Valproate as an adjunct to neuroleptic medication for the treatment of acute episodes of mania:: A prospective, randomized, double-blind, placebo-controlled, multicenter study
Valproate as an adjunct to neuroleptic medication for the treatment of acute episodes of mania:: A prospective, randomized, double-blind, placebo-controlled, multicenter study
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DOI：
10.1097/00004714-200004000-00012
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发表时间：
2000-04-01
影响因子：
2.9
通讯作者：
Walden, J
中科院分区：
文献类型：
--
作者：
M端ller-Oerlinghausen, B;Retzow, A;Walden, J
为了比较丙戊酸钠作为抗精神病药物辅助治疗急性躁狂患者的疗效与抗精神病药物单独治疗的疗效，作者进行了一项为期21天的随机、双盲、平行组、安慰剂对照试验。该研究设计密切反映了欧洲的临床精神病学背景，急性躁狂患者通常接受精神抑制药物治疗。在这项试验中，136名住院患者符合ICD-10急性躁狂发作的标准;这些患者接受20 mg/kg体重的固定剂量丙戊酸钠（Orfiril，Desitin Arzneimittel GmbH，Hamburg，德国）口服给药，主要结果测量是21天研究期间的平均抗精神病药物剂量（转换为氟哌啶醇当量后）。使用杨氏躁狂量表（YMRS）、总体评估量表和临床总体印象量表测量症状的严重程度。意向治疗分析基于69例丙戊酸盐治疗患者和67例安慰剂治疗患者。两组在人口统计学和临床基线数据方面具有可比性。仅13%的患者发生提前停药。丙戊酸盐组的平均抗精神病药物剂量持续下降，而安慰剂组仅观察到轻微变化;研究第2周和第3周的差异具有统计学显著性（p = 0.0007），证明抗精神病药物和丙戊酸盐联合用药在缓解躁狂症状方面上级抗精神病药物。与丙戊酸盐联合治疗组的应答者比例（YMRS上显示的改善率为50%）高于仅接受抗精神病药物治疗组（70% vs. 46%; p 0.005），不良事件包括已知的丙戊酸盐或抗精神病药物不良事件;唯一的不良事件是无力，联合治疗组发生频率更高。丙戊酸盐是治疗急性躁狂症状的有用辅助药物。丙戊酸盐是有益的，因为它允许给予更少的神经安定药物，并产生改善和更快的躁狂症状缓解。
To compare the efficacy of sodium valproate administered as adjunct to neuroleptic medication for patients with acute mania with the efficacy of neuroleptics alone, the authors conducted a 21-day, randomized, double-blind, parallel-group, placebo-controlled trial. The study design closely reflected a clinical psychiatric setting in Europe where patients with acute mania commonly receive neuroleptic medication. In this trial, 136 hospitalized patients met the ICD-10 criteria for acute manic episodes; these patients received a fixed dose of 20 mg/kg of body weight of sodium valproate (Orfiril, Desitin Arzneimittel GmbH, Hamburg, Germany) orally, in addition to basic neuroleptic medication, preferably haloperidol and/or perazine, The primary outcome measure was the mean dose of neuroleptic medication (after conversion into haloperidol-equivalents) for the 21-day study period. Severity of symptoms was measured using the Young Mania Rating Scale (YMRS), the Global Assessment Scale, and the Clinical Global Impression Scale. Intent-to-treat analysis was based on 69 patients treated with valproate and 67 patients who received placebo. Groups were comparable with regard to demographic and clinical baseline data. Premature discontinuations occurred in only 13% of the patients. The mean neuroleptic dose declined continuously in the valproate group, whereas only slight variations mere observed in the placebo group; the difference was statistically significant (p = 0.0007) for study weeks 2 and 3, The combination of neuroleptic and valproate proved superior to neuroleptics in attempts to alleviate manic symptoms. The proportion of responders (a 50% improvement rate shown on the YMRS) was higher for the combination with valproate than for the group receiving only neuroleptics (70% vs. 46%; p 0.005), Adverse events consisted of those known for valproate or neuroleptics; the only adverse event was asthenia, which occurred more frequently with the combination therapy. Valproate represents a useful adjunct medication for the treatment of acute manic symptoms. Valproate is beneficial because it allows the administration of fewer neuroleptic medications and produces improved and quicker remission of manic symptoms.