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[ACC2009]新型注射装置限制AMI后的心肌损伤
通过冠状动脉给予液体聚合物可以维持损伤的心肌,以促进愈合
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编辑:任芳吕树铮 时间:2009/4/1 12:30:00  关键字:BL-1040 心肌损伤 

    ACC.09是首屈一指的心血管医学会议,心脏病学专家和心血管专家汇聚一堂,展现最新和最具创新性的研究结果。在第58届ACC会议上,提出通过经冠状动脉向急性心肌梗死后的损伤心肌处注入一种低粘度液体,可以安全有效地防止受损心肌进一步恶化,并改善心功能和生存性。

    防止左室重构进展是治疗急性心肌梗死(MI)的关键点。经皮冠状动脉介入治疗(PCI)和支架的出现对于改善急性心肌梗死后的预后做出了重大贡献,但在随后的愈合过程中对受损组织的治疗一直存在不足。该项研究试图验证BL-1040(BioLineRX,耶路撒冷,以色列)--部分交联海藻酸盐基的液体聚合物,在防止心肌恶化中的安全性和有效性。

    作为BioLineRX的高级项目经理,Tuvia博士解释到,“BL-1040是第一个注入心肌来直接治疗急性心肌梗死后受损组织的物质。PCI手术后,可以通过梗死相关动脉内的导管轻松注入BL-1040,使之运输到梗死部位,BL-1040将通过受损的毛细血管渗透到受损的心脏组织,并在此处变成一种凝胶体。这就像一个三维支架,防止左室壁变得更薄,从而避免额外的心脏衰竭。约经过6周,BL-1040通过肾脏重新吸收和排泄,但给我们留下了一个更健康、更稳定的左心室。”

    该非盲的小型初步研究始于2008年3月,目前还在进行中。10例存在左室重构和充血性心力衰竭高危风险的急性心肌梗死患者BL-1040的注射,至今未出现副作用。Tuvia博士说“这是一个安全的研究,虽然该研究还在进行中,但到目前为止所收集的有效数据却令人鼓舞。我们假设其可以用来治疗急性心肌梗死。闭塞血管再次血运重建后,开通血管10至20分钟后,BL-1040将注入到闭塞部位或该部位的远端。生物降解支架将提供物理支持,来尽量减少左室重构,从而为急性心肌梗死患者带来益处。” Tuvia博士预测,BL-1040注射剂将最终成为所有经皮冠状动脉介入治疗中的一部分。

(任芳 吕树铮  首都医科大学附属北京安贞医院)

英文原文:
NOVEL INJECTABLE DEVICE LIMITS MYOCARDIAL DAMAGE AFTER AMI

Liquid Polymer Administered Via the Coronary Artery Supports Damaged Cardiac Tissue to Promote Healing
Orlando, FL –A low-viscocity liquid that is administered via the coronary artery to the site of damaged myocardium after an acute myocardial infarction effectively and safely prevents further deterioration of the myocardium and improves cardiac function and survival, according to research presented today at the American College of Cardiology’s 58th annual scientific session. ACC.09 is the premier cardiovascular medical meeting, connecting cardiologists and cardiovascular specialists to the latest and most innovative findings in cardiovascular science.

Preventing progressive left ventricular remodeling is a key therapeutic objective after acute myocardial infarction (MI). The advent of percutaneous coronary interventions (PCI) and stents has done a great deal to improve outcomes after acute MI, but treatment of the damaged tissue during the ensuing healing process has been lacking. This study sought to determine the safety and efficacy of BL-1040 (BioLineRX, Jerusalem, Israel), a partially cross-linked alginate-based liquid polymer, in preventing deterioration of the damaged myocardium.

“BL-1040 is the first myocardial implant for the direct treatment of damaged tissue after an acute MI. After the PCI procedure, you can easily inject it via a catheter in the infarct-related artery, delivering the BL-1040 to the infarct site where it penetrates through the damaged capillaries into the damaged heart tissue where it settles and turns into a gel,” said Shmuel Tuvia, Ph.D., senior project manager for BioLineRX. “It acts like a three-dimensional scaffold and prevents the left ventricular wall from getting thinner, thereby warding off additional heart failure. After about six weeks, BL-1040 is re-absorbed and excreted through the kidney, leaving behind a healthier, more stable left ventricle.”

This small, ongoing, open-label pilot study began in March 2008. Ten patients with acute MI at high risk for left ventricular remodeling and congestive heart failure have been injected with BL-1040 and have shown no adverse effects to date.
“This is a safety study, and although it is ongoing, the efficacy data gathered so far is encouraging,” Tuvia said. “We envision this as being used as part of the treatment of acute MI. After revascularization of the occluded vessel, 10 to 20 minutes after the opening of the vessel, BL-1040 will be injected at the site of the occlusion or distal to the site. The biodegradable scaffold will provide physical support to the heart which should minimize left ventricular remodeling and thereby provide benefit to patients with acute MI.”

Eventually, BL-1040 injections will be part of all percutaneous coronary intervention procedures, he predicts. 

 

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