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【medical-news】生物降解镁支架早期临床试验诱人

Early results good for biodegradable magnesium stents

Last Updated: 2007-06-01 17:20:15 -0400 (Reuters Health)

NEW YORK (Reuters Health) - Temporary coronary artery stenting is feasible and addresses many of the concerns about permanent stents, an international research team reports in the June 2nd issue of The Lancet. However, design improvements are still needed.

Permanent, drug-eluting stents are associated with long-term impairment of endothelial response, late stent thrombosis, and hypersensitivity reactions, Dr. Raimund Erbel, from the West German Heart Center in Essen, and his co-investigators write.

These issues may be averted by biodegradable stents, the authors maintain. The mechanical characteristics of absorbable magnesium alloy stents resemble those of stainless steel stents, except that they are degraded within 4 months.

In this first trial for treating coronary atherosclerosis with absorbable stents, Dr. Erbel and associates placed 71 magnesium stents in 63 patients with single de novo lesions in a coronary artery.

"All patients achieved device and procedural success," the authors report. The residual diameter of the stenosis was reduced from 61.5% to 12.6%.

However, during the first 4 months, 24% of patients experienced major adverse cardiac events that required target lesion revascularization. Stenosis diameter in the targeted lesions was back up to 50%.

During the 12-month follow-up, no stent thromboses, MIs, or deaths were observed. On the other hand, restenosis developed in 47% of patients, versus reported rates of 28% for bare metal stents and 6% after drug-eluting stents. Recurrent ischemia due to neointimal growth and negative remodeling necessitated target lesion vascularization in 45%.

In an accompanying Comment, Dr. John Ormiston and Dr. Mark Webster, from Auckland City Hospital in New Zealand, contend that the magnesium stents may be absorbed too quickly. They suggest that negative remodeling could be resolved by slower stent absorption, and that "the excessive healing response could be limited by the controlled release from the stent of an antiproliferative drug." 本人已认领该文编译,48小时后若未提交译文,请其他战友自由认领 NEW YORK (Reuters Health) - Temporary coronary artery stenting is feasible and addresses many of the concerns about permanent stents, an international research team reports in the June 2nd issue of The Lancet. However, design improvements are still needed.
一个国际性研究小组在7月份第2期柳叶刀杂志上撰文指出:尽管设计上有待进一步改进,临时的冠状动脉支架植入是可行的,而且是针对永久性支架存在的问题。

Permanent, drug-eluting stents are associated with long-term impairment of endothelial response, late stent thrombosis, and hypersensitivity reactions, Dr. Raimund Erbel, from the West German Heart Center in Essen, and his co-investigators write.
来自西德心脏中心的Raimund Erbel医生和他的合作者指出:永久性药物涂层支架的植入与长期的内皮反应损伤、迟发的支架内血栓形成和高敏反应有关。

These issues may be averted by biodegradable stents, the authors maintain. The mechanical characteristics of absorbable magnesium alloy stents resemble those of stainless steel stents, except that they are degraded within 4 months.
作者认为生物降解支架可以防止这些问题。只要不在4个月内降解,可吸收镁合金支架的机械特征与不锈钢支架是相似的。

In this first trial for treating coronary atherosclerosis with absorbable stents, Dr. Erbel and associates placed 71 magnesium stents in 63 patients with single de novo lesions in a coronary artery.
在第一个应用可吸收支架治疗冠状动脉粥样硬化的临床试验中,Erbel医生和他的同事在63名新生单支冠脉病变的患者体内植入71枚镁支架。

"All patients achieved device and procedural success," the authors report. The residual diameter of the stenosis was reduced from 61.5% to 12.6%.
作者报道:“支架本身和植入过程在每位患者都是成功的”,残余狭窄直径由61.5%降至12.6%。

However, during the first 4 months, 24% of patients experienced major adverse cardiac events that required target lesion revascularization. Stenosis diameter in the targeted lesions was back up to 50%.
但是在最初的4个月内,24%的患者出现了需要进行损伤部位血运重建的严重心脏意外,损伤部位狭窄直径又增加到50%。

During the 12-month follow-up, no stent thromboses, MIs, or deaths were observed. On the other hand, restenosis developed in 47% of patients, versus reported rates of 28% for bare metal stents and 6% after drug-eluting stents. Recurrent ischemia due to neointimal growth and negative remodeling necessitated target lesion vascularization in 45%.
在12个月的随访期里,未出现支架内血栓形成、心肌梗死或者是死亡。另一方面,47%的患者出现了再狭窄,而应用裸支架的患者再狭窄发生率据报道是28%,而应用涂层支架的是6%。由于新生内膜生长和负性重塑迫使损伤部位再血管化引起缺血复发的占45%。

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作者:admin@医学,生命科学    2011-03-06 17:11
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