药品不良反应病例报告评价标准的探讨

Evaluation Criteria of ADR Case Report

目的:提出更完善的药品不良反应评价标准。方法:总结分析现有的药品不良反应病例报告评价标准和规范,对因果关系评价的方法、因果关系评价考虑的主要因素、现有评价方法的不足进行讨论。结果与结论:指出了现行药品不良反应病例报告评价标准和规范的局限性,并提出了相应的修改意见。

OBJECTIVE： To put forward a consumate evaluation criteria for the adverse drug reactions （ADR） . METHODS： The current criteria and norm in ADR evaluation were summarized, and methods and factors needed to be taken into consideration of the causality assessment as well as the drawbacks of the current evluation method were discussed. RESULTS ＆ CONCLUSION： The limitatation of the current criteria and norm in ADR evaluation has been pointed out and the corresponding proposal on its modification has been came up with.