Bourret P, Eisinger F, Moatti J P
Inserm U379, institut Paoli-Calmettes, Marseille, France.
Bull Cancer. 1995 Jul;82 Suppl 3:224s-229s.
The orientation of the medical activity toward preventive strategies knows currently an important development. This movement shows various logic, which are: on one hand a rational step, a strategic choice in favour of prevention, and on the other hand a choice by elimination, when the other forms of intervention establish insufficient efficiency. Prevention had to follow the path of validity to acquire pertinence. The gold-standard is randomised blinded trials and it is this kind of procedure that has been proposed in the BCPT (Breast cancer prevention trial). By comparison with a classic therapeutic trial the main differences of prevention trial lay in: criteria of inclusion, analyses of impact larger than the simple efficiency (quality of life), on the focus on the risk (especially genetic) and the legal context. One of the main points is the question of risks induced by an intervention on healthy persons. In this context, even the passage of an uncertainty to a "certainty" concerning induced risks can not always suffice to close the controversy. Physicians cannot in this case, refer to norms and to models since this type of intervention is new.
当前，医学活动向预防策略的转向取得了重要进展。这一转变呈现出多种逻辑，一方面是合理的举措，是支持预防的战略选择；另一方面是一种排除性选择，当其他干预形式效率不足时。预防必须遵循有效性的路径以获得相关性。金标准是随机双盲试验，而这正是乳腺癌预防试验（BCPT）中所采用的程序。与经典治疗试验相比，预防试验的主要差异在于：纳入标准、比单纯效率更广泛的影响分析（生活质量）、对风险（尤其是遗传风险）的关注以及法律背景。要点之一是对健康人进行干预所引发的风险问题。在这种情况下，即使将诱导风险的不确定性转变为“确定性”，也往往不足以平息争议。在这种干预类型尚属新颖的情况下，医生无法参考规范和模式。
