Paholpak Suchat, Jaikasemwong Sirikul, Roumcharoenkiat Ajchara, Paholpak Patharee, Rangseekajee Poonsri
J Med Assoc Thai. 2014 Apr;97(4):431-8.
To determine-in a clinical setting-the rate and time to recurrence of any mood episode during valproate maintenance treatment for bipolar I disorder.
A retrospective cohort based on medical records of both in- and out-patient with bipolar I disorder (DSM-IV-TR) seen at Srinagarind Hospital between January 1, 2009 and December 31, 2010 was done. A recurrence was observed if the patient had fulfilled the remission criteria and valproate was the maintenance drug. Survival analysis and Cox regression analysis were used to analyze the data.
Eighty-five patients with 124 remitted mood episodes met the inclusion criteria. Of the 85 patients, the average age was 41.4 +/- 17.1 years (range, 18-89); 49.4% were males; 48.2% married; 42.4% completed secondary school, 30.6% completed a bachelor degree; 35.3% were unemployed, and 34.1% were government employees. Twenty remitted mood episodes (16.1%) were in maintenance treatment with valproate only. The remaining 104 (83.9%) were in maintenance treatment with valproate in combination with other agents. There were 50 recurrences from 36 patients during the two years of study, the recurrence per a patient ranged from 1 to 3 times. The rate of recurrence was 21%/year or 2.2/100 person-months (95% CI = 1.65-2.93). The average time to recurrence to any mood episode was 33 months (95% CI = 15.06-50.94). With multivariable Cox regression, a statistically significant greater risk for a recurrence was associated with: (a) the previous episode being hospitalized (adjusted hazard ratio = 5.88, 95% CI = 2.76-12.36, p < 0.001); (b) blood valproate concentration during maintenance treatment < 50 microg/mL (adjusted hazard ratio = 3.07, 95% CI = 1.11-8.53, p = 0.03); and (c) time duration (month) of valproate maintenance treatment (adjusted hazard ratio = 0.98, 95% CI = 0.96-0.99, p = 0.001). With the adjusted hazard ratio 0.98, it could be interpreted in the other way that each additional month of taking valproate was associated with a statistically significant protective factor that decreased the risk of recurrence by 2% from the previous month.
In the authors'clinical setting, valproate both singly and in combination with other psychotropic agents used for maintenance treatment of bipolar I disorder yielded a recurrence rate of 21% per year or 2.2 per 100 person-months and time to any mood episode recurrence of 33 months. The present result has importance for both clinical treatment decision-making and patient economic status.
在临床环境中确定双相I型障碍患者丙戊酸盐维持治疗期间任何心境发作的复发率及复发时间。
基于2009年1月1日至2010年12月31日在诗里拉吉医院就诊的双相I型障碍（DSM-IV-TR）门诊及住院患者的病历进行回顾性队列研究。若患者达到缓解标准且丙戊酸盐为维持治疗药物，则观察到复发情况。采用生存分析和Cox回归分析对数据进行分析。
85例患者的124次缓解心境发作符合纳入标准。85例患者中，平均年龄为41.4±17.1岁（范围18 - 89岁）；49.4%为男性；48.2%已婚；42.4%完成中学教育，30.6%完成本科学位；35.3%失业，34.1%为政府雇员。20次缓解心境发作（16.1%）仅接受丙戊酸盐维持治疗。其余104次（83.9%）接受丙戊酸盐与其他药物联合维持治疗。在两年的研究期间，36例患者出现50次复发，每位患者的复发次数为1至3次。复发率为每年21%或每100人月2.2次（95%置信区间 = 1.65 - 2.93）。任何心境发作的平均复发时间为33个月（95%置信区间 = 15.06 - 50.94）。多变量Cox回归分析显示，复发风险显著增加与以下因素相关：（a）既往发作曾住院治疗（调整后风险比 = 5.88，95%置信区间 = 2.76 - 12.36，p < 0.001）；（b）维持治疗期间丙戊酸盐血药浓度 < 50μg/mL（调整后风险比 = 3.07，95%置信区间 = 1.11 - 8.53，p = 0.03）；（c）丙戊酸盐维持治疗的时间（月）（调整后风险比 = 0.98，95%置信区间 = 0.96 - 0.99，p = 0.001）。调整后风险比为0.98，也可以理解为，服用丙戊酸盐每增加一个月，与一个具有统计学意义的保护因素相关，该因素使复发风险较前一个月降低2%。
在作者的临床环境中，丙戊酸盐单独及与其他精神药物联合用于双相I型障碍维持治疗时，每年复发率为21%或每100人月2.2次，任何心境发作的复发时间为33个月。本研究结果对临床治疗决策和患者经济状况均具有重要意义。
