Division of Mood and Anxiety Disorders, University of Texas Health Science Center at San Antonio, San Antonio, TX 78229, USA.
J Clin Psychiatry. 2012 Jul;73(7):e913-7. doi: 10.4088/JCP.10m06737.
Post hoc mediator/moderator analyses were designed to identify risk factors and their relationships in predicting relapse in olanzapine- or lithium-treated bipolar patients with an index manic or mixed episode. The aim was to identify moderators that precede and influence other variables to affect relapse and mediators that explain how or why a second variable affects relapse.
We examined DSM-IV-diagnosed bipolar I disorder patients who met symptomatic remission criteria of an index manic or mixed (6.3%) episode after acute (6-12 weeks), open-label, combined therapy with olanzapine (5-20 mg/d; mean dose = 13.5 mg/d) plus lithium (300-1,800 mg/d; mean dose = 1,003.3 mg/d) followed by double-blind randomization to lithium (n = 214) or olanzapine (n = 217) for up to 52 weeks. The study started on August 5, 1999, and finished on June 14, 2002. Mediator/moderator analyses with α cut at .05 were used to understand how variables work together to impact rate of relapse.
For lithium-treated patients, variables identified for relapse were country of residence, smoking status, previous episode history, and previous lithium use. For olanzapine-treated patients, risk factors included smoking status, previous episode history, amount of time patients had a 21-Item Hamilton Depression Rating Scale (HDRS-21) score ≤ 8 at pre-randomization, and HDRS-21 score at randomization. For lithium-treated patients, no mediators/moderators were identified among relapse variables. For olanzapine-treated patients, several baseline variables--such as previous number of mood episodes (manic or depressive)--operate through severity of depressive symptoms prior to remission (mediator) to affect relapse rate. On the other hand, the effect of the patient's pre-remission depressive symptoms on outcome is moderated by the polarity of the first episode, whether manic, depressive, or mixed.
Mediators and moderators may provide valuable information in the treatment planning of patients with bipolar disorder and potentially influence treatment outcomes.
采用事后中介/调节分析来确定风险因素及其与预测奥氮平或锂盐治疗的有躁狂或混合发作既往史的双相障碍患者复发的关系。目的是确定先于其他变量并影响其他变量以影响复发的调节因素，以及解释第二变量如何或为何影响复发的中介因素。
我们对符合 DSM-IV 诊断的双相 I 型障碍患者进行了研究，这些患者在急性（6-12 周）、开放性、奥氮平（5-20 mg/d；平均剂量为 13.5 mg/d）联合锂盐（300-1800 mg/d；平均剂量为 1003.3 mg/d）治疗后达到有躁狂或混合（6.3%）发作既往史的症状缓解标准，并随后进行为期 52 周的双盲随机分组至锂盐（n=214）或奥氮平（n=217）治疗。研究于 1999 年 8 月 5 日开始，2002 年 6 月 14 日结束。采用 α 值为 0.05 的中介/调节分析来理解变量如何协同作用以影响复发率。
对于锂盐治疗的患者，复发的相关变量包括居住地、吸烟状况、既往发作史和既往锂盐使用史。对于奥氮平治疗的患者，风险因素包括吸烟状况、既往发作史、患者在随机分组前达到 Hamilton 抑郁量表（HDRS-21）评分≤8 的时间、以及随机分组时的 HDRS-21 评分。对于锂盐治疗的患者，在复发相关变量中未发现中介/调节因素。对于奥氮平治疗的患者，一些基线变量，如既往躁狂或抑郁发作次数，通过缓解前的抑郁严重程度（中介）影响复发率。另一方面，患者缓解前的抑郁症状对结局的影响受到首发发作极性的调节，即躁狂、抑郁或混合。
中介因素和调节因素可能为双相障碍患者的治疗计划提供有价值的信息，并可能影响治疗结局。
