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监测 TNF-α 抑制剂对不同疾病的实验室参数和不良反应的影响:一项回顾性、单中心研究。

Monitoring the effect of TNF-alpha inhibitors on laboratory parameters and adverse effects in different diseases: a retrospective, single-center study.

机构信息

From the Department of Dermatology, College of Medicine, King Saud University, Riyadh, Saudi Arabia.

From the College of Medicine, King Saud University, Riyadh, Saudi Arabia.

出版信息

Ann Saudi Med. 2022 Sep-Oct;42(5):309-318. doi: 10.5144/0256-4947.2022.309. Epub 2022 Oct 6.

Abstract

BACKGROUND

The introduction of biological treatments has revolutionized the management of moderate-to-severe psoriasis. Multiple clinical trials have established the efficacy of biological agents in the treatment of moderate-to-severe psoriasis. Nevertheless, there are no clear indications for optimal monitoring intervals during treatment.

OBJECTIVES

Collect and analyze laboratory evaluation data from patients receiving biological therapy to provide a better understanding of the need for laboratory investigations before and during treatment with biological agents, and to analyze adverse events and other factors.

DESIGN

Retrospective cohort SETTINGS: Tertiary care center in Riyadh, Saudi Arabia.

PATIENTS AND METHODS

Data were collected from the electronic medical records of patients attending the dermatology, rheumatology, and gastroenterology clinics from June 2014 to June 2019. The laboratory parameters of patients who have received one of the TNF-alpha inhibitors (adalimumab, etanercept, or infliximab) were collected starting at baseline and up to at least one year from treatment initiation.

MAIN OUTCOME MEASURES

The time points at which patients developed significantly abnormal laboratory results during treatment with one of the TNF-alpha inhibitors.

SAMPLE SIZE

250 patients RESULTS: Most patients were treated with adalimumab (38.4%); a similar proportion (38%) with infliximab, whereas only 23.6% were treated with etanercept. The majority of the significant abnormal laboratory results occurred at baseline, 3-6 and 9-12 months. Most abnormalities were among patients using infliximab, followed by etanercept, and then adalimumab. The median number of laboratory abnormalities for dermatology patients was significantly lower than that for gastroenterology patients (<.001), and for rheumatology patients (=.002).

CONCLUSIONS

Because dermatology patients showed a lower median number of laboratory abnormalities than patients treated by other specialties in our study, we believe that dermatology patients require less frequent laboratory monitoring. Therefore, we recommend laboratory evaluation at baseline, after 3-6 months, 1 year from the beginning of treatment, and annually thereafter for patients using TNF-alpha inhibitor agents. However, more frequent testing might be warranted according to patient comorbidities, concomitant medications, and physician judgment.

LIMITATIONS

Single center and retrospective design.

CONFLICT OF INTEREST

None.

摘要

背景

生物制剂的引入彻底改变了中重度银屑病的治疗模式。多项临床试验已经证实生物制剂在中重度银屑病治疗中的疗效。然而,目前仍缺乏治疗过程中最佳监测间隔的明确指征。

目的

收集并分析接受生物治疗的患者的实验室评估数据,以更好地了解在开始接受生物制剂治疗前和治疗期间进行实验室检查的必要性,并分析不良事件和其他因素。

设计

回顾性队列研究

设置

沙特阿拉伯利雅得的三级保健中心。

患者和方法

数据来自 2014 年 6 月至 2019 年 6 月期间皮肤科、风湿病科和胃肠病科就诊患者的电子病历。从基线开始收集并记录每位接受 TNF-α 抑制剂(阿达木单抗、依那西普或英夫利昔单抗)治疗的患者的实验室参数,直至治疗开始至少 1 年。

主要观察指标

患者在接受 TNF-α 抑制剂治疗期间实验室结果显著异常的时间点。

样本量

250 例患者

结果

大多数患者接受阿达木单抗治疗(38.4%),接受英夫利昔单抗治疗的患者比例相似(38%),而接受依那西普治疗的患者仅占 23.6%。大多数显著的实验室异常结果发生在基线时、3-6 个月和 9-12 个月。大多数异常发生在使用英夫利昔单抗的患者中,其次是依那西普,然后是阿达木单抗。皮肤科患者的实验室异常中位数明显低于胃肠病患者(<.001),也低于风湿病患者(=.002)。

结论

由于本研究中皮肤科患者的实验室异常中位数低于其他专科治疗的患者,我们认为皮肤科患者需要较少的实验室监测。因此,我们建议在基线、治疗开始后 3-6 个月、1 年以及此后每年进行实验室评估,用于接受 TNF-α 抑制剂治疗的患者。然而,根据患者的合并症、伴随用药和医生的判断,可能需要更频繁的检测。

局限性

单中心、回顾性设计。

利益冲突

无。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9ca6/9557780/e575149a3469/0256-4947.2022.309-fig01.jpg

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