一項(xiàng)評(píng)估新藥物治療顱內(nèi)出血的精確性和效能的最大規(guī)模的臨床試驗(yàn)剛剛完成。

顱內(nèi)出血是腦中風(fēng)致死率最高治療方法最少的一種形式。在臨床試驗(yàn)中使用的新型重組激活因子，叫做NovoSeven凝集因子VIIa(rFVIIa)，是由期刊研制開(kāi)發(fā)的。試驗(yàn)結(jié)果顯示：這種藥物可以限制出血的進(jìn)一步增加，與安慰劑相比較減少了死亡率和發(fā)病率。

“顱內(nèi)出血死亡率和發(fā)病率最強(qiáng)大的預(yù)測(cè)指標(biāo)是血腫體積，使用NovoSeven之后，血腫增長(zhǎng)得到了限制限制。”Setpnah Mayer醫(yī)生說(shuō)，他是這項(xiàng)試驗(yàn)的首席研究員，哥倫比亞大學(xué)醫(yī)學(xué)中心神經(jīng)重癥監(jiān)護(hù)室的副教授和主任。“當(dāng)前對(duì)顱內(nèi)出血的的藥物和外科手術(shù)治療效果并不理想。35％～50％患者在1月內(nèi)死亡，即使能夠存活，他們會(huì)并發(fā)嚴(yán)重的神經(jīng)系統(tǒng)疾病。”

這項(xiàng)結(jié)果證實(shí)：在出項(xiàng)癥狀的4小時(shí)之內(nèi)使用這種藥物進(jìn)行顱內(nèi)出血的治療，除了減少血腫增長(zhǎng)速度之外，還降低了死亡率而且改善了3個(gè)月的臨床轉(zhuǎn)歸，盡管血栓發(fā)生事件發(fā)生的頻率更多。這項(xiàng)臨床試驗(yàn)包括399例患者，都在顱內(nèi)出血發(fā)病3小時(shí)內(nèi)由CT明確診斷。這項(xiàng)試驗(yàn)結(jié)果發(fā)表在2005年3月3日《新英格蘭醫(yī)學(xué)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.