University of Bordeaux, Inserm, Bordeaux Population Health Research Center, Pharmacoepidemiology research team, UMR 1219, F-33000 Bordeaux, France; Hospital Charles Perrens, F-33000 Bordeaux, France.
Department of Studies in Public Health, French National Health Insurance (Assurance Maladie/CNAM-TS), 75 986 Paris Cedex20, France.
J Affect Disord. 2019 Oct 1;257:412-420. doi: 10.1016/j.jad.2019.07.054. Epub 2019 Jul 6.
The study compared treatment failure when using three therapeutic strategies in bipolar disorders: (i) mood stabilizers (MSs: lithium, valpromide, divalproate, carbamazepine, lamotrigine) without second-generation antipsychotic (SGAP); (ii) SGAPs (aripiprazole, olanzapine, risperidone, quetiapine) without MS; (iii) combination of MSs and SGAPs.
A historical cohort study was conducted using the French national healthcare databases in 20,086 outpatients aged 21+, newly treated with one of the three treatment strategies in 2011-2012, and diagnosed with a bipolar disorder. A composite outcome was based on indicators of treatment failure identified over 12 months: treatment discontinuation, switch or addition, psychiatric hospitalisation, suicide attempt, and death. For each strategy, the cumulative incidence of treatment failure was calculated while adjusting for covariates by propensity score weighting.
A total of 8,225 patients (40.9%) were newly dispensed MSs, 9,342 (46.5%) SGAPs, and 2,519 (12.5%) both MSs and SGAPs. The one-year adjusted cumulative incidence of treatment failure was 75.7% (95%CI 74.9;76.3) in patients using MSs, 75.3% (74.6;76.0) in patients using SGAPs, and 60.5% (58.3;62.6) in patients with the combination. The adjusted difference in incidence for SGAPs compared with MSs was -0.40% (-1.4;0.6 p = 0.4) in the whole population, -2.2% (-3.3; -1.2 p < 0.002) in patients under 65 years and +6.7% (4.1;9.1 p < 0.002) in patients 65 years and over.
Combinations of MSs and SGAPs could not be directly compared with MS or SGAP monotherapies.
One-year treatment failure was high. Overall, no difference in treatment failure was observed between MS or SGAP strategy but differences might exist depending on age.
本研究比较了在双相情感障碍中使用三种治疗策略时的治疗失败情况：（i）情绪稳定剂（MSs：锂、丙戊酸盐、丙戊酸钠、卡马西平、拉莫三嗪）不联合第二代抗精神病药物（SGAPs）；（ii）SGAPs（阿立哌唑、奥氮平、利培酮、喹硫平）不联合 MSs；（iii）MSs 和 SGAPs 的联合治疗。
这是一项使用法国国家医疗保健数据库进行的历史队列研究，共纳入了 2011-2012 年间新接受三种治疗策略之一治疗的 21 岁及以上的 20086 名门诊患者，诊断为双相情感障碍。复合结局基于 12 个月内的治疗失败指标确定：治疗中断、转换或添加、精神病住院、自杀未遂和死亡。对于每种策略，在通过倾向评分加权调整协变量后，计算治疗失败的累积发生率。
共有 8225 名患者（40.9%）新处方了 MSs，9342 名患者（46.5%）新处方了 SGAPs，2519 名患者（12.5%）同时处方了 MSs 和 SGAPs。使用 MSs 的患者一年调整后的累积治疗失败发生率为 75.7%（95%CI 74.9%；76.3%），使用 SGAPs 的患者为 75.3%（95%CI 74.6%；76.0%），联合使用 MSs 和 SGAPs 的患者为 60.5%（95%CI 58.3%；62.6%）。在整个人群中，SGAPs 与 MSs 相比，调整后的发生率差异为-0.40%（-1.4%；0.6 p=0.4），65 岁以下患者为-2.2%（-3.3%；-1.2 p<0.002），65 岁及以上患者为+6.7%（4.1%；9.1 p<0.002）。
MSs 和 SGAPs 的联合治疗无法直接与 MS 或 SGAP 单药治疗进行比较。
一年的治疗失败率很高。总体而言，MS 或 SGAP 策略之间的治疗失败没有差异，但可能因年龄而异。
