Kamhi-Nesher Shiri, Taub Sharon, Halimi Shikma, Frenkel Maria, Azam Mahmud, Bormant Gil, Isakov Helena, Radzinsky Dikla, Weizman Abraham, Krivoy Amir
Geha Mental Health Center, 1 Helsinki street, P.O. Box 102, Petah-Tikva 49100, Israel.
Geha Mental Health Center, Petah-Tikva, Israel.
Ther Adv Psychopharmacol. 2022 Jun 14;12:20451253221094435. doi: 10.1177/20451253221094435. eCollection 2022.
Therapeutic drug monitoring (TDM) is useful to assess clozapine adherence and optimize treatment. However, analysis of venous blood levels by liquid chromatography tandem mass spectrometry (LC-MS/MS) is often logistically complicated and process time is prolonged.
To assess the feasibility and reliability of a new point-of-care device, (MyCare™ Insite), using capillary blood for clozapine therapeutic monitoring.
Matched venous and capillary blood samples were collected from patients treated with clozapine on a stable dose. Samples were analyzed by LC-MS/MS and MyCare Insite Clozapine Test. Clozapine plasma levels were compared between methods using linear regression model. Both patients and treatment team completed questionnaires about the feasibility of blood sampling.
Of the total sample (44 patients, 61% males, mean age 43 ± 12 years), mean daily clozapine dose was 293 ± 134 mg/day. Linear regression model demonstrated high correlation with = 0.83 ( < 0.0001) and mean difference of 26 ± 162 ng/ml. More than 60% of the patients found the clozapine TDM to be important. Most of the participants (58%) favored the capillary sampling and 11% claimed that testing method would affect their adherence to TDM. Moreover, a larger portion (72%) strongly preferred to be tested at the office rather than at the lab.
The point-of-care device offers an accessible and satisfactory measurement of clozapine blood levels. Both patients and healthcare providers reported preference for capillary sampling as well as for the in-office TDM procedure. The immediate results provided by the device can facilitate rapid and informed clinical decisions and therefore improve clozapine treatment outcomes.
治疗药物监测（TDM）有助于评估氯氮平的依从性并优化治疗。然而，通过液相色谱串联质谱法（LC-MS/MS）分析静脉血水平在后勤方面通常很复杂，且处理时间较长。
评估一种新型即时检测设备（MyCare™ Insite）使用毛细血管血进行氯氮平治疗监测的可行性和可靠性。
从接受稳定剂量氯氮平治疗的患者中采集配对的静脉血和毛细血管血样本。样本通过LC-MS/MS和MyCare Insite氯氮平检测进行分析。使用线性回归模型比较两种方法之间的氯氮平血浆水平。患者和治疗团队均完成了关于采血可行性的问卷调查。
在总样本（44例患者，61%为男性，平均年龄43±12岁）中，氯氮平平均日剂量为293±134毫克/天。线性回归模型显示高度相关性，r = 0.83（P < 0.0001），平均差异为26±162纳克/毫升。超过60%的患者认为氯氮平TDM很重要。大多数参与者（58%）倾向于毛细血管采样，11%声称检测方法会影响他们对TDM的依从性。此外，更大比例（72%）的人强烈倾向于在办公室而不是实验室进行检测。
即时检测设备提供了一种可获取且令人满意的氯氮平血药浓度测量方法。患者和医疗服务提供者均表示倾向于毛细血管采样以及办公室内的TDM程序。该设备提供的即时结果有助于快速做出明智的临床决策，从而改善氯氮平的治疗效果。
