主动监测在中药注射剂上市后临床安全性评价的应用及范例

摘要

Objective:To explore and evaluate the post-marketing safety evaluation methods with the example of three heat-clearing and detoxifying injections of traditional Chinese medicine.Methods:We monitored patients taken the above injections based on active surveil-lance methods.It is a prospective,multi-center,large sample and nested case-controlled design,to investigate the incidence,character-istics and influencing factors of adverse reaction (ADR).Results:Among 10,029 patients monitored,26 patients had ADR,5 of them experienced allergic reactions.IgE of the 5 patients who had allergic reactions was elevated.Conclusion:The overall ADR incidence rate is 0.26% (0.1% ~1%)and allergic reactions are probably mediated by IgE.%目的：以三种清热解毒类中药注射剂为例，为其上市后临床安全性评价及方法学研究提供范例。方法：基于前瞻性、多中心、大样本主动监测嵌套巢式病例对照设计的方法，监测使用三种中药注射剂的患者，探索不良反应发生率、发生特征及过敏反应可能的影响因素。结果：监测10029例患者，共发生26例 ADR，包括5例过敏反应，经过人体免疫毒理学指标检测，患者的IgE 皆有所升高。结论：基于监测数据计算总体 ADR 发生率为0.26％，属于偶见（0.1％～1％），过敏反应可能由 IgE 介导，这也为此类问题的研究探索了方法学范式。