Clinical Professor of Psychiatry, George Washington University School of Medicine, Bipolar Collaborative Network, Bethesda, MD, USA.
University of British Columbia, Vancouver, BC, Canada.
Bipolar Disord. 2019 Nov;21(7):650-659. doi: 10.1111/bdi.12813. Epub 2019 Aug 19.
The evidence for efficacy of many currently available treatments for bipolar disorder is based on studies of nonrefractory patients with bipolar disorder. Therefore, not surprisingly, most treatment recommendations and guidelines for the treatment of bipolar disorder and its many comorbidities depend heavily on data from placebo controlled randomized clinical trials (RCTs), but these RCTs provide little direction for the clinician as to what next steps might be optimal in non- or partial-responders and in those with ongoing medical and psychiatric comorbidities. Given this and the paucity of RCTs at later treatment junctures, we thought it appropriate to begin a discussion of the quality of the data that some experts in the field might consider using in choosing and sequencing drugs and their combination. We acknowledge that many other clinical investigators may prefer very different sequences, but thought the suggestions offered here might be useful to some clinicians in the field, might start discussions of other options in the literature, and, at the same time, provide a preliminary outline for a new round of much-needed clinical trials to better inform clinical practice. Given the very wide range of the quality of the data and clinical principles on which the current suggestions are based, only minimal references are included and a comprehensive review of the literature supporting each option would be outside the scope of this manuscript.
目前许多治疗双相情感障碍的有效方法的证据都是基于对非难治性双相情感障碍患者的研究。因此，毫不奇怪，大多数双相情感障碍及其许多共病的治疗建议和指南主要依赖于安慰剂对照随机临床试验 (RCT) 的数据，但这些 RCT 几乎没有为临床医生提供关于非应答者和持续存在医学和精神共病的患者下一步可能的最佳治疗方案的指导。鉴于此，以及后期治疗阶段 RCT 的缺乏，我们认为开始讨论一些该领域的专家可能会考虑在选择和调整药物及其组合时使用的数据质量是合适的。我们承认，许多其他临床研究人员可能更喜欢非常不同的方案，但我们认为这里提出的建议可能对该领域的一些临床医生有用，可能会引发文献中对其他选择的讨论，同时为急需的新一轮临床试验提供初步大纲，以更好地为临床实践提供信息。鉴于当前建议所依据的数据质量和临床原则范围非常广泛，因此仅包含最小的参考文献，并且支持每种选择的文献全面审查将超出本手稿的范围。
