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目的:以卡培他滨和氟尿嘧啶在治疗进展性胃癌时出现的药品不良反应(ADR)为例,通过比较其随机对照试验(RCTs)数据的Meta分析结果、文献中的病例报告和国家药品不良反应监测中心提供的自发报告这3种来源数据的ADR频次分布,找到合适的方法综合评价药品上市后的安全性.方法:从3种来源的数据中,分别选取卡培他滨和氟尿嘧啶排名居前5位的ADR,通过计算ADR频次的相对值,对3类数据的ADR频次分布进行比较.结果:对于两种药物,3类数据中排名前5位的ADR症状不一致,排列次序不同,相同ADR症状的相对值也不同,结果差别大.对于卡培他滨,3类数据中频次最高的ADR症状均不同,Meta分析中频次最高的ADR症状是手足综合征,病例报告中是骨髓抑制,自发报告是恶心呕吐.对于氟尿嘧啶,虽然频次最高的ADR症状均为恶心呕吐,但其3种来源数据的相对值相差较大.结论:3种来源的ADR数据有所不同,各有侧重,应选用适宜的分析方法对三者进行分析处理,综合多种数据的信息,互相补充完善,才能得到完整可靠的药品安全评估结果.“,”Objective:To find the appropriate method to comprehensive evaluate post-marketing drug safety.We compare the frequencies of ADR of fluorouracil and capecitabine from three separate datasets:the Meta-analysis of RCT,reports published in medical journals and the spontaneous reports sent to the state food and drug administration ADR monitoring center.Methods:Choose the top five ADR phenomenon of capecitabine and fluorouracil from three separate datasets.By calculating the relative value of ADR frequency to compare the frequencies of ADR of these three separate datasets.Results:For both drugs,the top five ADR phenomenon from three separate datasets are inconsistent,the order are different,and the same ADR phenomenon has different value.For capecitabine,the highest frequency of ADR phenomenon are different:it is the brotherhood of syndrome in the Meta-analysis;it is bone marrow suppression in case reports;it is nausea and vomiting in spontaneous ADR reports.For fluorouracil,all the highest frequency of ADR phenomenon are nausea and vomiting,but the relative value are different.Conclusion:Three separate datasets could provide different ADR information,so we should choose the suitable method to analyze these datasets.Integrate many kinds of information and complete each other to obtain comprehensive and reliable drug safety evaluation results.