双相情感障碍和分裂情感性障碍患者中丙戊酸镁缓释制剂与标准制剂的初步比较。
Pilot comparison of extended-release and standard preparations of divalproex sodium in patients with bipolar and schizoaffective disorders.
作者信息
Centorrino Franca, Kelleher James P, Berry Judith M, Salvatore Paola, Eakin Marion, Fogarty Kate V, Fellman Veronica, Baldessarini Ross J
机构信息
Department of Psychiatry, Harvard Medical School, Boston, USA.
出版信息
Am J Psychiatry. 2003 Jul;160(7):1348-50. doi: 10.1176/appi.ajp.160.7.1348.
OBJECTIVE
The authors compared the new extended-release and standard preparations of divalproex sodium.
METHOD
Twelve patients with DSM-IV bipolar disorder or schizoaffective disorder who were clinically stable while taking the standard form of divalproex participated in the study. These patients were given a single daily dose of the extended-release preparation of divalproex in an open 6-week trial. Clinical symptoms and adverse effects were rated weekly. Doses were adjusted to maintain steady serum valproate concentrations.
RESULTS
The medication change was associated with negligible changes in clinical status and tolerability. To maintain serum drug levels, however, 21% higher doses of the extended-release preparation were required.
CONCLUSIONS
Use of extended-release divalproex once a day was as well tolerated as the standard preparation, with no change in efficacy within 6 weeks, but the daily dose needed to maintain stable serum valproic acid concentration was 21% higher.
目的
作者比较了丙戊酸二钠新的缓释制剂和标准制剂。
方法
12名患有DSM-IV双相情感障碍或分裂情感性障碍的患者，在服用丙戊酸二钠标准制剂时临床症状稳定，参与了本研究。在一项为期6周的开放性试验中，这些患者每日服用一剂丙戊酸二钠缓释制剂。每周对临床症状和不良反应进行评分。调整剂量以维持血清丙戊酸盐浓度稳定。
结果
药物变更与临床状态和耐受性的微小变化相关。然而，为维持血清药物水平，需要比标准制剂高21%的缓释制剂剂量。
结论
每日一次服用丙戊酸二钠缓释制剂的耐受性与标准制剂相同，6周内疗效无变化，但维持稳定血清丙戊酸浓度所需的每日剂量高21%。
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