Jeong Hyun-Ghang, Lee Moon-Soo, Ko Young-Hoon, Han Changsu, Jung In-Kwa
Department of Psychiatry, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Korea.
Clin Neuropharmacol. 2012 May-Jun;35(3):97-102. doi: 10.1097/WNF.0b013e3182560401.
Despite the fact that combination treatment for patients with acute bipolar is prevalent in clinical practice, the outcomes of adjunct treatment with aripiprazole and a mood stabilizer have rarely been reported. The aim of this single-blind, randomized, controlled trial was to investigate treatment efficacy and safety of aripiprazole as an adjunct to valproic acid (Ari+Val), compared with haloperidol plus valproic acid (Hal+Val), in acute manic patients.
Treatment efficacy was prospectively assessed for 8 weeks in 42 patients with acute mania using the Young Mania Rating Scale and the Clinical Global Impression-Severity of illness scale. Emergent adverse events were assessed by the Drug-Induced Extrapyramidal Symptoms Scale and the Liverpool University Neuroleptic Side Effect Rating Scale.
Both Ari+Val and Hal+Val produced a high rate of response (85.7% and 92.9%, respectively) and remission (82.1% and 85.7%, respectively) after the 8-week trial. Changes in the Young Mania Rating Scale and the Clinical Global Impression-Severity of illness scale over the study period and time to remission and response were not significantly different between the 2 groups. Patients treated with Ari+Val showed significantly fewer extrapyramidal adverse events than those treated with Hal+Val (t = -2.048, F = 40, P = 0.048). However, significant weight gain was more prevalent in the Ari+Val group than the Hal+Val group (t = 2.055, F = 40, P = 0.046).
Our findings suggest that both combination strategies with Ari+Val and Hal+Val are beneficial for acute manic episode. Although patients receiving Ari+Val showed fewer extrapyramidal symptoms than those taking Hal+Val, careful consideration of adverse events such as weight gain and sedation is warranted.
尽管急性双相情感障碍患者的联合治疗在临床实践中很普遍，但阿立哌唑与心境稳定剂辅助治疗的结果鲜有报道。本单盲、随机、对照试验的目的是研究在急性躁狂患者中，与氟哌啶醇加丙戊酸（Hal+Val）相比，阿立哌唑作为丙戊酸辅助药物（Ari+Val）的治疗效果和安全性。
使用青年躁狂评定量表和临床总体印象-疾病严重程度量表，对42例急性躁狂患者进行了为期8周的前瞻性治疗效果评估。通过药物性锥体外系症状量表和利物浦大学抗精神病药物副作用评定量表评估突发不良事件。
8周试验后，Ari+Val组和Hal+Val组的有效率（分别为85.7%和92.9%）和缓解率（分别为82.1%和85.7%）均较高。两组在研究期间青年躁狂评定量表和临床总体印象-疾病严重程度量表的变化以及缓解和起效时间无显著差异。与Hal+Val组相比，Ari+Val组治疗的患者锥体外系不良事件明显更少（t = -2.048，F = 40，P = 0.048）。然而，Ari+Val组显著体重增加比Hal+Val组更普遍（t = 2.055，F = 40，P = 0.046）。
我们的研究结果表明，Ari+Val和Hal+Val的联合治疗策略对急性躁狂发作均有益。尽管接受Ari+Val治疗的患者锥体外系症状比服用Hal+Val的患者少，但仍需仔细考虑体重增加和镇静等不良事件。
