Bauer Mark S, Mitchner Landis
Department of Psychiatry and Human Behavior, Brown University, Providence, RI, USA.
Am J Psychiatry. 2004 Jan;161(1):3-18. doi: 10.1176/appi.ajp.161.1.3.
The term "mood stabilizer" is widely used in the context of treating bipolar disorder, but the U.S. Food and Drug Administration (FDA) does not officially recognize the term, and no consensus definition is accepted among investigators. The authors propose a "two-by-two" definition by which an agent is considered a mood stabilizer if it has efficacy in treating acute manic and depressive symptoms and in prophylaxis of manic and depressive symptoms in bipolar disorder. They review the literature on the efficacy of agents in any of these four roles to determine which if any agents meet this definition of mood stabilizer.
The authors conducted a comprehensive review of English-language literature describing peer-reviewed, U.S. Agency for Healthcare Research and Quality class A controlled trials in order to identify agents with efficacy in any of the four roles included in their definition of a mood stabilizer. The trials were classified as positive or negative on the basis of primary outcome variables. An "FDA-like" criterion of at least two positive placebo-controlled trials was required to consider an agent efficacious. The authors also conducted a sensitivity analysis by raising and relaxing the criteria for including trials in the review.
The authors identified 551 candidate articles, yielding 111 class A trials, including 81 monotherapy trials with 95 independent analyses published through June 2002. Lithium, valproate, and olanzapine had unequivocal evidence for efficacy in acute manic episodes, lithium in acute depressive episodes and in prophylaxis of mania and depression, and lamotrigine in prophylaxis (relapse polarity unspecified). Thus, only lithium fulfilled the a priori definition of a mood stabilizer. Relaxing the quality criterion did not change this finding, while raising the threshold resulted in no agents fulfilling the definition.
When all four treatment roles are considered, the evidence supported a role for lithium as first-line agent for treatment of bipolar disorder. The analysis also highlights unmet needs and promising agents and provides a yardstick for evaluating new treatment strategies.
“心境稳定剂”一词在双相情感障碍的治疗中被广泛使用，但美国食品药品监督管理局（FDA）并未正式认可该术语，且研究人员之间也未接受统一的定义。作者提出了一个“二乘二”定义，即如果一种药物在治疗双相情感障碍的急性躁狂和抑郁症状以及预防躁狂和抑郁症状方面具有疗效，那么它就被视为心境稳定剂。他们回顾了关于药物在这四种作用中任何一种作用下疗效的文献，以确定哪些药物符合心境稳定剂的这一定义。
作者对描述经同行评审的美国医疗保健研究与质量局A类对照试验的英文文献进行了全面综述，以确定在其心境稳定剂定义中所包含的四种作用中任何一种作用下具有疗效的药物。根据主要结局变量，将试验分为阳性或阴性。要认为一种药物有效，需要至少两项阳性安慰剂对照试验符合类似FDA的标准。作者还通过提高和放宽纳入综述试验的标准进行了敏感性分析。
作者确定了551篇候选文章，产生了111项A类试验，包括截至2002年6月发表的81项单药治疗试验及95项独立分析。锂盐、丙戊酸盐和奥氮平有明确证据表明对急性躁狂发作有效，锂盐对急性抑郁发作以及预防躁狂和抑郁有效，拉莫三嗪对预防（复发极性未明确）有效。因此，只有锂盐符合心境稳定剂的先验定义。放宽质量标准并未改变这一结果，而提高阈值则导致没有药物符合该定义。
当考虑所有四种治疗作用时，证据支持锂盐作为双相情感障碍治疗的一线药物。该分析还突出了未满足的需求和有前景的药物，并为评估新的治疗策略提供了一个标准。
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