序贯多项适应性随机治疗（SMART）在任何疾病阶段和至少轻度症状严重程度的双相障碍中的应用。
Sequential Multiple Assignment Randomized Treatment (SMART) for Bipolar Disorder at Any Phase of Illness and at least Mild Symptom Severity.
机构信息
Gao, MD, PhD, Schinagle, MD, Calabrese, MD, Mood and Anxiety Clinic in the Mood Disorders Program, Department of Psychiatry, University Hospitals Cleveland Medical Center, Cleveland, Ohio, and Case Western Reserve University School of Medicine, Cleveland, Ohio. Arnold, PhD, Bowden, MD, Department of Psychiatry, University of Texas Health Science Center at San Antonio, San Antonio, Texas. Prihoda, PhD, Department of Pathology, University of Texas Health Science Center at San Antonio, San Antonio, Texas. Quinones, MD, IKARE Mood, Trauma, and Recovery Clinic, San Antonio, Texas. Singh, MD, Department of Psychiatry, Texas Tech University Health Sciences Center at El Paso, El Paso, Texas. Conroy, MPH, D'Arcangelo, MSW, Case Western Reserve University School of Medicine. Cleveland, Ohio. Bai, MD, MS, Mood and Anxiety Clinic in the Mood Disorders Program, Department of Psychiatry, University Hospitals Cleveland Medical Center, Cleveland, Ohio, and Shenzhen Kangning Hospital, Shenzhen, Guandong Province, China.
出版信息
Psychopharmacol Bull. 2020 May 19;50(2):8-25.
OBJECTIVES
To sequentially study the effectiveness of lithium and divalproex monotherapy and adjunctive therapy with quetiapine or lamotrigine in the acute and continuation treatment of bipolar I or II disorder at any phase of illness and at least mild symptom severity.
METHODS
From June 2011 to December 2016, patients with bipolar I or II disorder (using DSM-IV diagnostic criteria) and CGI-S (Clinical Global Impression-Severity) ⩾ 3 were randomized to receive lithium or divalproex monotherapy for 2 weeks. Patients who had CGI-S-depression ⩾ 3 for 2 weeks at any time after 2-week monotherapy were randomly assigned to receive quetiapine or lamotrigine, or remaining on monotherapy for a total of 26 weeks.
RESULTS
The rates of early termination due to lack of efficacy and side effects and changes in BISS (Bipolar Inventory of Symptoms Scale) and CGI-S total score were not significantly different between lithium and divalproex. The completion rate was significantly higher with adjunctive therapy than with monotherapy. BISS and CGI-S total scores, and their sub-scores were significantly reduced with adjunctive therapy compared to monotherapy. Adjunctive therapy significantly increased survival times compared to monotherapy (hazard ratio = 6.8), the monotherapy group had a significantly increased risk for not reaching sustained recovery from depression (hazard ratio = 12.7). Patients who did not need the 2nd randomization and remained on monotherapy had a significantly reduced hazard for discontinuation (hazard ratio = 3.8).
CONCLUSIONS
The efficacy of lithium and divalproex as monotherapy was modest. Adjunctive lamotrigine and quetiapine to either one was well-tolerated and equally effective in reducing bipolar symptomatology, but adjunctive therapy should be initiated as early as possible when depression symptoms are present.
目的
连续研究锂盐和丙戊酸钠单药治疗以及联合喹硫平或拉莫三嗪治疗在疾病任何阶段和至少轻度症状严重程度的双相 I 或 II 障碍的急性期和维持治疗中的疗效。
方法
从 2011 年 6 月至 2016 年 12 月，使用 DSM-IV 诊断标准诊断为双相 I 或 II 障碍且 CGI-S（临床总体印象-严重程度）≥3 的患者被随机分为锂盐或丙戊酸钠单药治疗 2 周。任何时候在单药治疗 2 周后，如果 CGI-S-抑郁评分≥3 持续 2 周，患者被随机分配接受喹硫平或拉莫三嗪治疗，或继续单药治疗共 26 周。
结果
由于缺乏疗效和副作用以及 BISS（双相症状量表）和 CGI-S 总分的变化，锂盐和丙戊酸钠之间早期停药率无显著差异。与单药治疗相比，联合治疗的完成率显著更高。与单药治疗相比，BISS 和 CGI-S 总分及其子评分显著降低。与单药治疗相比，联合治疗显著延长了生存时间（危险比=6.8），单药治疗组未达到持续缓解抑郁的风险显著增加（危险比=12.7）。不需要第二次随机分组并继续单药治疗的患者停药风险显著降低（危险比=3.8）。
结论
锂盐和丙戊酸钠单药治疗的疗效适中。联合应用拉莫三嗪和喹硫平对任一药物的耐受性良好，均能有效减轻双相症状，但当出现抑郁症状时，应尽早开始联合治疗。
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