Papatheodorou G, Kutcher S P
Sunnybrook Health Science Centre, University of Toronto, Ontario, Canada.
Psychopharmacol Bull. 1993;29(2):213-9.
This is a preliminary report on 6 subjects in an ongoing open trial of divalproex sodium in the treatment of adolescents with bipolar affective disorder who are experiencing an acute manic episode. The 7-week study was designed to determine the relative potential efficacy and safety of divalproex sodium in this condition before further assessment of the medication with a comparative lithium condition. Patients were assessed weekly with the Modified Mania Rating Scale (MMRS), the Brief Psychiatric Rating Scale (BPRS), and the Global Assessment Scale (GAS). The primary outcome measure was the MMRS. Of the 6 patients, 5 showed marked improvement (pre-post decrease > 60%), 1 showed some improvement (pre-post decrease of 20-60%), and none failed to improve (pre-post decrease of < 20%). The mean MMRS score was significantly reduced by 7 weeks of treatment (pre to post mean score: 77 +/- 25.79 to 29 +/- 24.97, t = 9.45, p < .0002), as were the BPRS (40.67 +/- 14.91 to 18.67 +/- 11.83, t = 5.98, p < .0019) and the GAS (28.5 +/- 12.78 to 48 +/- 15.03, t = 6.71, p < .0011). All patients were on ancillary psychotropic medications during this study.
这是一份关于丙戊酸二钠正在进行的开放试验的初步报告，该试验针对患有双相情感障碍且正经历急性躁狂发作的青少年。这项为期7周的研究旨在确定丙戊酸二钠在此种情况下的相对潜在疗效和安全性，以便在与锂盐对照进一步评估该药物之前进行相关研究。每周使用改良躁狂评定量表（MMRS）、简明精神病评定量表（BPRS）和总体评定量表（GAS）对患者进行评估。主要结局指标是MMRS。6名患者中，5名显示出显著改善（前后降低>60%），1名显示出一定改善（前后降低20 - 60%），且无患者未改善（前后降低<20%）。治疗7周后，MMRS平均得分显著降低（前后平均得分：77±25.79至29±24.97，t = 9.45，p <.0002），BPRS（40.67±14.91至18.67±11.83，t = 5.98，p <.0019）和GAS（28.5±12.78至48±15.03，t = 6.71，p <.0011）也是如此。在本研究期间，所有患者均服用辅助精神药物。
