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以两项阿司匹林试验为例,尸检结果在多中心治疗评估中的作用。

The role of autopsy findings in multicenter treatment evaluations as exemplified by two aspirin trials.

作者信息

Britton M

机构信息

Department of Medicine, St Göran Hospital, Stockholm, Sweden.

出版信息

Qual Assur Health Care. 1993 Dec;5(4):299-302. doi: 10.1093/intqhc/5.4.299.

DOI:10.1093/intqhc/5.4.299
PMID:8018886
Abstract

In many treatment trials the aim is to prevent deaths from one type of disease. The cause of death evaluation is therefore of the utmost importance. A high autopsy rate is required, even as regards sudden deaths that cannot routinely be referred to as ischemic heart disease. Autopsies are also necessary for studying non-lethal and lethal side effects of the involved drug. Even in the best of cases the post-mortem rate is far from 100% and correctness of the cause of death evaluation is not ensured. If the treatment has prevented deaths from the cause studied, this gain must not be outweighed by increases of other causes of death, for the result to be considered reliably positive.

摘要

在许多治疗试验中,目标是预防某类疾病导致的死亡。因此,死因评估至关重要。即使对于那些通常不能归为缺血性心脏病的猝死病例,也需要较高的尸检率。尸检对于研究相关药物的非致命性和致命性副作用也很有必要。即便在最佳情况下,尸检率也远未达到100%,且死因评估的准确性也无法保证。如果治疗预防了所研究病因导致的死亡,那么为了使结果被可靠地视为积极结果,这种益处绝不能被其他死因的增加所抵消。

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