Medical Department, EORTC Headquarters, E. Mounierlaan 83/11, 1200 Brussels, Belgium.
Br J Cancer. 2012 Jun 26;107(1):1-6. doi: 10.1038/bjc.2012.252. Epub 2012 Jun 7.
Toxic death is defined as study treatment-related mortality and as such is considered as an iatrogenic death. This belongs to unnatural death where an autopsy is advised. Until now, conventional autopsy is the gold standard to discriminate between pre- and post-mortem discrepancies.
The consequences of lack of systematically performing an autopsy will be explored in the setting of oncological clinical trials.
During more than one decade, 6428 Serious Adverse Events have been registered in the EORTC Safety database on a total of 34 734 subjects. The number of deaths were 764 (mortality rate of 2.2%) whereof 255 (rate of 0.7%) toxic deaths. In 89.8% of these toxic deaths, no autopsy has been done; in 25.1% (64 cases) an inconsistent cause of death was found based on studying of the medical narrative. The autopsy rate was only 10.2% (26 out of 255) and, in 46.2% of the performed autopsies, there was a clinical pathological discrepancy.
When no autopsy is performed, there is a high risk for a wrong diagnosis in case of suspected toxic death. The high discrepancy rate, possibly due to a low autopsy rate, shows that toxic death is an Achilles' heel in iatrogenic mortality.
中毒性死亡被定义为与研究治疗相关的死亡率，因此被认为是医源性死亡。这属于非正常死亡，建议进行尸检。到目前为止，传统的尸检是区分生前和死后差异的金标准。
将探讨在肿瘤临床试验中系统进行尸检的缺失会带来哪些后果。
在超过十年的时间里，EORTC 安全数据库共登记了 34734 名受试者的 6428 例严重不良事件。死亡人数为 764 人（死亡率为 2.2%），其中 255 人（0.7%）为中毒性死亡。在这些中毒性死亡中，89.8%未进行尸检；在基于对医疗记录研究的基础上，有 25.1%（64 例）发现死因不一致。尸检率仅为 10.2%（26 例），在进行的 46.2%尸检中，存在临床病理差异。
如果不进行尸检，在疑似中毒性死亡的情况下，误诊的风险很高。高差异率可能是由于尸检率低所致，表明中毒性死亡是医源性死亡率的一个致命弱点。
