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首页 » 冠心病 » CSL公司将进一步研究防御严重冠心病CSL-111药物

CSL公司将进一步研究防御严重冠心病CSL-111药物

来源:华文生技网 2007-04-05 09:09

    根据发表于3月26日JAMA中的文章,血液及生物科技公司CSL有限公司进行的初步研究显示,重组的HDL对于冠状动脉粥样硬化患者具有治疗益处,可以扭转他们的动脉粥样硬化。动脉粥样硬化是动脉发生的一种非炎症性病变,可使动脉管壁增厚、变硬,失去弹性和管腔狭小。

    这项试验性药物CSL-111中,含有从人类血浆获得的脂蛋白A-I与大豆磷脂胆碱(phosphatidylcholine),就生物和化学特性上与HDL相似。CSL-111可以提高「好」胆固醇含量,以减少心脏血管壁的脂肪凝固硬块。

    研究人员于2005 年7月至2006 年之间10月,进行CSL-111药物的第二期试验,共包含183名加拿大的动脉粥样硬化患者,结果发现有效减少冠心脏的脂肪凝固,虽然这次结果在统计学上并不显著。但是这次研究是CSL-111发展的重要一步。研究人员表示,CSL-111在防御严重冠心病方面具有潜在价值。

     (资料来源 : Bio.com)

部分英文原文:

JAMA-EXPRESS


Effects of Reconstituted High-Density Lipoprotein Infusions on Coronary Atherosclerosis

A Randomized Controlled Trial

Jean-Claude Tardif, MD; Jean Grégoire, MD; Philippe L. L’Allier, MD; Reda Ibrahim, MD; Jacques Lespérance, MD; Therese M. Heinonen, DVM; Simon Kouz, MD; Colin Berry, MD; Russell Basser, MD; Marc-André Lavoie, MD; Marie-Claude Guertin, PhD; Josep Rodés-Cabau, MD; for the Effect of rHDL on Atherosclerosis-Safety and Efficacy (ERASE) Investigators

JAMA. 2007;297:(doi:10.1001/jama.297.15.jpc70004).

ABSTRACT

Context  High-density lipoprotein (HDL) cholesterol is an inverse predictor of coronary atherosclerotic disease. Preliminary data have suggested that HDL infusions can induce atherosclerosis regression.

Objective  To investigate the effects of reconstituted HDL on plaque burden as assessed by intravascular ultrasound (IVUS).

Design and Setting  A randomized placebo-controlled trial was conducted at 17 centers in Canada. Intravascular ultrasound was performed to assess coronary atheroma at baseline and 2 to 3 weeks after the last study infusion.

Patients  Between July 2005 and October 2006, 183 patients had a baseline IVUS examination and of those, 145 had evaluable serial IVUS examinations after 6 weeks.

Intervention  Sixty patients were randomly assigned to receive 4 weekly infusions of placebo (saline), 111 to receive 40 mg/kg of reconstituted HDL (CSL-111); and 12 to receive 80 mg/kg of CSL-111.

Main Outcome Measures  The primary efficacy parameter was the percentage change in atheroma volume. Nominal changes in plaque volume and plaque characterization index on IVUS and coronary score on quantitative coronary angiography were also prespecified end points.

Results  The higher-dosage CSL-111 treatment group was discontinued early because of liver function test abnormalities. The percentage change in atheroma volume was –3.4% with CSL-111 and –1.6% for placebo (P = .48 between groups, P<.001 vs baseline for CSL-111). The nominal change in plaque volume was –5.3 mm3 with CSL-111 and –2.3 mm3 with placebo (P = .39 between groups, P<.001 vs baseline for CSL-111). The mean changes in plaque characterization index on IVUS (–0.0097 for CSL-111 and 0.0128 with placebo) and mean changes in coronary score (–0.039 mm for CSL-111 and –0.071 mm with placebo) on quantitative coronary angiography were significantly different between groups (P = .01 and P =.03, respectively). Administration of CSL-111 40 mg/kg was associated with mild, self-limiting transaminase elevation but was clinically well tolerated.

Conclusion  Short-term infusions of reconstituted HDL resulted in no significant reductions in percentage change in atheroma volume or nominal change in plaque volume compared with placebo but did result in statistically significant improvement in the plaque characterization index and coronary score on quantitative coronary angiography. Elevation of HDL remains a valid target in vascular disease and further studies of HDL infusions, including trials with clinical end points, appear warranted.

Trial Registration  clinicaltrials.gov Identifier: NCT00225719

Published online: March 26, 2007 (doi:10.1001/jama.297.15.jpc70004).

英文全文链接:http://jama.ama-assn.org/cgi/content/full/297.15.jpc70004v1?

 

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