期刊文献+

NeoVasTM可降解支架植入的护理配合与安全管理 被引量:1

Nursing cooperation and safety management in implantation of NeoVasTM biodegradable stents
原文传递
导出
摘要 目的:评价植入NeoVas TM聚合物基体药物(雷帕霉素)洗脱支架系统的护理方法,为今后NeoVasTM聚合物基体药物洗脱支架应用于临床提供护理参考。方法对心导管室参与并完成NeoVasTM完全可降解聚合物基体药物(雷帕霉素)洗脱支架系统安全性和有效性前瞻性、多中心、单盲、随机对照研究的10例植入NeoVasTM可降解支架受试者实施的护理方法进行回顾性分析与总结。结果10例接受完全可降解支架植入术的冠心病患者在护士的配合下,全部成功植入了NeoVasTM可降解支架,且无一例患者被剔除。结论护理团队的参与为NeoVas TM可降解支架的安全植入提供了强有力的保障,护理要点合理,方法可行。 Objective To evaluate the nursing strategies about implantation of NeoVas TM biodegradable drug (rapamycin) eluting stents and to provide references for clinical application in the future .Methods A prospective, multicenter, single-blind, randomized controlled study was performed to evaluate the safety and effectiveness of NeoVas TM biodegradable stents .Ten patients with coronary artery disease were enrolled in Department of Cardiac Catheterization , Peking Union Medical College Hospital , Chinese Academy of Medical Sciences .The nursing strategies were analyzed and summarized retrospectively .Results Ten patients with coronary artery disease all underwent successful implantations of NeoVas TM biodegradable stents with cooperation of nursing team.None of the participators were excluded .Conclusions Cooperation of nursing team provides powerful guarantee for safe implantation of NeoVas TM biodegradable stents .The nursing strategies are reasonable and practicable .
出处 《中华现代护理杂志》 2016年第20期2903-2905,共3页 Chinese Journal of Modern Nursing
关键词 护理 临床试验 NeoVasTM支架 可降解 单盲 Nursing Clinical trial NeoVasTM stent Biodegradable Single-blind
  • 相关文献

参考文献3

二级参考文献15

  • 1中华人民共和国国务院令第276号,医疗器械监督管理条例[S].
  • 2药品临床试验机构资格认定公告[EB/OL].2010-1-22[2010-03-30].http://www.sda.gov.cn/WS01/CL0554/45600.html.
  • 32008年度统计年报[EB/OL].2009-9-23[2010-3-30].http://www.sda.gov.cn/WS01/CL0108/41834.html.
  • 4与药物临床试验相比医疗器械临床试验规模过小[EB/OL] 2010-3-12[2010-3-30].http://www.gd.chinanews.com.cn/2010/2010-03-12/2/39524.shtml.
  • 5方剑春.医疗器械临床试验在摸索中前行[N].中国医药报.2006-12-21(B6).
  • 6GHTF/SG5/N1R8:2007,Clinical Evidence Key Definitions and Concepts[EB/OL].2007-6-29[2010-01-22].http://www.ghff.org/documents/sg5/sg5_n2r8_2007final.pdf.
  • 7GHTF/SG5/N2R8:2007,Clinical Evaluation[EB/OL].2007-6-29[2010-01-22].http://www.ghtf.org/documents/sg5/sg5_n3_2010.pdf.
  • 8GHTF/SG5/N3:2010,Clinical Investigations[EB/OL].2010-4-26[2010-01-22].http://www.ghff.org/documents/sg5/sg5_n3_2010.pdf.
  • 9FDA.Guidance on IDE Policies and Procedures[S].IDE Staff,office of Device Evaluation,Center for Devices and Radiological Health,US FDA,1998-01-20.
  • 10马建民,付金德.医疗器械临床研究方式和监管的探讨[J].中国医疗器械信息,2009,15(2):29-29. 被引量:2

共引文献27

同被引文献16

引证文献1

二级引证文献20

相关作者

内容加载中请稍等...

相关机构

内容加载中请稍等...

相关主题

内容加载中请稍等...

浏览历史

内容加载中请稍等...
;
使用帮助 返回顶部