From the Departments of Pediatrics.
Obstetrics and Gynecology, Texas Tech University Health Sciences Center, Amarillo, TX.
J Clin Psychopharmacol. 2023;43(5):407-410. doi: 10.1097/JCP.0000000000001711. Epub 2023 May 23.
PURPOSE/BACKGROUND: Ketamine is an N -methyl- d -aspartate-antagonistic dissociative anesthetic infused intermittently for off-label management of treatment-resistant depression, acute suicidality, and postpartum depression. Despite the prevalence of postpartum depression nearing upward of 15% of deliveries, almost no research has been done to evaluate its safety during lactation.
In this study, human milk samples were released from the InfantRisk Center's Human Milk Biorepository of 4 participants treated with intermittent ketamine infusions (49-378 mg) to determine the levels of the drug and its active norketamine metabolite using liquid chromatography-mass spectrometry.
The absolute infant dose of ketamine from human milk was 0.003 to 0.017 mg/kg per day, and norketamine was 0.005 to 0.018 mg/kg per day. The relative infant dose (RID) for ketamine ranged from 0.34% to 0.57%. The RID for norketamine ranged from 0.29% to 0.95%. There were no reported infant adverse effects.
The findings of this study suggest that the transfer of ketamine, as well as its active metabolite, norketamine, into human milk is minimal, as estimated by RIDs less than 1% in all participants. These relative doses are well below standardly accepted safety thresholds.
目的/背景：氯胺酮是一种 N-甲基-D-天冬氨酸拮抗剂，作为一种非标签药物，间歇性输注氯胺酮可用于治疗难治性抑郁症、急性自杀意念和产后抑郁症。尽管产后抑郁症的患病率接近分娩的 15%，但几乎没有研究评估其在哺乳期的安全性。
在这项研究中，从婴儿风险中心的母乳生物库中释放了 4 名接受间歇性氯胺酮输注（49-378mg）的参与者的母乳样本，使用液相色谱-质谱法来确定药物及其活性去甲氯胺酮代谢物的水平。
从母乳中摄入的氯胺酮绝对婴儿剂量为 0.003 至 0.017mg/kg/天，去甲氯胺酮为 0.005 至 0.018mg/kg/天。氯胺酮的相对婴儿剂量（RID）范围为 0.34%至 0.57%。去甲氯胺酮的 RID 范围为 0.29%至 0.95%。没有报告婴儿不良反应。
本研究的结果表明，通过 RID 小于 1%，估计所有参与者的母乳中氯胺酮及其活性代谢物去甲氯胺酮的转移量极小。这些相对剂量远低于标准公认的安全阈值。
