The Law of Mass Action
The Law of Mass Action
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DOI：
10.1080/15265160600755730
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发表时间：
2006-08
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影响因子：
--
通讯作者：
H. Trachtman
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文献类型：
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作者：
H. Trachtman
如果临床研究是通过1962年的经典电影《两个人玩跷跷板》的透镜来看待的，那么一定有一个支点，围绕着这个支点，倾斜因素会把平衡推到两种治疗方法中的一种或另一种。在这幅图中，如果跷跷板不倒向任何一方，而是悬在半空中，那么治疗平衡就占了上风。在这种情况下，一个研究项目的表现是符合个性化的病人护理，并在伦理上是合理的。Chiong（2006）对治疗平衡概念的批评提出了两个核心问题：1）平衡仍然是评估临床研究行为的有效标准吗？支点是衡量单个病人的利益还是在更大的社会群体背景下衡量个人的利益？Chiong主张将平衡支点视为康德的一种手段，它可以沿着一条轨道移动，在这条轨道上，利益的优先顺序从病人一个人的利益到更大的第三方利益。在下面的讨论中，我将提出，治疗平衡应作为临床研究的标准。此外，我将沿着与伦敦（2006）相同的思路进行论证，即它应该作为以个体患者为中心的洛克原理来应用（坎宁安，2003）。没有必要计算更广泛的医学界所获得的利益。为了准确地评估治疗平衡，我建议扩大对个体患者支点两侧施加压力的外力范围。我特别要强调的是，除了那些如此强烈地关注治疗效果的问题之外，还有其他问题。开始，我承认治疗性和非治疗性研究项目之间存在着深刻的差异。然而，如果研究代表了一种异质性活动，位于沿着的中间，一端是常规医疗护理，另一端是非治疗性研究，那么有两种合理的方法来评估中间的怪物。由于在非治疗类别中缺乏对受试者的直接益处，米勒（2006）认为，所有研究都应被判定为完全超出标准临床治疗范围。相比之下，我对那些从事临床研究的人代表他们的病人采取行动并试图改善他们的结果的真诚愿望印象深刻。因此，我赞成保持研究和个性化患者护理之间的联系，并使用治疗平衡作为衡量是否进行临床试验的工具。在标准的临床实践中，患者的明确期望是，医生推荐的治疗方法明确地符合他们的最佳利益，并且非平衡条件占上风。循证医学运动是基于这样一种假设，即医学界可以被委托编写高质量的数据，以确定治疗干预措施的疗效和副作用（Reilly和Evans 2006）。利用同事和专家的已发表和未记录的经验，医生有望就什么对他们的病人最好做出净判断。然后，他们可以提供建议，并提供具体的建议，或反对治疗。倾斜角度可能很窄，并且可能存在严重的保留。有时，这些决定可能是痛苦的，但从理论上讲，平衡的概念在私人医生的办公室没有实际的位置。事实上，这可能是一种夸张的说法，因为在办公室或在床边为个别病人权衡因素从来没有像对病人那样仔细检查过。
If clinical research is viewed through the lens of the classic 1962 movie Two for the Seesaw, then there must be a fulcrum around which tilt factors act to push the balance down in favor of one or the other of the two treatments under consideration. In this picture, therapeutic equipoise prevails if the seesaw does not fall to either side and hangs in midair. Under these circumstances, the performance of a research project is consistent with individualized patient care and is ethically justified. The central questions raised in Chiong’s (2006) engaging critique of the concept of therapeutic equipoise are twofold: 1) Is equipoise still a valid criterion to evaluate the conduct of clinical research? and, 2) Does the fulcrum weigh the interests of the single patient or of the individual in the context of a larger social community? Chiong advocates seeing the equipoise pivot as a Kantian device that can move along a track in which the priority of interests ranges from those of the patient alone to those of the larger group of involved third parties. In the following discussion, I will propose that therapeutic equipoise should be maintained as a standard for clinical research. Moreover, I will argue along the same lines as London (2006) that it should be applied as a Lockean principle that is centered on the individual patient (Cunningham 2003). It is unnecessary to resort to calculations of the benefit that accrues to the wider medical community. To assess therapeutic equipoise accurately, I suggest broadening the range of external forces that exert pressure on both sides of the fulcrum for the individual patient. I especially wish to emphasize concerns beyond those that focus so intensely on therapeutic efficacy. To begin, I acknowledge that profound differences exist between therapeutic and nontherapeutic research projects. However, if research represents a heterogeneous activity positioned midway along a spectrum with routine medical care at one end and nontherapeutic studies at the other, there are two plausible ways to assess the monster in the middle. Because of the lack of direct benefit to the subject in the nontherapeutic category, Miller (2006) argues that all research should be judged to be completely outside the sphere of standard clinical treatment. In contrast, I am impressed by the genuine desire of those engaged in clinical research to act on behalf of their patients and to try to improve their outcomes. Therefore, I favor maintaining the link between research and individualized patient care and using therapeutic equipoise as an instrument to measure whether to proceed with clinical trials. In standard clinical practice, the explicit expectation of patients is that the physician’s recommended treatment is unequivocally in their best interests and that nonequilibrium conditions prevail. The evidence-based medicine movement is predicated on the presumption that the medical community can be entrusted with the task of compiling high-quality data to determine the efficacy and side effects of therapeutic interventions (Reilly and Evans 2006). Using both the published and unrecorded experience of colleagues and specialists, physicians are expected to arrive at a net judgment about what is best for their patients. They can then dispense advice and offer concrete recommendations for or against treatments. The tipping angle may be narrow and there may be serious reservations. At times, the decisions may be agonizing but, in theory, the concept of equipoise has no practical place in the private physician’s office. In actuality, this is probably an overstatement because the weighing of factors in the office or at the bedside for the individual patient is never scrutinized as carefully as for the …