Szarmach Joanna, Cubała Wiesław Jerzy, Włodarczyk Adam, Gałuszko-Węgielnik Maria
Department of Psychiatry, Faculty of Medicine, Medical University of Gdansk, 7 Dębinki St. Build. 25, 80-952 Gdansk, Poland.
Medicina (Kaunas). 2021 Mar 16;57(3):274. doi: 10.3390/medicina57030274.
There is evidence for ketamine efficacy in treatment-resistant depression (TRD). Several safety and tolerability concerns arise that some psychotropic agents may provide blood pressure or/and heart rate alterations. The aim of this study is to review blood pressure measurements in course of the treatment with ketamine on treatment refractory inpatients with somatic comorbidities in the course of MDD and BP. The study population of 49 patients comprised MDD and BP subjects treated with ketamine registered in the naturalistic observational protocol of treatment-resistant mood disorders (NCT04226963). The conducted analysis showed that among people suffering from hypertension there is a higher increase in systolic blood pressure (RR) after infusion 2 ( = 0.004) than among people who do not suffer from hypertension. Patients with hypertension have a higher increase in diastolic RR compared to those not suffering from hypertension ( = 0,038). Among the subjects with diabetes mellitus, significant differences occurred for infusions 2 ( = 0.020), 7 ( = 0.020), and 8 ( = 0.035) for heart rate (HR), compared to subjects without diabetes mellitus. A higher increase in diastolic RR was noted in the group of subjects suffering from diabetes mellitus ( = 0.010) compared to those who did not. In the hyperlipidemic patients studied, a significantly greater decrease in HR after infusion 5 ( = 0.031) and systolic RR after infusion 4 ( = 0.036) was noted compared to nonpatients. People after a stroke had significantly higher increases in diastolic RR after infusions 4 ( = 0.021) and 6 ( = 0.001) than those who did not have a stroke. Patients suffering from epilepsy had a significantly greater decrease in systolic RR after the 8th infusion ( = 0.017) compared to those without epilepsy. The study may be underpowered due to the small sample size. The observations apply to inhomogeneous TRD population in a single-site with no blinding and are limited to the acute administration. This study supports evidence for good safety and tolerability profile for short-term IV ketamine use in TRD treatment. However, risk mitigation measures are to be considered in patients with metabolic and cardiovascular comorbidities.
有证据表明氯胺酮对难治性抑郁症（TRD）有效。人们担心一些精神药物可能会导致血压或/和心率改变，从而引发了一些关于安全性和耐受性的问题。本研究的目的是回顾氯胺酮治疗伴有躯体合并症的难治性重度抑郁症（MDD）和双相情感障碍（BP）住院患者过程中的血压测量情况。该研究纳入了49例患者，他们均为在难治性情绪障碍自然观察治疗方案（NCT04226963）中登记接受氯胺酮治疗的MDD和BP患者。所进行的分析表明，与无高血压的患者相比，高血压患者在第2次输注后收缩压升高幅度更大（RR，P = 0.004）。高血压患者的舒张压RR升高幅度高于无高血压患者（P = 0.038）。与无糖尿病的患者相比，糖尿病患者在第2次（P = 0.020）、第7次（P = 0.020）和第8次（P = 0.035）输注时心率（HR）有显著差异。与未患糖尿病的患者相比，糖尿病患者组的舒张压RR升高幅度更高（P = 0.010）。在接受研究的高脂血症患者中，与非患者相比，第5次输注后心率显著下降（P = 0.031），第4次输注后收缩压RR显著下降（P = 0.036）。中风患者在第4次（P = 0.021）和第6次（P = 0.001）输注后舒张压RR升高幅度显著高于未中风患者。与无癫痫的患者相比，癫痫患者在第8次输注后收缩压RR显著下降（P = 0.017）。由于样本量较小，该研究可能效能不足。这些观察结果适用于单中心、非盲法、异质性的TRD患者群体，且仅限于急性给药情况。本研究支持了短期静脉注射氯胺酮治疗TRD具有良好安全性和耐受性的证据。然而，对于患有代谢和心血管合并症的患者，应考虑采取风险缓解措施。
