Kleindienst N, Greil W
Department of Psychiatry. University of Munich, Germany.
Psychol Med. 2002 Apr;32(3):493-501. doi: 10.1017/s0033291702005251.
Evaluation of mood-stabilizing treatment strategies usually focuses on their efficacy in preventing recurrences. The aim of this study is to supplement evaluation by two important aspects: inter-episodic morbidity and drop-out.
Using a global outcome measure, response to prophylactic lithium and carbamazepine was evaluated in N = 171 bipolar patients (DSM-IV) participating in a randomized controlled trial with an observation period of 2 1/2 years (MAP study).
The rates of re-hospitalization were similar for both treatments. However, the percentage of good clinical response (i.e. patients with a low score of inter-episodic morbidity and without both re-hospitalization and drop-out during the observation period) was significantly higher in patients randomized to lithium (40% v. 24%). This superiority of lithium resulted essentially from a lower drop-out rate in patients without re-hospitalization (17% v. 42%). Regarding severity of inter-episodic morbidity, no clear difference between the drugs was found. For both medications the predominant symptomatology was minor depressive (but not manic, mixed or schizoaffective) symptoms. In the lithium group, inter-episodic morbidity in patients without re-hospitalization significantly decreased during the first 10 months and remained on the lower level for the rest of the observation period. For carbamazepine, reduction of inter-episodic morbidity over time did not reach statistical significance. Inter-episodic morbidity was significantly related to drop-out and to re-hospitalization for both medications.
Taking inter-episodic morbidity, drop-out and re-hospitalization into consideration, the response rate in bipolar patients (DSM-IV) was higher for prophylactic lithium than for carbamazepine. The global outcome parameter used appears to be a valuable measure of clinical response to mood stabilizing drugs.
心境稳定剂治疗策略的评估通常侧重于其预防复发的疗效。本研究的目的是从两个重要方面补充评估：发作间期的发病率和脱落率。
使用一项整体结局指标，对参与一项为期2年半的随机对照试验（MAP研究）的N = 171例双相情感障碍患者（DSM - IV）预防性使用锂盐和卡马西平的反应进行评估。
两种治疗的再次住院率相似。然而，随机分配到锂盐组的患者中，良好临床反应（即发作间期发病率得分低且在观察期内既无再次住院也无脱落的患者）的百分比显著更高（40%对24%）。锂盐的这种优势主要源于未再次住院患者的较低脱落率（17%对42%）。关于发作间期发病率的严重程度，未发现两种药物之间有明显差异。对于两种药物，主要症状是轻度抑郁（而非躁狂、混合或分裂情感性）症状。在锂盐组中，未再次住院患者的发作间期发病率在最初10个月显著下降，并在观察期的其余时间保持在较低水平。对于卡马西平，发作间期发病率随时间的降低未达到统计学意义。两种药物的发作间期发病率均与脱落和再次住院显著相关。
综合考虑发作间期发病率、脱落率和再次住院率，双相情感障碍患者（DSM - IV）预防性使用锂盐的反应率高于卡马西平。所使用的整体结局参数似乎是衡量心境稳定剂临床反应的一项有价值的指标。
