Rush A John, Kraemer Helena C, Sackeim Harold A, Fava Maurizio, Trivedi Madhukar H, Frank Ellen, Ninan Philip T, Thase Michael E, Gelenberg Alan J, Kupfer David J, Regier Darrel A, Rosenbaum Jerrold F, Ray Oakley, Schatzberg Alan F
Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX 75390-9086, USA.
Neuropsychopharmacology. 2006 Sep;31(9):1841-53. doi: 10.1038/sj.npp.1301131. Epub 2006 Jun 21.
This report summarizes recommendations from the ACNP Task Force on the conceptualization of remission and its implications for defining recovery, relapse, recurrence, and response for clinical investigators and practicing clinicians. Given the strong implications of remission for better function and a better prognosis, remission is a valid, clinically relevant end point for both practitioners and investigators. Not all depressed patients, however, will reach remission. Response is a less desirable primary outcome in trials because it depends highly on the initial (often single) baseline measure of symptom severity. It is recommended that remission be ascribed after 3 consecutive weeks during which minimal symptom status (absence of both sadness and reduced interest/pleasure along with the presence of fewer than three of the remaining seven DSM-IV-TR diagnostic criterion symptoms) is maintained. Once achieved, remission can only be lost if followed by a relapse. Recovery is ascribed after at least 4 months following the onset of remission, during which a relapse has not occurred. Recovery, once achieved, can only be lost if followed by a recurrence. Day-to-day functioning and quality of life are important secondary end points, but they were not included in the proposed definitions of response, remission, recovery, relapse, or recurrence. These recommendations suggest that symptom ratings that measure all nine criterion symptom domains to define a major depressive episode are preferred as they provide a more certain ascertainment of remission. These recommendations were based largely on logic, the need for internal consistency, and clinical experience owing to the lack of empirical evidence to test these concepts. Research to evaluate these recommendations empirically is needed.
本报告总结了美国神经精神药理学院（ACNP）工作组关于缓解概念的建议，以及该概念对临床研究人员和执业临床医生定义康复、复发、再发和反应的影响。鉴于缓解对更好的功能和更好的预后具有重要意义，缓解对从业者和研究人员而言都是一个有效的、与临床相关的终点。然而，并非所有抑郁症患者都能达到缓解状态。在试验中，反应作为主要结局不太理想，因为它高度依赖于症状严重程度的初始（通常是单一的）基线测量。建议在连续3周内维持最低症状状态（既无悲伤情绪，兴趣/愉悦感也未降低，且其余7项DSM-IV-TR诊断标准症状中出现少于3项）后判定为缓解。一旦达到缓解状态，只有在随后出现复发时才会失去缓解。在缓解开始后至少4个月且未发生复发的情况下判定为康复。康复一旦达成，只有在随后出现再发时才会失去。日常功能和生活质量是重要的次要终点，但它们未被纳入反应、缓解、康复、复发或再发的拟议定义中。这些建议表明，测量所有9项标准症状领域以定义重度抑郁发作的症状评级更受青睐，因为它们能更确定地判定缓解情况。由于缺乏实证证据来检验这些概念，这些建议主要基于逻辑、内部一致性的需要以及临床经验。需要开展实证研究来评估这些建议。
