Rainka Michelle, Aladeen Traci, Westphal Erica, Meaney Jacqueline, Gengo Fran, Greger Jessica, Capote Horacio
J Psychiatr Pract. 2019 Jul;25(4):258-267. doi: 10.1097/PRA.0000000000000400.
Previous studies have shown l-methylfolate to be a safe and beneficial therapy for neuropsychiatric conditions, including major depressive disorder and schizophrenia in adults. The purpose of this study was to assess safety and describe patient experience using l-methylfolate calcium in a real-world pediatric and adolescent population. A retrospective chart review of patients (7 to 20 y of age, mean age 16 y) prescribed l-methylfolate calcium at a psychiatry clinic in Amherst, NY, between January 1, 2010 and November 10, 2015 was conducted. Patients to whom l-methylfolate calcium 15 mg/d (n=139) or 7.5 mg/d (n=7) was administered were identified; 44 patients who were prescribed but to whom l-methylfolate calcium was not administered were included as a comparator population. Common neuropsychiatric diagnoses included anxiety disorders (68% in the treatment population vs. 50% in the comparator population) and mood disorders (57% in the treatment population vs. 52% in the comparator population). Antidepressants (69% vs. 55%) and mood stabilizers or antiepileptic drugs (63% vs. 57%) were frequently prescribed in combination with l-methylfolate calcium. Adverse events occurred less frequently in the treated population, possibly due to the addition of l-methylfolate calcium (10% vs. 25%, P=0.02). The most common adverse events in the treated population were impaired sleep (5 patients) and increased anxiety (3 patients). Rates of laboratory abnormalities did not differ significantly between the treated and comparator populations (P=0.13). Positive subjective treatment experiences were reported by 22.5% of treated patients and negative subjective treatment experiences were reported by 5.4% of treated patients. L-methylfolate calcium was well-tolerated in a pediatric/adolescent population and may provide benefits for patients with a range of neuropsychiatric conditions.
既往研究表明，L-甲基叶酸对神经精神疾病是一种安全且有益的治疗方法，包括对成人的重度抑郁症和精神分裂症。本研究的目的是评估L-甲基叶酸钙在真实世界儿科和青少年人群中的安全性，并描述患者的使用体验。对2010年1月1日至2015年11月10日期间在纽约州阿默斯特一家精神病诊所开具L-甲基叶酸钙处方的患者（年龄7至20岁，平均年龄16岁）进行了回顾性病历审查。确定了接受15mg/d（n=139）或7.5mg/d（n=7）L-甲基叶酸钙治疗的患者；44名开具了L-甲基叶酸钙处方但未接受治疗的患者被纳入作为对照人群。常见的神经精神诊断包括焦虑症（治疗人群中为68%，对照人群中为50%）和情绪障碍（治疗人群中为57%，对照人群中为52%）。抗抑郁药（69%对55%）和心境稳定剂或抗癫痫药物（63%对57%）经常与L-甲基叶酸钙联合使用。不良事件在治疗人群中发生频率较低，可能是由于添加了L-甲基叶酸钙（10%对25%，P=0.02）。治疗人群中最常见的不良事件是睡眠障碍（5例患者）和焦虑增加（3例患者）。治疗人群和对照人群之间实验室异常率无显著差异（P=0.13）。22.5%的治疗患者报告了积极的主观治疗体验，5.4%的治疗患者报告了消极的主观治疗体验。L-甲基叶酸钙在儿科/青少年人群中耐受性良好，可能对一系列神经精神疾病患者有益。
