老年双相障碍：锂盐与丙戊酸治疗老年双相障碍躁狂发作的随机双盲对照试验
GERI-BD: A Randomized Double-Blind Controlled Trial of Lithium and Divalproex in the Treatment of Mania in Older Patients With Bipolar Disorder.
作者信息
Young Robert C, Mulsant Benoit H, Sajatovic Martha, Gildengers Ariel G, Gyulai Laszlo, Al Jurdi Rayan K, Beyer John, Evans Jovier, Banerjee Samprit, Greenberg Rebecca, Marino Patricia, Kunik Mark E, Chen Peijun, Barrett Marna, Schulberg Herbert C, Bruce Martha L, Reynolds Charles F, Alexopoulos George S
机构信息
From the Department of Psychiatry and the Department of Healthcare Policy and Research, Weill Cornell Medicine, New York, and New York Presbyterian Hospital, New York; the Department of Psychiatry, University of Toronto, and the Centre for Addiction and Mental Health, Toronto; the Department of Psychiatry, University of Pittsburgh, Pittsburgh; the Department of Psychiatry, Case Western Reserve University School of Medicine, Cleveland; the Department of Psychiatry, Louis Stokes Cleveland VA Medical Center, Cleveland; the Department of Psychiatry, University of Pennsylvania, Philadelphia, and the Corporal Michael J. Crescenz VA Medical Center, Philadelphia; the Department of Psychiatry, Baylor College of Medicine, and the Michael E. DeBakey VA Medical Center, Houston; the Department of Psychiatry, Duke University Medical College, Durham, N.C.; and NIMH, Bethesda, Md.
出版信息
Am J Psychiatry. 2017 Nov 1;174(11):1086-1093. doi: 10.1176/appi.ajp.2017.15050657. Epub 2017 Aug 4.
OBJECTIVE
Clinicians treating older patients with bipolar disorder with mood stabilizers need evidence from age-specific randomized controlled trials. The authors describe findings from a first such study of late-life mania.
METHOD
The authors compared the tolerability and efficacy of lithium carbonate and divalproex in 224 inpatients and outpatients age 60 or older with bipolar I disorder who presented with a manic, hypomanic, or mixed episode. Participants were randomly assigned, under double-blind conditions, to treatment with lithium (target serum concentration, 0.80-0.99 mEq/L) or divalproex (target serum valproate concentration, 80-99 μg/mL) for 9 weeks. Participants with an inadequate response after 3 weeks received open adjunctive risperidone. The authors hypothesized that divalproex would be better tolerated and more efficacious than lithium. Tolerability was assessed based on a measure of sedation and on the proportions of participants achieving target concentrations. Efficacy was assessed with the Young Mania Rating Scale (YMRS).
RESULTS
Attrition rates were similar for lithium and divalproex (14% and 18% at week 3 and 51% and 44% at week 9, respectively). The groups did not differ significantly in sedation. Participants in the lithium group tended to experience more tremor. Similar proportions of participants in the lithium and divalproex groups achieved target concentrations (57% and 56%, respectively). A longitudinal mixed model of improvement (change from baseline in YMRS score) favored lithium (change in score, 3.90; 97.5% CI=1.71, 6.09). Nine-week response rates did not differ significantly between the lithium and divalproex groups (79% and 73%, respectively). The need for adjunctive risperidone was low and similar between groups (17% and 14%, respectively).
CONCLUSIONS
Both lithium and divalproex were adequately tolerated and efficacious; lithium was associated with a greater reduction in mania scores over 9 weeks.
目的
使用心境稳定剂治疗老年双相情感障碍患者的临床医生需要来自特定年龄随机对照试验的证据。作者描述了首个此类老年躁狂症研究的结果。
方法
作者比较了碳酸锂和丙戊酸镁对224名60岁及以上患有双相I型障碍且出现躁狂、轻躁狂或混合发作的住院和门诊患者的耐受性和疗效。参与者在双盲条件下被随机分配接受锂盐治疗（目标血清浓度为0.80 - 0.99 mEq/L）或丙戊酸镁治疗（目标血清丙戊酸盐浓度为80 - 99 μg/mL），为期9周。3周后反应不足的参与者接受开放辅助使用利培酮治疗。作者假设丙戊酸镁比锂盐耐受性更好且更有效。耐受性通过镇静测量以及达到目标浓度的参与者比例来评估。疗效通过青年躁狂评定量表（YMRS）进行评估。
结果
锂盐组和丙戊酸镁组的脱落率相似（第3周分别为14%和18%，第9周分别为51%和44%）。两组在镇静方面无显著差异。锂盐组的参与者更容易出现震颤。锂盐组和丙戊酸镁组达到目标浓度的参与者比例相似（分别为57%和56%）。改善情况的纵向混合模型（YMRS评分相对于基线的变化）更支持锂盐治疗（评分变化为3.90；97.5%可信区间=1.71, 6.09）。锂盐组和丙戊酸镁组的9周反应率无显著差异（分别为79%和73%）。辅助使用利培酮的需求较低且两组相似（分别为17%和14%）。
结论
锂盐和丙戊酸镁耐受性良好且疗效显著；锂盐在9周内与更大程度的躁狂评分降低相关。
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