The New England Journal of Medicine.