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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 indicators, evaluation methods and results of the monitoring of adverse events in the phase I clinical trials of new drugs. Methods: One phase oral clinical trial of three new drugs, pripenem hydrochloride and two glimepiride, was conducted orally. The adverse events were observed and analyzed. Results: The three new drugs in the conventional oral dose, have good tolerance, only some patients with mild adverse drug reactions. Conclusion: The evaluation of adverse events in Phase I clinical trials of new drugs is of great significance for the discovery of new adverse drug reactions.