MacMillan Carlene M, Korndörfer Sergio R, Rao Sneha, Fleisher Carl A, Mezzacappa Enrico, Gonzalez-Heydrich Joseph
Psychopharmacology Program, Children's Hospital, Harvard Medical School, 300 Longwood Avenue, Boston, MA 02115, USA.
J Psychiatr Pract. 2006 Jul;12(4):214-22. doi: 10.1097/00131746-200607000-00003.
Divalproex (DVP) and oxcarbazepine (OXC) are used to treat pediatric bipolar disorder (PBPD) with severe aggression but these agents have not been compared in head to head trials.
Electronic medical records were reviewed for those (age < 18) who received DVP (n = 20) or OXC (n = 11) for the treatment of PBPD with severe aggression. Change in prospectively rated Clinical Global Impressions-Severity (CGI-S) scores that measured global improvement of mental illness from baseline and rates of discontinuation due to adverse effects at approximately 4 months were the primary outcomes. CGI-S specific to aggression (CGI-Ag-S), which was rated retrospectively and blinded to treatment, was a secondary outcome.
Greater reduction in CGI-S scores occurred with DVP compared with OXC at 4 months (p = 0.007). Both CGI-S and CGI-Ag-S scores improved significantly from baseline to the 4-month timepoint with DVP but not OXC. There were no significant differences in weight changes between the groups. Rates of discontinuation due to adverse events were similar. However, more discontinuations due to worsening aggression occurred with OXC (DVP 0%, OXC 27.3%, p = 0.037). More patients receiving DVP had a decrease of 1 point or more on the CGI-S and had not discontinued due to adverse events as of the patient's last recorded visit on the index medication (DVP 13 (65%), OXC 2 (18%), p = 0.023).
OXC appeared less effective than DVP for PBPD with aggression in this study. Limitations included the small sample size and the open, nonrandomized, retrospective study design. Future prospective, double-blind studies are warranted to determine the place of OXC in the treatment of PBPD.
丙戊酸二钠（DVP）和奥卡西平（OXC）用于治疗伴有严重攻击行为的儿童双相情感障碍（PBPD），但尚未在头对头试验中对这些药物进行比较。
回顾了年龄小于18岁、接受DVP（n = 20）或OXC（n = 11）治疗伴有严重攻击行为的PBPD患者的电子病历。主要结局指标为前瞻性评定的临床总体印象-严重程度（CGI-S）评分从基线开始的变化，该评分衡量精神疾病的总体改善情况，以及在约4个月时因不良反应导致的停药率。对攻击行为特异性的CGI-S（CGI-Ag-S）是次要结局指标，该指标为回顾性评定且对治疗情况设盲。
在4个月时，与OXC相比，DVP使CGI-S评分降低得更多（p = 0.007）。从基线到4个月时间点，DVP治疗组的CGI-S和CGI-Ag-S评分均显著改善，而OXC治疗组则未改善。两组间体重变化无显著差异。因不良事件导致的停药率相似。然而，OXC组因攻击行为恶化导致的停药更多（DVP组为0%，OXC组为27.3%，p = 0.037）。截至患者在索引药物上的最后一次记录就诊时，更多接受DVP治疗的患者CGI-S评分降低了1分或更多且未因不良事件停药（DVP组为13例（65%），OXC组为2例（18%），p = 0.023）。
在本研究中，对于伴有攻击行为的PBPD，OXC似乎不如DVP有效。局限性包括样本量小以及开放、非随机、回顾性研究设计。未来有必要进行前瞻性、双盲研究以确定OXC在PBPD治疗中的地位。
