| 陈静静,钱佩佩,曹凯,田京辉,赵亮,兰丙欣.我国药品不良反应关联性评价方法与诺氏评估量表法的对比与分析[J].中国药事,2020,34(8):988-992 |
| 我国药品不良反应关联性评价方法与诺氏评估量表法的对比与分析 |
| Comparison and Analysis of Causality Assessment Method in China and Naranjo’s Method in the Evaluation of Adverse Drug Reactions |
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| DOI：10.16153/j.1002-7777.2020.08.021 |
| 中文关键词: 药品不良反应 关联性评价 诺氏评估量表法 |
| 英文关键词: adverse drug reaction causality assessment Naranjo’s method |
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| 中文摘要: |
| 目的：探讨我国药品不良反应监测中心所采用的关联性评价方法与诺氏评估量表法(Naranjo 法)在药品不良反应(ADR)关联性评价中的差异和各自特点。方法：分别采用两种方法对我院2016 年1月1日至2018年6月30日上报的202例ADR进行关联性评价，对两种方法的评价结果进行一致性分析。结果：两独立评价者应用国家ADR监测中心关联性评价方法分别对202例ADR进行关联性评价， kappa值0. 509，一致性中度。两独立评价者应用Naranjo法分别对202例ADR进行关联性评价，kappa值 0.697，一致性较高。两位独立评价者分别应用国家ADR监测中心关联性评价方法和Naranjo法对202例 ADR进行关联性评价，kappa值0.100，一致性差。结论：(1)两种评价方法单独应用时均有较好的一致性；(2)两种评价方法对于“肯定”结果的一致性高；(3)对于新的和未“去激发”的ADR，两种评价方法易出现评价结果不一致的情况；(4)Naranjo法用于常规监测时部分问题应答率低。 |
| 英文摘要: |
| Objective: To explore the differences and respective characteristics between the causality assessment method adopted by National Monitoring Center for ADR in China and Naranjo’s method. Methods: Both methods were used in the causality assessment of 202 ADRs reported in our hospital from January 1, 2016 to June 30, 2018. Consistency of the results of the two methods was analyzed. Results: Two independent evaluators used the method adopted by National Monitoring Center for ADR in China to assess the correlation of 202 ADRs respectively. The kappa value was 0.509, which showed the consistency was moderate. Two independent evaluators used Naranjo's method to assess the correlation of 202 ADRs respectively. The kappa value was 0.697, which showed the consistency was substantial. Two independent evaluators used method aclaped by the China mational center for ADR monitoring and Naranjo’s method to assess 202 ADRs respectively. The kappa value was 0.100, which showed the consistency was slight. Conclusion: (1) Both assessment methods have good validity when they are applied separately. (2) Both assessment methods are in good agreement with the "positive" result. (3) Both new and dechallenge ADRs, two assessment methods are prone to be inconsistent. (4) Both Naranjo’s method is used for routine monitoring, the response rate of some questions is low. |
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