El-Mallakh Rif S, Salem Mary Ruth, Chopra Amarjit, Mickus Gregory J, Penagaluri Praveen, Movva Radhika
Mood Disorders Research Program, Department of Psychiatry and Behavioral Sciences, University of Louisville School of Medicine, Louisville, KY 40202, USA.
Ann Clin Psychiatry. 2010 Feb;22(1):3-8.
The anticonvulsant carbamazepine is approved by the FDA for treatment of acute mania. It is available in 2 formulations: immediate-release (IR) and extended-release carbamazepine capsules (ERCC). The relative efficacy of these formulations in acutely ill bipolar patients has not been previously investigated.
This study is a subanalysis of a 3-month, blinded, equal, random-assignment comparison of adverse effect load of an IR carbamazepine formulation (Tegretol) and ERCC (Equetro) in type I or type II bipolar patients already receiving carbamazepine or clinically determined to benefit from carbamazepine treatment. Dosages were titrated to patients' clinical needs. Subjects who scored >15 on the Montgomery Asberg Depression Rating Scale (MADRS) or >14 on the Young Mania Rating Scale (YMRS) were included in this analysis. The primary outcome measures were the relative mood scores at the end of the study.
At the end of 3 months of treatment, all patients improved compared with their baseline, but there was no difference in mood ratings in subjects with an initial MADRS >15 (ERCC, 18.2 +/- SD 11.9, vs IR, 12.0 +/- 4.5; P = .3) or YMRS >15 (ERCC, 6.5 +/- 6.4, vs IR, 4.7 +/- 3.1; P = .7). When compared with their baseline, patients receiving IR improved earlier than patients receiving ERCC. There were no differences in overall adverse events in patients receiving IR or ERCC (23.1 +/- 13.42 vs 22.3 +/- 13.40; P = .9).
Carbamazepine is effective in treating symptoms of both mania and depression, and there are no significant differences in the relative efficacy of the IR or ERCC formulations.
抗惊厥药卡马西平已获美国食品药品监督管理局（FDA）批准用于治疗急性躁狂症。它有两种剂型：即释型（IR）和缓释卡马西平胶囊（ERCC）。此前尚未研究过这些剂型在急性病双相情感障碍患者中的相对疗效。
本研究是一项为期3个月的双盲、等效、随机分配比较研究的亚分析，比较了已接受卡马西平治疗或临床判定可从卡马西平治疗中获益的I型或II型双相情感障碍患者中，IR卡马西平制剂（得理多）和ERCC（依来曲普坦）的不良反应负荷。剂量根据患者的临床需求进行滴定。蒙哥马利-阿斯伯格抑郁评定量表（MADRS）得分>15或杨氏躁狂评定量表（YMRS）得分>14的受试者纳入本分析。主要结局指标是研究结束时的相对情绪评分。
治疗3个月结束时，所有患者与基线相比均有改善，但初始MADRS>15的受试者（ERCC，18.2±标准差11.9，vs IR，12.0±4.5；P = 0.3）或YMRS>15的受试者（ERCC，6.5±6.4，vs IR，4.7±3.1；P = 0.7）的情绪评分无差异。与基线相比，接受IR治疗的患者比接受ERCC治疗的患者改善得更早。接受IR或ERCC治疗的患者总体不良事件无差异（23.1±13.42 vs 22.3±13.40；P = 0.9）。
卡马西平对治疗躁狂和抑郁症状均有效，IR或ERCC剂型的相对疗效无显著差异。
