Massachusetts General Hospital, Boston, USA.
Am J Psychiatry. 2013 Jan;170(1):102-10. doi: 10.1176/appi.ajp.2012.12060751.
Lithium salts, once the mainstay of therapy for bipolar disorder, have tolerability issues at a higher dosage that often limit adherence. The authors investigated the comparative effectiveness of more tolerable dosages of lithium as part of optimized personalized treatment (OPT).
The authors randomly assigned 283 bipolar disorder outpatients to 6 months of open, flexible, moderate dosages of lithium plus OPT or to 6 months of OPT alone. The primary outcome measures were the Clinical Global Impression Scale for Bipolar Disorder-Severity (CGI-BP-S) and "necessary clinical adjustments" (medication adjustments per month). Secondary outcome measures included mood symptoms and functioning. The authors also assessed sustained remission (defined as a CGI-BP-S score ≤2 for 2 months) and treatment with second-generation antipsychotics. The authors hypothesized that lithium plus OPT would result in greater clinical improvement and fewer necessary clinical adjustments.
The authors observed no statistically significant advantage of lithium plus OPT on CGI-BP-S scores, necessary clinical adjustments, or proportion with sustained remission. Both groups had similar outcomes across secondary clinical and functional measures. Fewer patients in the lithium-plus-OPT group received second-generation antipsychotics compared with the OPT-only group (48.3% and 62.5%, respectively).
In this pragmatic comparative effectiveness study, a moderate but tolerated dosage of lithium plus OPT conferred no symptomatic advantage when compared with OPT alone, but the lithium-plus-OPT group had less exposure to second-generation antipsychotics. Only about one-quarter of patients in both groups achieved sustained remission of symptoms. These findings highlight the persistent and chronic nature of bipolar disorder as well as the magnitude of unmet needs in its treatment.
锂盐曾是双相情感障碍治疗的主要药物，但高剂量锂盐的耐受性问题往往会限制其应用。本研究旨在探讨更为耐受的锂盐剂量在优化的个体化治疗（OPT）中的比较疗效。
研究人员将 283 例双相情感障碍门诊患者随机分为 6 个月的开放性、灵活、中等剂量锂盐联合 OPT 治疗组和 6 个月的 OPT 单独治疗组。主要观察指标为双相障碍临床总体印象严重程度量表（CGI-BP-S）和“必要的临床调整”（每月药物调整次数）。次要观察指标包括情绪症状和功能。研究人员还评估了持续缓解（定义为 CGI-BP-S 评分≤2 且持续 2 个月）和第二代抗精神病药物的治疗情况。研究人员假设锂盐联合 OPT 治疗会带来更大的临床改善和更少的必要临床调整。
研究人员未观察到锂盐联合 OPT 治疗在 CGI-BP-S 评分、必要的临床调整或持续缓解比例方面具有统计学优势。两组在次要临床和功能指标上的结果相似。与 OPT 单独治疗组相比，锂盐联合 OPT 组接受第二代抗精神病药物治疗的患者更少（分别为 48.3%和 62.5%）。
在这项实用的比较疗效研究中，与 OPT 单独治疗相比，中等但可耐受的锂盐剂量联合 OPT 治疗并未带来症状改善方面的优势，但锂盐联合 OPT 组接受第二代抗精神病药物治疗的比例较低。只有约四分之一的患者在两组中达到了症状的持续缓解。这些发现突显了双相情感障碍的持续性和慢性特征，以及其治疗中存在的大量未满足的需求。
