Review; post‐marketing surveillance of the safety of cimetidine—the problems of data interpretation
Review; post‐marketing surveillance of the safety of cimetidine—the problems of data interpretation
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西咪替丁安全性上市后监测——数据解读问题
DOI：
10.1111/j.1365-2036.1987.tb00616.x
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发表时间：
1987
影响因子：
7.6
通讯作者：
M. Vessey
中科院分区：
文献类型：
--
作者：
D. G. C. Jones;M. Langman;D. H. Lawson;M. Vessey
在西咪替丁上市后安全性监测期间获得的经验强调了吸毒者所有类型疾病的高背景频率带来的解释困难。混杂因素的多个来源及其高流行率，使得不可能检测到模拟普通疾病的不良事件，特别是当没有观察到不良事件与药物暴露之间的一致关系时。纳入控制措施强调了困难，但并没有减轻解释的难度。
Experience obtained during post‐marketing surveillance of the safety of cimetidine emphasizes the difficulties in interpretation posed by the high background frequency of disease of all types in drug takers. The multiple sources of confounding factors, and their high prevalence, make it impossible to detect adverse events which mimic ordinary disease, particularly when a consistent relationship between adverse event and drug exposure is not observed. The inclusion of controls emphasizes the difficulties but does not ease interpretation.