Altamura A C, Mundo E, Dell'Osso B, Tacchini G, Buoli M, Calabrese J R
Department of Psychiatry, University of Milan, IRCCS Fondazione Ospedale Maggiore Policlinico Mangiagalli e Regina Elena, Milan, Italy.
J Affect Disord. 2008 Sep;110(1-2):135-41. doi: 10.1016/j.jad.2008.01.017. Epub 2008 Mar 10.
The aim of this naturalistic study was to compare the effectiveness of quetiapine and classical mood stabilizers, as mono- or combination therapy, in the long-term treatment of Bipolar Disorder (BD).
232 DSM-IV BD I (n=91) or BD II (n=141) patients, treated and followed up for four years, were studied. Mood stabilizers were chosen by the treating psychiatrists on the basis of their clinical judgement. The sample was subdivided into 6 treatment groups: quetiapine (n=41), lithium (n=39), sodium valproate (n=73), lamotrigine (n=31), quetiapine plus lithium (n=25), and quetiapine plus sodium valproate (n=23). Throughout the 4-year follow-up period patients were assessed monthly, or whenever a recurrence occurred, by the administration of HAMD-21 and of the YMRS. Primary outcome measures were the duration of euthymia and the cumulative proportion of subjects who maintained euthymia. Kaplan-Meier survival analyses were done to tabulate and compare the differences in survival distributions across the different treatment groups (Log-Rank Mantel-Cox test).
The combined treatments with quetiapine plus lithium or sodium valproate were more effective overall in maintaining euthymia, (percentages of patients who maintained euthymia: 29.3% for quetiapine, 46.2% for lithium, 32.9% for sodium valproate, 41.9% lamotrigine, 80% for quetiapine plus lithium, and 78.3% for quetiapine plus sodium valproate). In addition, quetiapine monotherapy was as effective as lithium monotherapy or combination treatment with lithium or sodium valproate in preventing the recurrence of major depressive episodes.
The main limitations of the study are the lack of randomized, controlled conditions and the low doses of quetiapine used.
If the results from this study will be replicated, there will be important implications for the use of quetiapine in the long-term treatment of BD.
这项自然主义研究的目的是比较喹硫平与传统心境稳定剂作为单一疗法或联合疗法在双相情感障碍（BD）长期治疗中的有效性。
对232例接受治疗并随访四年的DSM-IV BD I型（n = 91）或BD II型（n = 141）患者进行了研究。治疗精神科医生根据临床判断选择心境稳定剂。样本被分为6个治疗组：喹硫平组（n = 41）、锂盐组（n = 39）、丙戊酸钠组（n = 73）、拉莫三嗪组（n = 31）、喹硫平加锂盐组（n = 25）以及喹硫平加丙戊酸钠组（n = 23）。在整个4年的随访期内，每月或每当复发时，通过使用HAMD-21和YMRS对患者进行评估。主要结局指标是心境正常期的持续时间以及维持心境正常的受试者的累积比例。采用Kaplan-Meier生存分析来列表并比较不同治疗组生存分布的差异（对数秩Mantel-Cox检验）。
喹硫平加锂盐或丙戊酸钠的联合治疗在总体上维持心境正常方面更有效（维持心境正常的患者百分比：喹硫平组为29.3%，锂盐组为46.2%，丙戊酸钠组为32.9%，拉莫三嗪组为41.9%，喹硫平加锂盐组为80%，喹硫平加丙戊酸钠组为78.3%）。此外，喹硫平单一疗法在预防重度抑郁发作复发方面与锂盐单一疗法或锂盐或丙戊酸钠联合治疗效果相当。
该研究的主要局限性在于缺乏随机对照条件以及使用的喹硫平剂量较低。
如果该研究结果能够得到重复，那么对于喹硫平在BD长期治疗中的应用将具有重要意义。
