我国药品不良反应个例报告质量评估方法研究

Methods for Quality Evaluation of Individual Case Reports of Adverse Drug Reactions in China

目的探索一种便于长期运用的药品不良反应个例报告质量评估方法,对个例报告进行更加科学的评估。方法通过文献分析法,借鉴国内外已有的评价方法,运用专家咨询法确立指标权重,运用层次分析法构建药品不良反应个例报告质量评估体系。结果通过对某三甲医院40份药品不良反应报告的评估验证,该评价体系具有合理性。结论经检验,以乘法计算特征建立的药品不良反应个例评估体系是科学合理的,便于对不良反应报告内容的动态管理,并可以进一步建立高效的科学评估。

Objective To seek a long-term method for evaluating the quality of individual case reports of adverse drug reactions so as to evaluate case reports more accurately.Methods By analyzing literature,looking at current evaluation methods at home and abroad,and consulting experts,the weight of indicators was determined.AHP was used to establish the quality evaluation system of individual case reports on ADRs.Results This evaluation system was well-designed as evidenced by the evaluation of 40 ADR reports from a big A hospital.Conclusion The evaluation system of individual ADR cases based on characteristics of multiplication calculation is scientific and well-grounded,which can facilitate the dynamic management of the content of ADR reports and improve the efficiency of evaluation.