From the Department of Psychiatry and Deaddiction, Guru Gobind Singh Medical College and Hospital, Faridkot, Punjab, India.
Department of Psychiatry and Psychology, Mayo Clinic.
J Clin Psychopharmacol. 2021;41(6):681-686. doi: 10.1097/JCP.0000000000001475.
The aim of the study was to appraise the current evidence on the optimal serum level for lamotrigine (LAM) in the treatment of mood disorders (major depressive disorder, bipolar disorder).
Major databases were searched for randomized controlled trials, open-label trials, and observational studies reporting serum LAM levels in adult patients treated with LAM for mood disorders.
A total of 814 abstracts were screened and 24 articles were selected for full-text review. Seven studies (226 bipolar disorder and 17 major depressive disorder patients) including 1 randomized controlled trial (n = 43), 3 prospective (n = 53), and 3 retrospective (n = 147) studies met the study criteria with a study duration range from 6 to 96 weeks. Lamotrigine daily dosage varied from 25 to 425 mg/d among the studies. Studies reported inconsistent findings between LAM concentration and efficacy. Three studies did not identify a relationship between LAM levels and a significant improvement in mood symptoms. Two studies (n = 99) reported higher response rates with LAM serum levels of greater than 3.25 μg/mL and 1 study (n = 25) reported a wide therapeutic window of 5 to 11 μg/mL. Overall, LAM was well tolerated with no major significant adverse effects.
Most studies showed a minimum LAM threshold level of 3 μg/mL in patients with mood disorders; however, the data are inconsistent regarding the therapeutic range for LAM. Based on the pooled data, there is inconsistent evidence to make conclusive recommendations on therapeutic LAM serum levels for mood improvement. Further studies including larger sample sizes are required to address this relevant clinical question.
本研究旨在评估拉莫三嗪（LAM）治疗心境障碍（重性抑郁障碍、双相障碍）的最佳血清水平的现有证据。
主要数据库检索了报告成人患者用 LAM 治疗心境障碍时血清 LAM 水平的随机对照试验、开放标签试验和观察性研究。
共筛选出 814 篇摘要，选取 24 篇全文进行评估。7 项研究（226 例双相障碍和 17 例重性抑郁障碍患者）符合研究标准，包括 1 项随机对照试验（n = 43）、3 项前瞻性研究（n = 53）和 3 项回顾性研究（n = 147），研究持续时间 6 至 96 周不等。研究中 LAM 的日剂量范围为 25 至 425 mg/d。各项研究报告的 LAM 浓度与疗效之间的结果不一致。3 项研究未发现 LAM 水平与情绪症状显著改善之间存在关系。2 项研究（n = 99）报道 LAM 血清水平大于 3.25μg/mL 时应答率更高，1 项研究（n = 25）报道 LAM 的治疗窗较宽，为 5 至 11μg/mL。总体而言，LAM 具有良好的耐受性，无重大不良反应。
大多数研究表明，心境障碍患者的最低 LAM 阈值水平为 3μg/mL；然而，关于 LAM 的治疗范围，数据并不一致。基于汇总数据，关于改善情绪的 LAM 治疗血清水平，目前尚无确凿的证据支持做出明确的推荐。需要进一步开展包括更大样本量的研究来解决这一临床相关问题。
