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干血斑样本可支持炎症性肠病患者英夫利昔单抗浓度监测:一项临床验证。

Dried blood samples can support monitoring of infliximab concentrations in patients with inflammatory bowel disease: A clinical validation.

机构信息

Department Hospital Pharmacy, Amsterdam University Medical Centres, Amsterdam, The Netherlands.

Department of Gastroenterology and Hepatology, Amsterdam University Medical Centres, Amsterdam, The Netherlands.

出版信息

Br J Clin Pharmacol. 2019 Jul;85(7):1544-1551. doi: 10.1111/bcp.13939. Epub 2019 May 11.

DOI:10.1111/bcp.13939
PMID:30927375
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6595298/
Abstract

AIMS

Therapeutic drug monitoring (TDM) can optimize the efficacy of infliximab (IFX) in patients with inflammatory bowel disease (IBD). Because of the delay between blood samples taken at trough and availability of results, dose adjustments can only be carried out at the next infusion, typically 8 weeks later. Dried blood samples (DBS) performed at home to measure IFX concentrations can reduce the time to adapt dose/dosing interval. Here, we aimed to validate the clinical application of DBS for IFX in IBD patients and to evaluate the feasibility of home sampling.

METHODS

DBS results from 40 IBD patients on IFX treatment were compared to serum sample results at trough, peak, and 3-5 weeks after IFX infusion. Subsequently, patients performed DBS home sampling one week before the next IFX infusion. These were compared to serum concentrations as predicted by Bayesian analysis.

RESULTS

IFX concentrations from finger prick and venous puncture correlate well. DBS IFX concentrations showed high correlation with serum IFX concentrations (Spearman correlation: ≥0.965), without bias. Passing-Bablok regression for IFX concentrations in DBS from home sampling also showed no bias (intercept: 1.02 mg L (95% CI -1.77-2.04 mg L ), slope: 0.82 (95% CI 0.63-1.40)), with reasonable correlation (Spearman correlation: 0.671).

CONCLUSIONS

Timely adjustment of IFX dose/dosing interval can be facilitated by IFX concentration measurement in home-sampled DBS. DBS is a reliable method to measure IFX and can be used to predict IFX trough concentrations.

摘要

目的

治疗药物监测(TDM)可以优化英夫利昔单抗(IFX)在炎症性肠病(IBD)患者中的疗效。由于在抽取谷值血样与获得结果之间存在时间延迟,只能在下一次输注时(通常是 8 周后)调整剂量。在家中进行的干血斑(DBS)采样可用于测量 IFX 浓度,从而缩短调整剂量/给药间隔的时间。在此,我们旨在验证 DBS 在 IBD 患者中用于 IFX 的临床应用,并评估家庭采样的可行性。

方法

将 40 例接受 IFX 治疗的 IBD 患者的 DBS 结果与 IFX 输注后谷值、峰值和 3-5 周时的血清样本结果进行比较。随后,患者在下次 IFX 输注前一周在家中进行 DBS 采样。将这些结果与贝叶斯分析预测的血清浓度进行比较。

结果

手指穿刺和静脉穿刺的 IFX 浓度相关性良好。DBS IFX 浓度与血清 IFX 浓度高度相关(Spearman 相关系数:≥0.965),无偏差。来自家庭采样的 DBS 中 IFX 浓度的 Passing-Bablok 回归也没有偏差(截距:1.02mg/L(95%CI-1.77-2.04mg/L),斜率:0.82(95%CI0.63-1.40)),具有合理的相关性(Spearman 相关系数:0.671)。

结论

通过在家中采集的 DBS 中测量 IFX 浓度,可以促进 IFX 剂量/给药间隔的及时调整。DBS 是一种可靠的测量 IFX 的方法,可用于预测 IFX 谷值浓度。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3412/6595298/3b8dbe352249/BCP-85-1544-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3412/6595298/b20bc6ce03bf/BCP-85-1544-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3412/6595298/a4dbe958c8d1/BCP-85-1544-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3412/6595298/3b8dbe352249/BCP-85-1544-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3412/6595298/b20bc6ce03bf/BCP-85-1544-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3412/6595298/a4dbe958c8d1/BCP-85-1544-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3412/6595298/3b8dbe352249/BCP-85-1544-g003.jpg

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