摘要
目的探讨静脉留置针在药物临床试验采血中的适用性。方法在进行Ⅰ药物临床试验(phaseⅠclinical trial)时,对158例受试者使用静脉留置针进行采血,按照标准操作规程进行操作,观察采血效果及受试者的适宜性和安全性。结果在静脉留置针平均保留时间为1天的情况下,顺利完成了临床试验的采血工作,受试者无明显不适主诉,仅有3例出现穿刺部位渗血,6例发生堵管,无一例发生感染。结论静脉留置针用于I期药物临床试验的连续采血是有效和安全的。
Objective To discuss the applicability of venous indwelling needle in drug clinical trial blood sampling. Methods A total of 15g patients use vein needle to draw blood in phase I clinical trial according to the standard procedures. To observe blood sampiing effect and the suitability and safety of participants, Results We successfully completed the clinical test collection work under the condition of vein needle average retention time which is one day. Subjects had no obvious discomfort chief complaint. Only 3 eases of subjects had puncture blood, 6 cases had blocking pipe. No subject get infection. Conclusion It is effective and safe that using venous indwelling needle in continuous blood sampling of phase I clinical trial.
出处
《中国病案》
2013年第3期76-77,共2页
Chinese Medical Record
关键词
静脉留置针
药物临床试验
采血
Venous indwelling needle
Drug clinical trials
Blood sampling