| 新药Ⅰ期临床试验中血标本采集的护理管理 |
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| 引用本文： | 杨春梅.新药Ⅰ期临床试验中血标本采集的护理管理[J].中国医药导报,2013,10(1):163-164. |
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| 作者姓名： | 杨春梅 |
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| 作者单位： | 华中科技大学同济医学院附属荆州医院药物临床试验机构 |
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| 摘 要： | 目的探讨新药Ⅰ期临床研究中血标本采集的护理管理。方法对2009-2011年6个新药Ⅰ期临床试验项目的 8 956个血标本的采集进行全程管理。结果 8 956个血标本采集时间均控制在±1 min,无一个血标本出现溶血或凝血,血标本合格率在100%。结论加强护理人力资源、血标本采集的流程及消毒隔离工作与受试者的安全等各方面管理,能够保证血标本采集的质量及能为试验结果的分析或评价提供准确、客观的依据。
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| 关 键 词： | Ⅰ期临床试验 血标本采集 护理管理 |
Nursing management of blood sample collection in phase Ⅰ clinical trial |
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| YANG Chunmei.Nursing management of blood sample collection in phase Ⅰ clinical trial[J].China Medical Herald,2013,10(1):163-164. |
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| Authors: | YANG Chunmei |
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| Institution: | YANG Chunmei The Institution of Clinical Trial,Affiliated Jingzhou Hospital,Tongji Medical College,Huazhong University of Science and Technology,Hubei Province,Jingzhou 434020,China |
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| Abstract: | Objective To explore the nursing management of blood sample collection in phase Ⅰ clinical trial.Methods 8 956 cases of blood samples in six new drugs phase Ⅰ clinical trial program collected 2009-2011 were carried out overall management.Results The collecting time of 8 956 cases of blood samples were controlled within ±1 min,without a blood specimen hemolysis or clotting,the qualified rate of blood was 100%.Conclusion To strengthen the management of nursing human resources,blood specimen collection process,disinfection and isolation work and the safety of subjects,to ensure the quality of the blood samples,and provide evidence for analysis or evaluation of the test results. |
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| Keywords: | Phase Ⅰ clinical trial Blood sample collection Nursing management |
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