抗酸药物Ⅰ期临床试验的护理要点与体会

Nursing key points and experience of phaseⅠclinical trial of antacid drugs

目的评价本院Ⅰ期临床研究室在抗酸药物Ⅰ期临床试验中的护理方法,为其他Ⅰ期临床试验提供护理参考。方法对本院Ⅰ期临床研究室开展并完成的一抗酸药物Ⅰ期临床试验的20例受试者实施的护理方法进行回顾性分析与总结。结果 20例受试者对受试药物及24hpH值监测仪持续24h胃内监测表现出良好的耐受性,在用药、采血与置管操作中积极配合研究者,无一例中途剔除。结论本院在抗酸药物Ⅰ期临床试验中的护理要点合理,方法可行。

Objective To evaluate the nursing method of phase Ⅰ clinical research unit of our hospital in the phase Ⅰ clinical trial of antacid drugs, so as to provide nursing reference for other phase Ⅰ clinical trials. Methods The nursing methods taken by 20 subjects who carried out and completed phase Ⅰ clinical trial of antacid drugs in phase Ⅰ clinical research unit of our hospital were analyzed retrospectively and summarized. Results The 20 subjects showed good tolerabil- ity for the test drugs and lasted 24 h intragastric monitoring by 24 h pH monitor, and cooperated with researchers actively in medication, blood sampling and tube insertion operation, no patients were eliminated during the research. Conclusion The nursing points of phase Ⅰ clinical trial of antacid drugs in our hospital are reasonable, and the method is feasible.