新药Ⅰ期临床耐受性试验中不良事件的评价方法

Evaluation of Adverse Events in the Phase I Clinical Trial of Tolerance to New Drugs

目的:对新药I期临床耐受性试验中不良事件监察的指标、评价方法、结果判定进行探讨。方法:通过对盐酸丙哌维林、两种格列美脲等三种新药单剂量口服的I期临床耐受性试验,观察、分析其不良事件。结果:此三种新药在常规口服剂量时,有良好的耐受性,仅有部分患者出现轻度药物不良反应。结论:新药I期临床耐受性试验中不良事件评价对发现新药不良反应苗头具有重要意义。

Objective: To investigate the criteria, evaluation method and result judging of adverse events in the phase I clinical trial of tolerance to new drugs. Methods: Three kinds of new drugs , Propiverine hydioehloride, dimepiridc (A, B), were researched in the phase I clinical trial of tolerance (single oral dosing) to observe and analyze the adverse events . Results: The three drugs are safe in the routine oral dose. Conclusion : The phase I clinical trial of tolerance is very important for ADR surveillance of new drugs.